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Medical Devices Data Bank User Manual DM Manufacturer Profile

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1. SEA Detail Fields Field Name Description Tipo Dispositivo Medico Type of DM There are three types Device System Kit Nome commerciale e Commercial name or model of the DM modello Codice attribuito dal Code attributed to the DM by the manufacturing fabbricante identicativo company better known as the identification catalogo da a catalogue Fabbricante Corporate name of the DM Manufacturing Company Progressivo di sistema Unique identification number assigned to each DM attributo al DM in the database If R appears next to the consecutive number assigned to the DM by the system it means that the DM has been registered on the index Data fine immissione in Off market date of DM commercio Operations available Action Description Page name Salva Saves the information inserted Pagina Lista DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 17 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 1 4 DM Approval page This page allows the user to view the DM which have begun the process of data approval from the DMs selected The approval activates a series of congruity and consistency tests on the released data and any errors discovered are noted on the activity list page If no errors are found the status of the DM changes to Consolidato and it is therefore possible to activate the validation of the device by means o
2. Stato di Porte utilizzata det tessuti Faminhe di sppartonenza provenienza Sostanza l medicinali fosclusi derivan da sengue o plasmo umano medicinale paia da sangue medicinale patanen de plasma Denominazione Principio attive Perl dbpnrtiv medici contenenti medicinali celezionere d prnepio attivo Vi matoriali prevalenti costituenti i f confezionamento primario del DM necossitano di in zj f condizioni speciali di smaltimento f f Per i soli DI sterili f n da sterilizzare Ri f Indicare t materiali prevalenti del confezionamento Modalit di pulizia disinfezione f TRUR Descrizione altro Metodi di risterilizzazione ili PAR i metodo di i steniizzazioni seeritizzaziont SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 35 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Field Name Description General technical characteristics Descrizione Description of the general technical characteristics of the DM Destinazione d uso ai sensi del Intended use In accordance with the D Lgs 46 97 D Lgs 46 97 Misura ove Indication of the measurable criteria actually used and present in applicabile commercial catalogues with the corresponding unit of measurement of the DM Sterilisation data Sterile Indication of whether or not the DM is ste
3. 139 2 4 1 5 UtenteDatiFabbricanteModifica 142 2 4 1 6 UtenteDatiFabbricanteVisualizza 0 144 SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 3 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 1 Introduction This document contains the user manual of the Banca Dati Dispositivi Medici system functions The Banca Dati Dispositivi Medici System provides features used to record the Class I a b and III Medical Devices available on the national market purchasable by the NHS as well as the information regarding the Marketing of the Devices The moment in which the objects have been registered as available for purchase or that is when the relative data to enable the payment transaction the devices result as registered on the index The System was realised in accordance and complying with the following regulations e Directive 93 42 EEC e Legislative decree 24 February 1997 no 46 modified and integrated by the legislative decree of February 25 1998 no 95 and September 8 200 No 332 implemented regulation in Italy from the EEC directive e Article 57 of the 27 December 2002 law No 289 financial law 2003 For the purpose of using the functionality of the IDM index of medical devices System Four types of users were defined and given access to the system 1 FABBRICANTEDM 2 UFFICIDGFDM
4. SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 138 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Nome File The name of the file attached by the user containing the DM data Data invio Date in which the user uploaded the file Codice attribuito dal Code attributed to the DM by the Manufacturer Fabbricante Fabbricante Business name of the DM Manufacturing company Tipo operazione Description of the type of operation carried out Operations available Action Description Page name Indietro Allows the user to return to the error list UploadListaErrori 2 3 4 7 AreaDownloadAnagrafiche This page allows the Fab Man RIC ASD user to download clicking on the corresponding link the following Database CND Classification Database Methods of sterilisation Database Material that make up the DM Database Elements in the case of metal Database Material that make up the packaging Database Active ingredients Database Animal families Database Tissues of animal origin biological substances Database Nations Database SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 139 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Area Download Anagrafiche Area Download Anagrafiche Da tale area possibile
5. The list contains the types of assembled devices They vary based on the choice made in the corresponding Tipo field Therefore distinct types of system and kits exist Assembled Components List Data Field Field Name Description Descrizione Nome commerciale e modello Brief description of the component of the assembled device Commercial name given to the component SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 102 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Codice attribuito dall Indication of product code assigned to component assemblatore identificativo catalogo Fabbricante Titolare Indication of the Manufacturer title holder of the component Tipo prodotto Type of component The component of an assembled device can be Stato nella base dati e Classified Medical Device DM e Medical and surgical aids PMC e Medicines SPM e Other ALT This field is only given value if the component is a DM Indicates the status of the DM in the database The status can be changed in the following order e L Processing e V Valid e P Published Operations available Action Description Page name Aggiungi Grants access to the search page of the RicercaComponenti components in order to add one to a system or kit Cancella Allows user to delete the association Same between
6. Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile The default setting displays Italia Operations available Action Description Page name Ricerca Runs a search with criteria entered allowing the UtentiDatiFabbricante existence of the manufacturer with whom the user Inserimento wishes to be linked to be verified 2 4 1 4 UtenteDatiFabbricanteInserimento This page allows the user to link a new manufacturer to himself If the manufacturer after having carried out the search see previous paragraph is present in the database the information on the Manufacturer resulting from the search will be displayed in the Dati Fabbricante box Then clicking on the Salva button the link between the user and the manufacturer is created SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 160 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dati Azienda gt Gestione Dati Azienda gt Dichiarazione altri fabbricanti Inserimento Altro Fabbricante Ricerca per Inserimento Fabbricante A Codice Fiscale Corea Partita IVA VAT number rr Nazione A _Ricerca Correlazione dell Utente con il Fabbricante gi esistente Dati falce EEEE eee Fabbricante e ER Codice Fiscale 42444412344442 Partita IVA VAT number 12211122222 Nazione ITALIA Comune PROS
7. 124 SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 2 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 4 1 Upload DepOsitivied x cscs hs rnrn alari 124 2 3 4 2 ConfermaUploadDepositivi cece cece ence ence eenens 125 2 3 4 3 UploadFormaRicetta cariinion aaa 126 2 3 4 4 Wploadeis aie wavs dectawagedewnr seandadenyaeetaeseeagueeneees 126 2 3 4 5 WploadhistaBrror s ices ss visducecestagiswaw snes abyesdsasetensnesss 127 2 3 4 6 WploadListaSIntesi cisiiriz ini errante aan 129 2 3 4 7 AreaDownloadAnagrafiche eee e eee eeeeaes 130 2 3 5 Menu Option Certificati CE sascbceriiereeokeren eid series 140 2 3 5 1 Pagina Ricerca Certificati iii 140 DIS Pagina Lista Certificati 141 2 3 5 3 Pagina Inserimento Certificati 2 0 0 0 00 c cece ereere eere 144 2 3 5 4 Pagina Dettaglio Certificato eeeeeseeeeeeeerennerrerreeeee ee 146 2 3 5 5 Pagina Modifica Certificato ence eee enee 147 2 3 5 6 Pagina Dettaglio Proroga LL 149 24 DETAILED DESCRIPTION OF FUNCTIONAL AREA DATI AZIENDA rata 130 2 4 1 Menu Option Gestione Dati azienda iii 131 2 4 1 1 DatiAnagraficiUtente crea 132 2 4 1 2 CorrelazioneUtenteFabbricanteLista 136 2 4 1 3 FormaRicercaFabbricante eens 138 2 4 1 4 UtenteDatiFabbricanteInserimento
8. Destinazione d uso ai sensi Intended use In accordance with the D Lgs 46 97 delD Lgs 46 97 Misura ove Indication of the measurable criteria actually used and present in applicabile commercial catalogues with the corresponding unit of measurement of Sterilisation data the DM Sterile Indication of whether or not the DM is sterile Metodo di Method used to sterilise the DM sterilizzazione This field is required if the Sterile field is marked Si Specify if another Description of the sterilisation method if it is not already present on the Metodo di loaded list previously sterilizzazione is used This field is required if the Metodo di sterilizzazione field is marked Altro Metodo di sterilizzazione validato secondo The method of sterilisation can be validated according to the harmonised norms other This field is required if the Sterile field is marked Si Periodo massimo di utilizzo Maximum length of use of the DM This field is required if the Sterile field is marked Si Material contained in the DM that comes in direct contact with the Patient Latex free Indication as to whether or not the DM contains latex Fila da allegare File containing the Latex free certification E mail Sito web Indication of email or web site where the Latex free certificate can be requested Data of biological tissue or
9. Cerca Pagina i dii Seleziona Per effettuare una delle operazione possibili cliccare su uno dei cerchietti in corrispondenza di uno dei componenti della lista La voce ALTRO in corrispondenza del campo Tipo Prodotto riferita ad articoli non DM diversi da Presidi Medici Chirurgici o Specialit Medicinali Ltnserisci Chiudi omne Vieualizzs SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 122 166 Ministry for Health User Manual DM Manufacturer Profile Design and Development NSIS Detail Fields Field Name Description Tipo prodotto The product type has already been inserted as a non DM product type Altro Nome Option to specify the commercial name or beginning of the commerciale e modello product Codice attribuito dall assemblatore identificativo catalogo The product code assigned to the product can be specified Fabbricante Manufacturer Option to specify the name or the beginning of the Operations available Action Description Page name Ricerca Runs a search with criteria entered and displays the Same list of products that match that criteria Chiudi Closes the non DM product management window ListaAssemblati Inserimento Displays the insertion page of a non DM product LookUpArtDatiGen type Altro Modifica Displays the data page of the non DM product
10. f JOHNSON amp JOHNSON ICODICES NOME PROVA H50 non L r im Pagina i di 1 Tale funzionalit consente di collegare dispositivi medici tra di loro E possibile selezionare i OM necessari tra quelli che sono stati preventivamente inseriti se i OM si riferiscono ad altri fabbricanti mandatarifresp imm in comm sono selezionabili indipendentemente dal loro stato nel repertorio Per ciascuno dei dispositivi necessari viene richiesto di indicare se l unico utilizzabile uso esclusivo o meno uso non esclusivo per un determinato scopo Seleziona Cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista a seconda delle operazioni Inserisci Modifica Cancella DM required Detail Fields Field Name Description Fabbricante Manufacturer of the DM required Codice attribuito dal fabbricante identicativo catalogo Nome commerciale e The commercial name of the DM required modello Uso esclusivo Uso non Indicates if the DM to be linked has an exclusive esclusivo use regarding the Father DM Motivo dell esclusivit The code attributed by the manufacturer to the DM required Reason for its exclusiveness Stato nella base dati e P Published Operations available Status of he DM in the database This status can change in the following order e L in progress e V Valid SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 do
11. Ruolo dell utente rispetto all Assemblato Tipo Assemblato aj Ricerca Nuova ricerca Progressivo di Codice attribuito NONE Ta Cesione sistema Assemblatore dall assemblatore commerciale Tipo Stato del nel Seleziona attribuito identificativo S madaig Assemblato Dispositivo Fansrtonia all assemblato catalogo P SISTEMA DI SISTEMI PER 463 BAYER 45501 PROVA RADIOLOGIA L N mM NOME SISTEMI PER poe ema MEBDE COMMERCIALE ODONTOIATRIA G K m Pagina 1i di 1 Stato del Dispositivo L IN LAVORAZIONE C CONSOLIDATO V VALIDATO P PUBBLICATO Seleziona Cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista a seconda delle operazioni Inserisci Modifica Cancella Fine Immissione in Commercio Validazione Consolida Dettaglio Gestione Prodotti Search Detail Fields Field Name Description Progressivo di sistema attribuito Option to serch an Assembled device by its identification number assigned by the system during registration into the all assemblato database Assemblatore Option to specify the name or the beginning of the Assembler Tipo Type of Assembled device The user has the option to choose between two types e System e Kit Codice attribuito dall assemblatore Range of codes which includes the product code assigned to the assembled system or kit by the assembler identificativo catalogo da a Nome Option to specify t
12. 3 REGIONEDM 4 AZIENDESANITARIEDM The FABBRICANTEDM users can register DM data activate the publication process while awaiting the validation of the DM and register it on the index The UFFICIDGFDM users can consult valid DM data along with its publications or request the correction of the same The REGIONEDM and AZIENDESANITARIEDM users can look at Medical Devices data after the pubblication process and registration into the index SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 4 166 Ministry for Health User Manual DM Manufacturer Profile 1 1 Definitions and Glossary 1 1 1 Glossary of terms Terms Definitions Consolidame This operation checks registered data regarding a DM or an assembled nto device Validazione A key action in which the user who has registered the DM data signs for the data inserted into the system and makes them visible to the Ministry for Health Pubblicazione The publication of data is the way in which the Ministry makes DMs previously passed over from the Manufacturer available for a subsequent publication on the data portal Mandatario Individual or legal entity within the European Union territory who after being expressively assigned by the manufacturer acts on behalf of the Manufacturer and can thus be consulted by the national authority concerned and by Community bodies in place of the Manufacturer
13. DISPOSITIVI MEDICI DI CLASSE LII1A B 11I L arsa Gestione Dispostbvi Medici di Classe I IIa b I qualla che consente ai Fabbricant Mandatan Responsabili Immissione in Commercio Altro soggett delegato al Fabbricante di costituire e gestire il Repertori o dei Dispositivi Medici commercializzati sul territorio nazionale In quest arco Fabbricanti Mandatari Res ponsabili Immissione in Commercia Altro soggette delegato dal Fabbricante di Dispositivi Medici possono insenre modificere e cancellare i propri Dispositivi Le informazioni sul Dispositivo derono une volta consolidate passare dalla fase di Validazione nelle quale previst l apposizione della propria Firma Di gitale La notifica di Validazione di un sitive da parte dei Fabbricanti consente all ufficio preposto della Direzione Generale Farmaci e Dispositivi Medici di effettuar un controlla di merito su quant erito dai Fabbricanti e consentirne o meno la pubblicazione sul Repertorio dei Dispositivi Medici risultanza del controll etfattuato dall Ufficio sara notificato in un apposita sezione dell applicazione al Fabbricante Mandatario Responsabile Immissiona in Commercio Altro soggett delegato dal Fabbricante del Dispositivo I FabbricantMandatarifResponsabili Immissione in CommerciorAltro soggetto delegato dal Fabbricante possano iscrivere nel repertorio un dispositivo fornend gli estremi del versamento effettuato secondo quanto previsto dall articolo 1 comma 409 lettera
14. Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Dispositivo Medico DM Dispositivo Medico DM Criteri di Ricerca Progressivo di sistema attribuito al DM Fabbricante Tipo DM DISPOSITIVO J Codice attribuito dal fabbricante identificativo da fiassse o catalogo a 123456 Nome commerciale e modello Classificazione CND 7j Cerca Stato del DM zj Ruolo dell utente rispetto al DM a Ricerca Nuova ricerca a Codice Progressivo sane di sistema Fabbricante prin anei e Classificazione Stato del Seleziona attribuito al identificati I CND Dispositivo DM identificativo modello catalogo Y031299 AUSILI PER LA TERAPIA DISPOSITIVO DELL ERNIA 10003 BAYER 123456 MEDICO AUSILI L 5 ADDOMINALI ALTRI Pagina 1 di 1 Stato del Dispositivo L IN LAVORAZIONE C CONSOLIDATO Y VALIDATO P PUBBLICATO Seleziona Cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista a seconda delle operazioni Inserisci copia Modifica Cancella Dettaglio Aggiornamento Dat Commerciali Iscrizione Repertorio Consolida Yalida Fine Immissione in Commercio DM Search Detail Fields Field Name Description Progressivo di Option to serch a Medical Device by its identification number assigned sistema attrib
15. This page allows the user to insert edit visualise the information regarding the Non CE marked DM or other non DM products type Altro SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 66 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Inserimento Prodotto Tipo Prodotto DM NON MARCATO CE Nome commerciale e modello Codice attribuito dal fabbricante identificativo Po catalogo Fabbricante BAVER Cerca Classificazione CND oOo g n J Cerca La voce ALTRO in corrispondenza del campo Tipo Prodotto riferita ad articoli non DM diversi da Presidi Medici Chirurgici o Specialit Medicinali Salva Chiudi ___ tista Prodotti ___ Detail Fields Field Name Description Tipo prodotto The user can choose between the following types of product e Non CE marked DM e Other Nome commerciale e The commercial name of the product as given by the modello Manufacturer Codice attribuito dal The specific code attributed to the DM by the fabbricante identicativo manufacturer catalogo Fabbricante Indicates the manufacturer of the product For Non CE marked Medical Devices only this field cannot be edited In this case it is set by default to the manufacturer name indicated by the user in the Gestione Dati Azienda feature To select a different manufacturer click on Cerca a look up window will appear from whic
16. Titolare The Title holder referring exclusively to Medicinal products Numero pezzi Indication of pieces which the system or kit requires referring to the components This field can be edited Operations available Action Description Page name Ricerca Runs a search with criteria put in place and Same displays the DM list or list of Non DM products that match the same criteria Reset Clears the search criteria previously put in place Same Product Opens a window where the user has the option to LookUpRicercaPro management manage Non DM articles i e the Altro and Non dotti CE marked kind Aggiungi Adds the component s selected to the system or ListaElementiCorre Componente kit lati Page Name LookUpRicercaProdotti This page is displayed in look up format and can be activated in the system and kit components function area Para 3 Art 12 It allows the user to enter search criteria in order to view the non stamped DM list or other non DM products type altro SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 64 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Ricerca Lista Prodotti Tipo Prodotto DM NON MARCATO CE Nome commerciale e modello Codice attribuito dal fabbricante identificativo oa ii catalogo Fabbricante Classificazione CND fo Cerca Cerca Lista Prodotti
17. User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Sistemi o Kit Assemblati c 2 Art 12 Sistemi o Kit Assemblati c 2 Art 12 Progressivo di sistema attribuito all Assemblato Lista degli Assemblati in fase di consolidamento Codice attribuito i Assemblatore dall assemblatore identificativo catalogo EB NEURO SPA 3454557 Avviato ELETTRONICA BIO MEDICALE SRL 23432 n cl Avviato Per verificare l esito del Consolidamento utilizzare il pulsante Vai alla lista attivit Vai alla Lista attivit Assembled Devices in the approval phase List Data Fields Field Name Description Progressivo attribuito Product code assigned to each assembled device all Assemblato Assemblatore Name of the assembler Codice attribuito dall Indication of product code assigned to the system or kit by the assemblatore Assembler identificativo catalogo Stato processo validazione The status of the process It can change status in the following order e Initiated e Not Initiated Operations available Action Description Page Name Lista attivita Vai alla Allows user to return to the activity list listaAttivita 2 3 2 12 Assembled Device Signature Page This page allows user who has inserted the specific assembled device to digitally sign in order to validate that
18. functional area the features available are displayed on the left hand menu Dati Azienda Y Gestione Dati Azienda Dati Generali Dichiarante Dichiarazione altri fabbricanti This area is only accessible by FABBRICANTEDM users In this area the Fab Man RIC ASD user can perform two types of operations 1 Integrate their own general data which has already been indicated in the initial phase of access to the application clicking on the lateral menu and choosing Dati Generali Dichiarati Z Indicate the manufacturers he represents clicking on the lateral menu and choosing Dichiarazione altri fabbricanti The Dati Generali Dicharati feature must be used the first time the system is accessed by the user as all other functions remain disabled until such time as the user s personal details have been completed Therefore only after this process can the user gain access to the Dispositivi Medici di classe I II a b III area SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 151 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 4 1 Gestione Dati azienda Menu option Screen flowchart Salva DatiAnagra ficiUtente Dati Generali Dichiarante FormRicerca Fabbricante Ae Inserisci UtenteDatiF abbric antelnseriemnto UtenteDatiFabbri canteModifica Dichiarazine Altri Fabbricanti Ricer a Cancella Sa
19. Certificato Expity date of the Certificate Estremi delle norme The essential details of the National an Community norms acknowledged during the fabrication of the DM armonizzate comunitarie e delle norme nazionali di recepimento eventualmente applicate Direttiva CE 32 2003 States whether or not the certificate should be in compliance with EC Directive 32 2003 the user will have to indicate whether the certificate is relative only to EC Directive 32 2003 also to the EC Directive 32 2003 or is not relative to the ECDirective 32 2003 If the certificate is relative only to the EC Directive 32 2003 the field Allegato secondo cui stato certificato il dispositivo mustn t be compiled Allegato secondo cui stato certificato il Indication of the attachments according to which the device has been changed dispositivo File contenente il A pdf file to be attached containing the image of the EC certificate To attach certificato another file it 1s necessary to use the Annulla button Then it is necessary to use the button Sfoglia to individuatea new pdf file which supposed to be attached Operations available Action Description Page Name Salva Memorizes in the data base the modifications and Pagina Lista Certificati comes back to the previous page Indietro Voids the insertion and comes back to the previous Pagina Lista Certificati page 2 3 5
20. Disponibilit dei doc sulla provenienza del tessuto sostanza Indication of the presence of documentation on the origin of the tissue substance Fila da allegare in riferimento al campo Disponibilt de doc Sulla provenienza del tessuto sostanza File containing the documentation on the origin of the tissue substance The file must be in pdf format This field is required if the Disponibilt de doc Sulla provenienza del tessuto sostanza field has been ticket This field is an alternative to the Indirizzo email sito web Indirizzo e mail sito web in riferimento al campo Disponibilta dei doc Sulla provenienza del tessuto sostanza Email address Web site from which the origin of the tissue substance can be traced This field is required if the Disponibilt dei doc sulla provenienza del tessuto sostanza field was ticket This field is an alternative to the File da allegare field Disponibilit dei doc sui metodi di trattamento e inattivazione Indication of the presence of documentation on methods of treatment and deactivation Fila da allegare in riferimento al campo Disponibilta dei doc sui metodi di trattamento e inattivazione File containing the documentation on methods of treatment and deactivation The file must be in pdf format This field is required if the Disponibilt dei doc sui metodi di trattamento e inatt
21. If the user selects Si therefore expressing their wish to register their DM on the index the data cannot be edited Operations available Action Description Page Name Aggiungi Versamento Allows the user to add a Finestra Pop up payment for a DM This action may be executed more than once Detail Fields Motivo pagamento Reason for making the payment Data Versamento The date in which the transaction was made Quota_ver_post_ Amount paid SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 23 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile nsermento Versamento Microsoft Internet Explorer Inserimento versamenti Inserire gli estremi di pagamento del conto corrente postale per l evento selezionato secondo le indicazioni del fac simile illustrato Sezione Data versamento N N gg mm aaaa Ufficio Postale Progressivo delle operazioni svolte Importo versamento Progressivo del cc postale 60413416 Tassa postale 1 0 Motivo pagamento inserimento delle informazioni ai fini dell istituzione e della gestione del repertorio v Conferma Esci Detail Fields Sezione Department of office where the payment was made Data Versamento The date in which the payment was made Post Office Post Office co ordinates where the transaction was performed Progressivo delle operazione svolte Id num
22. Imagine del DM File containing the image of the DM Not obligatory The file attached must be a pdf file Scheda tecnica del DM The file containing the specifications of the DM or Schema di alternatively the link to the site where the same funzionamento utilizzo information may be found Required manutenzione The file attached must be in pdf format conservazione e manipolazione del dispositivo precauzioni di utilizzo controindicazioni e iterazioni tossicit dichiarata modalit di trasporto e smaltimento Bibliografia scientifica di supporto all evidenza clinica delle prestazioni e della sicurezza Operations available File containing the Scientific bibliography supporting the clinical evidence of the effectivness and safety of the DM or alternatively a link to a site where the same information may be found Required The file attached must be in pdf format Action Description Page Name Salva Allows a file uploaded or a link entered to be saved Same Cancella Allows user to delete a file or link Same Apri Allows the user to download he attached document SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 49 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 1 8 1 4 Commercial Data Salva Dati Commerciali DatiComm ercialiDM Page Name DatiCommercialiDM This page allows the user to insert edit the co
23. Localit straniera Sede Legale The foreign location of legal Headquarters of he manufacturer Provincia If the legal Headquarters is Italia then Comune and Provinca must be indicated otherwise state the Localit straniera Sede Legale Postcode or Zip code of the legal Headquarters of the Manufacturer C A P Zip code Sede Legale Address of the legal Headquarters of the Manufacturer Indirizzo Sede Legale Telephone number of the legal Headquarters of the Manufacturer Telefono Sede Legale Email address of the legal Headquarters of the Manufacturer email General company data legal representative Legale rappresentante Cognome Legale rappresentante Nome Name of the Manufacturer s legal representative Surname of the Manufacturer s legal representative General company data Contact reference Riferimento per Name of individual to contact to make official communications SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 156 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile comunicazioni Nome Alternatively the following must be stated e The name and surname of the individual to whom official communications must be referred e The department to which official communications must be referred Riferimento per comunicazioni Cognome Surname of individu
24. Motivo dell esclusivit Reason for its exclusiveness This field cannot be edited Operations available Action Description Page name Salva Saves the actions carried out by the user GesDmNecessariLista Annulla Cancels the changes GesDmNecessariLista 2 3 1 9 DM Editing The edit feature of a DM in In lavorazione phase can be activated upon the selection from the DM list of the device whose information the user intends to edit SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 75 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile by clicking in the Modifica button Following the completion of these actions the general data page appears on which the side menu displays menu options which open the data page of each DM in editable mode in order to insert edit the DM For the description of the data pages see parg 4 1 3 1 2 3 1 10 View DM Data The detailed information of a DM can be viewed by the following types of users 1 Fab Man RIC SD users as regards their own inserted DM 2 DGFDM users as regards all DM that are have the validato or publicato status In order to view the data of a DM both types of user must proceed as follows 1 Run the DM search by clicking on Dispositivo Medico DM in the menu insert the search criteria by clicking on the Ricerca button in order to select the desired DM Click the Visualizza butt
25. Presenza del codice a barre Si DM oggetto di fornitura alle strutture dell SSN Si Prezzo unitario di listino del singolo dispositivo senza IVA 100 Euro Ferme Operations available Action Description Page Name Firma Allows the user to validate a DM after having PaginaSintesiDM entered their PIN in the space provided SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 20 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 1 6 PaginaSintesiDM This page displays the principle information on the DMs which have been validated by the user in read only mode Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM Dispositivo Medico DM Lista dei DM in fase di validazione Progressivo di Codice attribuito dal n LI Stato sistema Fabbricante fabbricante Nome commerciale e processo attribuito al DM poneva modello validazione 1796 ELEKTA S p A li MAX999 Avviato EEELEPEEPEPPELEPPEPPEPEELIPEP PEPEDPPPPEPPEPETEP PEPPE PEEPI PEPPE PEPPI PELDE PEPPPPEPPELPEPPTEPPPELEEPET PEPEPEPE PIIPER CEPTE PRET sana een oe ET pem EEA 3 ANGEL NOME COMME PRE ET medical devices De 333 MODELLO re Per verificare l esito della Validazione utilizzare il pulsante Vai alla lista attivit Vai alla Lista attivit DM list in approval phase Field Details Field Name Description Progressivo di sistema
26. Provincia Province of the manufacturer To select a Province click on Cerca a look up will open where the user can search for the Province If the nation of the manufacturer is Italia then Comune and Provinca must be indicated otherwise state the Localit straniera Localit Straniera The foreign location of the manufacturer If the nation was identified as Italia then Comune and Provinca must be indicated otherwise state the Localit SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 164 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile straniera Indirizzo Address of the Manufacturer C A P Zip code Postcode or Zip code of the Manufacturer Telefono Telephone number of the Manufacturer Email Email address of the Manufacturer Operations available Action Description Page name Salva is present Saves the changes made by the user CorrelazioneUtenteFa only if the user is bbricanteLista authorised to edit the information of the Manufacturer selected Lista Allows the user to return to the list of CorrelazioneUtenteFa manufacturers linked to the user bbricanteLista 2 4 1 6 UtenteDatiFabbricante Visualizza This page grants the user access to the data of the manufacturer selected in read only format Home gt Dati Azienda gt
27. User Manual Design and Development NSIS DM Manufacturer Profile Field Name Description Registration deta ils of the delegated individual Codice Fiscale Fiscal code of the delegated individual This field cannot be edited Cognome Surname of the delegated individual This field cannot be edited Nome Name of the delegated individual This field cannot be edited General company data Nome Name of the Manufacturer This field cannot be edited Codice Fiscale Fiscal code of the manufacturer This field can only be edited this first time the user accesses the system Such information is required for companies who have registered as having legal Headquarters in Italy Partita IVA VAT Number VAT number of the manufacturer This field can only be edited this first time the user accesses the system Such information is required for companies who have registered as having legal Headquarters in a country other than Italy General company data legal Headquarters Sede Legale Nation of legal Headquarters of the manufacturer Nazione Sede Legale Council of the legal Headquarters of the manufacturer Comune To select a town from the legal places of Headquarters click on Cerca a look up will open where the user can search for a council If the legal Headquarters is Italia then Comune and Provinca must be indicated otherwise state the
28. aseriedd Modifies fosncena vj pissatizza Search Detail Fields Field Name Description Fabbricante The name or beginning of the manufacturer can be indicated Codice Fiscale The Fiscal code of the manufacturer can be indicated Partita IVA VAT Number The VAT number of the manufacturer can be indicated Nazione The manufacturer s nationality can be selected from the mono selection list Correlated Manufacturer List Detail Fields Field Name Description Fabbricante Name of the Manufacturer correlated Codice Fiscale The Fiscal code of the manufacturer correlated Partita IVA VAT Number The VAT number of the manufacturer correlated Nazione The correlated manufacturer s nationality Operations available Action Description Page name Ricerca Runs a search with criteria entered and displays the Same SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 158 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile list of products that match that criteria Reset Clears the search criteria previously put in place Same Inserisci Grants the user access to the page that allows him to UtenteDatiFabbricante create a new link with another manufacturer Inserimento Modifica Grants the user access to the data page of the UtenteDatiFabbricante Manufacturer selected in order to edit the details Modifica Visua
29. attributo al DM Unique identification number assigned to each DM in index Fabbricante Corporate name of the DM Manufacturing Company Codice attribuito dal fabbricante identicativo catalogo Code attributed to the DM by the manufacturing company better known as the identification catalogue Nome commerciale e modello Stato processo validazione Commercial name or model of the DM The status of the process It can change status in the following order e Initiated e Not Initiated Operations available Action Description Page Name Vai alla Lista attivita Allows user to return to the activity list Lista Attivita SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 21 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 1 7 Registration on the Index In order to register a DM on the index the user must proceed as follows 1 Run the DM search from the Dispositivo Medico DM option in the menu specifying the search criteria and then clicking on Ricerca 2 Select a DM in Validato or Pubblicato status 3 Click on Iscrizione nel repertorio pas Gites tre i 5 Repertorio Disposilivi Medi N Sistema Ta y CE Desk Informativo Pe Da Sanitario spesitivi Medio di class a I Dati Azienda pero MER tasse Home gt Dispositivi Medici di Classe I IIa b III gt Disposit
30. catalogue identification number Nome commerciale e modello Commercial name of the system or kit the assembler has given Assembled device Tipo Indication of the type of assembled device Stato nella base dati The status of the assembled device in the database The status can change in the following order e L Processing e V Valid e P Published Operations available Action Description Page name Ricerca Runs a search with criteria entered and displays the Same list of assembled systems or kits that match that criteria Reset Clears the search criteria previously put in place Same Inserisci Grants the user access to the insertion page of the DetAssemblatoInsMod assembled systems and kits Only visible by FABBRICANTEDM users Modifica Allows the user to access the data page of the DetAssemblatoInsMod assembled system or kit selected in order to edit its details Cancella Allows user to delete the system or kit In Same lavorazione selected SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 99 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Validazione Activates the signature page through which the user has the option to validate one or more system or kit in the Consolidato stage Only visible by FABBRICANTEDM users Changing the status of the system or kit does not occur si
31. 10 DM View Detail display rt 71 2 3 1 10 1 DM detail page for information detail consultation 72 2 3 2 Menu option Sistemi e Kit assemblati c 2 Art 12 90 2 3 2 1 Assembled SGarChyy vrs acne ssa syste de re raro 90 DI Assembled List ai 91 2 3 2 3 D tAssemblati s elia 94 2 3 2 4 RicercaComponenti DM ssssesssssssssssssssrrrrrrrereerere 97 2 3 2 5 ListaComponenti DM 99 2 3 2 6 RicercaComponenti Non DM items 101 2 3 2 7 ListaComponenti Non DM Articles 103 2 3 2 8 DetAssemB late Vis cal Rie 105 2 3 2 9 Registration on the Index LL 107 2 3 2 10 Off Market aee oane iee EEE cease venweeavenedpainks EEA 108 2 3 2 11 Assembled Approval page Li 110 2 3212 Assembled Signature page Lei 108 23 213 Assembled summary page 110 2 3 2 14 LookUpRicercaProdotti ssssricriien birrerie 111 ZIZAS LooKkUpGestioneProdotti ria 112 2 3 3 Menu option Attivit in corso Fab Man RIC ASD 116 2 3 3 1 ListaAttivit InCorso Fab Man RIC ASD 116 2 3 3 2 FiltroAttivitaIncorso Fab Man RIC ASD 118 2 3 3 3 DettaglioDM Fab Man RIC ASD L cece eee e eee ceeee eee eneeenenaes 118 2 3 3 4 DettaglioAssemblato Fab Man RIC ASD 121 2 3 4 Menu Option Caricamento DM da file
32. 114 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile e Other individual delegated by the Manufacturer Tipo Assemblato Indication of the type of assembled devices Assembled Components List Data Fields Field Name Description Descrizione Brief description of the component of the assembled device Nome commerciale e modello Commercial name given to the component Codice attribuito dall assemblatore identificativo catalogo Indication of product code assigned to component Fabbricante Titolare Name of the Manufacturer title holder of the component Tipo prodotto Type of component The component of an assembled device can be e Classified Medical Device DM e Medical and surgical aids PMC e Medicines SPM e Other ALT Stato nella base dati Operations available This field is only given value if the component is a DM Indicates the status of the DM in the database The status can change in the following order e L Processing e V Valid e P Published Action Description Page name List of assembled devices Allows the user to return to the list of the ListaAssemblati assembled devices 2 3 2 9 Registration on the index To register an assembled device that contains at least one DM the user must proceed as follows 1 Runa search for DM by clicking on Dis
33. 6 Pagina Dettaglio Proroga Activated by the page Lista certificati selecting a certificate and clicking on the Proroga button the page allows the user to insert an extension to a certificate exitent if it has never been extended before or if it has already been extended it is associated with at least one device validated or published The page called is divided in two sections in the first section Dati certificate esistente informations concerning the certificate in expiry are visualized in non editable mode the second one Dati certificate di proroga gives the same informations which can be edited to allow the user to insert the data of the certificate of extension Moreover if the certificate is associated with medical devices the page will give evidence of it visualizing the list with elements selected of all the devices associated In a specific there will SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc 149 166 February 2008 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile be visualized as the devoces in processing as those already validated and published that need a new signature Selecting the elements the user is proposed to extend the association of all the medical devices associated already with the certificate extended to that of extension All the same the user will be able to exclude deselecting them one or more medical devices expressing
34. A Codice attribuito dal fabbricante identificativo a catalogo Numero Registrazione EA Codice AIC Fabbricante ZII Titolare FOCHE SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 62 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Nome commerciale e modello ALEVE 220 MG COMPRESSE RIVESTITE CON FILM 10 COMPRESSE ALEVE 220 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE Codice AIC Titolare pesi Seleziona 032790014 ROCHE S P A DES 032790026 ROCHE S P A h Pagina 1 dii Stato nel repertorio C CONSOLIDATO L IN LAVORAZIONE P PUBBLICATO V VALIDATO Seleziona Per aggiungere un componente occorre preventivamente cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista Aggiungi Componenti Gestione Prodotti Non DM Item Components Search Detail Fields Field Name Description Cerca Tra The user must provisionally choose if he intends to request a DM list or other non DM product list Different search criteria will be displayed depending on this choice Tipo prodotto The user can choose between the following types of product e Non CE marked DM e Surgical and Medical Aids e Medicines e Other Nome commerciale e modello The DM s name or beginning thereof given by the manufacturer can be inserted Fabbricante The user can insert the name or p
35. Active ingredient Tipo Type of Active ingredient Operations available Action Description Page Name Ricerca Runs a search of the active ingredients base on the Same search criteria specified Agg Allows the user to link active ingredients selected to Same Principi the DM Attivi al DM Cancella Allows the user to delete the link between the active Same ingredients selected and the DM Conferma Closes the window confirming the operations SchedaTecnicaGen carried out by the user Chiudi Closes the window without confirming the actions SchedaTecnica carried out by the user Page Name LookUpMaterialiConfezionamento This page is displayed in look up format and allows the insertion and deletion of the primary material used to package the DM This is activated by clicking the inserisci modifica materiali button found on the Scheda Tecnica page Only the primary packaging material of sterile DM need be inserted The material of non sterile DM does not need to be specified Pic Materiali PLASTICA E ee e CARTONE X tng Ale Materiale Cancella Conferma Chiudi SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 44 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Primary packaging material of a DM Detail Fields Field Name Description Materiali Material necessary for the prim
36. Gestione Dati Azienda Dichiarazione altri fabbricanti Visualizzazione Dati Fabbricante Data Fields Fabbricante BRISTOL Codice Fiscale BRL234TRD347V56y Partita IVA VAT number 12345678901 Nazione lrn Comune LATINO raro Provincia CH Localit Straniera Indirizzo 11234 C A P ZIP code Telefono 56565656 e mail mail ang it Lista SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 165 166 Design and Development NSIS Ministry for Health User Manual DM Manufacturer Profile Field Name Description Fabbricante Name of the manufacturer Codice Fiscale Fiscal code of the manufacturer Partita IVA VAT number VAT number of the manufacturer Nazione Nationality of the manufacturer Cannot be edited Comune City of the manufacturer Provincia Province of the manufacturer Localita Straniera The foreign location of the manufacturer Indirizzo Address of the Manufacturer C A P Zip code Postcode or Zip code of the Manufacturer Telefono Telephone number of the Manufacturer e mail Email address of the Manufacturer Operations available Action Description Page name Lista Allows the user to return to the list of CorrelazioneUtenteFa manufacturers linked to the user bbricanteLista SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 166 166
37. LookUpArtDatiGen selected from the list in read only format Visualizza Displays the data page of the non DM product LookUpArtDatiGen selected from the list in read only format Cancella Deletes the non DM product selected from the list Same 2 3 2 15 LookUpGestioneProdotti This page allows the user to insert edit the information regarding the non DM products type Altro SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc 123 166 February 2008 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Gestione Prodotti Inserimento Prodotto Tipo Prodotto A Nome commerciale e modello Codice attribuito dal fabbricante identificativo catalogo Fabbricante ESa0TE SpA Cerca Classificazione CND a 4 Cerca La voce ALTRO in corrispondenza del campo Tipo Prodotto riferita ad articoli non DM diversi da Presidi Medici Chirurgici o Specialit Medicinali Salva Chiudi Lista Prodotti Detail Fields Field Name Description Tipo prodotto e The product type has already been inserted as a non DM product type Altro Nome e Name assigned to the product by the Manufacturer commerciale e modello Codice attribuito dall assemblatore identificativo catalogo Product code assigned to the product by the manufacturer Fabbri
38. Page name Ricerca Runs the search with criteria in place and displays the UploadListaFile list of files attached by the user Reset Clears the search criteria previously put in place Same 2 3 4 4 UploadListaFile This page allows the Fab Man RIC ASD user to view the result of the loading procedure of each file sent SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 135 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Caricamento DM da file gt Esito Caricamento Lista File Criteri di Ricerca l Nome file Ricerca Nuova ricerca EEE ao a LC ifile2 xml 08 03 2006 15 25 File elaborato con errori i C ese_Ins TXT 08 03 2006 15 25 File elaborato con errori Pagina 1 di 1 sintasi Bisborezione Detail Fields Field Name Description Nome File The name of the file attached by the user containing the DM s data Data invio Date in which the user uploaded the file Esito Indicates whether the file was examined by the automatic process of mass uploading of the DM contained in the database or not and if so whether the errors have been edited Operations available Action Description Page name Ricerca Runs the search with criteria in place and displays the Same list of files attached by the user Nuova Clears the search criteria previousl
39. Pagina 1 dil Tipo del Prodotto NCE DM NON MARCATO CE PMC PRESIDIO MEDICO CHIRURGICO SPM SPECIALITA MEDICINALE ALT ALTRO Seleziona Cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista a seconda delle operazioni Inserisci Componenti Gestione Prodotti Cancella Componenti Salva Component list Data Fields Field Name Description Nome Commerciale Commercial name of DM or Non DM article Fabbricante Titolare Indication of the number of pieces which the system or kit require regarding the components Tipo prodotto The following types of products can be recognised Para 3 Art 12 as a system or kit DM Medical Device NCE Non CE marked DM PMC Medical and surgical aids SM Medicines ALT Other Non DM type of Article Stato nella base dati The status of the DM in the database The status can change in the following order e L Processing e V Valid e P Published SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 54 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Operations available Action Description Page Name Inserisci Grants the user access to the component FormRicercaElementiDa Componente search page in order to make additions toa Correlare system or kit Gestione Opens a window where the user has the LookUpRicercaProdotti Prodotti option to manage Non DM
40. Responsabile Individual or legal entity who in the case that the Manufacturer is not dell immissio appointed within the Community is obliged to keep the relative ne in documentation available to the authorities of the merchandise commercio Altro Individual or legal entity whois delegated by the Manufacturer in soggetto order to register the DMs in to the system e g The delegato dal distributor Wholesaler fabbricante Iscrizione al repertorio A process in which the data regarding fee payment transaction is inserted 1 1 2 Acronyms Acronyms Definitions SSN Local Health Board CUB Unique Board for Devices CND National Classification of Medical Devices DGFDM General Management of Medicines and Medical Devices DM Medical Device SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 Design and Development NSIS 5 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile GMDN Global Medical Device Nomenclature Mds Ministry of Health NSIS New Health Information System 2 DM MANUFACTURER Profile 2 1 Access to the System In order to access the system it is necessary to refer back to the MdS web site www ministerosalute it 2 2 Function areas of the System Once logged on the user may access the functions of the system gt ACCESS PIO na peneem i q ie stpinamenamznzare y EJ Stemi ni re ca
41. SmartCard nel lettore quindi cliccare su bottone Firma Per utilizzare la funzionalit di firma con SmartCard sar necessario aver per installato sul Proprio PC il Layer Crittografico Firma e Cifra Si raccomanda di rileggere attentamente il testo prima di firmarlo Verra firmato solo il testo contenuto nell area di testo sottostante Il sottoscritto Lara Santacroce per conto di DATEX OHMEDA SPA convalida il SISTEMI PER OFTALMOLOGIA PROVA 1 con identificativo catalogo PRVO101 in data 01 03 2005 Firma Operations available Action Description Page Name Firma Allows user to validate an assembled device after PaginaSintesiAssemblato having entered the PIN in the space provided 2 3 2 13 Assembled Device Summary Page This page displays the principle information of the assembled device awaiting validation in read only format SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 120 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Dispositivo Medico DM Dispositivo Medico DM RIZZA Progressivo di Codice attribuito Stato sistema dall assemblatore Nome commerciale e attribuito rie identificativo modello erje paraa all Assemblato catalogo gt APPARECCHIATURE DA i See eget VEN SALA OPERATORIA vva PRICES E
42. User Manual Design and Development NSIS DM Manufacturer Profile gt Dieppe Medica DM gt Scheda Tecnica 2 Visualizzazione Scheda Tecnico Tipo Dispositivo Medico DISPOSITIVO Ulteriori N mercial delom NOME 1 Nome commerciale e modella NOME PROVA Codice attribuito dal fabbricante identificativo CER catalogo Fabbricante JOHNSON amp Jc Progressive di sistema attribuito al OM 2720 SON MEDICAL S P A xal del Dispasdiva Medica Ron Caratteristiche tecniche generali Descrizione pel ica Destinazione d uso ai sensi del DA9s 46 97 A Misura ove applicabile Indicare i parametri misurabili attusimente utilizzati e presenti nei catsloghi commerciali con le relative unita di misura Dati di sterilizzazione sterile Fietodi di an Metodi di Porkodo maccime Stomizzazione Descrizione altro storilizzazione i utilizze meci validato secondo metodo di norme sterilizzazione j Afateriali costitueati i DN a diretto contatto con di Paziente condizioni materialo special di perre xX _ smaltimento ACRILATI s Lotex frees gt gt a File da allegare woga E m il sito web dotio pu freg arxi dell utichiutta Lakwx fraw xe in nexxune faxe abato a contatto con molecole del Inttica prodotti scronm allegara il socumerts relstisa alla cariticazione oppure indicum l incirizza a mailetto web a
43. a Province click on Cerca a look up will open where If the legal Headquarters is Italia then Comune and Provinca must be indicated otherwise state the Localit straniera Localit Straniera The foreign location of the manufacturer Localit straniera If the nation was identified as Italia in the insertion phase then Comune and Provinca must be indicated otherwise state the Indirizzo Address of the Manufacturer C A P Zip code Postcode or Zip code of the Manufacturer Telefono Telephone number of the Manufacturer Email Email address of the Manufacturer Operations available Action Description Page name Ricerca Runs a search with criteria entered allowing the Same existence of the manufacturer with whom the user wishes to be linked to be verified Salva Saves the link with the manufacturer selected or inserted CorrelazioneUtenteFa bbricanteLista Lista Allows the user to return to the list of manufacturers CorrelazioneUtenteFa linked to the user bbricanteLista 2 4 1 5 UtenteDatiFabbricanteModifica This page allows the user to edit the data of the Manufacturer selected The user can only edit the data of manufacturers that he has entered personally SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 163 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profil
44. a collection of information provided by Manufacturers each Manufacturer accepts full responsibility for the information supplied both for the General data and data regarding single Medical Devices The publication of this data does not represent any form of approval by the Ministry for Health The General Administrative Office of pharmaceutical products and medical devices reserves the right to carry out inspections at any time as stated according to the provisions of the Legislative Decree February 24 1997 No 46 Within the confines of this functional area the following functions are present 1 Dispositivo Medico DM Di Sistemi e kit assemblati c 2 Art 12 3 Attivit 4 Caricamento DM da file 5 Certificati CE The Dispositivo Medico DM feature is both visible by FABBRICANTEDM users as well as UFFICIDGFDM users This functionality allows e The FABBRICANTEDM users to have access to the management functions of the information relative to their own devices insert edit or delete and to validate the same by inserting their electronic signature and lastly making them visible to the head department of the GMFMD e The UFFICIDGFDM users can access the consultation function of the DM that have at least been Validated The Assembled systems and kits feature para 2 Art 12 is visible to both FABBRICANTEDM users and UFFICIDGFDM users The menu options allow both users to consult
45. appears which allows the user to define the search criteria of the DM registered on the system To activate a search on the DM the user must define at least one margin From this page the user may also access the page containing the general data of a DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 11 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Dispositivo Medico DM Ricerca DM Criteri di Ricerca Progressivo di sistema attribuito al DM Fabbricante Tipo DM aj Codice attribuito dal fabbricante da identificativo catalogo a Nome commerciale e modello Classificazione CND 2j Cerca Stato del DM Ruolo dell utente rispetto al DM z Ricerca Nuova ricerca Inserisci Details of DM search Fields Field Name Description Progressivo di sistema attribuito al DM Option to serch a Medical Device by its identification number assigned by the system during registration into the database Fabbricante Option to specify the name or the beginning of the Manufacturer of the DM Tipo DM Option to indicate the type of classified DM choosing between Codice attribuito dal fabbricante Device System Kit Option to indicate the range of codes which includes the product code assigned to the DM by the Manufacturer ide
46. criteria Reset Clears the search criteria previously put in place Same Salva Saves the actions carried out by the user GesDmNecessariLista SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc Design and Development NSIS February 2008 74 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Page Name GesDMNecessariModifica This page allows the user to view the details of a linked DM by stating its principle data From that page the data which stipulates the exclusiveness or otherwise of the association can be edited Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Eventuali altri DM necessari al funzionamento Modifica esclusivit per il funzionamento Fabbricante BRISTOL Tipo DM DISPOSITIVO Codice attribuito dal fabbricante identificativo catalogo Nome commerciale e modello DISPOSITIVO MEDICO DI PROVA 2 MANDATARIO Progressivo di sistema attribuito al DM 1833 DMP02M Le Salva Annulla List Detail Fields Field Name Description Fabbricante The name of the Manufacturer of the DM Codice attribuito dal Specific code attributed to the DM by the fabbricante identicativo manufacturing company catalogo Nome commerciale e The name of the DM as given by the manufacturer modello Uso esclusivo Uso non Indicates if the DM to be linked has an exclusive esclusivo use regarding the Parent DM
47. edit delete and view non DM items type Altro 2 3 2 7 ListaComponenti DM This page allows the user to view the list of non DM items to add as components to an assembled system or kit corresponding to the search criteria in place Detailed information concerning the system or kit which is being inserted or edited are displayed SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 110 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Sistemi o Kit Assemblati c 2 Art i2 Composizione di sistemi o kit c 3 Art 12 Nome commerciale e modello Tipo Codice attribuito dall assemblatore identificativo catalogo Assemblatore Ruolo dell utente rispetto all Assemblato Tipo Assemblato lt I Criteri dir ricerca a dei componenti Cerca tra ARTICOLO NON DM om Tipo Prodotto PRESIDIO MEDICO CHIRURGICO v Nome commerciale e modello PASTA DDT Codice attribuito dal fabbricante identificativo TE EEN II catalogo Numero Registrazione Codice AIC Fabbricante Titolare Nome commerciale e Numero 0 Registrazione RR Seleziona modako oee p ese ox PASTA DDT EXTRA 897 P p POTENZIATA 2007 Bo INDUSTRIE CHIMICHE CAFFARO O SPA LA n x Pagina 1 di 1 Stato nel repertorio C CONSOLIDATO L IN LAVORAZIONE P PUBBLICATO V VALIDATO Selezion
48. following information is displayed the certificate number of the EC stamp the expiry date the organization notified which issued it the essential details of the National and Community harmonized norms acknowledged and eventually applied SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 141 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile e the file attached containing the image of the certificate From the page the user can ask for the insertion of a new certificate clicking on the always available Inserisci button Choosing a certificate from the list the user will also be able to do the following e visualize the Dettaglio of the certificate e ask for the Modifica of the certificate only if the certificate selected has no extension and no medical devices validated or published inserted e ask for the Cancellazione of the certificate only if the certificate selected has no extension and no medical devices validated or published inserted Activating the button Cancella the system will ask the user to give a voluntary confirmation to delete the certificate selected and if so it will proceed to the cancellation Then the list of the remained certificates will be visualized e access the Proroga page of a certificate only if the certificate selected has no extension inserted or if there is an extension it is related to at least one
49. in commercio Cerca Dettaglio Progressivo di sistema attribuito al DM 2075 Classificazione Classificazione CND ee oe s 3 Sw 2 3 PART DIFFERENTIAL BLOOD a Nomenclatore GMDN completo CELL COUNTER 35479 0 6 NOT FOR si Cerca SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 78 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Certificazioni Classificazione CE D L vo 46 97 attuazione Dir CE 93 42 D L vo 507 92 Classe Ila zj attuazione Dir CE 90 385 Allegati secondo cui stato certificato il dispositivo T Allegato II I Allegato II M Allegato IV TT allegato v I Allegato VI T Allegato VII Estremi delle norme armonizzate P EN Ba afiertificato pata scadenza Organismo Notficato Comunitarie e delle Direttiva ifi i Ex CE Certificato Codice Nome optato 00000007 x 32 2003 eventualmente f applicate f 0434 DET NORSKE 1 VERITAS REGION NORGE No rr e ff tq6666 ASIONURNI enne 0434 DET NORSKE i il 1 01 01 2001 VERITAS REGION NORGE No AS DNY RN iegame con altri DM Il DM per svolgere la sua funzione necessita di altri DM sif no In caso di risposta affermativa indicare gli altri DM tramite la funzionalit Eventuali altri DM necessari per il funzionamento General DM data Detail Fields Field Name De
50. kit from the relevant page accessible through the corresponding menu options Inserisci Modifica Salva The General Data page allows the user to insert general data regarding a DM The general data of a DM are subdivided in four areas e General data e Classification data e Certification data e Links with other DM It will be necessary to consult the General Data page of a DM in the following cases e In the insertion phase of the DM e In the editing phase of the DM e In the insertion phase of the DM by coping a DM that already exists The user can also connect different DM on this page which are interdependent for operational purposes by clicking on the Eventuali altri DM necessari per il SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 26 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile funzionamento after having saved the Dati Generali by clicking on the Salva button Page Name General Data Page TYR PTEEEE 2 ESE 2D De ERO RE SR ES Po e uovo fi Repertorio Dispositivi Medi Sis sta z a ci Fi eee i vi euge 5 Informative eee fois HelpDesk _ a Sanitario Dispositivi Medici di classe 1 Ita7b 1Mt ati Azienda Dispositivi Medici di Classe Home gt Dispositivi Madici di tlacca I 11a b IIT gt Dicpocitivo Medico DM gt Dati Generali I Ilafb Hll gt Dispositivo Medico DM Inserimento Dati Generali Dat
51. of DM pieces old excluding pieces sold to the restante mercato SSN Tipo di dato Indication of the type of data No of pieces sold to the rest of the market either estimated or exact Operations available None SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 90 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 1 10 1 5 Systems and Kit contents Para 3 Art 12 Composizione di sistemi o kit c 3 Art 12 Men GesCorrelazioneArt icoliLisVisInsMod Page Name GesCorrelazioneArticoliLisVisInsMod This page allows the user to view the list of components of a system or kit in accordance with Para 3 Art 12 The components of a system or kit according to Para 3 Art 12 can be 3 types e CE marked DM e Non CE marked DM e Non DM articles The commercial name of every system or kit component has a corresponding link which opens a window where the principle information of the selected component are synthesised In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 91 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Comp
52. singolo dispositivo io IVA be senza IVA Presenza del codice a barre xi Gli importi sono espressi in Euro Dati di vendita delbM GG Anno di ii Se N pezzi venduti vendita FAI Tipo di dato al restante Tipo di dato del DM mercato 2004 Ji23 effettivo stimato i231 effettivo stimato 2005 421313 effettivo stimato 213123 effettivo stimato Per SSN si intende Aziende Sanitarie Locali Aziende Ospedaliere Strutture pubbliche e private accreditate Commercial data Fields Field Name Description Current data DM oggetto di Indication whether or not the DM is destined to be used by the SSN fornitura alle strutture dell SSN Prezzo unitario di Unit sale price of a DM excluding tax listino del singolo dispositivo senza IVA TIVA Indication of the IVA applied to the DM Presenza del codice Indication as to whether or not the DM bears a barcode a barre DM Sales data Anno di vendita del Indication of the year the DM was sold DM N pezzi venduti al Indication of the number of pieces sold to the National Health Service SNN Tipo di dato Indication of the type of data No of pieces sold to the SSN either estimated or exact SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 89 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile N pezzi venduti al Indication of the number
53. substances of animal origin not vital Presenza Tessuti Sostanze Indication of whether or not the DM contains Biological tissue animal substances Medicinal products Present Presenza Medicinali Indication as to whether or not the DM contains medicinal products Medicinali esclusi derivati da sangue o plasma umano Indicates if there are medicines present in the DM excluding those derived from blood or human plasma Medicinali o cosituenti di medicinale derivati da sangue umano Indicates if there are medicines present in the DM derived from human blood Medicinali o cosituenti di medicinale derivati da plasma umano Indicates if there are medicines present in the DM derived from human plasma Primary packaging Prevalent material making up the primary packaging of the DM that of the DM require specific Indicates if the primary packaging of the DM must be disposed of in a specific manner SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 83 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile disposal Directions for use Monouso Indicates whether or not the DM is disposable Metodo di Method used to re sterilise the DM re sterilisation This field is required if in the Monouso field it was marked No Specify existing Description of method of re sterilisation if it is not found on
54. the alternative Metodo previously loaded list di re sterilisation This field is required if in the Metodo di Re sterilizzazione field it was marked Other Modalit di Method used to clean disinfect the DM pulizia disinfezione This field is required if in the Monouso field it was marked No Numero di Maximum number of times it is permitted to sterilise a DM sterilizzazione This field is required if in the Monouso field it was marked No consentite ove stabilito Operations available Action Description Page name Visualizza Grants the user access to a window where he can LookUpTessuti tessuti view the detailed information of each biological tissue animal substance associated with the DM Page Name LookUpTessuti This page allows the user to view the data on each biological tissue animal substance associated with the DM In particular this window permits the user to download or view a link to a site where the information of each tissue substance can be found regarding e The origin of the tissue substance e The treatment and deactivation methods e Other documentation provided by the Health Authority State di Parte utilizzato det tessuti provenienza bestanza BOVINA ITALIA ANNESSI CUTAMEI Famiglia di spp artanonza gt Stato di Famiglia di appartenenza provenionza Parte utilizzata del tessuti fra pra i Ji I Akra famiglia SR c
55. the system alerts the user that the choice made cannot be changed and checks that all of the components have been registered on the index If the check results positive the assembled device is then registered on the index otherwise a message stating the opposite is sent to the user 2 3 2 10 Off Market Date This page allows the user o insert the off market date in reference to an assembled system or kit in the Validato or Pubblicato stage SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 116 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Sistemi o Kit Assemblati c 2 Art 12 Ricerca Sistemi o Kit Assemblati c 2 Art 12 Criteri di Ricerca Progressivo di sistema attribuito hi all assemblato Assemblatore Tipo SISTEMA Codice attribuito dall assemblatore da identificativo catalogo 45 Nome commerciale e modello Stato Ruolo dell utente rispetto all Assemblato lt j Tipo Assemblato zj Ricerca Nuova ricerca Progressivo di Codice attribuito Name Tecrizione sistema Assemblatore dall assemblatore commerciale Tipo Stato del nel Seleziona attribuito identificativo nera Assemblato Dispositivo repertorio all assemblato catalogo _ SISTEMA DI SISTEMI PER 455 BATER ASSE PROVA RADIOLOGIA E N a NOME SISTEMI PER oe BRAR Frase CO
56. types e CE marked DM e Non CE marked DM e Non DM articles This page is accessible by the user in the following cases e During the insertion phase of a System or kit after the registration of the general data e During the editing phase of a System or kit e During the insertion phase of a System or kit by means of coping one that already exists in the system In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 53 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Each system or kit s commercial name has a corresponding link which allows the user to see additional detailed information about the component selected Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Composizione di sistemi o kit c 3 Art 12 Composizione di sistemi o kit c 3 Art 12 Tipo Dispositivo Medico KIT Nome commerciale e modello KIT 5 Codice attribuito dal fabbricante identificativo 555 catalogo Fabbricante 5AYER Progressivo di sistema attribuito al DM 1738 site _ Componenti Sistema o Kit a ui peri CRA Nome commerciale Fabi Titolare Numero Tipo Prodoito RARA I Pezzi i repertorio BAYER E pm E BAYER 1 Jom amp
57. user can adopt the following roles Manufacturer Mandate Holder Marketing Director Other individual delegated by the Manufacturer Fabb Man Resp I Indicates the Manufacturing company Mandate Holder Marketing mm Comm Altr S Director Other individual from the Manufacturer of the DM 0gg Del Fabbr Fabbricante Name of the Manufacturer of the DM If the user has selected the role of Manufacturer of the DM the system therefore selects the Manufacturer that has been previously stipulated by the user in the Gestione Dati Azienda feature If the user has selected a role other than fabbricante he can select the Manufacturer clicking on the Cerca link a look up will open where Option to search for and select a Manufacturer Mandatario Name of Mandate Holder of DM If the user has selected the role of Mandate holder regarding the DM the system will automatically display the user s company as SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 28 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Mandate holder in the Gestione Dati Azienda feature He can select the Mandate holder by clicking on the Cerca link a look up will open where the user has the option to search for and select a Mandate holder The mandate holder may be selected only if the Manufacturer is registered in a non EU country Responsabile dell immissio
58. window of the primary packaging material ezionamento contained in the DM Inserisci Modifica Allows the user access to the administrative lookUpMetodiRisteril metodo window of the re sterilisation methods of the DM risterilizzazione Page Name LookUpMetodiSteril SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 37 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile This page is displayed in look up format and allows the user to insert and cancel methods of sterilisation of DM that come in direct contact with the patient It is activated by clicking on the Inserisci Modifica metodi sterilizzazione button which is found on the Scheda Tecnica page When saving the data on the specifications data sheet it is required to indicate at least one method of sterilisation of the DM in the case that it has been marked as being sterile Metodi di sterilizzazione METODI DI STERILIZZAZIONE Metodi di sterilizzazione validato Periodo massimo di Descrizione altro metodo utilizzo secondo di sterilizzazione mesi norme armonizzate IRSA SASS OEY Sede ietadelb ice ANSA SI 4 CT z z __Inserisci Metodo J _Conferma OS Al fine di effettuare il salvataggio del i metodi di sterilizzazione necessario cliccare nell ordine in corrispondenza dei bottoni Inserisci Materiali e Conferma Methods of sterilisation of DM Detail F
59. 1 1 doc February 2008 45 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Metodo di Method used to re sterilise the DM risterilizzazione This field is required if the Monouso field is marked Si Modalit di Method used to clean disinfect the DM pulizia disinfezion This field is required if the corresponding e Monouso field was marked No Se altro metodo di Description of method of re sterilisation if it sterilizzazione is not found on the list previously loaded specificare Numero di Maximum number of times it is permitted to sterilizzazioni sterilise a DM To specify that an illimited number of sterilisations are allowed the option Illimitato must by selected Otherwise the corresponding field must be filled in with the number of sterilisations allowed The field is editable if the check Tllimitato its not selected This field is required if in the Monouso field has been set to No Operations available Action Description Page Name Inserisci Confirms the method of re sterilisation indicated by Same Metodo the user providing a new line so that new method can be inserted Cancella Deletes the method of re sterilisation selected by the Same user Conferma Closes the window confirming the actions carried SchedaTecnica out by the user 2 3 1 8 1 3 Documentation Documentazione _ D
60. DM 2705 Dati Generali del Dispositivo Medico Selezionare il file da allegare oppure indicare il link remoto al documento o l indirizzo email cui richiederlo Salva Cancell Documento File da allegare Link Indirizzo Email I t t Etichetta Acc_quad_2_2004 pdf Apri Cancella Istruzioni per l uso if Sfoglia Salva Immagine del DM I Sfoglia Salva Fosse serine II E IRE SCSI IEEE EI EA PIE RAI IAA CRETA PELI TI Scheda tecnica del DM Schema di funzionamento utilizzo manutenzione conservazione e manipolazione del dispositivo precauzioni M N if M Cancella di utilizzo controindicazioni e iterazioni eventuale tossicit dichiarata modalit di trasposrto e smaltimento Bibliografia scientifica di supporto all evidenza clinica MCHIUSAN ETHIT Cancella delle prestazioni e della sicurezza i f Il formato dei file da allegare deve essere PDF Documentation Detail Fields Field Name Description SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 48 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Etichetta File containing the label of the DM Required The attached file must be a pdf file Istruzioni per l uso File containing the direction for use of the DM
61. Estremi delle norme armonizzate N certificato i i comunitarie e delle Direttiva della marcatura Data Sead vesto Orgentsm ss Neeiticate norme nazionali di CE recepimento eventualmente applicate 1 12 12 2009 E EE ANA SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 27 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Legame con altri DM Il DM per svolgere la sua funzione necessita di altri DM i no In caso di risposta affermativa indicare gli altri DM tremite la funzionalit Eventuali alri DM necessari per il funzionamento General DM Data Field Detail Field Name Description General Data Tipo DM Indication of the type of classified Medical Device The following types of DM exist Device System Kit Nome commerciale e Denomination of the DM as given by the Manufacturer modello Ulteriori Nomi List of commercial names subsequently assigned to the DM commerciali del DM Codice attribuito dal Specific code attributed to the DM by the manufacturer fabbricante identicativo catalogo Regolamento recante Name of DM according to the nomenclature charges in force norme per le prestazioni di assistenza protesica erogabili nell ambito del Servizio Sanitario Nazionale Mobilit di Erogazione e Tariffe Ruolo dell utente Indicates the role carried out by the user with respect to the DM The rispetto al DM
62. GRECA Assemblatore DATEX OHMEDA SPA Progressivo di sistema attribuito ba all Assemblatore Campi Mancanti L assemblato deve contenere almeno un DM valallAccemblato _Chindiattvita Tomaaliatisteativit Detail Fields Field Name Description Tipo Assemblato Type of Assembled Device The following types of Assembled device exist e System e Kit Nome commerciale e modello Denomination of the system or kit as assigned by the Assembler Codice attribuito dall Specific code attributed to the Assembled system or kit by the assemblatore Assembler identificativo catalogo Assemblatore Name of the Assembler of the Assembled system or kit Progressivo di sistema attribuito all assemblato Consecutive number of Assembled device by the system Note per la rettifica Indication of the reasons that made the DGFDM reject the request for publication of the Assembled Device Campi mancanti The list of errors that caused the Assembled Device to fail the automatic tests of the system for the validation of the Assembled Device Operations available Action Description Page name Vai Grants access to the general data page of the DetAssemblatoIndMod all assembl Assembled device ato Chiudi Allows the user to return to the activities in progress ListaAttivitaIncorso Attivit list eliminating the activity previously selected SISG_SSW MSW_DI
63. INONE ees Provincia FR Localit Straniera DA Indirizzo VIA MARITTIMA C A P ZIP code 03100 Telefono fosizz4ase A e mail nesae SSS campo obbligatorio Il salvataggio permette la registrazione della relazione tra il fabbricante e l Utente usi If the manufacturer after having carried out the search see previous paragraph is not present in the database the Dati Fabbricante fields are left empty so that the user can enter the information regarding a new manufacturer Then clicking on the Salva button the manufacturer is inserted into the database and subsequently the system creates a link between the user and the manufacturer entered SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 161 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dati Azienda gt Gestione Dati Azienda gt Dichiarazione altri fabbricanti Inserimento Altro Fabbricante Ricerca per Inserimento Fabbricante GET Codice Fiscale aawsws25225 Partita IVA VAT number Nazione ITALIA z Fabbricante inesistente per il codice fiscale digitato Dati Fabbricante Fabbricante OSIO Codice Fiscale es Partita IVA VAT number Nazione i Comune CO RESIS RRR Cerca Provincia Fa Localit Straniera aR EEA Spal SENSES SSS ESM C A P ZIP code Telefono n esmalil no campo obbligat
64. LETTRONICA BIO isa APPARECCHIATURE DA ti E MEDICALE SRL ro SALA OPERATORIA Per verificare l esito della Validazione utilizzare il pulsante Vai alla lista attivit Assembled Devices in the Validation phase List Data Fields Field Name Description Assemblatore Name of the assembler Codice attribuito dall Indication of product code assigned to the system or kit by the assemblatore Assembler identificativo catalogo Nome commerciale e Name of the system or kit assigned by the assembler modello Stato processo The status of the process It can change status in the following validazione order e Initiated e Not Initiated Operations available Action Description Page Name ListaAssemblati Allows user to return to the list of assembled listaAssemblati devices with the status of the device valid and updated 2 3 2 14 LookUpRicarcaProdotti This page allows the user to put search criteria in place in order to view the list of non DM products Type Altro SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 121 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIs b II gt Dispositivo Medico DM gt Gestione Prodotti Tipo Prodotto ALTRO a Nome commerciale e modello Codice attribuito dal fabbricante identificativo nni catalogo Fabbricante i Classificazione CND 4
65. ListaSintesi This page allows the user to view the list of operations carried out successfully by mass upload Home gt Dispositivi Medici di Classe I IIa b IIl gt Caricamento DM da file gt Esito Caricamento Dettaglio delle operazioni effettuate con successo Nome file ESE_INS TXT Data invio 08 03 2006 15 25 n Dettaglio delle operazioni effettuate con successo PE e R1R1 1 10 1t1iIm 1 I 1 1 1 t mqm R OO kn olo Codice attribuito dal fabbricante Fabbricante Tipo operazione batea _ AZIENDAFARMACEUTICASPA inserimento __ batcb AZIENDA FARMACEUTICA S P A Inserimento batce AZIENDA FARMACEUTICA S P A Inserimento bated AZIENDA FARMACEUTICA S P A Inserimento lbatce AZIENDA FARMACEUTICA S P A Inserimento batet AZIENDA FARMACEUTICA S P A Inserimento lt bateg AZIENDA FARMACEUTICA S P A Inserimento ate AZIENDA FARMACEUTICA S P A Inserimento a batei AZIENDA FARMACEUTICA S P A Inserimento batel AZIENDA FARMACEUTICA S P A Inserimento baten AZIENDA FARMACEUTICA S P A Inserimento ibatet AZIENDA FARMACEUTICA S P A Inserimento batek AZIENDA FARMACEUTICA S P A Inserimento batow AZIENDA FARMACEUTICA S P A Inserimento pae oo AZIENDA FARMACEUTICA S P A Inserimento a Pagina 1 di 1 Indietro Detail Fields Field Name Description
66. M Manufacturer Profile material Cancella Eliminates the material selected by the user Same Conferma Closes the window confirming the Scheda Tecnica operations carried out by the user Chiudi Closes the window with out confirming the Scheda Tecnica actions carried out by the user Page Name LookUpTessuti This page is displayed in look up format and allows the user to insert edit and delete the biological tissues animal substances contained in the DM This is the activated by clicking on the Inserisci Modifica materali button visible on the Scheda Tecnica page On the upper part of the page the list of Biological tissues animal substances associated with the DM are displayed On the lower part of the page a box is displayed where the user can insert edit the information related to a biological tissue animal substance to be associated with the DM ___ Elenco degli eventuali tessuti biologici sostanze animali contenuti nel DM _ lt lt Presenza ae aa Stato di ee x x Famiglia di appartenenza provenienza Parte utilizzata dei tessuti Sostanza documenti BOVINA ITALIA CUORE N O Inserisci Modifica Cancella i _ conferma Famiglia di appartenenza Stato di provenienza Parte utilizzata dei tessuti i Sostanza BOVINA v Altra famiglia ITALIA y xj ANNESSI CUTANEI x Altra parte utilizzata ceee il o xj 3 i Disponibilit dei doc sulla provenien
67. M requires other DM for it s fuctionality SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 80 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Operations available None 2 3 1 10 1 2 Specifications Data Sheet Scheda Tecnica PaginaSch edaTecnica Visualizza tessuti LookUpTes suti Page Name Specifications Data Sheet This page allows users to view the technical data of a DM The data on a DM specifications Data Sheet are subdivided in the following areas e General technical characteristics e Sterilisation date e Material that the DM is made up of that come in direct contact with the Patient Each material is marked as to whether or not specific disposal is required e Biological tissues or substances of animal origin not vital Data The family of origin original condition the part utilised the presence or otherwise of documentation associate with the tissue are all specified e Presence of medicinal products the code name of each active ingredient is stated e Primary packaging of DM with the list of materials that form it e Directions for use In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 81 166 Ministry for Health
68. MMERCIALE ODONTOIATRIA da n Pagina 1 di 1 Stato del Dispositivo L IN LAVORAZIONE C CONSOLIDATO V VALIDATO P PUBBLICATO Seleziona Cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista a seconda delle operazioni Inserisci Modifica Cancella Fine Immissione in Commercio Validazione Consolida Dettaglio Iscrizione nel Repertorio Gestione Prodotti Assembled Device Data Fields Field Name Progressivo di sistema attribuito all assemblato Nome commerciale e modello Description Identification number assigned to the Assempbed device by the system during registration into the database Name of the system or kit as given by the manufacturer Tipo Codice attribuito dall assemblatore identificativo catalogo Type of assembled device The device can be one of two types e System e Kit Indication of product code assigned to the system or kit by the Assembler SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 117 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Assemblatore Name of the assembler of the assembled system or kit Stato Option to serch an Assembled device by its current status into the system In lavorazione Consolidato Validato Pubblicato Ruolo dell utente rispetto all assemblato Indicates t
69. MTR_Manufacturer_v1 1 doc February 2008 95 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Sistemi o Kit Assemblati c 2 Art 12 Ricerca Sistemi o Kit Assemblati c 2 Art 12 Criteri di Ricerca Progressivo di sistema attribuito CT all assemblato Assemblatore e Tipo O Codice attribuito dall assemblatore da identificativo catalogo a rTT ECM Nome commerciale e modello I Stato Ruolo dell utente rispetto OE all Assemblato Ricerca Nuova Ricerca Inserisci Gestione Prodotti Search Detail Fields Field Name Description Progressivo di Option to serch an Assembled device by its identification number assigned sistema attribuito by the system during registration into the database all assemblato Assemblatore Option to specify the name or the beginning of the Assembler Tipo Type of Assembled device The user has the option to choose between two types e System e Kit Codice attribuito A range of codes which includes the product code assigned to the dall assemblatore assembled system or kit by the assembler identificativo catalogo da a Nome Option to specify the commercial name or beginning of the commerciale e system or kit given by the assembler modello Assembled Tipo The list contains the types of assembled devices It varies based n th
70. Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Medical Devices Data Bank User Manual DM Manufacturer Profile Version 1 1 February 2008 SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 1 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile SUMMARY 1 INTRODUCTION ia aaacasa dii 4 1 1 DEFINITIONS AND GLOSSARY pr rara ae e 5 1 1 1 Glossary Of terms pia o aa 5 1 1 2 ACTON VIN siate ape 5 2 DM MANUFACTURER PROFILE sssoeeessesssssssooccesssssssssssooosesesseee 6 2 1 SYSTEM ACCESS aa aee tvs N ened A cer apa AAT 6 2 2 FUNCTIONAL AREAS OF THE SYSTEM Le 6 2 2 1 Dispositivi medici di Classe I Ha b HI Functional area 7 2 2 2 Dati azienda Functional area 8 2 3 DETAILED DESCRIPTION OF DISPOSITIVI MEDICI DI CLASS I ILA B M FUNCTIONAL AREA a ii 10 2 3 1 Menu option Dispositivo Medico DM iii Il 2 3 1 1 DSC ARG isco ele 11 2 3 1 2 View DM Uleist pe oneei tarn ela 12 2 3 1 3 Off m rket date css vandasawevesyervesay dive ira tt 16 2 3 1 4 DM Approval page rile 17 2 3 1 5 DM Signature pass ei iatrai 18 2 3 1 6 DM Summary Pages alan la e epe aeie 21 2 3 1 7 Registration on the 1Ndex i ire 22 2 3 1 8 DM IS StU ozio chee eee a athe ioe Sita aunts ae a 24 2 3 1 8 1 DM insert edit detail pages 25 2 3 1 9 Edit DM gala ahead 71 2 3 1
71. Notificato This field cannot be edited Codice Nome To select the code of the organization notified it is necessary to click on link Cerca a look up will appear from which it will be possible to search for the organization notified by code and name N Certificato Identification number of the EC certificate Such number cannot contain blank della marcatura spaces CE Data 1 Date of first release update renewal of the certificate rilascio aggiorna mento rinnovo Data Scadenza Expity date of the Certificate Certificato Estremi delle The essential details of the National an Community norms acknowledged during SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 145 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile norme armonizzate comunitarie e delle norme nazionali di recepimento eventualmente applicate Direttiva CE 32 2003 the fabrication of the DM ECDirective 32 2003 States whether or not the certificate should be in compliance with EC Directive 32 2003 the user will have to indicate whether the certificate is relative only to EC Directive 32 2003 also to the EC Directive 32 2003 or is not relative to the If the certificate is relative only to the EC Directive 32 2003 the field Allegato secondo cui stato certificato il dispositivo mustn t be compiled Allegato secondo cui stato certificato
72. OHNSON MEDICAL S P A Mandatario Responsabile dell immisione in commercio Tipo Assemblato SISTEMI PER RADIOLOGIA Altro Tipo Assemblato Componenti Sistema o Kit Codice attribuito Nome o Hesceene RAI dal fabbricante Fabbricante Tipo Stato nel identificativo Titolare Prodotto repertorio e modello ANELLO A ELLO SOCIETA AZIONARIA ACETABOLARE DI ACETABOLARE ARM0044 MATERIALE OSPEDALIERO DM P RINFORZO DI RINFORZO S A M O SPA AZIENDA FRANCESCO O TEIS Mice CATAUDELLA pei Assembled Device Data Fields Field Name Description Nome commerciale e modello Name of the system or kit the manufacturer has given Tipo Type of assembled device The device can be one of two types e System e Kit Codice attribuito dall assemblatore identificativo Indication of product code assigned to the system or kit by the Assembler catalogo Assemblatore Name of the assembler of the assembled system or kit Mandatario Name of Mandate Holder of the assembled system or kit Responsabile dell immissione in commercio Name of Marketing Director of the assembled system or kit Ruolo dell utente rispetto all assemblato Indicates the role carried out by the user with respect to the assembled device The user can adopt the following roles Assembler Manufacturer Mandate Holder Marketing Director SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008
73. SERS RSD PERS EREDE PES EDS VEDE DA ISEE DESDE DE EDS EDEN SEDE EDS ED VEE EDS DEVE RAR PS DEERE PETER pue re ten eedt E Dae eo ch hI PRES DEVE PEH PEN EDS EREDE ZA EREDE PE RS PERE PED PS ESD IEEE SEEN SEDE NE EN Tipo Nome commerciale e Codice attribuito dal Prodotto modio fabbricante ar NCE 33 J BAYER c f f NCE AA AA BAYER Pagina i dii Seleziona Per effettuare una delle operazione possibili cliccare su uno dei cerchietti in corrispondenza di uno dei componenti della lista La voce ALTRO in corrispondenza del campo Tipo Prodotto riferita ad articoli non DM diversi da Presidi Medici Chirurgici o Specialit Medicinali Inserisci Chiudi Modifica j Cancella Product Search Detail Fields Field Name Description Tipo prodotto The user can choose between the following types of product e Non CE marked DM e Other Nome commerciale e The commercial name or beginning thereof of the modello product can be inserted Codice attribuito dal The code attributed to the DM by the manufacturing fabbricante company can be specified identicativo catalogo Fabbricante The user can specify the name or part thereof of the Manufacturer of the product Classificazione CND The user can search for the national classification of the SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 65 166 Ministry for Health User Manual Design and Development NSIS DM Manufactur
74. SPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 132 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Torna alla Allows the user to return to the list of activities in ListaAttivitaIncorso lista attivit progress 2 3 4 Menu option Caricamento DM da file Screen flowchart AreaDownload Anagrafiche e Area Download AndGrafiche gi Caricamento UploadDispositivi Esito Caricamento Invio UploadFor mRicerca ConfermaUploadDi spositivi Ricerca Sinetsi Elaborazione UploadLisW UploadLisV uy isualiz is 2 3 4 1 UploadDispositivi This page allows a Fab Man RIC ASD user to attach a text or xml file containing data regarding their DM Such a file must comply with the format previously set out and has to be programmed by an automatic procedure which will upload the data of the DM within the database SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 133 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b HI gt Upload DM gt Upload DM Upload DM Sfoglia Invia Detail Fields Field Name Description Upload DM Having clicked on the Sfoglia button the user must select a text or xml file containing data on the DM from his own file System according to the record previously indicated Operation
75. SPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 9 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 Detailed description of the Dispositivo Medico di Classe I IIa b and IIT Functional area After having accessed the Dispositivo medico di Classe I Ila b and HI Functional area on the left hand side of the page the menu appears for the available functions in the area This menu will offer different options depending on the profile of the user connected In particular the FABBRICANTEDM user will see all of the options on the menu Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Sistemi o Kit Assemblati c 2 Art 12 gt Attivita in corso gt Caricamento DM da file SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 10 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 1 Dispositivo Medico DM Menu option Screen flowcharts Pagina Pagina di Sintesi Firm ListaD Dispositivo Medico Cancell Pagina Immissione in Commerci Ricere Fine Immissione i Iscrizione nel repertorio Visualizz a Pagina Iscrizione nel repertorio Pagine di dettaglio di un DM za di z modalit non editabile Pagine di dettaglio Di Un Dm editabile 2 3 1 1 DM Search Having clicked on Dispositivo Medico DM on the menu a page
76. SW_DISPO_RDM_MTR_Manufacturer_v1 1 doc 146 166 February 2008 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Moreover if the certificate is associated with the medical devices the page will give evidence of it displaying the list of the devices connected Home gt Dispositivi Medici di Classe I IIa b III gt Certificati CE gt Dati Certificato Dati Certificato Dati Certificato Fabbricante BAYER Di 0473 AMTAC CERTIFICATION Organismo Notificato SERVICES LTD Codice Nome N certificato della marcatura CE 1 ee Data 1 rilasciof aggiornamento rinnovo r Bee Data Scadenza Certificato 01 Z los Z 2008 Estremi delle norme armonizzate comunitarie e delle PPP norme nazionali di recepimento eventualmente applicate aes Direttiva CE 32 2003 Il certificato relativo solo alla Direttiva CE 32 2003 Il certificato relativo anche alla Direttiva CE 32 2003 Il certificato non relativo alla Direttiva CE 32 f 2003 Allegato secondo cui stato certificato il dispositivo Allegato VII File contenente il certificato cos 05Nov2002 zip Lista Dispositivi collegati Codice Progressivo ERE di sistema Fabbri t Sn LO I Classificazione Stato del Firma orbulo al tti e ione CONE nahh CND Dispositivo Mare DM identificativo e mo
77. The essential details of the National an Community norms acknowledged during norme the fabrication of the DM armonizzate States whether or not the certificate should be in compliance with EC Directive 32 2003 the user will have to indicate whether the certificate is relative only to EC Directive 32 2003 also to the EC Directive 32 2003 or is not relative to the ECDirective 32 2003 If the certificate is relative only to the EC Directive 32 2003 the field Allegato secondo cui stato certificato il dispositivo mustn t be compiled Indication of the attachments according to which the device has been changed SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 150 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile File contenente il A pdf file to be attached containing the image of the EC certificate To attach this certificato file it is necessary to use the Sfoglia button Operations available Action Description Page Name Salva Inserts in the data base the certificate of extension Pagina Lista Certificati associating it with the devices selected if the latter need a signature calls back the page of signature Indietro Voids the insertion and comes back to the previous Pagina Lista Certificati page 2 4 detailed description of the Dati Azienda functional area Having gained access to the dati Azienda
78. _DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 56 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile classification click on the cerca link a look up will open from which it will be possible to search for a CND classification by code and description Operations available Action Description Page name Gestione Opens a window where the user has the option to LookUpRicercaProdotti Prodotti manage Non DM articles i e the Altro and Non CE marked kind Ricerca Runs a search with criteria put in place and ListaElementiDaCorrela displays the DM list or list of Non DM products re that match the same criteria Reset Clears the search criteria previously put in place Same Page Name FormRicercaElementiDaCorrelare Articoli Non DM This page allows the user to put search criteria in place in order to view the listo f DM and other Non DM products to add as components of a system or kit This page will display different search criteria depending on the type of DM chosen In the is paragraph we will examine the case in which the user wishes to search among the Non DM items In particular if the user chooses Articolo Non DM he can refine his search choosing between Non CE marked DM Medicinies Medical and surgical aids Other Should a DM non marcati CE be chosen a search will be run of the Non CE marked DM registered in the databa
79. a page In the box at the top of the page a list of possible active ingredients associated with the DM is displayed In the box in the middle of the page displays the search fields to be determined at least one margin must be put in place in order to obtain the list of active ingredients from which the user may select and then link to the DM In the box at the end of the page a list of consistent active ingredients are visible with the search criteria in place TROT ARI ICodice Princio o oa Sua DER Ativ f Denominazione Principio Attivo Tipo 2601 RELA Sinonimo E Principi Attivi Codice Principio Attivo Denominazione Principio Attivo i seca Principi Attivi Codice Princio Attivo Denominazione Principio Attivo Tipo Farmacopea italiana o r I 2601 CARISOPRODOLO europea Agg Principi Attivi al DM Active Ingredients Search Detail Fields Field Name Description Codice Principio Attivo Option to search by inserting the active ingredient code Nome Principio Attivo Option to search by inserting the active ingredient name or part there of SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 43 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Active Ingredients List Detail Field Field Name Description Codice Principio Attivo Code of the Active ingredient Nome Principio Attivo Name of the
80. a Per aggiungere un componente occorre preventivamente cliccare su uno dei quadratini in corrispondenza de componente o dei componenti presenti nella lista Aggiungi Componenti Dettaglio Assemblato Gestione Prodotti Non DM Item Data Search Fields Field Name Description Cerca Tra The user must choose if he wants to search among DM or other non DM items Different search criteria will be displayed depending on this choice Tipo di Prodotto The user can choose between the following types of non DM items e Surgical and medical aids e Medicinal products e Other Nome commerciale e The non DM item s name or beginning of given by the modello manufacturer or title holder can be indicated SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 111 166 Ministry for Health User Manual DM Manufacturer Profile Codice attribuito dal fabbricante identicativo catalogo Product code assigned to the non DM item by the Manufacturer Numero Registrazione The registration is only in reference to Medical and surgical aids Codice AIC The AIC code refers solely to Medicinal products Fabbricante The user can indicate the name or part thereof of the Manufacturer referring to DM that are not stamped medical and surgical aids and other Titolare The Title holder s name or beginning of can be indicated In reference to medicines Non DM Item Data List Search Fi
81. al to contact to make for official communications Alternatively the following must be stated e The name and surname of the individual to whom official communications must be referred e The department to which official communications must be referred Riferimento per comunicazioni Ufficio Office to contact to make official communications Alternatively the following must be stated e The name and surname of the individual to whom official communications must be referred e The department to which official communications must be referred Riferimento per e Telephone number of the office of the person to contact in order to comunicazioni make official communications Telefono Riferimento per e Fax number of the office of the person to contact in order to make comunicazioni official communications Fax Riferimento per e Email address of the office of the person to contact in order to make comunicazioni official communications e mail Registration in accordance with Art 13 Dlgs 46 97 Eventuale num Di registrazione art 13 Digs 46 97 Art 13 Dlgs 46 97 Final registration no Data of person responsible for vigilance over DM Responsible della vigilanza sul DM Nome Name of the person responsible for vigilance over DM Responsible della vigilanza sul DM Cognome Surname of the person responsible for vigilance over DM Responsible della vigilanza sul DM Telefo
82. ame Description Progressivo di sistema Unique identification number assigned to each DM in the attributo al DM database If R appears next to the consecutive number assigned to the DM by the system it means that the DM has been registered on the index Fabbricante Corporate name of the DM Manufacturing Company Codice attribuito dal fabbricante identicativo Code attributed to the DM by the manufacturing company better known as the identification catalogue catalogo da a Nome commerciale e Commercial name or model of the DM modello Classificazione CND CND Classification assigned to the DM Stato nella base dati The status of the DM in the database It can change status in the following order e L Processing e V Valid e P Published e C Confirmed Operations available Action Description Page Name Ricerca Activates a search based on the criteria inserted Same Nuova Clears the search criteria previously defined Same SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc Design and Development NSIS February 2008 15 166 Ministry for Health User Manual DM Manufacturer Profile Design and Development NSIS ricerca Inserisci Allows access to the DM general data entry page Pagine di dettaglio di un DM in Modalit editabile Modifica Allows the user to access the pages containing Pagine di dettaglio di deta
83. ante mercato Indication of the number of DM pieces old excluding pieces sold to the SSN This field is required if the year of sale has been entered Tipo di dato Indication of the type of data No of pieces sold to the rest of the market either estimated or exact This field is required if the year of sale has been entered Operations available Action Description Page Name Ins Altro Adds an empty line in which the user can insert the Same dato di commercial information of a DM regarding a sales year vendita Salva Allows the information entered to be saved Same SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 52 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 1 8 1 5 Composition of Systems and kits Para 3 Art 12 NE TEO CURCI Cancella Componente Salva Composizione di sistemi o kit c 3 Art 12 ListaElementiCorrel ati p 1 lookUpGest oneProdotti Inserimento Modifica Pd 35 Gestione Prodotto Ins risci Componente i NA lookUpRice rcaProdotti Ricerca ListaElement iDaCorrelare Cancella Riterca Pa FormRicercaEleme ntiDaCorrelare Page Name ListaElementiCorrelati This page allows the user to add or delete a component in a system or kit in accordance with Para 3 Art 12 The components of a system or kit in accordance with Para 3 Art12 There are three possible
84. art thereof of the Manufacturer of the DM Codice attribuito dal fabbricante identicativo catalogo The code attributed to the DM by the manufacturing company can be indicated referring to non CE marked DM and to others Numero registrazione The registration number refers exclusively to surgical and medical aids Codice AIC The AIC code refers exclusively to Medicinal products Fabbricante The name of the Manufacturer or part thereof can be indicated referring to non stamped DM Surgical and medical aids and other Titolare The name of the Title holder or part thereof can be indicated referring exclusively to Medicinal products Non DM Item List Detail Fields Field Name Description Nome commerciale e modello The name given to the product by the manufacturer Codice attribuito dal The code attributed to the product by the manufacturing SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 63 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile fabbricante identicativo catalogo company refering to non stamped DM and other Numero registrazione The registration number refers exclusively to surgical and medical aids Codice AIC The AIC code refers exclusively to Medicinal products Fabbricante The name of the Manufacturer referring to non stamped DM Surgical and medical aids and other
85. articles i e the Altro and Non CE marked kind Cancella Allows the user to delete components Same Componenti selected from the composition of the system or kit Salva Allows the information entered to be saved Same Page Name FormRicercaElementiDaCorrelare DM This page allows the user to put search criteria in place in order to view the DM list or the list of other Non DM products to add as components to the system or kit Depending on the criteria specified in the Cerca tra field the page will display different search criteria In this paragraph we will examine the case in which the user intends to search among DM After having requested a DM list it is necessary to put another search margin in place In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 55 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Dispositivo Medico DM gt Composizione di sistemi o kit a3 Art 12 Composizione di sistemi o kit c 3 Art 12 Tipo Dispositivo Medico SISTEMA Nome commerciale e modello DISPOSITIVO MEDICO Codice attribuito dal fabbricante identificativo AOL catalogo Fabbricante MAILBOX Progress
86. ary packaging of the DM Operations available Action Description Page Name Ins Altro Confirms the material indicated by the user Same Materiale providing a new line so that new material can be selected Cancella Deletes the material selected by the user Same Conferma Closes the window confirming the operations SchedaTecnica carried out by the user Chiudi Closes the window without confirming the actions SchedaTecnica carried out by the user Page Name LookUpMetodiRisteril This page is displayed in look up format and allows the user to insert and delete methods of sterilisation applied to the DM which come in direct contact with the patient It is activated by clicking the inserisci modifica materiali button found on the Scheda Tecnica page When saving the specification data at least one method of sterilisation of the DM must be indicated if the DM has been marked as being Sterile METODI DI RISTERILIZZAZIONE SR i Descrizione altro Metodi di Numero di metodo di risterilizzazione sterilizzazioni p PERS roio sterilizzazioni Inserisci Metodo Cancella Conferma AI fine di effettuare il salvataggio del i metodi di risterilizzazione necessario cliccare nell ordine in corrispondenza dei bottoni Inserisci Materiali e Conferma Methods of re sterilisation of DM Detail Fields Field Name Description SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v
87. at come into direct contact with the patient This is the activated by clicking on the Inserisci Modifica materali button visible on the Scheda Tecnica page Should the Classe Materiali field read Metallici Leghe it will the be necessary to indicate the name of the metal When saving the data on the specifications data sheet the user must indicate at least one of the materials contained in the DM that comes in direct contact with the patient Sanaa Spero Classe del Materiale Materiale speciali di smaltimento POLIMERICI ACRILATI Ss ALLUMINIO a ANADIO ANTIMONIO METALLICI LEGHE p Nome Lega si Materials contained in the DM Detail Fields Field Name Description Class di Materiale Type of material that the DM is made up of Materiali Material that the DM consists of Condizioni speciali di_ Indication if the material indicated requires specific disposal smaltimento Nome Lega Name of the metal This field is displayed if in the corresponding Classe del Materiale field the Metallici Leghe option was selected Operations available Action Description Page Name Ins Altro Materiale Confirms the material indicated by the user Same providing a new line in order to chose a new SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 39 166 Ministry for Health User Manual Design and Development NSIS D
88. ates the national classification of the DM To select a CND classification click on the Cerca link a look up will open from which it will be possible to search for a CND classification by code and description Operations available Action Description Page name Ricerca Runs a search with criteria put in place ListaComponenti and displays the DM list that match the same criteria Reset Clears the search criteria previously put Same in place Dettaglio Allows user to return to the data page of DetAssemblatoInsMod Assemblato the assembled device Gestione Opens a window where the user has the LookUpRicercaProdotti Prodotti option to manage insert edit delete view Non DM items type Altro 2 3 2 5 ListaComponenti DM This page allows the user to view the list of DM to add as components of the assembled system or kit coherent with the search criteria put in place Detailed information concerning the system or kit which is being inserted or edited are displayed SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 105 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b IIl gt Sistemi o Kit Assemblati c 2 Art 12 Composizione di sistemi o kit c 3 Art 12 Nome commerciale e modello SISTEMA DI PROVA Tipo SISTEMA Codice attribuito dall assemblatore ASSO1 identi
89. ati Generali del Dispositivo Medico Ricerce Progressivo di sistema attribuito al DM CETTE Tipo DM Fabbricante esd Nome commerciale e modello I Codice attribuito dal fabbricante identificativo da catalogo a Classificazione CND zi Cerca Search Detail Fields Ricerca Nuova ricerca Field Name Description Progressivo di sistema attribuito al DM Option to serch a Medical Device by its identification number assigned by the system during registration into the database Tipo DM Indicate the class of Medical device There are three following types of DM e Device e System e Kit Fabbricante The name or or beginning thereof of the Manufacturer of the DM can be specified Nome commerciale e modello The commercial name of the DM or beginning thereof can be specified Codice attribuito dal fabbricante identicativo catalogo The specific code attributed to the DM by the manufacturer Classificazione CND Indicates the national classification of the DM This field is cannot be edited To select a CND classification click on cerca a SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 71 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile look up will open from which it will be possible to search for a CND classification by code and description Oper
90. ations available Action Description Page name Ricerca Runs a search with criteria put in place and GesDMNecessariD displays the DM list or list of Non DM products aAquistare that match the same criteria Reset Clears the search criteria previously put in place Same Page Name GesDMNecessariDaAquistare This page displays a list of DM to be linked according to the criteria put in place in the search page In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM Once the DM to be linked have been selected The Uso esclusivo Uso non esclusivo and Motivo dell esclusivita fields will automatically become unblocked SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 72 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Eventuali altri DM necessari al funzionamento Ricerca Eventuali altri DM necessari al funzionamento Tipo Dispositivo Medico SISTEMA Nome commerciale e modello DISPOSITIVO MEDICO Codice attribuito dal fabbricante identificativo ADI catalogo Fabbricante MAILBOX Progressivo di sistema attribuito al DM 9942 Dati Generali del Dispositivo Medico Criteri di Ricerca Progressivo di siste
91. b III L Assemblato PRY0101 DATEX OHMEDA SPA Pubblicato E stata accettata la richiesta di pubblicazione ell Assemblato Dati dell assemblato Tipo Assemblato sistema o Nome commerciale e modello PROVA TE dall Assemblatore PEVO101 Assemblatore patexconmena spa TTT Progressivo di sistema attribuito Be o all Assemblatore Inserire eventuali note per il rifiuto Chiudi attivita Torna alla Lista attivita 2 Modification request from the DGFDM department In this case at the top of the page the phrase Non e stata accettata la richiesta di pubblicazione dell assemblato will appear and then the principle data of the assembled device will be synthesised 3 Modification request due to failure to pass the automatic tests in the system In this case the list of errors which determined the failure to pass the automatic tests in the system is displayed with the principle data of the assembled device SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 131 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III L Assemblato NOMEO1 DATEX OHMEDA SPA incompleto L Assemblato non composto correttamente Yedi la lista dei campi obbligatori mancanti disegutio riportata Dati dell assemblato Tipo Assemblato SISTEMA Nome commerciale e modello nome 1 Codice attribuito Gy dall Assemblatore
92. ber of the transaction carried out Importo versamento The amount deposited Progressivo del cc postale Account number of postal checking account Tassa postale Postal tax paid for the transaction carried out Motivo pagamento Reason for the payment Operations available Action Description Page Name Conferma Saves the information Pagina Iscrizione nel inserted repertorio Esci Closes the window without Pagina Iscrizione nel saving the actions carried repertorio out by the user 2 3 1 8 DM Insertion In order to insert a new DM the user must proceed as follows 4 Run the DM search from the Dispositivo Medico DM option in the menu specifying the search parameters and then clicking on Ricerca after having verified the DM you wish to insert is not already on the index SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 24 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile A Click on the Inserisci button 6 Insert the relative information relative to Dati Generali and confirm the action by clicking on the Salva button da Insert the specific information that corresponds to the menu options that will then be accessible after the Dati Generali has been saved using the Salva button 2 3 1 8 1 DM detail page for insertion editing The detail pages of a DM in read only mode are only accessible b
93. bricante BAYER Progressivo di sistema attribuito al DM 1738 Dati Generali del Dispositivo Medico PEDEN AUIEN VENIEN NIEN ENEK NENEK NEN N NEINN MYCIA NIEN AIEN EIEN ONY ICK NIIIN NIC EK MNN NEN Ye o Y o o _Y y e P ee ei Codice casi Fabbricante pria i carota Stato nel PRE ee la vi Uso non dell esclusivit repertorio we l catala aj esclusivo i z ANGEL NOME I i ANSEL NOME ET pedea A caga COMM E si aa v ER S p A MODELLO DS sivo x t f i i GA i ESAOTE SPA 556667 SIRINGA USO FF L o i Ie Lido 0 8 RS Co na e cn Pagina i dii Tale funzionalit consente di collegare dispositivi medici tra di loro E possibile selezionare i DM necessari tra quelli che sono stati preventivamente inseriti se i DM si riferiscono ad altri fabbricanti mandatari resp imm in comm sono selezionabili solo i DM validati o pubblicati Per ciascuno dai dispositivi necessari viene richiesto di indicare se l unico utilizzabile uso esclusivo o meno uso non esclusivo per un determinato scopo Il DM corrente pu essere validato se i DM necessari al suo funzionamento sono stati validati Seleziona Cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista a seconda delle operazioni DM required Detail Fields Field Name Description Fabbricante Manufacturer of t
94. c February 2008 69 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Action Description Page name Inserisci Grants access to the DM search page of the DM to be linked GesDMNecessariFormRicerca Modifica Grants access to the details of the linked DM selected in order to edit the data regarding the exclusiveness or otherwise of the association GesDMNecessariModifica Cancella Allows the association between the DM and the DM selected from the list to be removed Same Page Name GesDMNecessariForm Ricerca This page allows the user to search for DM to link up At least one search margin is required In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 70 166 User Manual Design and Development NSIS DM Manufacturer Profile Ministry for Health Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Eventuali altri DM necessari al funzionamento Ricerca Lista DM Tipo Dispositivo Medico SISTEMA Nome commerciale e modello DISPOSITIVO MEDICO Codice attribuito dal fabbricante identificativo AOL catalogo Fabbricante MAILBOX Progressivo di sistema attribuito al DM 9942 D
95. cante Nome commerciale e modello Codice attribuito dal fabbricante identificativo da a catalogo Classificazione CND j 7j Cerca Ricerca Nuova ricerca Codice commerciale e fabbricante Fabbricante iii gueie Tipo DM Seleziona alli rg eee BAYER c fi KIT n n a ESAOTE SPA c fo kit n Pagina 1 dii Stato nel repertorio C CONSOLIDATO L IN LAVORAZIONE P PUBBLICATO V VALIDATO Seleziona Per aggiungere un componente occorre preventivamente cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista Aggiungi Componenti Gestione Prodotti DM Components Search Detail Fields Field Name Description Cerca tra The user must provisionally choose if he intends to request a DM list or other Non DM product list Different search criteria will be displayed depending on this choice Progressivo di sistema Option to serch a Medical Device by its identification SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 60 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile attribuito al DM number assigned during registration into the database Tipo DM Indicate the class of Medical device There are the following types of DM e Device e System e Kit Fabbricante The user can insert the name or part thereof of the Manufacturer of the DM Codice attribu
96. cante Indication of the Manufacturer of the product Classificazione CND Operations available Action Description Page name Salva Saves the information entered by the user Same Chiudi Closes the product management window ListaAssemblati Lista Allows the user to return to the product list without LookUpProdRic Prodotti saving the information entered 2 3 3 Menu option Attivit in corso Fab Man RIC ASD Screen flowchart SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 124 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Lista Attivita ListaAttivit DettaglioDM alnCorso Filtro DettaglioA ssembalto FiltroAttivit alncorso 2 3 3 1 ListaAttivitaInCorso Fab Man RIC ASD In order to gain access to the page containing the list of activities in progress the user must click on the Lista Attivit menu option This page allows the Fab Man RIC ASD user to view the activity list in progress referring to DM am assembled systems or kits Para 2 Art 12 that have been validated by the respective user The user may receive the following messages in reference to each DM validated e Successful publication by the DGFDM department e Modification request from the DGFDM department e Modification request due to failure to pass the following automatic tests 1 2 3 Missing required gene
97. cription Page name Ricerca Runs a search with the criteria in place and Same displays a list of the DM that correspond to the same criteria Reset Clears the search criteria previously DetAssemblatoInsMod SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 107 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile entered Aggiungi Allows user to add the components DetAssemblatoInsMod Component selected to the assembled system or kit e Dettaglio Allows he user to return to the data page of DetAssemblatoInsMod Assemblato the assembled device Gestione Opens a window where the user has the LookUpRicercaProdotti Prodotti option to manage insert edit delete and view Non DM items type Altro 2 3 2 6 RicercaComponenti Non DM items This page allows search criteria for the components to be put in place The user must choose whether he wants to search among the DM or non DM items Based on this choice the page will display differing search criteria In this paragraph we will examine the case in which the user wishes to search among non DM items The user may associate the following typology 1 Medical and surgical aids Ze Medicinal products 3 Other After having decided whether to search among the DM or non DM items the user must insert an additional search margin Detailed information concerning the system or kit which is be
98. d by the health authority regarding the tissue substance selected can be found This field is required if the Disponibilt dei doc delle Autorit Sanitarie field is ticked This field is an alternative to the File da allegare field Operations available Action Description Page Name Inserisci Displays a box in which the user can insert information Same regarding biological tissue animal substance to be associated with the DM Modifica Displays a box in which the user can edit information Same regarding biological tissue animal substance selected Cancella Eliminates the selected biological tissue animal Same substance associated with the DM Salva Saves the information inserted by the user of a biological Same tissue animal substance associated with the DM in the insert edit box Conferma Closes the window confirming the operations carried out Scheda by the user Tecnica Chiudi Closes the window without confirming the actions Scheda carried out by the user Tecnica SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 42 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Page Name LookUpSostanze This page is displayed in look up format and allows one or more active ingredients to be linked to a DM This is achieved by clicking the Inserisci Modifica principi attivi button which is found on the Scheda Tecnic
99. d fichiodeno Dati tessut biologici o sostanze di origine animale nom vitalt Presenza Tessuti sostanze N Elenco degh eventuali tessuti biofogici sostanze animali contenuti nel Dos Stato di Parte utilizzata dei tessuti Presenza Lada proventenza Sostanza documenti Mieunlizzateceus Presenza Modicmali Preseare Medicinal sodden Goan dome Uta medicinale derivato de plasma da sangue o plasma umano umano Umano Principi Attivi Codice Principio Attivo Denominazione Principio Attive Peri dispostiv medic contenant medicinali selezionare principio stuvo contezionamento primerio del OM I 1 materiali prevalenti costituenti fl confezionamento primario del DM necessitano di n condizioni speciali di smaltimento Peri soli DM sterili o da sterilizzare Materiali indicare materiali FAL prevalenti del ENTE J contezionamento a Modalit di pulizia disinfezione zi Numero di i So i Descrizione altro Mated di risterilizzazione ciorsiiszazioni metodo di sterilizzazioni DM Specifications Data Fields Field Name Description General technical characteristics Descrizione Description of the general technical characteristics of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 82 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile
100. d used to re sterilise the DM risterilizzazione This field is required if in the Monouso field it was marked No Se altro Metodo di Description of method of re sterilisation if it is not found on the risterilizzazione previously loaded list specificare This field is required if in the Metodo di Re sterilizzazione field it was marked Other Modalita di Method used to clean disinfect the DM pulizia disinfezione This field is required if in the Monouso field it was marked No Numero di Maximum number of times it is permitted to sterilise a DM sterilizzazione This field is required if in the Monouso field it was marked No consentite ove stabilito Operations Available Action Description Page Name Salva Saves the information inserted Same Inserisci Modifica Allows the user access to the administrative LookUpMetodiSteril metodi window of the sterilisation methods of a DM sterilizzazione Inserisci Modifica Allows the user access to the administrative LookUpMateriali materiali window of the Material contained in the DM Inserisci Modifica Allows the user access to the administrative LookUpTessuti Tessuti window of the biological tissues animal substances contained in the DM Inserisci Modifica Allows the user access to the administrative LookUpSostanze i window of the Active ingredients contained in the DM Inserisci Modifica Allows the user access to the administrative LookUpMateraliConf material
101. della legge 23 dicembre 2005 n 266 come modificat dall articolo 1 comma 625 lettere b della legge 27 dicembre 2006 n 296 a seguito dell iscrizione in repertorio ad alla pubblicazione un Dispositivo Medico consultabile dalle aziende sanitarie dalle regioni e dalle Province autanome c Trento e Bolzano a meno dei dati di vendita Il repertorio costituisce una raccolta delle informazioni fornite dei dichiarant ciascun dichiarante si assume la piena responsabilit riguardo alle informazior fornite sia in merito ai dati generali che a quelli relativi ai singoli Dispositivi Medici La pubblicazione dei dati non configura alcuna forma di approvazione de part del Ministero della Salute La Direzione Generale dei farmaci e disposibri medici si riserva la facolt di effettuare in ogni momento controlli su quanto dichiarate ai sensi del decreto legislative 24 febbraio 1997 n 46 DATI AZIENDA L Area di Gestione Dati Azienda consente il completamento dei dati anagrafici dell utente relativamente alle informazioni sulle propria Azienda These areas display different functions depending on the user connected 2 2 1 Functional Area of Dispositivi medici di classe I IIa b III The Functional Area of Dispositivi medici di classe I Ila b II contains the administration functions of the purchase and validation process of the Classified medical devices In this area the Manufacturers Mandate Holders and Marketing directors of the Med
102. dello catalogo Y031299 AUSILI PER LA TERAPIA 10044 BAYER 78945 PRES cat DELL ERNIA Lo AUSILI ADDOMINALI ALTRI Indietro Operations available Action Description Page Name Indietro Comes back to the previous page Pagina Lista Certificati 2 3 5 5 Pagina Modifica Certificato SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 147 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile This page is activated by the page Lista certification selecting a certificate and clicking on button Modifica allows the user to modify the data of the certificate which has no extension and no medical devices validated or published inserted If the certificate selected to be modified is associated with a medical device in processing the name of the manufacturer becomes unmodifiable talking in fact of the same manufacturer of the device associated Home gt Dispositivi Medici di Classe I Ila b IIl gt Certificati CE gt Dati Certificato Dati Certificato Dati Certificato Ri 2 Ai A Estremi delle norme armonizzate comunitarie e delle PPP norme nazionali di recepimento eventualmente Direttiva CE 32 2003 Il certificato relativo solo alla Direttiva CE 32 2003 Il certificato relativo anche alla Direttiva CE 32 2003 Il certificato non relativo alla Direttiva CE 32 2003 Allegato secondo cui stato certifica
103. device validated or published SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 142 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Certificati CE Ricerca Certificati CE Criteri di Ricerca Data Scadenza Certificato Organismo Notificato Codice Nome SE Cerca Reset Ricerca Nuova ricerca Doo i dele i ie N norme armonizzate a Data scadenza Organismo Comunitarie e delle File da esteziona Certificato Notificato E allegare marcatura recepimento CE eventualmente MIAO REGIO AMAR e He _applicate si AMTAC 2020 31 12 2008 CERTIFICATION E Care zip O ___SERVICES LTD _ oon AMTAC io 2020 31 12 2009 CERTIFICATION BALLARIN O SERVICES LTD MARIO zip Pagina 1 di 1 Inserisci Fields Details Field Name Description N Certificato della marcatura CE Data Scadenza Identification number of the EC certificate Expiry date of the Certificate Codice Nome Certificato Organismo Indication of the code and name of the organization notified Notificato This field cannot be edited To select the code of the organization notified it is necessary to click on the Cerca link a look up will appear from which it will be possible to search for the organization notified by code and name Operation
104. e 2 3 2 8 DetAssemblatoVis This page allows the user to view information regarding an assembled system or kit in read only mode The detailed information of an assembled device can be viewed by the following types of users 1 Fab Man RIC ASD users as regards their own inserted assemble devices 2 DGFDM users as regards all assembled devices that are have the validato or publicato status 3 REGIONE and AZIENDESANITARIEDM users In order to view the data of a DM both types of user must proceed as follows 1 Run the search for the assembled device by clicking on Gestione Assemblati in the menu insert the search criteria by clicking on the Ricerca button 2 Select the desired device and click on the Visualizza button to access the data page SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 113 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b IIIl gt Sistemi o Kit Assemblati c 2 Art 12 Dettaglio Sistema o Kit Assemblato c 2 Art 12 Nome commerciale e modello ASSEMBALTO PROVA Ulteriori Nomi commerciali dell assembalto IR Rie Tipo SIS Codice attribuito dall assemblatore identificativo catalogo CODICE1 Azienda che ha inserito l assemblato JOHNSON amp JOHNSON MEDICAL S P A Ruolo dell utente rispetto ssEMBLATORE all assemblato Assemblatore JOHNSON amp J
105. e However the data of companies that also have other users acting as manufacturers may no longer be edited Those users who evidently registered in a later phase may then edit the data regarding the companies in question using the Gestione Dati Azienda gt Dati Generali Dichiarante feature Home gt Dati Azienda gt Gestione Dati Azienda gt Dichiarazione altri fabbricanti Modifica Dati Fabbricante Dati Fabbricante Fabbricante BRISTOL Codice Fiscale BRL234TRD347V56 Partita IVA VAT number 123455678901 Data Fields Nazione ITALIA Comune ALTINO Cerca Provincia CH Localit Straniera Indirizzo fi 1234 C A P ZIP code Telefono 56565656 e mail mail eng it Field Name Description Fabbricante Name of the manufacturer Cannot be edited Codice Fiscale Fiscal code of the manufacturer Cannot be edited Partita IVA VAT number VAT number of the manufacturer This field can only be in the insertion phase Required if the Nation indicated is a country other than Italy Nazione Nationality of the manufacturer Cannot be edited Comune City of the manufacturer To select a city click on Cerca a look up will open where the user can search for the city If the nation of the manufacturer is Italia then Comune and Provinca must be indicated otherwise state the Localit straniera
106. e 2 3 1 3 Off Market This page allows the user to insert edit the off market date of a Valida or Pubblicato DM To insert the off market date of a DM the user must proceed as follows 1 Run the search for the DM from the Dispositivo Medico DM option on the menu 2 Select a Valido or Pubblicato DM and click on Fine immisione in commercio 3 Insert the off market date and confirm the operation by clicking on the Salva button SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 16 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile If the off market date has been indicated it will appear in the general data page in reference to the DM In the upper part of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM Fine Immissione in Commercio Tipo Dispositivo Medico DISPOSITIVO DISPOSITIVO MEDICO DI PROVA MODIFICATO PER Nome commerciale e modello RICHIESTA DI RETTIFICA Codice attribuito dal fabbricante identificativo catalogo Fabbricante BAYER Progressivo di sistema attribuito al DM 1832 00t Dati Generali del Dispositivo Medico lt Data di fine immissione in commercio fiz foi 2223
107. e DM in the database The status can be changed in the following order e L Processing e V Valid e P Published SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 92 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Operations available None 2 3 1 10 1 6 Other possible DM required for its functionality Menu Eventuali altri DM necessari al funzionamento GoslMinec essariLista Page Name GesDMnecessariLista This page allows the user to view the list of DM required for the functionality of a Parent DM In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM In correspondence to the Nome commerciale e modello of each correlated DM there is a link which allows the user to view the general data of the respective DM selected SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 93 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Eventuali altri DM necessari al funzionamento Elenco Eventuali altri DM necessari al funzionamento Tipo Dispositivo Medico KIT Nome commerciale e modello KIT 5 Codice attribuito dal fabbricante identificativo catalogo Fab
108. e choice made in the corresponding Tipo field Therefore two distinct types of system and kits exist Stato Option to serch an Assembled device by its current status into the system In lavorazione Consolidato Validato Pubblicato Ruolo dell utente Option to serach an Assembled device by the role carried out by the user rispetto with respect to it Assemblatore Mandatario Responsabile al Assemblato dell immissione in commercio Altro soggetto delegato dal fabbricante Operations available Action Description Page name SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 96 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Ricerca Runs a search with criteria entered and displays ListaAssemblati the assembled system or kit that match that criteria Reset Clears the search criteria previously put in Same place Inserisci Grants access to the systems and kits data entry DetAssemblatoInsMod page Gestione Opens a window where the user has the option LookUpRicercaProdotti Prodotti to manage insert edit delete view Non DM articles type Altro 2 3 2 2 Assembled device list This page allows the user to view the list of assembled system and kits based on the search criteria entered The following information is available on each system and kit Identification numbe
109. e per Indicates the type of communication There can be three il Fabbricante e types of communication regarding a validated DM or Comunicazione assembled device e Successful publication by the DGFDM department e Modification request from the DGFDM department e Modification request due to failure to pass the automatic tests in the system Data Comunicazione Indicates the data where the activity is assigned to the DGFDM department Operations available Action Description Page name Filtra Runs a search of the activities in progress based on ListaAttivitaIncorso search criteria inserted Cancella Clears the search criteria previously put in place Same filtro Chiudi Closes the search margin window without running the ListaAttivitaIncorso search 2 3 3 3 DettaglioDM Fab Man RIC ASD This page allows the user to view the principle information regarding the activity in progress resulting in validation publication There are three possible types of communication for a validated DM l Successful publication in the DGFDM department In this case at the top of the page the phrase E stata accettata la richiesta di pubblicazione per la dispositivo will appear and then the principle data of the DM will be synthesised SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 127 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile H
110. effettuare il download delle anagrafiche di riferimento da utilizzare ai fini dell invio massivo dei dati Sono a disposizione tutte le anagrafiche dei file in formato microsoft excel a meno della classificazione GMDN per motivazioni legate alla licenza Anagrafica Classificazione CND Anagrafica Metodi di sterilizzazione Anagrafica materiali costituenti il DM Anagrafica elementi nel caso di leghe metalliche Anagrafica materiali costituenti il confezionamento Anagrafica principi attivi Anagrafica famiglie animali Anagrafic suti di origine animale sost iolegiche Anagrafica Nazioni 2 3 5 Menu option Certificati CE Screen flowcharts Salva Gestione certificati CE Inserimento Pagina Inserimento Certificato Pagina Ricerca certificati Inseriment Ricerca Pagina Lista b s Certificati Dettaglio Pagina Modifica Cancella Proroga ee Pagina Proroga Certificato Pagina Dettaglio Certificato Certificato 2 3 5 1 Pagina Ricerca Certificati Having clicked on Certificati CE gt Gestione Certificati CE on the menu a page appears which allows the user to define the search criteria of the EC certificates To activate a search of these certificates the user must define at least one margin From this page the user may also access the insertion page of a new certificate clicking on the Inserisci button SISG_SSW MSW_DISPO_RDM_MTR_Manufac
111. elds Field Name Nome commerciale e modello Codice attribuito dal fabbricante identicativo catalogo Description Name of non DM item or beginning of given by the manufacturer or Title holder Product code assigned by the Manufacturer to the non DM item type Altro Numero Registrazione Registration number Referring only to Medical and surgical aids Codice AIC AIC code referring solely to Medicinal products Fabbricante Name of the Manufacturer of medical and surgical aids and other Titolare Title holder In reference to medicines Operations available Design and Development NSIS Action Description Page name Ricerca Runs a search with the criteria in place Same and displays a list of the non DM items that correspond to the same criteria Reset Clears the search criteria previously Same entered Aggiungi Allows user to add the components DetAssemblatoInsMod Componente selected to the assembled system or kit Dettaglio Allows the user to return to the data DetAssemblatoInsMod Assemblato page of the assembled device Gestione Opens a window where the user has LookUpRicercaProdotti Prodotti the option to manage insert edit delete and view non DM items type Altro SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc 112 166 February 2008 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profil
112. elected in the case of Class IIb Attachment II or Attachment III together with either Attachment IV V or VI must be selected in the case of Class III Attachment II or Attachment III together with either Attachment IV or V must be selected in the case of a Active implant device Attachment II or Attachments III together with either IV V or VI must be selected Links to other DM The DM is dependent on other DM in order to operate Indication of whether or not the DM is dependant on other DM in order to operate Operations Available Action Description Page name Salva Saves inserted information Same Cancella Deletes the association with the EC Certificate Same Certificato selected Inserisci Allows access to the page of the EC Pagina Inserimento Certificato Certificates association Certificati Aggiungi Allows user to add a field which the user can Same insert an additional commercial name Rimuovi Allows the removal of additional commercial Same name selected Page Name Certificates This page is displayed in look up format and allows the user to search and associate the EC certificates with the DM This feature is activated by clicking on the Inserisci Certificato button found on the Dati Generali page The certificates which can be inserted are those registered in the section management of the certificates issued to the same manufacturer of the device In corres
113. em In this case the list of errors which determined the failure to pass the automatic tests in the system is displayed with the principle data of the DM Home gt Dispositivi Medici di Classe LIIa b III Il DM C03 COPIA COPIA PLUTO ha dei campi incompleti Il DM C03 COPIA COPIA PLUTO non puo essere validato perche non tutti i campi obbligatori sono stati valorizzati Yedi la lista dei campi obbligatori mancanti disegutio riportata Dati del dispositivo Tipo DM pIsposITIVvo Nome commerciale e modello copice ZERO TRE Codice attribuito dal fabbricante coa copra cora TT identificativo catalogo NOS COLTA SORIA Fabbricante PLUTO Progressivo di Sistema Attribuito aa TTT al DM Campi Mancanti Documentazione incompleta Vai al DM Chiudi attivita Torna alla Lista attivita j SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 129 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Detail Fields Field Name Description Tipo DM Indication of the type of classified Medical Device The following types of DM exist Device System Kit Nome commerciale e modello Denomination of the DM as assigned by the Manufacturer Codice attribuito dal fabbricante identicativo catalogo Specific code attributed to the DM by the manufacturer Fabbricante Name of the Manufacturer of the DM Progressivo di sistema att
114. em register the device as part of the index SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 22 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile The index contains a collection of information supplied by Manufacturers each Manufacturer assumes full responsibility for the information supplied be it for the general data as for that regarding single Medical Devices The publication of data does not represent the approval of the Health Department in any form The executive management of pharmaceutical products and medical devices reserve the right to carry out an inspection on what has been declared at any time as laid out in the legislative decree February24 1997 No 46 In order to register a DM inserted in the databank onto the index it must be either a valid or published status Detail Fields Field Name Description Tipo Dispositivo Medico Type of DM Three types exist Device System Kit Nome commerciale e Commercial name or model of the DM modello Codice attribuito dal Code attributed to the DM by the manufacturing fabbricante identicativo company better known as the identification catalogo catalogue Fabbricante Corporate name of the DM Manufacturing Company Flag iscrizione repertorio A flag which indicates whether or not the user wishes to place their DM on the index and thus make it available to the S S N The default setting is No
115. ents must be added one of which must be a DM Corresponding with the Nome commerciale e modello field of each component of the assembled device a link is provided which allows users to view additional information regarding the component selected SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc 100 166 February 2008 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Sistemi o Kit Assemblati c 2 Art 12 Sistema o Kit Assemblato c 2 Art 12 Nome commerciale e modello Ulteriori Nomi commerciali dell assembalto f f f f f Tipo si Codice attribuito dall assemblatore EEE identificativo catalogo Ruolo dell utente rispetto all Assemblato ASSEMBLATORE mi Azienda che ha inserito l assemblato BoHnson STO ANSONEARDICOL EDA Dettaglio OHNSON amp JOHNSON MEDICAL S P A Assemblatore OD MEDI Dettaglio Cerca Mandatario Dettaglio Cerca Responsabile dell immisione in commercio Dettaglio Cerca Componenti Sistema o Kit 7 e modello identificativo Titolare Prodotto repertorio catalogo Aggiungi j Elimina Codice i Nome attribuito dal Descrizione commerciale fabbricante Fabbricante fine Stato nel Seleziona il i 1 Seleziona Cliccare su uno dei quadratini in corrispondenza del componen
116. er Profile product referring solely to non CE marked DM This field is cannot be edited To select a CND classification click on cerca a look up will open from which it will be possible to search for a the same classification by code and description or part there of Product List detail Fields Field Name Description Tipo prodotto The user can choose between the following types of product e Non CE marked DM NCE e Other ALT Nome commerciale e The name given to the product by the manufacturer modello Codice attribuito dal The specific code attributed to the product by the fabbricante manufacturer identicativo catalogo Fabbricante The name of the Manufacturer of the product Operations available Action Description Page name Cerca Runs a search with criteria put in place and Same displays the DM list or list of Non DM products that match the same criteria Chiudi Closes the product management window The page from which the window was opened Inserimento Displays the insertion page of a product LookUpGestioneProdotti Modifica Displays a details page in editable mode LookUpGestioneProdotti of the product selected from the list Visualizza Displays a detail page in non editable LookUpGestioneProdotti mode of the product selected from the list Cancella Deletes the product selected from the list Same Page Name LookUpGestioneProdotti
117. eri pansan i i Dorumenti Disponibilit del Dispantbritt det doc sulla provenienza del tessuto doc sui metodi di Dispenibilit dei doc EHTI vratiamento e SINS r sostanza 7 inattivezione I documantac logs oat LookUpTessuti Detail Fields Field Name Description SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 84 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Famiglia di appartenenza Family of origin of the biological tissue animal substance contained in the DM Altra Famiglia Stato di provenienza Description of the family of origin of the biological tissue animal substance contained in the DM This field is required if the corresponding Famiglia di Appartenenza was indicated as Altro Original condition of the biological tissue animal substance Parte utilizzata dei tessuti Parts of tissue used in DM Altra parte utilizzata Description of the parts of the biological tissue animal substance used in the DM This field is required if the corresponding parte utilizzata dei tessuti was marked Altro Disponibilit dei doc sulla provenienza del tessuto sostanza Indication of the presence of documentation on the origin of the tissue substance Fila da allegare in riferimento al campo Disponibilta de doc Sulla provenienza del tessuto sostanza File containing the documentati
118. f a electronic signature Home gt Dispositivi Medici di Classe I IIa b III gt Dispositivo Medico DM Dispositivo Medico DM Lista dei DM in fase di consolidamento Codice i a Some attribuito dal Nome Classificazione Stato processo attua af Fabbricante fabbricante commerciale e CND amt cake DM identificativo modello i M030202 BENDE MEDICATE CON ZINCO OSSIDOE Avviato CON ALTRI COMPONENTI BH EEE ILL PH RR A LOLLI LILLE LL LRRE RE LELE J DISPOSITIVO CHIRURGICO Per verificare l esito del Consolidamento utilizzare il pulsante Torna alla lista attivit DM List in approval phase Detail Fields Field Name Description Progressivo di sistema Unique identification number assigned to each DM attributo al DM in index Fabbricante Corporate name of the DM Manufacturing Company Codice attribuito dal Code attributed to the DM by the manufacturing fabbricante identicativo company better known as the identification catalogo catalogue Nome commerciale e Commercial name or model of the DM modello Stato processo validazione The status of the process It can change status in the following order e Initiated e Uninitiated Operations available Action Description Page Name Vai alla Allows user to return to the activity list Lista Attivit Lista attivit SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 18 166 Minis
119. f the DM can be inserted Codice attribuito dal fabbricante identicativo catalogo da a Range of codes which includes the product code assigned to the DM by the Manufacturer Nome commerciale e modello The commercial name of the DM or beginning thereof as given by the Manufacturer can be inserted Classificazione CND Indicates the national classification of the DM This field is cannot be edited To select a CND classification click on cerca a look up will open from which it will be possible to search for a CND classification by code and description List Detail Fields Field Name Description Fabbricante the name of the Manufacturer of the DM Codice attribuito dal fabbricante identicativo catalogo The code attributed to the DM by the manufacturing company Nome commerciale e modello The name of the DM as given by the manufacturer Uso esclusivo Uso non esclusivo Indicates if the DM to be linked has an exclusive use regarding the Parent DM Motivo dell esclusivit Reason for its exclusiveness Stato nella base dati The status of the DM in the database It can change status in the following order e L Processing e V Valid e P Published Operations available Action Description Page name Ricerca Runs a search with criteria put in place and Same displays the DM list or list of Non DM products that match the same
120. ficativo catalogo Ruolo dell utente rispetto all Assemblato ASSEMBLATORE Assemblatore BAYER Mandatario Responsabile dell immissione in commercio Tipo Assemblato SISTEMI PER RADIOLOGIA Progressivo di sistema attribuito al DM 463 Criteri di ricerca dei componenti Cerca tra ARTICOLO NON DM DM Progressivo di sistema attribuito al DM Tipo DM pIsPOSITIVO e Fabbricante i Nome commerciale e modello Girinsamo Codice attribuito dal fabbricante identificativo da a catalogo Classificazione CND p E vi Cerca Ricerca Nuova ricerca Codice f Nome attribuito dal Stato nel i commerciale e fabbricante Fabbricante repertorio Tipo DM Seleziona modello identificativo i i catalogo i SIRINGA a ee ee een Me Pagina 1 di 1 Stato nel repertorio C CONSOLIDATO L IN LAVORAZIONE P PUBBLICATO V VALIDATO Seleziona Per aggiungere un componente occorre preventivamente cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista Aggiungi Componenti Dettaglio Assemblato Gestione Prodotti DM Data Search Fields Field Name Description Cerca tra The user must choose if he wants to search among DM list or other Non DM products Different search criteria will be displayed depending on this choice Progressivo di sistema Option to serch a Medical device by its identifica
121. h the user can search for and select a new manufacturer Classificazione CND Indicates the national classification of the DM referring solely to Non CE marked DM This field is cannot be edited To select a CND classification click on cerca a look up will open from which it will be possible to search for a the same classification by code and description or part thereof Operations available Action Description Page name Salva Saves the information entered by the user Same Chiudi Closes the product management window The page from which the window was opened Lista Allows the user to return to the product LookUpRicercaProdotti SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 67 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Prodotti search page 2 3 1 8 1 6 Other possible DM required for one to function Cancella GesDMnec essariLista Eventuali altri DM necessari al funzionamento Inserisci GesDMNecess ariDaAcquisire difica GesDMNece ssariModifica GesDMNecessa riFormRicerca Page Name GesDMNecessariLista This page allows the user to link one DM to another DM that are required for its functionality This page is accessible by the user in the following cases e During the insertion phase of the DM after the registration of the general data e During the edi
122. he DM required Codice attribuito dal The code attributed by the manufacturer to the DM fabbricante identicativo required catalogo Nome commerciale e The commercial name of the DM required modello Uso esclusivo Uso non Indicates if the DM to be linked has an exclusive esclusivo use regarding the Parent DM Motivo dell esclusivit Reason for its exclusiveness Stato nella base dati Status of he DM in the database This status can be changed in the following order e L in progress eV Valid SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 94 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile e P Published Operations available None 2 3 2 Menu option Sistemi o kit assemblati c 2 Art 12 Screen flowchart Iscrizione al repertorio ListaAssembiat Elimina DetAssemdla oinsMo Visuallzz Aggiungi 2 3 2 1 Assembled device search After selecting Gestione assemblati from the menu a page appears that allows the user to put criteria in place to run a search of the assembled systems or kits according to Para 3 Art 12 To run the search of the assembled devices it is necessary to enter at least one search parameter If the user uses the Tipo as a search parameter choosing between Sistema or Kit the page refreshes displaying another search margin Tipo Assemblato SISG_SSW MSW_DISPO_RDM_
123. he National classification of the DM This field is not editable The system automatically completes the field following the choice of a GMDN associated with one unique CND Alternaively it is also possible to specify a CND code unconnected with the GMDN code selecting a specific check in the same look up Certifications Classificazione CE D L vo 46 97 attuazione Dir CE 93 42 D L vo 517 92 attuazione Dir CE 90 385 Indication of the EC classification of the DM The EC classification can adopt the following principles Class I with measurement functions Class I non sterile and or measurement functions Class I sterile Class I sterile with measurement functions Class Ila Class IIb Class III Active implant devices Allegati secondi cui stato marcato il Indication of the attachments according to which the device has been marked SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 29 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile dispositivo The following inspections are initiated in the case of Class I sterile I DM with measurement functions Attachments VII and IV or Attachments VII and V or Attachments VII and VI must be selected in the case of Class I DM Attachment VII must be selected in the case of Class IIa Attachment II or Attachment VII together with either Attachment IV V or VI must be s
124. he commercial name or beginning of the commerciale e system or kit the assembler has given modello Iscrizione nel Repertorio SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 98 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Assembled Tipo Such search criteria are visible only after having set out the Tipo field The list contains the types of assembled devices It varies based on the choice made in the corresponding Tipo field Therefore distinct types of system and kits exist Stato Option to serch an Assembled device by its current status into the system In lavorazione Consolidato Validato Pubblicato Ruolo dell utente rispetto all Assemblato Option to serach an Assembled device by the role carried out by the user with respect to it Assemblatore Mandatario Responsabile dell immissione in commercio Altro soggetto delegato dal fabbricante Assembled Devices List Detail Fields Field Name Description Progressivo di sistema attribuito all assemblato Assemblatore Identification number assigned to the Assembled device by the system during its registration into the database Name of the Assembler Codice attribuito dall assemblatore identificativo catalogo da a Product code assigned to the assembled system or kit by the assembler
125. he role carried out by the user with respect to the assembled device The user can adopt the following roles e Assembler e Mandate Holder e Marketing Director e Other individual delegated by the Manufacturer Tipo Assemblato Indication of the type of assembled device Assembled Components List Data Fields Field Name Description Nome commerciale e Name of the component modello Fabbricante Titolare Indicates the name of the Manufacturer title holder of the component Tipo prodotto Type of component The component of an assembled device can be e DM e Medical and surgical aids PMC e Medicines SPM e Other ALT Operations available Action Description Page name Salva Saves the information entered ListaAssemblati 2 3 2 11 Assembled Device Approval Page This page allows the user to view the list of assembled devices in the approval phase The activation of approval corresponding to one or more assembled devices involves the activation of consistency ad coherency tests on the information entered Should errors arise in this phase these will be visible on the activity list feature on the menu option Attivit in corso Should the tests result positive the device s status is updated to Consolidato a preliminary stage before the validation while awaiting the electronic signature SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 118 166 Ministry for Health
126. her non DM items Different search criteria will be displayed depending on this choice Tipo di Prodotto The user can choose between the following types of non DM items e Surgical and medical aids e Medicinal products e Other SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 109 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Nome commerciale e The DM s name or beginning of given by the modello manufacturer can be indicated Codice attribuito dal Product code assigned to the DM by the fabbricante identicativo Manufacturer catalogo Codice AIC The AIC code refers solely to Medicinal products Fabbricante The user can indicate the name or part thereof of the Manufacturer referring to DM that are not stamped medical and surgical aids and other Titolare The title holder s name or beginning of can be indicated In reference to medicines Operations available Action Description Page name Ricerca Runs a search with the criteriain ListaComponenti place and displays a list of the non DM items that correspond to the same criteria Reset Clears the search criteria Same previously entered Dettaglio Allows the user to return to the DetAssemblatoInsMod Assemblato data page of the assembled device Gestione Opens a window where the user LookUpRicercaProdotti Prodotti has the option to manage insert
127. i i Indietro Dettaglio Operazioni Detail Fields Field Name Description Nome File The name of the file attached by the user containing the DM data Data invio Date in which the user uploaded the file N DM Position of the Dm within the file Nome Campo Name of field incorrectly evaluated Tot Inserimento Number of insertions carried out by mass uploading distinguishing between those with a positive result and those with a negative one Tot Aggiornamenti Number of upgrades carried out by mass uploading distinguishing between those with a positive result and those with a negative one Tot Cancellazione Number of deletions carried out by mass uploading distinguishing between those with a positive result and those with a negative one Tot Fine immissione in Number put in Off market carried out by mass uploading commercio distinguishing between those with a positive result and those with a negative one SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 137 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Descrizione Errore Description of the error Operations available Action Description Page name Indietro Allows the user to return to the file list Upload ListaFile Dettaglio Allows the user to view the data of the operations UploadSntesiFile Operazioni carried out successfully 2 3 4 6 Upload
128. i Generali Scheda Tecnica Documentazione Dati Commercali ERE Compoziziona di sistemi o kit Dati Generali 0 3 Art 12 ATER Z E TEETER Eventuali altri OM necessari al Tipo DM 1 I funzionamento ric Sistemi o Kit A blati c 2 nome commerciale e modello PISPOSITIVO ISOLE VANATI Art 12 _rr11r TR Codice attribuito dal fabbricante identificativo gt Attivita in corso 1 catalogo Caricamento DM da file Regolamento recante norme per le prestazioni di assistenza protesica erogabili nell ambito del 2145 APPARECCHI ACUSTICI O AUSILI A Servizio Sanitario Nazionale Modalit di DEF L UDITOIN T COD EN ISO 2145 x Erogazione e Tariffe Ruolo dell utente che ha inserito il DM F46 Azienda che ha inserito il DM DITTA GARAT e a ia Dettaglio 4 DITTA DISABATINO Fabbricante Mandatario Responsabile dell immissione in commercio Dettaglio Classificazione a 27845 A IMPLANTABLE APTI Nomenclatore GMDN completo lt amp STITUTE FOR A FINGER THUMB OR a x Classificazione CND POS10 PROTESI LIGAMENTOSE Certificazioni Classificazione CE D L vo 46 97 attuazione Dir CE 93 42 D L vo 507 92 attuazione Dir CE 90 385 Allegati secondo cui stato certificato il Il dispositivo Allegato II Allegato II Allegato IV Allegato Y Allegato VI Allegato VII
129. i z Gli importi sono espressi in Euro Dati di vendita det OM B Anno di N aes E N pezzi venduti vendita venduti al SSN Tipo di dato al restante Tipo di dato delom ORSONO SR IRR SOOT Eon mercato poo SIRIA GIRA leffettivo C stimato leffettivo stimato C Ins Altro dato di vendita Per SSN si intende Aziende Sanitarie Locali Aziende Ospedaliere Strutture pubbliche e private accreditate Salva Commercial data Fields Field Name Description Current data DM oggetto di Indication whether or not the DM is destined to be used by the SSN fornitura alle strutture dell SSN Prezzo unitario di Unit sale price of a DM free of tax listino del singolo dispositivo senza SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 51 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile IVA TIVA Indication of the IVA applied to the DM Presenza del codice a barre Indication as to whether or not the DM bears a barcode DM Sales data Anno di vendita DM Indication of the year DM was sold No pezzi venduti al SNN Indication of the number of pieces sold to the National Health Service This field is required if the year of sale has been entered Tipo di dato Indication of the type of data No of pieces sold to the SSN either estimated or exact No pezzi venduti al rest
130. ical Devices can insert edit and delete their pertaining devices Once the information on the device has been confirmed it must go through the validation process in which the user must provide his electronic signature When the Manufacturers announce the validation of a device this allows the head of pharmaceuticals and the executive management department of a device to carry out a credit merit inspection on what the Manufacturers have inserted and whether or not to allow their publication on the DM index The outcome of the inspection carried out by the department will then be communicated to the manufacturers Mandate Holders Marketing directors other individuals delegated by the Manufacturer s device Manufacturers Mandate Holders Marketing directors other individuals delegated by the Manufacturer s device can register a device in the index providing the essential details of the payment transaction in accordance with articlel paragraph 409 letter e of the 27 December 2006 Law No 266 as modified by Art 1 Para 825 letter b of the December 27 Law No 296 Having registered a Medical Device on the index and published it it is available to be consulted by the autonomous regional and provincial Health Boards of Trento and Bolzano except for the sales data SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 7 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile The index is made up of
131. ication according to the GMDN Global Medical completo Device Nomenclature of the DM Classificazione CND Indication of the National classification of the DM Certifications Classificazione CE Indication of the EC classification of the DM The EC classification D L vo 46 97 can adopt the following principles attuazione Dir CE 93 42 D L vo 517 92 attuazione Dir CE 90 385 Class I with measurement functions Class I non sterile and or measurement functions Class I sterile Class I sterile with measurement functions Class Ila Class IIb Class III Active implant devices Allegati secondo cui stato marcato il dispositivo Indication of the attachments according to which the device has been marked N Certificato della marcatura CE Identification number of the EC stamp Data Scadenza Certificate Expiry date of Certificate Organismo Notificato Nome Indication of the code and name of the organisation notified Estremi delle norme armonizzate comunitarie e delle norme nazionali di recepimento eventualmente applicate Direttiva CE 32 2003 Links to other DM Indication of the Essential details of the National and Community norms acknowledged during the fabrication of the DM States whether or not the certificate should be issued in compliance with EC Directive 32 2003 Il DM per svolgere li sua funzione necessita di altri DM Indicates whether or not the D
132. ich already exists see paragraph 2 3 5 6 SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 144 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b IIIl gt Certificati CE gt Dati Certificato Dati Certificato Dati Certificato Fabbricante Cerca Dettaglio Organismo Notificato Codice Nome E Cerca N certificato della marcatura CE L Data 1 rilascio aggiornamento rinnovo L Data Scadenza Certificato Anci Estremi delle norme armonizzate comunitarie e delle g norme nazionali di recepimento eventualmente applicate c ee Direttiva CE 32 2003 Il certificato relativo solo alla Direttiva CE 32 2003 Il certificato relativo anche alla Direttiva CE 32 2003 Il certificato non relativo alla Direttiva CE 32 f 2003 Allegato secondo cui stato certificato il dispositivo foo i w File contenente il certificato ees _Sfoglia Salva Indietro Fields Details Field Name Description Fabbricante Indication of the manufacturer of the DM for which the certificate has been issued To select a manufacturer it is necessary to click on link Cerca there will appear a look up from which it is possible to make a search Organismo Indication of the code and name of the organization notified
133. ields Field Name Description Metodo di Method used to sterilise the DM sterilizzazione This field is required if the Sterile field is marked Si Periodo massimo di Maximum length of use of the DM utilizzo This field is required if the Sterile field is marked Si Metodo di The method of sterilisation can be validated sterilizzazione according to the harmonised norms validato secondo other This field is required if the Sterile field is marked Si Se altro metodo di Description of method of sterilisation if it is not found on the previously sterilizzazione loaded list specificare This field is required if in the Metodo di sterilizzazione field it was marked Other Operations Available Action Description Page Name Inserisci Metodo Confirm the method of sterilisation indicated by Same the user providing a new line for the insertion of the new method Cancella Eliminates the method of sterilisation selected by Same the user SISG_SSW MSW_ DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 38 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Conferma Closes the window confirming the actions Scheda Tecnica carried out by the user Page Name LookUPMateriali This page is displayed in look up format and permits the insertion and deletion of materials contained in the DM th
134. il Indication of the attachments according to which the device has been changed dispositivo File contenente il A pdf file to be attached containing the image of the EC certificate To attach certificato this file it is necessary to use the Sfoglia button Operations available Action Description Page Name Salva Memorizes in the data base information relative to Pagina Lista Certificati the certificate inserted e comes back to the previous page Indietro Voids the insertion and comes back to the previous Pagina Lista Certificati page 2 3 5 4 Pagina Dettaglio Certificato Activated by the page Lista dei certificate selecting a certificate and clicking on the Dettaglio button the page allows the user to visualize in non editable mode the following detailed informations concerning a certificate the manufacturer of the device or devices for which the certificate has been issued the organization notified which issued the certificate the certificate number of the EC stamp the date of issue adjournment renewal the expiry date of the certificate the essential details of the National and Community norms acknowledged and eventually applied indication of whether or not the certificate should be in compliance with EC Directive 32 2003 the attachment according to which the device has been certficated the file attached containing the image of the certificate SISG_SSW M
135. ils of the DM selected and to edit those details un DM in Modalit only visible to FABBRICANTEDM users editabile Cancella Allows the user to delete the DM selected only Same visible to FABBRICANTEDM users Consolida Allows the approval of a DM in In Lavorazione Pagina di dettaglio status The Consolida action brings up the page sullo stato dell avvio with the list of DM in the approval phase del processo specifying whether the process has been activated or not The outcome of the process if negative will be marked on the activity list or will change it s status to C that is Consolidato Valida Activates the signature page through which Option Pagina di firma to validate one or more DM with Consildato status Changing the status of the DM does not occur simultaneously with the Valida action Copia Allows the user to copy a DM in order to insert a Pagine di dettaglio di new DM which has the same characteristics as the un DM in Modalit copied DM editabile Fine Grants access to the off market data entry page of Pagina di fine immission the DM selected immissione in ein commercio commerci o Iscrizione Allows the user to enter the payment details on the Pagina iscrizione nel al data entry page repertorio repertorio Visualizza Allows the user to enter the details of the DM Pagina di dettaglio di selected onto the detail page in read only form un DM in Modalit non editabil
136. ing inserted or edited are displayed SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 108 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Sistemi o Kit Assemblati c 2 Art 12 Composizione di sistemi o kit c 3 Art 12 Nome commerciale e modello Tipo Codice attribuito dall assemblatore identificativo catalogo Assemblatore Ruolo dell utente rispetto all Assemblato Tipo Assemblato Criteri di ricerca dei componenti Cerca tra ARTICOLO NON DM pm Tipo Prodotto PRESIDIO MEDICO CHIRURGICO x Nome commerciale e modello pasta DDT Codice attribuito dal fabbricante identificativo aaa catalogo Numero Registrazione E Codice AIC Pe Fabbricante eee 5 Titolare i o Nome commerciale e Numero Registrazione Fabbricante Seleziona modello PASTA DDT EXTRA FEO 2697 INDUSTRIE CHIMICHE CAFFARO S P A E Pagina 1 di 1 Stato nel repertorio C CONSOLIDATO L IN LAVORAZIONE P PUBBLICATO V VALIDATO Seleziona Per aggiungere un componente occorre preventivamente cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista Aggiungi Componenti Dettaglio Assemblato Gestione Prodotti Non DM Item Data Search Fields Field Name Description Ricerca The user must choose if he wants to search among DM or ot
137. io pa Informativo ds i ESHA Login too Sanitario IMPRESE PORTALE Questo il Portale di accesso all area privata del Nuovo Sistema Informativo Sanitario del Ministero delle Selute Nella colonna del menu a sinistra sono indicate tutte le applicazioni disponibili in base al proprio profilo autorizzativo Si pu fare click su una o pi applicazioni per operare Dispositivi Medici Scadenza password Il Portale di Accesso avverta l utente della imminente scadenza della password almeno 15 giorni prima In caso di comparsa di tale avvertimento l utente pregato di cambiare la propria password Si rammenta che una password scaduta non pu essere ripristinato eutonomemente ma il servizio deve essere richiesto all HelpDesk del Ministero della Salute al numero 06 4324393 nel sequente orariu dal luned al venerd 8 00 13 00 Il servizio di Help Desk dispone di 6 linee RA Gestione Profilo L applicazione ci Gastione Profilo sampre presenta permette di moditicara il propne profilo The system is contains two specific functionality areas 1 ClassI II a b and III Medical Devices 2 Company Data SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 6 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile SS dear are Repertorio Dispositivi Medici x WI Sistema i Informativo die ilari bra de Sanitario BANCA DATI DISPOSITIYI MEDICI
138. iteria previously put in Same place SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 61 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Gestione Opens a window where the user has the LookUpRicercaProdotti Prodotti option to manage Non DM articles i e the Altro and Non CE marked kind Aggiungi Adds the component s selected to the ListaElementiCorrelati Component system or kit e Page Name ListaElementiDaCorrelare Articoli Non DM This page allows the user to e View the list of DM and then choose which components to add to the system or kit e Runanew search In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Composizione di sistemi o kit c 3 Art 12 Composizione di sistemi o kit c 3 Art 12 Tipo Dispositivo Medico KIT Nome commerciale e modello KIT 5 Codice attribuito dal fabbricante identificativo 555 catalogo Fabbricante BAYER Progressivo di sistema attribuito al DM 1738 Dispositive Medico Dati Generali del Criteri di ricerca dei componenti Cerca tra ARTICOLO NON DM om Tipo Prodotto SPECIALITA MEDICINALE a Nome commerciale e modello ue A
139. ito dal Option to indicate the range of codes which includes the fabbricante identicativo product code assigned to the DM by the Manufacturer catalogo da a Nome commerciale e The DM s name or beginning of given by the modello manufacturer can be inserted Classificazione CND Indicates the national classification of the DM This field is cannot be edited To select a CND classification click on the cerca link a loo up will open from which it will be possible to search for a CND classification by code and description Numero Pezzi Indication of the number of pieces the system or lit requires referring to the components DM List Detail Fields Field Name Description Nome commerciale e The DM s name given by the manufacturer modello Codice attribuito dal The code attributed to the DM by the manufacturing fabbricante identicativo company catalogo Fabbricante The name of the Manufacturer of the DM Stato nella base dati Numero pezzi Indication of pieces which the system or kit requires referring to the components This field can be edited Tipo DM Indicate the class of Medical device There are the following types of DM e Device e System e Kit Operations available Action Description Page name Ricerca Runs a search with criteria put in place and Same displays the DM list or list of Non DM products that match the same criteria Reset Clears the search cr
140. ivazione field was ticked This field is an alternative to the Indirizzo email sito web field Indirizzo e mail sito web in riferimento al campo Disponibilit dei doc sui metodi di trattamento e Email address web site where the documentation on methods of treatment and deactivation can be found This field is required if the Disponibilt dei doc sui metodi di trattamento e inattivazione field was ticked This field is SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 41 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile inattivazione an alternative to the File da allegare field Disponibilit dei doc delle Autorit Sanitarie Indicate the presence of documentation provided by the Health authority regarding the tissues substances selected Fila da allegare in riferimento al campo Disponibilit dei doc delle Autorit Sanitarie File containing the documentation provided by the Health authority regarding the tissues substances selected The file must be in pdf form This field is required if the Disponibilta dei doc delle Autorit Sanitarie field is ticked This field is an alternative to the Indirizzio Email sito web field Indirizzo Email sito web in riferimento al campo Disponibilita dei doc delle Autorit Sanitarie Email address web site where the documentation provide
141. ivo Medico DM gt Documentazione alla gt Dispositivo Medico DM Documentazione Sistemi o Kit Assemblati c 2 Art 12 gt Attivita in corso gt Caricamento DM da file Tipo Dispositivo Medico DISPOSITIVO Nome commerciale e modello YTR Codice attribuito dal fabbricante identificativo 4955 catalogo Fabbricante DITTA DISABATINO Progressivo di sistema attribuito al DM 905 Ln cab recrerali del Disouslivo Mpuiog Il presente dispositivo medico sar oggetto di fornitura elle strutture del Servizio Sanitario Nazionale SM Si precisa che in caso di risposta affermativa necessario fornire di seguito gli estrami del versamento della tariffe di 100 previsto dall articolo 1 c 409 della L 232 02 2005 n 266 come modificato dall articolo 1 0 825 della L 27 12 2006 n 296 Versamenti MOTIVAZIONE DATA_VERS QUOTA_ ER_POST _ Aggiungi versamento This page allows the user to register a device on the index supplying the co ordinates of the payment made as in accordance with Article 1 Paragraph 409 e of the December 23 2005 Law No 266 and as modified by Articlel Paragraph 825 b of the December 27 2006 Law No 296 All of the DMs registered on the index may be viewed exclusively by the A S L and by the business This action has two steps The user expresses the desire to insert the DM in the index The user inserts the payment details Only after having done this can the syst
142. ivo di sistema attribuito al DM 9942 Dati Generali del Dispositivo Medico Criteri di ricerca dei componenti Cerca tra DM ALTRO PRODOTTO Progressivo di sistema attribuito al DM o TipoDM 3 Fabbricante EE Nome commerciale e modello _ oil Codice attribuito dal fabbricante identificativo da catalogo a Classificazione CND Zi Cerca Ricerca Nuova ricerca Gestione Prodotti DM Component Search Fields Field Name Description Cerca Tra The user must provisionally choose if he intends to request a DM list or other Non DM product list Different search criteria will be displayed depending on this choice Progressivo di sistema Option to serch a Medical Device by its identification attribuito al DM number assigned during registration into the database Tipo DM Indicate the class of Medical device There are the following types of DM e Device e System e Kit Fabbricante The user can insert the name or part there of of the Manufacturer of the DM Codice attribuito dal Option to indicate the range of codes which includes the fabbricante identicativo product code assigned to the DM by the Manufacturer catalogo da a Nome commerciale e The DM s name or beginning of given by the modello manufacturer can be inserted Classificazione CND Indicates the national classification of the DM This field is cannot be edited TO select a CND SISG_SSW MSW
143. lizza Grants the user access to the data page of the UtenteDatiFabbricante Manufacturer selected in read only format Visualizza Cancella Allows the user to delete a link with a selected Same Manufacturer 2 4 1 3 FormRicercaFabbricante This page allows the user to run a search of a manufacturer he represents to be indicated Other than the nation the fiscal code or the VAT number must be specified as search criteria Should the search have a positive outcome i e the manufacturer is present in the database the information resulting from the search on the Manufacturer will be displayed Should the search have a negative outcome i e the manufacturer is not present in the database the data entry fields of a new Manufacturer will be displayed Home gt Dati Azienda gt Gestione Dati Azienda gt Dichiarazione altri fabbricanti Inserimento Altro Fabbricante Ricerca per Inserimento Fabbricante Codice Fiscale Fr roi Partita IVA VAT number Nazione ITALIA xl _Ricerca Search Detail Fields Field Name Description Fabbricante The manufacturer can be indicated Codice Fiscale The Fiscal code of the manufacturer can be indicated Partita IV A V AT Number The VAT number of the manufacturer can be indicated Nazione The manufacturer s nationality can be selected from the mono selection list SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 159 166
144. lv CorrelazioneUtent eFabbricanteLista Modifica Visualizza UtenteDatiFabbric anteVisualizza 2 4 1 1 DatiAnagraficiUtente This page which is accessed by clicking on the corresponding menu option Dati Generali Dichiarante allows the user to manage his own company s personal data SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 152 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile This function must be used the first time the system is accessed by the user as all other functions remain disabled until such time as the user s personal details have been completed The page displays the general data in read only format which the Fab Man RIC ASD user has already indicated in the initial phase of access to the application In particular the following are indicated e Name Surname and Fiscal code of the individual delegated e Name Fiscal Code and VAT number of the company that the user represents The user must complete the data regarding his company n reference to e Legal Headquarters required e Legal representation required e Contact reference e Registration according to the provisions of Art 13 Legislative Decree 46 97 optional e Details of the person responsible for vigilance of the DM optional Having registered this information the user must enter his electronic signature SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_
145. ma attribuito al DM ss Tipo DM pIsposItIvo el Fabbricante eE Nome commerciale e modello fr TTT TI Codice attribuito dal fabbricante identificativo da catalogo a Classificazione CND yj Cerca Ricerca Nuova ricerca Codice attribuito dal Nome z z Uso esclusivo Motivo Stato nel Fabbricante fabbricante commerciale Uso non esclusivo dell esclusivit repertorio Seleziona identificativo e modello catalogo ELEKTA Uso esclusivo Al S p A LL14 MAX999 a pi Vv ET medical ANGEL NOME devices 333 COMM E z Vv S p A MODELLO x Pagina 1 di 1 Stato nel repertorio C CONSOLIDATO L IN LAVORAZIONE P PUBBLICATO V VALIDATO Seleziona Per aggiungere un componente occorre preventivamente cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista Saha Search Detail Fields Field Name Description Progressivo di sistema attribuito Option to serch a Medical Device by its identification al DM number assigned by the system during registration into the SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 73 166 Ministry for Health User Manual DM Manufacturer Profile database Tipo DM Indicate the class of Medical device The following are types of DM e Device e System e Kit Fabbricante The name or or beginning thereof of the Manufacturer o
146. marked with the CE logo 4 Publication of all components in reference to the systems or kits covered by Para3 Art12 SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 19 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Firma digitale Convalida del Dispositivo Medico con firma digitale Inserire la propria SmartCard nel lettore quindi cliccare su bottone Firma Per utilizzare la funzionalit di firma con SmartCard sar necessario aver per installato sul Proprio PC il Layer Crittografico Firma e Cifra Si raccomanda di rileggere attentamente il testo prima di firmarlo Verr firmato solo il testo contenuto nell area di testo sottostante Il sottoscritto verdi mario per conto di BAYER convalida in data 07 04 2005 i seguenti DM aie sr sie a t aie aie de sie aie sie ae aie sie aie ae ahe ahe sie aie sie she ahe TI E aie sie aie sheshe Tipo DM DISPOSITIVO Nome commerciale e modello DISPOSITIVO MEDICO DI PROVA 2 MANDATARIO Codice attribuito dal fabbricante identificativo catalogo DMP02M Ruolo dell utente rispetto al DM MANDATARIO Fabbricante BRISTOL Classificazione CND AGHI Nomenclatore GMDN completo AGAR IMPRESSION MATERIAL DENTAL 35862 0 3 10 NOT FOR PRODUCT IDENTIFICATION Classificazione CE Classe I non sterile e senza funzioni di misura Allegati secondo cui stato certificato il dispositivo Allegato VII Legame con altri DM No Dati Commerciali
147. mmercial data of a DM The commercial data of a DM are subdivided in two areas e Current data of the DM e Annual sales details of the DM The insertion page of commercial data of a DM is accessible by the user in the following cases e During the insertion phase of the DM after the registration of the general data e During the editing phase of the DM e During the insertion phase of the DM by means of coping one that already exists in the system In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 50 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Dati Commerciali Modifica Dati Commerciali L Ulteriori Nomi commerciali del DM PROVA Nome commerciale e modello VACUDRAIN Codice attribuito dal fabbricante identificativo 00VT404 catalogo Fabbricante JOHNSON amp JOHNSON MEDICAL S P A Progressivo di sistema attribuito al DM 2705 Dati Generali del Dispositivo Medico Dati attuali DM oggetto di fornitura alle strutture dell SSN si z Prezzo unitario di listino del singolo dispositivo a I A 20 senza IVA Presenza del codice a barre s
148. multaneously with the Validazione action it is necessary to wait a few moments to verify the successful completion of the process Should any errors occur during the validation they will be reported on the activity list otherwise the system or kit selected will be marked with a V symbol for Validato Valida Fine immissione in commercio Grants access to the insertion page of the off market date of Validato or Pubblicato system or kit selected Only visible by FABBRICANTEDM users GesFinProd Consolida Allows the user to confirm a system or kit in in Lavorazione status The Consolida action displays the page containing the list of systems and kits in the approval phase specifying whether the process has been activated or not Should the process result negative this will be stated in the activity list otherwise the state of the system or kit will change to C that is Consolidato Visualizza Grants the user access to the data page of the system or kit selected in read only mode DetAssemblatoVis Gestione Prodotti Opens a window where the user has the option to manage insert edit delete view Non DM articles type Altro LookUpRicercaProdotti 2 3 2 3 DetAssemblatoInsMod This page allows the Fab Man RIC ASD user to insert edit details concerning a system or kit In the insertion editing phase of an assembled device two compon
149. ne in commercio Name of Marketing Director If the user has selected the role of Marketing Director of the DM the system therefore selects the Marketing Director that has been previously stipulated by the user in the Gestione Dati Azienda feature If the user has selected a role other than Marketing Director he can select the Marketing Director clicking on the Cerca link a look up will open where the user has the option to search for and select a Marketing Director The Marketing Director may be selected only if the Marketing Director is registered in anon EU country Progressivo di sistema attributo al DM Unique identification number assigned to each DM by the system This field is not editable and is visible only when editing the DM Already Registered State that the registration has already been carried out in accordance with Legislative Decree 46 1997 Classifications Nomenclatore GMDN completo Indicates the classification according to the GMDN Global Medical Device Nomenclature of the DM This field cannot be edited To select classification according to the GMDN it is necessary to click on the Cerca link a look up will open with which the user can search such a classification by code and description or part there of The system will automatically indicate whether the GMDN chosen is linked to only one unique CND code or multiple codes Classificazione CND Indication of t
150. no Telephone number of the person responsible for vigilance over DM Responsible della vigilanza sul DM Fax Fax number of the person responsible for vigilance over DM Responsible della vigilanza sul DM e mail Email address of the person responsible for vigilance over DM Operations available Action Description Page name SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 157 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Salva Allows the user to save the information inserted Same 2 4 1 2 CorrelazioneUtentefabbricanteLista This page allows the user to view the list of manufacturers that he represents and to filter the same list by stipulating one or more search criteria Home gt Dati Azienda gt Gestione Dati Azienda gt Dichiarazione altri fabbricanti Lista fabbricanti rappresentati dall utente Criteri di Ricerca Fabbricante Codice Fiscale Partita IVA VAT number Nazione ITALIA azl t j Ricerca Reset Partita IVA Fabbricante Codice fiscale Nazione Seleziona VAT number BRISTOL BRL234TRO347vS6y 12345678901 ITALIA a MEDICALFACTORY 22222222222 CIPRO oor Pagina i di 1 Seleziona Cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista a seconda delle operazioni
151. nticativo catalogo da a Nome Option to specify the commercial name or beginning of the commerciale e DM modello Classificazione Option to run a search using the National classification of the CND DM This field cannot be edited To select a classified CND and click on the search link Cerca A look up will then open where the user has the option to search a CND by code or by description or part thereof Stato del DM Option to serch a Medical Device by its current status into the system In lavorazione Consolidato Validato Pubblicato Ruolo dell utente rispetto al DM Optino to serach a Medical Device by the role carried out by the user with respect to thatl Medical Device Fabbricante Mandatario Responsabile dell immissione in commercio Altro soggetto delegato SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 12 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile dal fabbricante Operations available Action Description Page Name Inserisci Allows access to the DM general data entry Pagine di dettaglio di un page DM in Modalit editabile Ricerca Activates a search on the basis of the criteria Pagina Lista DM inserted Nuova Clears the search criteria previously defined Same ricerca 2 3 1 2 Visualisation of DM List When at least one of the sea
152. o l indirizzo email cui richiederlo Email Etichetta Moduloc pat Apri Istruzioni per l uso Immagine del DM Moculoc pat April Scheda tecnica del DM Schema di funzionamento utilizzo manutenzione conservazione e manipolazione del dispositivo precauzioni di utilizzo controindicazioni e iterazioni eventuale tossicita dichiarata modalita di trasposrto e smaltimento Bibliografia scientifica di supporto all evidenza clinica delle prestazioni e della sicurezza Il formato dei file da allegare deve essere PDF Documentation Detail Fields Field Name Description Etichetta File containing the label of the DM Istruzioni per l uso File containing the direction for use of the DM Immagine del DM File containing the image of the DM Not obligatory Scheda tecnica del DM The file containing the specifications of the DM or Schema di alternatively a link to the site where the same funzionamento utilizzo information may be found manutenzione conservazione e manipolazione del dispositivo precauzioni di utilizzo controindicazioni e iterazioni tossicit dichiarata modalit di trasporto e smaltimento SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 87 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Bibliografia scientifica di File containing the Scientific bibliography supporting
153. ocumenta zioneDM This page allows the user to insert documentation attached to a DM This page is not accessible in the following phases e During the insertion phase of the DM after the registration of the general data e During the editing phase of the DM e During the insertion phase of the DM by means of coping one that already exists in the system SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 46 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM All of the fields on this page are required in order for the FAB MAN RIC ASD to validate the DM Page Name DocumentazioneDM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 47 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile File Home gt Dispositivi Medici di Classe I Ila b IIl gt Dispositivo Medico DM gt Documentazione Documentazione Tipo Dispositivo Medico DISPOSITIVO Ulteriori Nomi commerciali del DM PROVE TE Nome commerciale e modello VACUDRAIN m 2 z n po Codice attribuito dal fabbricante identificativo 0ovT404 catalogo Fabbricante JOHNSON amp JOHNSON MEDICAL S P A Progressivo di sistema attribuito al
154. ome gt Dispositivi Medici di Classe I Ila b III DM DMP02M BRISTOL Pubblicato E stata accettata la richiesta di pubblicazione per il dispositivo Dati del dispositivo Tipo DM pisposmrivo Nome commerciale e modello DISPOSITIVO MEDICO DI PROVA 2 MANDATAR Codice attribuito dal fabbricante TTS EGS ERSTE RIO identificativo catalogo Fabbricante ERISTOL Progressivo di Sistema 57 Attribuito al DM Note di rettifica Chiudi attivita j Torna alla Lista attivita 2 Modification request from the DGFDM department In this case at the top of the page the phrase Non e stata accettata la richiesta di pubblicazione per la dispositivo will appear and then the principle data of the DM will be synthesised SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 128 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe LIIz b III DM DMP02M BRISTOL non Pubblicato Non stata accettata la richiesta di pubblicazione per il dispositivo Dati del dispositivo Tipo DM JorsPosttiv Nome commerciale e modello DISPOSITIVO MEDICO DI PROVA 2 MANDATAR Codice attribuito dal fabbricante S ee identificativo catalogo ee Fabbricante JeRTSTOL Progressivo di Sistema has ISS Attribuito al DM Note di rettifica J 3 Modification request due to failure to pass the automatic tests in the syst
155. on on the origin of the tissue substance Indirizzo e mail sito web in riferimento al campo Disponibilta dei doc Sulla provenienza del tessuto sostanza Disponibilit dei doc sui metodi di trattamento e inattivazione Email address Web site from which the origin of the tissue substance can be traced Indication of the presence of documentation on methods of treatment and deactivation Fila da allegare in riferimento al campo Disponibilta dei doc sui metodi di trattamento e inattivazione File containing the documentation on methods of treatment and deactivation Indirizzo e mail sito web in riferimento al campo Disponibilita dei doc sui metodi di trattamento e inattivazione Email address web site where the documentation on methods of treatment and deactivation can be found Disponibilit dei doc delle Autorit Sanitarie Indicates the presence of documentation provided by the Health authority regarding the tissues substances selected Fila da allegare in riferimento al campo Disponibilita dei doc delle Autorit Sanitarie File containing the documentation provided by the Health authority regarding the tissues substances selected Indirizzo e mail sito web in riferimento al campo Disponibilita dei doc delle Autorit Sanitarie Email address web site where the documentation provided by the health authority regarding the tissue s
156. on to access the Dati Generali of the DM 3 Select the menu option corresponding to the specific information of the DM Specifications data sheet Documentation sales data System and Kit composition Art2 should the medical device be a system or a kit therefore accessing the DM data pages one by one in order to consult the information 19 2 3 1 10 1 DM data page for consultation purposes of its details The data pages of a DM in read only mode can be accessed by all users of the system and allows them to consult the information details of the DM selected on the Pagina Lista DM page The data pages are General Data Page Specifications Page Documentation Page commercial data Page System and Kit Composition Para 3 Art 12 Possible other DM necessary for its functionality OA e Oe tr SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 76 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 1 10 1 1 General Data Dispositivo medico DM Pagina ListaDM Dati generali Pagina Dati Generali Page Name PaginaDatiGenerali This page allows the user to view the general data of a DM The general data of a DM are subdivided in four areas e General data e Data concerning classifications e Data concerning certifications e Links with other DM In the Legami con altri DM box the Eventuali altri DM necessari per il funzionamento link all
157. orio Il salvataggio permette la registrazione del fabbricante e la relativa relazione con l Utente Salva Lista Search Detail Fields Field Name Description Codice Fiscale The Fiscal code of the manufacturer can be indicated VAT number The VAT number of the manufacturer can be indicated SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 162 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Nazione The manufacturer s nationality can be selected from the list The default setting displays Italia Manufacturer Data Fields Field Name Description Fabbricante Name of the manufacturer Codice Fiscale Fiscal code of the manufacturer This field can only be edited in the insertion phase Required if Italy has been indicated as the Nation Partita IVA VAT VAT number of the manufacturer number This field can only be in the insertion phase Required if the Nation indicated is a country other than Italy Nazione Nationality of the manufacturer Comune City of the manufacturer user can search for the city To select a city click on Cerca a look up will open where the If the legal Headquarters is Italia then Comune and Provinca must be indicated otherwise state the Localit straniera Provincia Province of the manufacturer the user can search for the Province To select
158. osizione di sistemi o kit c 3 Art 12 Composizione di sistemi o kit c 3 Art 12 Tipo Dispositivo Medico KIT Nome commerciale e modello KIT 5 Codice attribuito dal fabbricante identificativo 555 catalogo Fabbricante BAYER Progressivo di sistema attribuito al DM 1738 FI a i i Componenti Sistema o Kit a Numero Stato nel SR Nome commerciale Fabbricante Titolare Pezzi Tipo Prodotto PERSEE Seleziona f i i MAXSSS ELEKTA S p A 41 DM Vv pa Pagina 1 dil Tipe del Prodotto NCE DM NON MARCATO CE PMC PRESIDIO MEDICO CHIRURGICO SPM SPECIALITA MEDICINALE ALT ALTRO Seleziona Cliccare su uno dei quadratini in corrispondenza del componente o dei componenti presenti nella lista a seconda delle operazioni Component list Detail Fields Field Name Description Nome Commerciale Commercial name of the component The commercial name has a corresponding link which opens a window where the detailed information of the selected component Fabbricante Titolare Indication of the Manufacturer Title holder of the component Numero pezzi Indication of the number of pieces of the component the system or kit requires Tipo prodotto Indication of the component type The following types are possible DM Medical Device NCE Non CE marked DM PMC Medical and surgical aids SM Medicines _ALT Other Non DM type of Article Stato nella base dati The status of th
159. ows the user to access the page with he list of other possible DM required for the functionality of the Parent DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 77 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Dispositivo Medico DM gt Dati Generali Modifica Dati Generali Dati Generali Tipo DM pIispositIvo zj Nome commerciale e modello paeme 3200B TRAMITE BATCH 4 Per indicare gli ulteriori nomi commerciali necessario procedere come seque 1 cliccare sul pulsante Aggiungi 2 digitare il nome commerciale aggiuntivo 3 il salvataggio degli ulteriori nomi commerciali sulla base dati avverr contestulamente al salvataggio delle altre informazioni cliccando sul pulsante Salva Ulteriori Nomi commerciali del DM 7 NOME 1 Codice attribuito dal fabbricante identificativo AT catalogo Regolamento recante norme per le prestazioni di i assistenza protesica erogabili nell ambito del Servizio Sanitario Nazionale Modalita di Zi Cerca Erogazione e Tariffe Ruolo dell utente che ha inserito il DM RESPONSABILE DELL IMMISSIONE IN COMMERCIO sj Azienda che ha inserito il DM azieNDA SARMASCU TCA S DA Dettaglio r Pp Fabbricante clin Cerca Dettaglio Mandataria AZIENDA FARMACEUTICA S P A Cerca Dettaglio Responsabile dell immissione
160. pondence to every DM it is necessary to insert at least one certificate SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 30 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile CERTIFICAZIONE DELLA MARCATURA CE Certificazione della Marcatura CE N certificato della marcatura CE Lo gt uszzt nc11221 Data Scadenza Certificato estremi dele norme armonizzate comunitarie e delle Direttiva norme nazionali di recepimento eventualmente applicate 4 a Organismo Notificato Codice Nome a tI 32 2003 Cerca L Inserisci Certificato Al fine di effettuare il salvataggio del i certificati necessario cliccare nell ordine in corrispondenza dei bottoni Inserisci Certificato e Conferma Certificates with EC stamp Detail Fields Field Name Description N Certificato della marcatura CE Identification number of the EC stamp Data Scadenza Certificato Expiry date of Certificate Organismo notificato Codice Nome Indication of the code and name of the organisation notified This field cannot be edited To select the code of the organisation notified it is necessary to click on the Cerca link a look up will open which will allow the user to search for the notified Organisation by name and code Estremi delle norme armonizzate comunitarie e delle norme na
161. positivo Medico DM in the menu insert the search criteria and then click on the Ricerca button 2 Select an assembled device found in the Validato or Pubblicato Stage 3 Click on the Inscrizione nel repertorio button SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 115 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile ix a pico By rete ei B la K 3 B hitp Rocabact oaa ngodhe od mul adaptaHTT AEA ENELATO PAE gofig wi Egr Cino J Repertorio Dispositivi Medici _MelpDerk ragout Dispositivi Medid ci Clanes I 1La b 311 Mome Diapoaitivi Mwelict ch Classe 1 11a b ITI gt Sirtemi o Kt Arrernblati 1 3 Art 12 7 gt Depositiva Medico D74 Dettaglio Sistema o Kit assemblato t z Art 12 P Sistemi o Kit Assemblati fc 2 Art 12 Gestione Assemblati D atinata in con P Caricamento DM do Me Tipo SIS catalogo Aziende che ha inserito l assemblati Ruolo dell utente rispetto all assemblat Assemblator Mandatario Responsabile dell immissione in commercio Tipo Assemblato ALTRO Altro Tipo Assemblate Q TTA DISABATING MOLATORE ITTA DISABATINO U procenta assemblato sar oggetto di farritura alla struttura del Sereizio Sanitario Nazienale fe 2 Cperacore complete Sd intranet locale The user must then state that he wishes to make the assembled device available to the S S N by entering Si
162. r assigned to the Assembled device by the system Assembler Identification code given by the assembler identification catalogue Commercial name and model of the assembled device Type of assembled device e Status in the database The list of assembled devices changes depending on the criteria stipulated as well as the user connected a Manufacturer mandate holder marketing director user only sees the assembled devices which he inserted regardless of their status in the database on this page the following actions can be carried out Run new search Insert a new assembled device Edit an assembled device in the In lavorazione stage Delete an assembled device in the In lavorazione stage Insert the off market date of a Validato or Pubblicato assembled device Validate an assembled device e Register the assembled device on the index SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 97 166 Ministry for Health User Manual DM Manufacturer Profile Design and Development NSIS Home gt Dispositivi Medici di Classe I Ila b IIIl gt Sistemi o Kit Assemblati c 2 Art 12 Ricerca Sistemi o Kit Assemblati c 2 Art 12 Criteri di Ricerca Progressivo di sistema attribuito rT all assemblato Assemblatore Tipo SISTEMA Codice attribuito dall assemblatore da identificativo catalogo 45 Nome commerciale e modello Stato
163. ral data and attached documentation for the DM Missing required data for the assembled systems or kits Failure to indicate other DM required for its function if in the general data of the DM in correspondence with the data sheet Legami con altri DM it was marked Si Failure to indicate at least two systems and kits components of which one had to be a Non CE marked DM in accordance with Para 2 Art 12 Failure to indicate at least two assembled system and kit components of which one had to be a DM in accordance with Para 3 Art 12 Failure to publish all systems and kit components in accordance with Para 2 Art 12 Failure to publish all system and kit components in accordance with Para 3 Art 12 Clicking on the link corresponding with the Comunicazione e messaggi d errore column displays the data page containing the principle data of the activity in progress selected SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 125 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 1834 Detail Fields a b Ill Attivit in corso Filtra A DMPO2M Pubblic 06 04 2005 _ L Assemblato SADASDASDASD 11 04 2005 BRISTOL incompleto Il MED Y ha dei 12 04 2005 campi incompleti Field Name Description Progressivo di sistema attribuito al DM o Assemblato Consecutive System number of DM or Assembled device Messaggi d e
164. rch criteria has been entered and the user has clicked the Ricerca button the search is activated and a list of DM corresponding to the criteria specified comes up on screen For every DM the following information is displayed e Consecutive identification number assigned to the DM by the system The manufacturer The product code assigned to the DM by the manufacturer The Commercial name of the DM The CND classification The status of the DM If R appears next to the consecutive number assigned to the DM by the system it means that the DM has been registered on the index The DM list changes not only on the basis of the criteria entered but also on the basis of the user connected If the user is the Manufacturer Mandate holder Marketing Director he will only see the DM originating from the company he represents regardless of its status in the database he can put the following actions into operation from this page e Runa new search e Insert anew DM by copying an existing DM e Edit a DM that s status is In Lavorazione e Delete a DM that s status is In Lavorazione Insert the issue date of the placement of a DM on the market marked Validato or Pubblicato e Register a DM on the index by inserting the payment data of the fee due for a DM in Validato or Pubblicato status e Validate a DM e Consult the details of a DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 13 166
165. ributo al DM Consecutive number of DM device by the system Note per la rettifica Campi mancanti Indication of the reasons that made the DGFDM reject the request for publication of the DM The list of errors that caused the DM to fail the automatic tests of the system for the validation of the DM Operations available Action Description Page name Vai al DM Grants access to the general data page of the DM PaginaDatiGenerali Chiudi Allows the user to return to the activities in progress ListaAttivitaIncorso Attivit list eliminating the activity previously selected Torna alla Allows the user to return to the list of activities in ListaAttivitaIncorso lista attivit progress 2 3 3 4 DettaglioAssemblato Fab Man RIC ASD This page allows the user to view the principle data of the activity in progress resulting in validation publication There are three possible types of communication for a validated assembled device 1 Successful publication in the DGFDM department In this case at the top of the page the phrase E stata accettata la richiesta di pubblicazione dell assemblato will appear and then the principle data of the assembled device will be synthesised SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 130 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa
166. rile Metodo di Method used to sterilise the DM sterilizzazione This field is required if the Sterile field is marked Si Se altro Metodo di Description of the sterilisation method if it is not already present on the sterilizzazione loaded list previously specificare This field is required if the Metodo di sterilizzazione field is marked Altro Metodo di The method of sterilisation can be validated sterilizzazione according to the harmonised norms validato secondo other This field is required if the Sterile field is marked Si Periodo massimo di utilizzo Maximum length of use of the DM This field is required if the Sterile field is marked Si Material contained in the DM that comes in direct contact with the Patient Latex free Indication as to whether or not the DM contains latex Fila da allegare File containing the Latex free certification This field is required if in the Latex free field it was marked Si E mail Sito web Indication of email or web site where the Latex free certificate can be requested This field is required if in the Latex free field it was marked Si This field is an alternative to the File da allegare field Data of biological tissue or substances of animal origin not vital Presenza Tessuti Sostanze Indication of whether or not the DM contains Biological tissue animal subs
167. rrore per il Fabbricante e Comunicazione Indicates the type of communication There can be three types of communication regarding a validated DM or assembled device e Successful publication by the DGFDM department e Modification request from the DGFDM department e Modification request due to failure to pass the automatic tests in the system Data Comunicazione Indicates the data where the activity is assigned to the DGFDM department Operations available Action Description Page name Filtra Opens a window from where the user has the option to FiltroAttivitaIncorso filter the activity in progress list based on search criteria inserted 2 3 3 2 FiltroAttivitaIncorso Feb Man RIC ASD This page is displayed in look up format and allows the user to filter the activity in progress list based on search criteria put in place SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 126 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Filtri della Worklist Filtra per Progressivo di sistema a attribuito al OM o Assemblato Messaggi d errore per il een Fabbricante e Comunicazioni SS IRIZIZZARE T Data Comunicazione J ag Filtra Cancella Filtri Chiudi Detail Fields Field Name Description Progressivo di sistema Consecutive System number of DM or Assembled device attribuito al DM o Assemblato Messaggi d error
168. s available Action Description Page name Invio Allows the user to upload text or xml file selected ConfermaUploadDispo sitivi 2 3 4 2 ConfermaUploadDispositivi This page displays a message with the result of the upload carried out by the Fab Man RIC ASD user from the file containing data regarding their DM Home gt Dispositivi Medic di Classe I Ila b III gt Upload DM gt Upload DM Lista delle Attivita Il file marco txt stato salvato correttamente SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 134 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Operations available Action Description Page name Ok Allows the user to return to the page that where they UploadDispositivi can upload 2 3 4 3 UploadFormRicerca This page allows the Fab Man RIC ASD user to insert search criteria in order to view the list of files attached by the user and containing data regarding their DM Home gt Dispositivi Medici di Classe L IIla b III gt Upload DM gt Esito Upload DM Ricerca Esito Upload DM Criteri di Ricerca Nome file Data invio da ast if Ricerca Reset Detail Fields Field Name Description Nome File The name of the file attached by the user containing the DM s data Data invio da a The date range the user uploaded the file Operations available Action Description
169. s available Action Description Page Name Ricerca Activates a search of the certificates on the basis of Pagina Lista Certificati the criteria inserted SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 143 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Nuova ricerca Clears the search criteria previously defined Same Inserisci Allows access to the insertion page of a new EC Pagina Inserimento Certificato certificate Dettaglio Allows access to a detail page of the data associated Pagina Dettaglio Certificato with an EC certificate Modifica Allows access to the modification page of the Pagina Modifica Certificato certificate selected Cancella Deletes the certificate selected Same Proroga Alows the user to access the extension page of the Pagina Proroga Certificato certificate selected 2 3 5 3 Pagina Inserimento Certificato This page allows the user to insert a new EC certificate The page is activated by clicking on the Inserisci button present on the pages of search and visualization of the EC certificates list If the user inserts a certificate having N certificato della marcatura CE and Organismo Notificato Codice Nome which coincide with those of a certificate already present in data base the system will ask the user to insert such a certificate as an extension of that one wh
170. same device The user must be in possession of a Smart Card in order to sign digitally To validate an assembled device the user must proceed as follows 1 Runa search of assembled devices from the Gestione Assemblati option on the menu 2 Select an assembled device marked in lavorazione and click on the Validazione button 3 Click the Firma button 4 Insert the PIN code in the space provided SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 119 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Before digitally signing the user must be sure to read the text displayed on the signature page which is laid out as follows Il sottoscritto name and surname of user connected per conto di name of assembler convalida commercial name and type of assembled device con identicativo catologo in data today s date In order for the validation to be successful and the request for release to arrive at the DGFDM department the valid assembled device must have the following 1 All required general data of the assembled device Assembler Type code assigned by the assembler Commercial name and assembled device type 2 The indication of at least two components one of which must be a DM 3 Publication of all components of the assembled device Firma digitale Convalida dell Assemblato con firma digitale Inserire la propria
171. scription Tipo DM Indicate the class of Medical device The following are types of DM e Device e System e Kit Nome commerciale e Name of DM as given by the Manufacturer modello Ulteriori Nomi List of alternative commercial names that the DM has been called commercali del DM Codice attribuito dal Product code assigned to the DM by the Manufacturer fabbricante identicativo catalogo da a Nomenclature Name of DM according to the nomenclature charges in force Tariffario vigente SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 79 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Ruolo dell utente rispetto al DM Indicates the role carried out by the user with respect to the DM The user can adopt the following roles Manufacturer Mandate Holder Marketing Director Other individual delegated by the Manufacturer Fabb Man Resp I Indicates the Manufacturing company Mandate Holder Marketing mm Comm Altr S Director Other individual from the Manufacturer of the DM ogg Del Fabbr Fabbricante Name of the Manufacturer of the DM Progressivo di sistema attribuito al DM Consecutive invoice number attributed to the DM by the system If R appears next to the consecutive number assigned to the DM by the system it means that the DM has been registered on the index Classifications Nomenclatore GMDN __ Indicates the classif
172. se should Specialit Medicinali be chosen a search will be run in the General Pharmaceutical Database Should Presidi Medici Chirurgici be chosen a search will be run in the database of the P M C registered should a Altro be chosen a search will be run of the Altro type Non DM articles registered in the database In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 57 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Dispositivo Medico DM gt Composizione di sistemi o kit c 3 Art 12 Composizione di sistemi o kit c 3 Art 12 perego _ _ ros Q000 Nome commerciale e modello DISPOSITVO MEDICO Codice attribuito dal fabbricante identificativo catalogo Fabbricante MEDICALFACTORY Progressivo di sistema attribuito al DM 1834 0001 Dati Generali del Dispositivo Medico Criteri di ricerca dei componenti Cerca tra ARTICOLO NON DM om C Tipo Prodotto DM NON MARCATO CE Nome commerciale e modello Codice attribuito dal fabbricante identificativo Ci catalogo Numero Registrazione i Codice AIC Fabbricante Titolare Ricerca Reset Ges
173. selected components and an assembled system or kit Prodotti option to manage insert edit delete and 2 3 2 4 RicercaComponenti DM Salva Saves the operations carried out by the Same user Gestione Opens a window where the user has the LookUpRicercaProdotti view Non DM items type Altro This page allows the user to enter search criteria for the components The user must select whether he wants to search among DM or Non DM items Based on this choice the page will display differing search criteria In this paragraph we will examine the case in which the user intends to search among DM After having chosen between DM or Non DM items the user must enter an additional search margin Detailed information concerning the system or kit which is being inserted or edited are displayed SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 103 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Sistemi o Kit Assemblati c 2 Art 12 Composizione di sistemi o kit c 3 Art 12 Nome commerciale e modello SISTEMA DI PROVA Tipo SISTEMA Codice attribuito dall assemblatore assoi identificativo catalogo Ruolo dell utente rispetto all Assemblato ASSEMBLATORE Assemblatore BAYER Mandatario Responsabile dell immissione in commercio Tipo Assemblato SISTEMI PER RADIOLOGIA Progressivo di
174. sistema attribuito al DM 463 Criteri di ricerca dei componenti Cerca tra ARTICOLO NON DM pm Progressivo di sistema attribuito al DM ren Tipo DM E Fabbricante Nome commerciale e modello re Codice attribuito dal fabbricante identificativo da catalogo a Classificazione CND Zj Cerca Ricerca Nuova ricerca Dettaglio Assemblato Gestione Prodotti DM data search Fields Field Name Description Cerca tra The user must choose if he wants to search among DM list or other products Different search criteria will be displayed depending on this choice Progressivo di sistema Option to serch a Medical device by its identification attribuito al DM number assigned by the system during registration into the database Tipo DM The user can choose between the following types of DM e Device e System e Kit Fabbricante The user can insert the name or part thereof of the Manufacturer of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 104 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Codice attribuito dal Option to indicate the range of codes which includes fabbricante identicativo the product code assigned to the DM by the catalogo da a Manufacturer Nome commerciale e The DM s name or beginning of given by the modello manufacturer can be indicated Classificazione CND Indic
175. supporto all evidenza the clinical evidence of the effectiveness and the safety of clinica delle prestazioni e the DM or alternatively a link to a site where the same della sicurezza information may be found Operations available Action Description Page Name Apri Allows the user to download the attached document 2 3 1 10 1 4 Commercial Data Ment Dati Commerciali DatiComm ercialiDM Page Name DatiCommercialiDM This page allows the user to insert edit the commercial data of a DM The commercial data of a DM are subdivided into two areas e Current data of the DM e Annual sales details of the DM In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 88 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Dispositivo Medico DM gt Dati Commerciali Visualizzazione Dati Commerciali Tipo Dispositivo Medico SISTEMA Nome commerciale e modello DISPOSITVO MEDICO Codice attribuito dal fabbricante identificativo catalogo Fabbricante MEDICALFACTORY Progressivo di sistema attribuito al DM 1834 0001 DM oggetto di fornitura alle strutture dell SSN pa Prezzo unitario di listino del
176. tances Medicinal products Present Presenza Medicinali Indication as to whether or not the DM contains medicinal products Medicinali esclusi derivati da sangue o plasma umano Medicinali o cosituenti di medicinale derivati da sangue umano Medicinali o cosituenti di medicinale derivati Indicates if there are medicines present in the DM except for those derived from blood or human plasma This field can be ticked only if it was marked Si in the Presenza Medicinali field Indicates if there are medicines present in the DM derived from human blood This field can be ticked only if it was marked Si in the Presenza Medicinali field Indicates if there are medicines present in the DM derived from human plasma This field can be ticked only if it was marked Si in the Presenza SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 36 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile da plasma umano Medicinali field Primary packaging of the DM I materiali Indicates if the primary packaging of the DM must be disposed of in a prevalenti specific manner costituenti il confezionamento primario del DM necessitano di condizioni speciali di smaltimento Directions for use Monouso Indicates whether or not the DM is disposable Metodo di Metho
177. te o dei componenti presenti nella lista a seconda delle operazioni Salva Assembled Device Data Fields Field Name Description Nome commerciale Name of the system or kit the assembler has given e modello Alternative List of alternative commercial names that the DM has been called Commercial name for DM Tipo Type of assembled device The user can choose between two types e System e Kit Codice attribuito Indication of product code assigned to the system or kit by the Assembler dall assemblatore SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 101 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile identificativo catalogo Ruolo dell utente rispetto all assemblato Indicates the role carried out by the user with respect to the assembled device The user can adopt the following roles e Assembler Manufacturer Mandate Holder Marketing Director Other individual delegated by the Manufacturer In the insertion phase the Assembler is set to appear by default Fabb Man Resp I mm Comm Altr S ogg Del Fabbr Indicates the Manufacturing company Mandate Holder Marketing Director Other individual from the Manufacturer of the DM Assemblatore Name of the assembler of the assembled system or kit If the user has selected the assembler role with respect to the assembled device the system automatically chooses the manufact
178. the following areas e General technical characteristics e Date of sterilisation e DM material that comes in direct contact with the patient see relevant paragraph e Medicinal products present patient see relevant paragraph e Primary packaging of DM patient see relevant paragraph e Directions for use SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 32 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile The Scheda Tecnica page is accessible to users in the following cases e During the insertion phase of the DM after the registration of the data e During the editing phase of the DM e During the insertion phase of the DM by coping one that already exists in the system While saving the data of the specifications data sheet at least one material contained in the DM that comes in direct contact with the patient and can be pointed out as material contained in the primary packaging of the DM must be indicated only if the label Sterile corresponds being marked Si In the upper part of the page the principle data of the DM are displayed as well as the Dati Generali del Dispositivo Medico link which allows the user to see the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 33 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile SISG_SSW MSW_DISPO_RDM_MTR_Manufact
179. the announcements relative to validation publication activity entered in reference to the DM The Upload DM from file option is only visible to FABBRICANTEDM users and permits the loading of data of one or more DM from the file and also permits the consultation of any errors that may have occurred in the uploading process itself The functionality Certificati CE is visible only to the users with FABBRICANTEDM role and allows to manage the EC certificates issued by the Organizations notified for the medical devices 2 2 2 Company data Function area The Company Data functional area contains functions that allow the user to complete his personal data regarding information about their own company as well as that of other companies represented by the individual in order to register the data of the DM Within the confines of this function area the following functions are present 1 General Data Stated SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 8 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 Declaration of other Manufacturers The first time a user accesses the system he must run the General Data Statement feature in order to complete the Manufacturing Company s information The Other Manufacturer s Statements indicates the companies represented by the user and the data of their registered DM SISG_SSW MSW_DI
180. this way a wish to exclude the fact that certificate of extension should be associated with DM selected That is why if the user has had a wish to extend the association existent of the devices subscribed with the certificate extended to the certificate of extension clicking on the Salva button he will be directed to the signature page of such devices Fields Details Field Name Description Fabbricante Indication of the manufacturer of the DM for which the certificate has been issued To select a manufacturer it is necessary to click on link Cerca there will appear a look up from which it is possible to make a search Organismo Indication of the code and name of the organization notified Notificato This field cannot be edited Codice Nome To select the code of the organization notified it is necessary to click on link Cerca a look up will appear from which it will be possible to search for the organization notified by code and name N Certificato della marcatura CE Identification number of the EC certificate Such number cannot contain blank spaces comunitarie e delle norme nazionali di recepimento eventualmente applicate Direttiva CE 32 2003 Allegato secondo cui stato certificato il dispositivo Data 1 Date of issue adjournment renewal of the EC Certificate rilascio aggiorna mento rinnovo Data Scadenza Expity date of the Certificate Certificato Estremi delle
181. ti Prodotti has the option to manage Non DM articles i e the Altro and Non CE marked kind Ricerca Runs a search with criteria put in ListaElementiDaCorrelare place and displays the DM list or list of non DM products that match the same criteria Reset Clears the search criteria Same previously put in place Page Name ListaElementiDaCorrelare This page allows the user to View the list of DM and then choose which components to add to the system or kit Run a new search In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 59 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Dispositivo Medico DM gt Composizione di sistemi o kit a3 Art 12 Composizione di sistemi o kit c 3 Art 12 Tipo Dispositivo Medico SISTEMA Nome commerciale e modello DISPOSITIVO MEDICO Codice attribuito dal fabbricante identificativo AOL catalogo Fabbricante MAILBOX Progressivo di sistema attribuito al DM 9942 Dati Generali del Dispositivo Medico Criteri di ricerca dei componenti Cerca tra pm ALTRO PRODOTTO Progressivo di sistema attribuito al DM Tipo DM KIT Fabbri
182. ting phase of the DM e During the insertion phase of the DM by means of copying one that already exists in the system In the upper section of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM In correspondence to the Nome commerciale e modello of each correlated DM there is a link which allows the user to view the general data of the respective DM selected SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 68 166 Ministry for Health User Manual DM Manufacturer Profile Design and Development NSIS Home gt Dispositivi Medici di Classe I Ila b III gt Dispositivo Medico DM gt Eventuali altri DM necessari al funzionamento Elenco Eventuali altri DM necessari al funzionamento Tipo Dispositivo Medico DISPOSITIVO Ulteriori Nomi commerciali del DM PROVA Nome commerciale e modello VACUDRAIN Codice attribuito dal fabbricante identificativo catalogo Fabbricante JOHNSON amp JOHNSON MEDICAL S P A Progressivo di sistema attribuito al DM 2705 00VT404 Dati Generali del Dispositivo Medico Codice Uso Fabbricante piglia omane ale esclusivo MAE Stato nel Seleziona identificativo modello Uso non dell esclusivit repertorio catalogo esclusivo JOHNSON amp JOHNSON juso MEDICAL S P A a NOME PROVA esclusivo Prove x i
183. tion SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 106 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile attribuito al DM number assigned by the system during registration into the database Tipo DM The user can choose between the following types of DM e Device e System e Kit Fabbricante The user can insert the name or part Codice attribuito dal Product code assigned to the DM by the fabbricante identicativo Manufacturer catalogo Nome commerciale e The DM s name or beginning of given by the modello manufacturer can be indicated Classificazione CND Indicates the national classification of the DM To select a CND classification click on the Cerca link a look up will open from which it will be possible to search for a CND classification by code and description DM Data List Field Name Description Nome commerciale e Name of the component as given by Manufacturer modello Codice attribuito dal Specific code attributed to the DM by the manufacturer fabbricante identicativo catalogo Fabbricante Manufacturer of the component Stato nella base dati The status of the DM in the database The status can change in the following order e L Processing e V Valid e P Published Tipo DM There are three types of DM e Device e System e Kit Operations available Action Des
184. tione Prodotti Non DM article components Search Detail Fields Field Name Description Cerca Tra The user must provisionally choose if he intends to request a DM list or other non DM product list Different search criteria will be displayed depending on this choice Tipo prodotto The user can choose between the following types of product e Non CE marked DM e Surgical and Medical Aids e Medicines e Other Nome commercialee The DM s name or beginning of modello given by the manufacturer can be inserted Fabbricante The user can insert the name or part there of of the Manufacturer of the DM Codice attribuito dal The code attributed to the DM by the fabbricante manufacturing company can be identicativo catalogo indicated referring to Non CE marked DM and to others Numero registrazione The registration number refers SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 58 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile exclusively to surgical and medical aids Codice AIC The AIC code refers exclusively to Medicinal products Fabbricante medical aids and other The name of the Manufacturer or part thereof can be indicated referring to non stamped DM Surgical and Operations available Action Description Page name Gestione Opens a window where the user LookUpRicercaProdot
185. to il dispositivo P Data 1 rilascio aggiornamento rinnovo Fabbricante BAYER gt SI Dettaglio Da 0473 AMTAC CERTIFICATION Organismo Notificato SERVICES LTD Codice Nome Cerca N certificato della marcatura CE C E Data Scadenza Certificato 0i 5 applicate File contenente il certificato 5j Annulla Salva Indietro Fields Details Field Name Description Fabbricante Indication of the manufacturer of the DM for which the certificate has been issued To select a manufacturer it is necessary to click on link Cerca there will appear a look up from which it is possible to make a search Organismo Indication of the code and name of the organization notified Notificato This field cannot be edited Codice Nome To select the code of the organization notified it is necessary to click on link Cerca a look up will appear from which it will be possible to search for the organization notified by code and name N Certificato della marcatura CE Identification number of the EC certificate Such number cannot contain blank spaces Data 1 Date of issue adjournment renewal of the EC Certificate SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 148 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile rilascio aggiorna mento rinnovo Data Scadenza
186. try for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 1 5 DM Signature Page This page allows the user who has inserted the specific DM to digitally sign in order to validate that same device The user must possess a Smart Card in order to sign digitally To validate a DM a user must proceed as follows 1 Run the search for the DM from the Dispositivo Medico DM option on the menu 2 Select a DM marked in lavorazione and click on the Validazione button 3 Click the Firma button 4 Insert the PIN code in the space provided Before digitally signing the user must be sure to read the text displayed on the signature page that runs Il sottoscritto name and surname of user connected per conto di name of company for whom the user acts as manufacturer convalida il DISPOSITIVO commercial name of device con identicativo catologo in data today s date In order for the validation to run smoothly and the request for release to arrive at the DGFDM department the DM must have the following 1 All required general data and all of the relevant documentation present The indication of other DMs which are required in order for this DM to function when Legami con altri DM has been marked Si in its general data 3 Indication of systems and kits covered by in Para 3 Art 12 of at least two components one of which by necessity must be a DM not
187. turer_v1 1 doc February 2008 140 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Certificati CE Ricerca Certificati CE Criteri di Ricerca Data Scadenza Certificato lft Organismo Notificato Codice Nome Cerca Reset Ricerca Nuova ricerca Inserisci Fields Details Field Name Description N Certificato Identification number of the EC certificate della marcatura CE Data Scadenza Expiry date of the Certificate Certificato Organismo Indication of the code and name of the organization notified Notificato This field cannot be edited Codice Nome To select the code of the organization notified it is necessary to click on the Cerca link a look up will open from which it will be possible to search for the organization notified by code and name Operations available Action Description Page Name Ricerca Runs a search of the certificates on the basis of the Pagina Lista Certificati criteria inserted Nuova ricerca Clears the search criteria previously defined Same Inserisci Allows access to the insertion page of a new EC Pagina Inserimento certificate Certificato 2 3 5 2 Pagina Lista Certificati This page displays the list of the EC certificates which correspond to the criteria defined in the relative search page For every certificate the
188. ubstance selected can be found Operations available SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 85 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Action Description Page Name Visualizza Displays a box in which the user can view information Same regarding biological tissue animal substance selected Chiudi Closes the window Scheda Tecnica 2 3 1 10 1 3 Documentation Men Documentazione Documenta zioneDM Page Name DM Documentation This page allows the user to view the documentation attached to a DM ad therefore to download the files attached In the upper part of the page the principle data of the DM are displayed as well as the Dati Generali del Dipositivo Medico link which opens the page containing the general data of the DM SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 86 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dispositivi Medici di Classe I IIa b III gt Dispositivo Medico DM gt Documentazione Documentazione CCC and Tipo Dispositivo Medico DISPOSITIVO Nome commerciale e modello MAX Codice attribuito dal fabbricante identificativo LL12 catalogo Fabbricante BAYER Progressivo di sistema attribuito al DM 1794 Selezionare il file da allegare oppure indicare il link remoto al documento
189. uito al during registration into the database DM Fabbricante Option to specify the name or the beginning of the Manufacturer of the DM Tipo DM Option to indicate the type of classified DM choosing between Device System Kit SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 14 166 Ministry for Health User Manual DM Manufacturer Profile Codice attribuito Option to indicate the range of codes which includes the dal fabbricante product code assigned to the DM by the Manufacturer identicativo catalogo da a Nome Option to specify the commercial name or beginning of the commerciale e DM modello Classificazione Option to run a search using the National classification of the CND DM This field cannot be edited To select a classified CND and click on the search link Cerca A look up will then open where the user has the option to search a CND by code or by description or part thereof Stato del DM Option to serch a Medical Device by its current status into the system In lavorazione Consolidato Validato Pubblicato Ruolo dell utente rispetto al DM Optino to serach a Medical Device by the role carried out by the user with respect to that Medical Device Fabbricante Mandatario Responsabile dell immissione in commercio Altro soggetto delegato dal fabbricante DM List Detail Fields Field N
190. urer entered by the user in the Gestione Dati Azienda page Should the user choose a role other than assembler he may select an assembler by clicking on the Cerca link a look up will Open where the user has the option to select the assembler desired Mandatario Name of Mandate Holder of the assembled system or kit If the user has selected the role of Mandate holder regarding the assembled device the system will automatically display the user s company as Mandate holder as stipulated in the Gestione Dati Azienda feature He can select the Mandate holder by clicking on the Cerca link a look up will open where the user has the option to search for and select a Mandate holder The mandate holder may be selected only if the assembled device is legally registered in a non EU country Responsabile dell immissione in commercio Name of Marketing Director of the assembled system or kit If the user has selected the role of Marketing Director of the assembled device the system therefore selects the Marketing Director that has been previously stipulated by the user in the Gestione Dati Azienda feature He can select the Marketing Director clicking on the Cerca link a look up will open where the user has the option to search for and select a Marketing Director The Marketing Director may be selected only if the assembled device is legally registered in a non EU country Assembled Tipo
191. urer_v1 1 doc February 2008 34 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Homa gt Cicpocityi Medio di ciassa Lilarb JU gt Bizcontiec Medica DM gt Echeda Tecnica es Inserimento Scheda Tecnica Tipo Dispositivo Medico DISPOSITIVO Nome commerciale e modelle DISPOSITIVO DI PROVA f Codice attribuito dal fabbricante identificativo toca catalogo Fabbricante JOHNSON k JOHNSON MEDICAL S P A f Progressivo di sistema attribuito al OM 2859 Descrizione i x Destinazione d uso ai sensi del DL95 46 97 i Misura ove applicabile Indicare i parametri misurabili attusinente utiizestl e presenti nei cataloghi comrnestiali com le relasie unita di misura Deti di stertiizzazione Metodi di Periodo massime orilizzazione Descrizione altr i f f validato secondo etodo di i f sterilizzazione di utilizze mesi w a hai oe IO i i fi armonizzate j Material costituenti il OM a diretto contatto con d Paziente Latew froe no rile ds allegare Sfogia j E mafl sito web II prodetto pu fregiarsi dell atimutta Laces frag se in nessuna faro stato a contatto con molecole del lattico Per tel prodotti arcore allegare il diocurmento relatico alla certificazione oppure indicare l indrirzo mrrrimilxito veb a od fichiedetlo f Dati tessuti biologici o sostanze di origine animate i taki Presenze Tessuti Sostenze re z
192. v1 1 doc February 2008 153 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 154 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Home gt Dati Azienda gt Gestione Dati Azienda gt Dati Generali Dichisrante Inserimento Dati Generali Dichiarante i Codice Fiscale MRAVRD74L11F839M i Cognome mario i Nome verdi i Denominazione BAVER Codice Fiscale RRRARIZ3ARAAZI Partita IVA VAT number 12211122222 Sede legale Nazione traia RI Comune FROSINONE Garsa Provincia FR j p i 0 re C A P ZIP code 03100 Indirizzo via MARITTIMA i Telefono fosrz3456 e mail finita SS Legale rappresentante i Cognome LAROCA Nome EENIAMINO i Riferimento per comunicazioni Cognome LaRocca TTT l Nome BENIAMINO TTT Y ufficio TTT Telefono 354564 lt Fax 2iisess TT e mail TT f f Registrazione ai sensi dell art 13 Digs 46 97 f Eventuale num di registrazione art 13 Digs ar 46 97 Pasi Fazi f RNA Cognome ROSSI f Dj Nome RR TTT Telefono fosesses E Fax osese e mail feuardo rossigeanitae f f campo obbligatorio Detail Fields SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 155 166 Ministry for Health
193. y FABBRICANTEDM users and allow them to insert new DM and also to edit a DM selected from the Pagina Lista DM The detail pages are General Data Specifications Documentation Commercial Data System and kit settings Para 3 Art 12 Any other DM necessary for its function ea In particular if it s in insertion mode the General Data page will become activated once the user clicks on the Inserici button on the list page and only after the data has been saved on the Pagina Dati Generali will the options on the menu become available and allow the user access to other pages If it is in edit mode the General Data page will become available following the selection of a DM from the list and the menu option will become visible simultaneously to allow access to other pages SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 25 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 1 8 1 1 General Data Dispositivo Medico DM Pagina ListaDM Inserisci Dati Generali Pagina DatiGenerali l Pagina InserimentoCertificati In order to insert a new DM the manufacturer mandate holder marketing director must first specify general data of the DM in order to then go on to register other information specifications commercial data documentation any other DM necessary for its function system or kit components in the case of a system or
194. y put in place Same ricerca Sintesi Allows the user t view the summary of the operations UploadListaErrori elaborazion carried out and the details of any possible errors e regarding he file selected SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 136 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile 2 3 4 5 UploadListaErrori This page allows the user to view the list of any errors which were verified during the processing of the file selected during the automatic mass uploading of the DM as well as a summary of the operations carried out Home gt Dispositivi Medici di Classe I Ila b III gt Caricamento DM da file gt Esito Caricamento Sintesi Elaborazione Nome file ESE_INS TXT Data invio 08 03 2006 15 25 Esito Esito Tot Inserimenti 7 Tot Cancellazioni J a Pos E Nep of Poss Neg 17 BASSE o aj oo f r 1 r i Esito Tot Fine Imm in Esito Tot Aggiornamenti 1 I so Pos Neg commercio Pos Neg o 0 O o 0 O Dettaglio errori N DM Nome Campo Descrizione Errore NZA 202 DATATYPE ERRATO IN UN CAMPO NON T OBBLIGATORIO CAMPO NUMERICO 11 PARTE UTILIZZATA TESSUTO O SOSTA DISPOSITIVO CODICE_FABBRICANTE ID_FABBRICANTE U 200 DUPLICAZIONE CHIAVE Pagina i di 1 Per visualizzare il dettaglio delle operazioni effettuate con successo cliccare il pulsante Dettaglio Operazion
195. za del tessuto sostanza s O O File da Sfoglia File da File da Croda allegare v allegare x allegare j E Indirizzo e mail sito web Indirizzo e mail sito web Indirizzo e mail sito web salva Disponibilit dei doc sui metodi di Disponibilit dei doc delle Autorit trattamento e inattivazione ascumenti n Sanitarie SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 40 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile Tissue data Fields Field Name Description Famiglia di appartenenza Family of origin of the biological tissue animal substance contained in the DM Altra Famiglia Description of the family of origin of the biological tissue animal substance contained in the DM if it has not previously been loaded onto the list This field is required if the corresponding Famiglia di Appartenenza was indicated as Altro otherwise it is not taken into account Stato di provenienza Original condition of the biological tissue animal substance Parte utilizzata dei tessuti Parts of tissue used in DM Altra parte utilizzata Description of the parts of the biological tissue animal substance used in the DM if they haven t been previously loaded onto the list This field is required if the corresponding parte utilizzata dei tessuti was marked Altro otherwise it is not taken into account
196. zionali di recepimento eventualmente applicate Indication of the Essential details of the National and Community norms acknowledged during the fabrication of the DM Direttiva CE 32 2003 States whether or not the certificate should be issued in compliance with EC Directive 32 2003 Operations available Action Description Page name Ricerca Activates a search on the basis of the criteria Same inserted Nuova Clears the search criteria previously defined Same SISG_SSW MSW_DISPO_RDM_MTR_Manufacturer_v1 1 doc February 2008 31 166 Ministry for Health User Manual Design and Development NSIS DM Manufacturer Profile ricerca Conferma Closes the look up inserts the certificate or the Pagina Dati certificates selected adjourning the list of the Generali certificates on general DM data page Annulla Closes the look up without saving the work done by Pagina Dati user Generali 2 3 1 8 1 2 Specifications Inserisci Cancella LookUpMat enali Inserisci Cancella LookUpMaterialiC onfezionamento Inserisci Modifica Materiali Pa Scheda Tecnica Cerca Aggiungi Cancella LookUpSo stanza Page Name Specifications Inserisci Modifica Cancella LookUpTess uti The Scheda Tecnica page allows the user to insert edit information on the technical data of a DM The data of the specifications data sheet of a DM are subdivided in

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