IMDRF UDI_System_for_Medical_Devices(Version2.0)
Contents
1. UDI should allow for improved procurement inventory management and accounting UDI The existence of a single device identifier UDI DI to link disparate data bases should allow creative new medical and business applications and synergy among those applications UDI DI 2 3 Adverse Event Reporting 2 3 A ERRE UDI will allow industry and regulatory authorities to more rapidly identify medical devices involved in adverse events UDI will be available for inclusion in adverse event reports allowing 10 April 2013 Pa2. UDID data could be downloaded by healthcare providers to be used for internal reference of safety related information 10 April 2013 Page 8 of 34 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 IMDRF WG PD2 N7 R2 UDID 2 5 Documentation 25 The use of UDI System will facilitate and simplify the documentation of medical device use in various patient records including traditional as well as electronic health records and registries UDI should also enable linkages of medical device information across various systems and across geographies These applications of UDI could help identifying medical device problems and enhance comparative effectivenes
3. UDI Non prescription medical devices exclusively for retail Point of Sale POS do not need to encode Production Identifiers in AIDC on the point of sale package POS PI AIDC No particular AIDC methods should be required by a regulatory authority Globally accepted AIDC methods based on ISO standards that have been approved by the global organization e g GS1 HIBCC or ICCBBA shall be used AIDC ISO GS1 HIBCC ICCBBA AIDC RFID should comply with open commercially acceptable industry sta
4. 3 Rationale purpose and scope 3 3 1 Rationale 3 1 pH There are currently no global definitions of what constitutes a UDI or UDI System As a consequence discrepancies between different national approaches do exist and will most likely increase Common globally harmonized UDI System requirements would offer significant benefits to manufacturers healthcare providers patients and regulatory authorities In addition eliminating or reducing differences between regulatory authorities decreases the cost of gaining regulatory compliance There are currently no global definitions of what constitutes a UDI or UDI System UDI O UDI As aconsequence discrepancies between different national approaches do exist and will most likely increase Common globally harmonized UDI System requirements would offer significant benefits to manufacturers healthcare providers patients and regulatory authoritie
5. UDI UDI means Unique Device Identification The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard It allows the unambiguous identification of a specific medical device on the market The UDI comprises the UDI DI and UDI PI Note The word Unique does not imply serialization of individual production units UDI Unique Device Identification UDI UDI DI UDLPI unique UDI System The UDI System is the framework for the production of a UDI its application on the label or directly on device and the storage of the UDI DI and additional device related information in a UDID UDI UDI
6. Ne 10 April 2013 Page 27 of 34 1115 1116 1117 1118 1119 1120 1121 1122 1123 1124 1125 1126 1127 1128 1129 1130 1131 1132 1133 1134 1135 1136 1137 1138 1139 1140 1141 1142 1143 1144 1145 1146 1147 1148 1149 1150 1151 1152 1153 1154 1155 1156 IMDRF WG PD2 N7 R2 20 21 22 23 24 25 Need for sterilization before use Yes No if yes then the method of sterilization should be indicated Yes No yes DYAVL WED EETAZ S Restricted number of reuses if applicable License and or marketing authorization or registration number if required by the local regulatory authority URL for additional information e g electronic IFU optional URL Critical warnings or contraindications if ap
7. a traceability of medical devices b the identification of medical devices in adverse events reports and other post market safety surveillance activities c field safety corrective actions including recalls d the reduction of medical errors e establishing and maintaining registries This guidance intends to avoid country specific requirements regarding the core elements of the UDI System by developing common guidance for UDI a creating use and maintaining a UDI UDI b applying a UDI Carrier UDI c establishing the UDID model structure with a
8. pni 8 UDI Carrier 8 UDI 1 The UDI Carrier AIDC and HRI representation of the UDI shall be on the label of the device its package or on the device itself and on all higher levels of packaging 10 April 2013 Page 22 of 34 902 903 904 905 906 907 908 909 910 911 912 913 914 915 916 917 918 919 920 921 922 923 924 925 926 927 928 929 930 931 932 933 934 935 936 937 938 939 940 941 942 943 944 IMDRF WG PD2 N7 R2 UDI UDI ADC HRI ORI Do The UDI Carrier for low risk devices packaged and labeled individually does not need to be on its package but rather on a higher level of packaging e g carton However when the healthcare provider is not expected to have access e g home user to the higher level of packaging e g carton the UDI should be on its package UDI O
9. 2 Device Identifier UDI DI The UDI DI is a unique numeric or alphanumeric code specific to a model of medical device and that is also used as the access key to information stored in a UDID Examples of the UDI DI include GS1 GTIN HIBC LIC ISBT product code KGS F F UDI DI UDD UDI DI GS1 GTIN HIBC LIC ISBT Human Readable Interpretation HRI Human Readable Interpretation is a legible interpretation of the data characters encoded in the UDI Carrier A TL OWE CLF HRI UDI O Kits Kits are a c
10. 761 762 763 764 7 national or regional regulatory requirements shall not restrict methods of AIDC as this will 765 hinder the establishment of a globally harmonized UDI System RFID f J 766 UDI 767 AIDC O 768 769 8 the National Regional regulation for UDI System shall include a robust process for 770 evaluating and adjudicating applications for UDI exemptions that would exempt certain 771 device types or package levels including direct part marking from being labeled with UDI 772 or specific elements in the UDID 773 UDI O UDI 774
11. Data relating to discontinued medical devices shall be maintained in the UDID 10 April 2013 Page 25 of 34 1031 1032 1033 1034 1035 1036 1037 1038 1039 1040 1041 1042 1043 1044 1045 1046 1047 1048 1049 1050 1051 1052 1053 1054 1055 1056 1057 1058 1059 1060 1061 1062 1063 1064 1065 1066 1067 1068 1069 1070 1071 1072 IMDRF WG PD2 N7 R2 UDID 13 The UDID shall support the use of all the core UDID data elements UDID UDD 9 2 The core UDID data elements 9 2 27 UDIDO F2 BF All the core UDID data elements are mandatory unless marked optional If applicable means the information is mandatory to be in the UDID if it is on the label Data elements and their definitions for the UDID are listed below UDD optional QF applicable UDD
12. Global Medical Device Nomenclature GMDN preferred code term GMDN Brand Name if applicable Device software major version if applicable Reference and or catalogue number if applicable How the device is controlled serial lot batch number and or expiration date or manufacturing date or software version or software released date or ISBT 128 check boxes if applicable SBT 128 Clinical Size including Volume Length Gauge Diameter if applicable e g SF catheter Cat AL ERS AR EW Bil BF Additional product Description optional Additional clinic
13. Production Identifier UDI PI The Production Identifier is a numeric or alphanumeric code that identifies the unit of device production The different types of Production Identifier s include serial number lot batch number manufacturing and or expiration date EI F UDI PI Radio Frequency Identification RFID RFID is a technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object for the purpose of identification GME L S AGRE RFID Shipping containers Shipping container is a container where the traceability is controlled by a process specific to logistics systems YAY TT
14. meet the public health objectives of this guidance and to ensure that medical device user facilities healthcare providers regulatory authorities and others will be able to make efficient and effective use of the UDI there could be a need to limit the number of accredited global organizations and available coding systems UDI 7 The UDI 7 UDI 1 A UDI shall be assigned to the device itself or its package Higher levels of packaging shall have their own UDI UDI UDI Shipping containers should be exempted As an example UDI is not required on a logistics unit when a healthcare provider orders multiple m
15. 10 April 2013 Page 13 of 34 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560 561 562 IMDRF WG PD2 N7 R2 Configuration Configuration is a combination of items of equipment as specified by the manufacturer that operate together to provide an intended use or purpose as a medical device The combination of items may be modified adjusted or customized to meet a customer need Examples 1 CT gantry tube table console are items of equipment that can be configured combined to deliver an intended function 2 Anesthesia ventilator breathing circuit vaporizer are items of equipment that can be configured combine to deliver an intended function Ke 1 CT X
16. O The following changes would require a new UDI DI for Standalone Medical Device Software UDILDI 1 Changes to the Model Number or Part Number of the Standalone Medical Device Software not revision O Revision 2 Major Standalone Medical Device Software revisions shall be identified with a new UDI DI Revision UDI DI Major Standalone Medical Device Software revisions are meant as complex or significant changes affecting the original performance and effectiveness the efficacy of the safety or the intended use new or modified of the Standalone Medical Device Software These changes may include algorithms database s
17. IMDRF E 6 30 UDI System for Medical Devices Version 2 0 Authoring Group IMDRF UDI Working Group Date 10 April 2013 UDI System for Medical Devices Version 2 0 http www imdrf org docs imdrf final consultations imdrf cons udi 13041 7 doc Comments template http www imdrf org docs imdrf final consultations imdrf cons udi comments 130418 doc 2013 6 30 GS1 Healthcare Japan 10 April 2013 Page 1 of 34 oooNnNogoaGAaA O N IMDRF WG PD2 N7 R2 Contents l Preamble Dhl kk 2 Imtfodme ON 2 1 Traceability 2 2 Identification 2 3 Adverse Event Reporting 2 4 Medical Errors 2 5 Documentation 3 Rationale purpose and SCO PC si veacaniaisinixsaansasededuveaeteladscadussanqouaeenvacers 3 1 Rationale 3 2 Purpose 3 3 Scope 4 REPEFENCES RE S DEMMIMIONS SA AO E 6 Guidance
18. Standalone medical device software Standalone Medical Device Software is software intended to be a medical device in its own right and which is not embedded in another device Examples Radiation planning software surgical planning software cardiac patient management software picture archiving and communication systems PACS 10 April 2013 Page 16 of 34 647 648 649 650 651 652 653 654 655 656 657 658 659 660 661 662 663 664 665 666 667 668 669 670 671 672 673 674 675 676 677 678 679 680 681 682 683 684 685 686 687 688 689 690 IMDRF WG PD2 N7 R2 KRAS B FAY ORRRB A SLT h ozy PACS Unit of Use UoU UDI DI The Unit of Use UDI DI is an identifier assigned to an individual medical device when a UDI is not labelled on the individual device at the level of its unit of use Its purpose is to associate the use of a device to on a patient EM Ht fir UoU HO UDI DI 7 UDI
19. UDI DI UDID UDI Carrier The UDI Carrier is the means to convey the UDI by using Automatic Identification and Data Capture AIDC and if applicable its human readable interpretation HRI 10 April 2013 Page 17 of 34 691 692 693 694 695 696 697 698 699 700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 717 718 719 720 721 722 723 724 725 726 727 728 729 730 731 732 733 IMDRF WG PD2 N7 R2 Note Carriers can include linear bar codes 2D bar codes and RFID etc UDI AIDC HRI UDI 2D RFID UDI Database UDID The UDID contains identifying information and other elements associated with the specific medical device UDI UDID 6 Guidance for a UDI System 6 UDI A U
20. UDI Human Readable UDI QGS1 AI HIBCC Flag Character 10 April 2013 Page 34 of 34
21. a arisk based approach which is essential given the huge diversity of the medical devices b kits systems and other groups of devices which need to be managed appropriately c requirements which should be phased in over a period of years based on risk classes starting with the highest risk class to reduce the burden of implementation d the need for all supply chain stakeholders to have sufficient time to prepare their systems processes and staff for the proper use of the UDI system 10 April 2013 Page 9 of 34 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 IMDRF WG PD2 N7 R2 UDI
22. UDI DI a Brand Name b Device version model 10 April 2013 Page 21 of 34 862 863 864 865 866 867 868 869 870 871 872 873 874 875 876 877 878 879 880 881 882 883 884 885 886 887 888 889 890 891 892 893 894 895 896 897 898 899 900 901 IMDRF WG PD2 N7 R2 c Reference and or catalogue number d Clinical Size including Volume Length Gauge Diameter EE WE RS AE EW e Labelled as single use f Packaged sterile Daca g Need for sterilization before use 11 At a minimum a new UDI DI is required whenever there is a change that could lead to seer ae of the medical device and or ambiguity in its traceability Oe RR UDI DI 12 Reprocessors of single use medical devices remanufacturers Own Brand Private Labelers should create their own new UDI for the reprocessed rem
23. 3 Placement of UDI on IVD Kits IVD UDI a The IVD Kit UDI is generally affixed to the outside of the packaging IVD UDI The UDI must be readable or in the case of AIDC scan able whether placed on the outside of the IVD Kit package or inside a transparent package UDI O IVD UDI 10 April 2013 Page 31 of 34 1287 1288 1289 1290 1291 1292 1293 1294 1295 1296 1297 1298 1299 1300 1301 1302 1303 1304 1305 1306 1307 1308 1309 1310 1311 1312 1313 1314 1315 1316 1317 1318 1319 1320 1321 1322 1323 1324 1325 1326 1327 1328 1329 1330 IMDRF WG PD2 N7 R2 AIDC 10 5 Configurable medical device systems 10 5 BARNES WHE EGE GE RT AO For configurable medical device systems the rules listed below should be
24. Reagents used in automated systems bear barcodes necessary for their handling and identification by the automated systems This does not constitute a UDI UDI Individual single use disposable medical devices within an IVD Kit whose uses are generally known to the persons by whom they are intended to be used and which are not intended for individual use outside the context of the IVD Kit do not require their own UDI Carrier IVD IVD BO UDI O Medical devices that are normally exempted from having a UDI Carrier on the relevant level of packaging do not need to have a UDI Carrier when placed within an IVD Kit UDI O TVD UDI
25. GHTF SG1 N070 2011 GHTF SG1 N070 2011 http www imdrf org docs ghtf final sg 1 technical docs ghtf sg 1 n70 201 1 label instruction use medical devices 110916 doc Manufacturer Manufacturer means any natural or legal person with responsibility for design and or manufacture of a medical device with the intention of making the medical device available for use under his name whether or not such a medical device is designed and or manufactured by that person himself or on his behalf by another person s GHTF SG1 N55 2009 This includes reprocessors and remanufacturers that take responsibility for the device and reintroduce it into commercial distribution REX H OEM GHTF SGI N55 2009 http www imdrf org docs ghtf final sg 1 technical docs ghtf sg 1 n055 definition terms 090326 doc
26. UDI UDI DI UDI PI AIDC PI should have the following characteristics PI 10 April 2013 Page 28 of 34 1157 1158 1159 1160 1161 1162 1163 1164 1165 1166 1167 1168 1169 1170 1171 1172 1173 1174 1175 1176 1177 1178 1179 1180 1181 1182 1183 1184 1185 1186 1187 1188 1189 1190 1191 1192 1193 1194 1195 1196 1197 1198 1199 1200 IMDRF WG PD2 N7 R2 a serial number for active implants b serial number for other implants or lot number according to the manufacturer s quality management system O 3 The UDI of the implant must be identifiable prior to implantation UDI 10 2 Reusable devices requiring sterilization or high level disinfection between uses 10 2 HA E RAH OLN RHH D B WIEL NI OVS EE EER TF B FET
27. c identification of medical devices in adverse events d reduction of medical errors e documenting and longitudinal capture of data on medical devices 2 1 Traceability 21 The global use of a Unique Device Identifier UDI will facilitate traceability throughout distribution UDI In order to achieve traceability it is necessary to require all stakeholders to capture and store the UDI Device Identifier Production Identifier throughout distribution and use UDI DI O Pr This is especially important for recalls and other field safety corrective actions
28. 5 Manufacturer s address as required on the label 6 Manufacturer s customer service contact information country specific could be multiple O 10 April 2013 Page 26 of 34 1073 1074 1075 1076 1077 1078 1079 1080 1081 1082 1083 1084 1085 1086 1087 1088 1089 1090 1091 1092 1093 1094 1095 1096 1097 1098 1099 1100 1101 1102 1103 1104 1105 1106 1107 1108 1109 1110 1111 1112 1113 1114 IMDRF WG PD2 N7 R2 10 11 12 13 14 15 16 17 18 19 Authorized Representative s name regional representatives responsible for the medical device country specific could be multiple if required by the local regional regulatory authority see GHTF SG1 N55 GHTF SG1 N55 Authorized Representative s contact information country specific could be multiple
29. 4 The carrier of the System UDI should be put on the assembly that most likely does not get exchanged in its lifetime and should be identified as the System UDI UDI UDI 5 Each component sub system or accessory that is considered a medical device and a distributed or supplied unit needs a separate UDI NN ee ea UDI O 10 6 Standalone Medical Device Software 10 6 AX B Fa LORRBHST hoz FO 1 UDI Assignment Criteria 1 UDI The UDI should be assigned at the system level of the Standalone Medical Device Software 10 April 2013 Page 32 of 34 1331 1332 1333 1334 1335 1336 1337 1338 1339 1340 1341 1342 1343 1344 1345 1346 1347 1348 1349 1350 1351 1352 1353 1354 1355 1356 1357 1358 1359 1360 1361 1362 1363 1364 1365 1366 1367 1368 1369 1370 1371 1372 1373 1374 1375 1376 1377 IMDRF WG PD2 N7 R2 UDI
30. Though the UDI Database UDID does not capture Production Identifiers UDI PI it is expected that supply chain operators will capture and use these identifiers This is critical during recalls and other field safety corrective actions In addition the foundational use of UDI can help fight counterfeiting and secure the supply chain for all stakeholders UDID UDI PI UDI Traceability includes 10 April 2013 Page 6 of 34 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 IMDRF WG PD2 N7 R2 a recording medical devices from manufacturer to healthcare provider throughout the supply chain
31. UDI UDI 3 Placement of the UDI Carrier on Kits NZ a UDI The Kit UDI Carrier is generally affixed to the outside of the packaging OD UDI a The UDI must be readable or in the case of AIDC scan able whether placed on the outside of Kit package or inside a transparent package UDI UDI AIDC 10 4 IVD Kits 10 4 IVD Fy A IVD kits should follow the rules listed below 10 April 2013 Page 30 of 34 1244 1245 1246 1247 1248 1249 1250 1251 1252 1253 1254 1255 1256 1257 1258 1259 1260 1261 1262 1263 1
32. O b recording medical device use in patients c implementation of medical device recalls d a standardized way to input medical device identification into registries DB 2 2 Identification 2 2 A UDI will facilitate the adequate identification of the medical device through distribution and use by providing a single global identifier that can be used to link and integrate existing government clinical hospital and industry databases UDI should allow for improved procurement inventory management and accounting The existence of a single device identifier UDI DI to link disparate data bases should allow creative new medical and business applications and synergy among those applications UDI will facilitate the adequate identification of the medical device through distribution and use by providing a single global identifier that can be used to link and integrate existing government clinical hospital and industry databases UDI
33. API UDI Only the human readable portion of the UDI is required in electronic displays of the Standalone Medical Device Software The UDI AIDC marking needs not be used in the electronic displays e g about menu splash screen etc i e software not being distributed by the use of physical data carriers CDs DVDs or similar will not carry an AIDC UDI Human Readable UDI AIDC About Splash Screen CD DVD AIDC The human readable format of the UDI for Standalone Medical Device Software should include the Application Identifiers AI for GS1 and Flag Characters for HIBCC to assist the end user in identifying the UDI and determining which standard is being used to create the UDI
34. The UDID shall use HL7 Structured Product Labeling SPL standard for data submission and updates Additional submission means could also be accommodated UDID HL7 SPL The core elements are the minimum elements needed to identify a medical device through distribution and use Regional or National UDID may contain additional elements however these additional elements should be kept to a minimum UDD O The design of the UDID should support the official languages required in the jurisdictions where the medical device is put on the market UDID
35. The core UDID data elements are the following UDID 1 For every packaging level the following shall be provided in a related way for entire packaging hierarchy Y UDI DI UDI type e g GS1 GTIN HIBC LIC ISBT product code UDI DI UDI fil GS1 GTIN HIBC LIC ISBT v Quantity per package configuration e g each 10 each 5 shelf packs 1 10 5 v Additional device identifier s if applicable e g GS1 HIBC or ISBT 128 Bil GS1 HIBC ISBT 128 2 The Unit of Use UDI DI see section 7 6 code UoU UDI DI 7 6 3 The data for new UDI DI must be available at the time the medical device is put on the market UDI DI 4 Manufacturer s name as required on the label O
36. a The UDI Carrier of reusable medical devices that require reprocessing or sterilization between patient uses should be permanent and readable after reprocessing or sterilization cycles for the whole life of the device Manufacturers may determine that this may not be possible or warranted on some devices due to size design materials processing or performance issues DUDI The UDI Carrier should be readable during normal use and throughout intended life of the medical device UDI If the UDI Carrier is readily readable through the medical device s package then the UDI Carrier does
37. The core data elements in the UDID shall be accessible to the public free of charge UDID The presence of the medical device UDI DI in the UDID does not mean that the medical device is aun in all jurisdictions UDID cz 4 o 0 UDI DI Dalit ee een ate The database should allow for the linking of all the packaging levels of the medical device Manufacturers should update the UDID within 30 days when a change is made to an element that does NOT require a new UDI DI UDI DI O UDID 30
38. 775 DPM UDI UDD 776 10 April 2013 Page 19 of 34 777 778 779 780 781 782 783 784 785 786 787 788 789 790 791 792 793 794 795 796 797 798 799 800 801 802 803 804 805 806 807 808 809 810 811 812 813 814 815 816 817 818 IMDRF WG PD2 N7 R2 To common criteria for accreditation are a The employed UDI must meet the requirements of the globally harmonized UDI System to adequately identify a device through its distribution a UDI UDI O a b The employed UDI is in compliance with international standards ISO 15459 2 ISO 15459 4 and ISO 15459 6 UDI X ISO 15459 2 ISO 15459 4 U ISO 15459 6 c The employed UDI will be available to all users according to a single set of consistent fair and reasonable terms and conditions UDI
39. Do Own Brand Private Labelers An Own Brand or Private Labeler relabels a device from a 3 party with his own name without making any further changes to the device thereby taking responsibility for it as the manufacturer AGT FS amp FIMA ZNI 1 The term person that appears here includes legal entities such as a corporation a partnership or an association person 10 April 2013 Page 15 of 34 603 604 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645 646 IMDRF WG PD2 N7 R2 OEM Packaging Levels Packaging levels means the various levels of device packages that contain a fixed quantity of medical devices e g each carton case This does not include shipping containers such as pallets Pde HAIL
40. 997 998 999 1000 1001 1002 1003 1004 1005 1006 1007 1008 1009 1010 1011 1012 1013 1014 1015 1016 1017 1018 1019 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 1030 IMDRF WG PD2 N7 R2 10 11 12 No produce commercial confidential information shall be included in the UDID UDID The nda is responsible for the initial submission and updates to the identifying information and other medical device data elements in the UDID UDID Appropriate methods procedures for validation of the provided data shall be implemented The manufacturer shall periodically reconfirm all the data relevant to their medical devices except for discontinued medical devices O
41. UDID f the UDID should use the HL7 SPL for data submission 10 April 2013 Page 4 of 34 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 IMDRF WG PD2 N7 R2 UDID HL7 SPL g each medical device needs to be identified by a UDI UDI O D O The UDI System is intended to provide a single globally harmonized system for positive identification of medical devices Healthcare professionals and patients will no longer have to access multiple inconsistent and incomplete sources in an attempt to identify a medical device and its key attributes The UDID is a designated source for additional information It is critical to note that the benefits of UDI can only accrue if all stakeholders from the manufacturer to healthcare providers and patients use UDI throughout their systems Therefore it is imperative that all stakeholders be educated about the development and use of a UDI System The UDI System is intended to provide a single globally harmonized system for positive
42. identification of medical devices UDI Healthcare professionals and patients will no longer have to access multiple inconsistent and incomplete sources in an attempt to identify a medical device and its key attributes The UDID is a designated source for additional information UDID UDI It is critical to note that the benefits of UDI can only accrue if all stakeholders from the manufacturer to healthcare Ee and patients use UDI throughout their systems UDI MD a Therefore it is imperative that all stakehold
43. imdrf org docs ghtf archived sg1 technical docs ghtf sq1 pd n7r04 definition of term medical device 110315 pdf 4 References 4 GHTF final documents http www imdrf org documents documents asp ghtf SGI N071 2012 Definition of the Terms Medical Device and In Vitro Diagnostic IVD Medical Device http www imdrf org docs ghtf final sg1 technical docs ghtf sg1 n07 1 201 2 definition of terms 120516 docx SG1 N070 2011 Label and Instructions for Use for Medical Devices http Awww imdrf org docs ghtf final sg1 technical docs ghtf sg1 n70 201 1 label instruction use medical devices 110916 doc SG1 N055 2009 Definitions of Terms Manufacturer Authorized Representative Distributor and Importer http www imdrf org docs ghtf final sg1 technical docs ghtf sg1 n055 definition terms 090326 doc SG1 N065 2010 Registration of Manufacturers and other Parties and Listing of Medical Devices http Awww imdrf org docs ghtf final sg1 technical docs ghtf sg1 n065 listing of medical devices 100827 doc ISO IEC 15459 2 2006 IT Unique identifiers Part 2 Registration procedures http Awebstore iec ch preview info_isoiec15459 2 7Bed2 0 Den pdf 10 April 2013 Page 12 of 34 47
44. assigned to the system level software O CD DVD TH UDI Human Readable AIDC UDI UDI should be provided on a readily accessible screen by the user in an easily readable plain text format e g an about file or included on the startup screen UDI Pil About Software lacking a user interface e g middleware for image conversion must be capable of transmitting the UDI through an Application Programming Interface API Bl
45. defined list of Data Elements UDID O d establishing basic requirements for a data submission format based on a common standard e establishing basic requirements for a common data exchange standard In order to facilitate global traceability the UDI System should be promoted and used at all levels by all stakeholders including regulatory authorities medical device manufacturers distributors healthcare providers and patients UDI O This document does not address the use of the UDI System e g by healthcare providers Therefore it does not directly address issues associated with counterfeit medical devices or how to enable better control of purchasing which will depend on the use of the UDI System by health
46. for a UDI System ues T The UDI crinca n rE E ERA R EEE 8 UDI Carrier SE 9 The UDID vrnie ERA 9 1 General principles of the UDID sossen 9 2 The core UDID data elements 10 Rules for specific device types wcscccsscassiaisssssesnsanacssccacantadssaenpnascoasnanss 10 1 Implants e a 28 10 2 Reusable devices requiring sterilization or high level disinfection between uses 29 10 3 Non IVD kits 29 10 4 IVD Kits 30 10 5 Configurable medical device systems 32 10 6 Standalone Medical Device Software 32 10 April 2013 Page 2 of 34 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 IMDRF WG PD2 N7 R2 1 Preamble 1 This document is inscribed in the framework of the International Medical Device Regulators Forum IMDRF It replaces the Guidance on a Unique Device Identification System UDI for Medical Devices adopted by the Global Harmonization Task Force GHTF on 16 September 2011 IMDRF GHTF 2011 9 16 UDI AT BO The IMDRE Guidance on a Unique Device I
47. shall be favored However certain environments or use situations such as home care may warrant the use of HRI over AIDC AIDC HRI AIDC AIDC HRI 10 April 2013 Page 23 of 34 945 946 947 948 949 950 951 952 953 954 955 956 957 958 959 960 961 962 963 964 965 966 967 968 969 970 971 972 973 974 975 976 977 978 979 980 981 982 983 984 985 986 987 IMDRF WG PD2 N7 R2 10 11 12 13 14 9 In case of RFID a linear or 2D bar code shall also be provided on the label RFID RFID 2D Medical devices that are reusable should have a UDI Carrier on the device itself UDI
48. 264 1265 1266 1267 1268 1269 1270 1271 1272 1273 1274 1275 1276 1277 1278 1279 1280 1281 1282 1283 1284 1285 1286 IMDRF WG PD2 N7 R2 IVD 1 The manufacturer of the VD Kit is responsible for identifying it with a UDI including both UDI DI and UDI PI IVD Tk UDLDI UDIPI UDI UDI O 2 Medical device contents of IVD Kits should have a UDI Carrier on their packaging or on the device itself IVD UDI O 1 iil Re a The IVD Kit is a device and all aspects of this guidance that is relevant apply to it If an IVD Kit does not include any components which on their own are considered medical devices the only UDI is the UDI of the kit itself IVD y hO IVD UDI
49. 5 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 IMDRF WG PD2 N7 R2 ISO IEC 15459 4 2008 IT Unique identifiers Part 4 Individual items http Awebstore iec ch preview info_isoiec15459 4 7Bed2 0 Den pdf ISO IEC 15459 6 2007 IT Unique identifiers Part 6 Unique identifier for product groupings http Awebstore iec ch preview info_isoiec15459 6 7Bed1 0 Den pdf ISO IEC 16022 2006 IT AIDC technics Data Matrix bar code symbology specification http webstore iec ch preview info_isoiec16022 7Bed2 0 Den pdf ISO IEC 18004 2006 IT AIDC techniques QR Code 2005 bar code symbology specification http webstore iec ch preview info_isoiec18004 Bed2 0 Den pdf 5 Definitions 5 Accessory Accessory means an article intended specifically by its manufacturer to be used together with a specific medical device s to enable the medical device to be used in accordance with its intended use modified draft GHTF definition SG1 N071 2012 O GHTF SG1 N071 2012 http www imdrf org docs ght
50. DI System comprises 3 parts UDI 3 1 the development of the UDI using globally accepted standards UDI 2 the application of that UDI on the label and UDI 3 the submission of appropriate information to a UDID UDID In order to facilitate a globally harmonized approach to UDI it is imperative that UDI 1 the marking of the UDI should be an additional requirement it does not replace any other marking or labeling requirements UDI UDI 2 the manufacturer should create and maintain globally unique UDIs on his medical devices UDI 3 the UDI on the device should not be changed except in the cases of reprocessing remanufacturing or relabeling that lead to a reg
51. EERIE GS These devices should follow the rules listed below 1 The UDI of these products must be on the device and must be readable after each sterilization or high level disinfection UD 2 PI characteristics e g lot or serial number should be defined by the manufacturer according to the manufacturer s quality management system PL ay me 10 3 Non IVD kits 10 3 FAIVD 1 The manufacturer of the Kit is responsible for identifying the Kit with a UDI including both UDI DI and UDI PI a Orthopedic procedure trays whose contents are configured for a specific order are exempted from this UDI requirement Example a hospital orders 30 different orthopedic devices for total joint replacement surgery The 30 devices are delivered
52. I It is expected that the regulatory authorities will follow the guidance when developing their own UDI requirements UDI O The framework can be used at a local national or global level In order to reach the goal of a globally harmonized UDI System it is critical that these systems are implemented without regional or national differences UDI O This guidance is intended to provide a high level conceptual view of how a global UDI System should work UDI O It is recognized t
53. I which can be readable at any user side and keep the 746 appropriate marking based on the quality management such as clear readable label 747 including uniqueness 748 O UDI O 749 750 751 6 globally accepted coding standards managed by global organizations such as GS1 HIBCC 752 and ICCBBA meet the criteria of the UDI and manufacturers shall be permitted to choose 753 which system to use These organizations have responsibility for maintaining the global 754 uniqueness of their coding systems It is imperative that these coding systems be adopted 755 and implemented without national deviations or changes to these global coding systems 756 proliferation of coding systems must be discouraged 757 UDI GS1 HIBCC ICCBBA 758 759 760
54. WG PD2 N7R2 IM DRF International Medical Device Regulators Forum shall should ISO shall should IMDRF shall should must 5 9 International Medical Device Regulators Forum TO GS1
55. ally relevant information e g radio opaque Storage conditions as labeled on the product and or in the IFU if applicable to include temperature range needs to be refrigerated relative humidity range pressure range avoid direct sunlight Handling conditions if different than storage conditions as labeled on the product and or in the IFU if applicable to include temperature range needs to be refrigerated relative humidity range pressure range avoid direct sunlight Labeled as single use Yes No Yes No Packaged sterile Yes No Yes No
56. anufactured or relabeled medical device which will replace the OEM s UDI where it exists OEM UDI UDI 13 Reprocessors of single use medical devices remanufacturers Private Private Labelers shall retain record of the Original Equipment Manufacturer s OEM UDI Hi EN RU BRE O FE OEM UDI 14 A change of the label to display or modify a UDI DI should not in and of itself require a premarket submission and or re registration Manufacturers may be requested to notify inform the Regulator UDI DI UDLDIO
57. care providers 10 April 2013 Page 11 of 34 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 IMDRF WG PD2 N7 R2 UI UDI 3 3 Scope 3 3 AA This document applies to all products to be placed on the market that are regulated as medical devices For a definition of a medical device see the GHTF document Information Document Concerning the Definition of the Term Medical Device This document is addressed to the regulatory authorities and affects medical device manufacturers GHTF Information Document Concerning the Definition of the Term Medical Device J MANE VY http
58. dance provides a framework for those regulatory authorities that intend to develop their own UDI Systems such that when implemented it achieves a globally harmonized approach to UDI It is expected that the regulatory authorities will follow the guidance when developing their own UDI requirements The framework can be used at a local national or global level In order to reach the goal of a globally harmonized UDI System it is critical that these systems are implemented without regional or national differences This guidance is intended to provide a high level conceptual view of how a global UDI System should work It is recognized that further additional guidance may be needed once these core concepts are implemented This guidance provides a framework for those regulatory authorities that intend to develop their own UDI Systems such that when implemented it achieves a globally harmonized approach to UDI 10 April 2013 Page 3 of 34 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 IMDRF WG PD2 N7 R2 UDI UD
59. dentification System UDI for Medical Devices clarifies and supplements the above mentioned GHTF Guidance by providing non binding rules for use in the regulation of medical devices and has been subject to consultation throughout its development IMDRF UDI Unique Device Identification System UDI for Medical Devices GHTF There are no restrictions on the reproduction distribution or use of this document however incorporation of this document in part or in whole into any other document or its translation into languages other than English does not convey or represent an endorsement of any kind by the International Medical Device Regulators Forum MAR Wicxt LT IMDRF 2 Introduction 2 This gui
60. e g version revision number serial number etc o Revision UDILDI Revision Revision 4 The version number of the Standalone Medical Device Software is considered the manufacturing control mechanism and should be displayed in the UDI PI Version UDI PI 2 UDI Placement Criteria 2 UDI 10 April 2013 Page 33 of 34 1378 1379 1380 1381 1382 1383 1384 1385 1386 1387 1388 1389 1390 1391 1392 1393 1394 1395 1396 1397 1398 1399 1400 1401 1402 1403 1404 1405 1406 1407 1408 1409 1410 1411 1412 1413 1414 1415 IMDRF WG PD2 N7 R2 a When the Standalone Medical Device Software is delivered on a physical medium e g CD or DVD each package level shall bear the human readable and AIDC representation of the complete UDI The UDI that is applied to the physical medium containing the software and its packaging must be identical to the UDI
61. edical devices using the UDI or model number of individual devices and the manufacturer places these devices in a container for shipping or to protect the individually packaged devices the container logistics unit is not subject to UDI requirements O DUDI UDI UDI O 10 April 2013 Page 20 of 34 819 820 821 822 823 824 825 826 827 828 829 830 831 832 833 834 835 836 837 838 839 840 841 842 843 844 845 846 847 848 849 850 851 852 853 854 855 856 857 858 859 860 861 IMDRF WG PD2 N7 R2 3 10 The UDI contains two parts a Device Identifier UDI DI and a Production Identifier UDI PI UDI 2 UDLDI F UDI PI The UDI DI e g GS1 GTIN HIBC LIC ISBT p
62. en the electrode is distributed in a package of 10 and lowest level UDI is assigned to that package of 10 UDI O UoU Unit of Use UDI DI 10 UDI 10 UoU UDILDI Each component sub system or accessory that is regulated as a medical device needs a separate UDI UDI Kits should have their own UDI 0 UDI The manufacturer assigns the UDI to a device following the relevant coding standard UDI Any change of one of the following UDID data elements determines the need for a new UDLDI UDID
63. ers be educated about the development and use of a UDI System UDI A globally harmonized and consistent approach to UDI is expected to increase patient safety and help optimize patient care by facilitating the UDI O 10 April 2013 Page 5 of 34 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 IMDRF WG PD2 N7 R2 a traceability of medical devices especially for recalls and other field safety corrective actions b adequate identification of medical devices through distribution and use
64. f final sg 1 technical docs ghtf sg 1 n07 1 2012 definition of terms 120516 docx Automatic Identification and Data Capture AIDC AIDC refers to the methods for automatic identification of objects collecting data about them and entering the data directly into computer systems Aik L OF 2 BFF AIDC hl Configurable medical device system A configurable medical device system consists of several components which can be assembled in multiple configurations Those components may be medical devices itself and or non medical devices Examples are Computed Tomography CT systems Ultrasound systems Anesthesia systems Physiological Monitoring systems Radiology Information System RIS B RLE OS PT HEL EIERE RT A CT RIS
65. followed 1 A UDI is allocated to the entire configurable medical device system and is called the System UDI UDI UDIO 2 The system UDI DI is allocated to defined groups of configurations not per configuration within the group A group of configurations is defined as the collection of possible configurations for a given product line as described in a regulatory file UDI DI O 3 A system UDI PI is allocated to each individual system A later change of a component sub systems or accessory of the system does not change the UDI PI of the system UDI PI O UDIP O
66. ge 7 of 34 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 IMDRF WG PD2 N7 R2 greater accuracy in reporting and more rapid aggregation of related reports Using this information Health Authorities can more rapidly collate and analyze problem reports and identify the most appropriate solution for a particular concern UDI will allow more targeted safety alerts recalls and other corrective actions on the specific medical devices that are of concern UDI will allow industry and regulatory authorities to more rapidly identify medical devices involved in adverse events UDI UDI will be available for inclusion in adverse event reports allowing greater accuracy in reporting and more rapid aggregation of related reports UDI Using this information Health Authorities can more rapidly collate and a
67. hat further additional guidance may be needed once these core concepts are implemented The fundamental concepts of a globally harmonized UDI System include UDI a the UDI and UDI Carrier are based on global standards UDI b a UDI applied to a medical device anywhere in the world should be able to be used globally to meet the UDI requirements of any regulatory authority UDI UDI c national or local identification numbers should NOT be a substitute for UDI UDI OF ARE d regulatory Authorities should not specify how to modify these standards e the UDI Database UDID core elements should not be modified UDI
68. nalyze problem reports and identify the most appropriate solution for a particular concern UDI will allow more targeted safety alerts recalls and other corrective actions on the specific medical devices that are of concern UDI 3 Ty 18 2 4 Medical Errors 2 4 Rea By providing rapid and electronic access to critical patient safety information relating to a medical device the UDI system may help clinicians more safely select and use the proper medical device for a patient UDID data could be downloaded by healthcare providers to be used for internal reference of safety related information By providing rapid and electronic access to critical patient safety information relating to a medical device the UDI system may help clinicians more safely select and use the proper medical device for a patient UDI
69. ndards such as EPC Electronic Product Code and be vendor neutral RFID EPC When AIDC carriers other than the UDI Carrier are part of the product labeling the UDI Carrier shall be readily identifiable UDI AIDC UDI If linear bar codes are used the UDI DI and UDI PI can be concatenated or non concatenated in two or more bar codes All parts and elements of the linear bar code shall be distinguishable and identifiable UDLDI UDLPI O If there are significant constraints limiting the use of both AIDC and HRI on the label the AIDC format
70. not also need to be on the package UDI OR UDI A single finished medical device made up of multiple parts that have to be assembled may have the UDI Carrier only on one part UDI O The placement of the UDI Carrier should be done in a way that AIDC method can be accessed during normal operation or storage UDI O ALDC CT The UDID 9 UDID 9 1 General principles of the UDID 9 1 UDID DIARI 10 April 2013 Page 24 of 34 988 989 990 991 992 993 994 995 996
71. ollection of products including medical devices that are packaged together to achieve a common intended use and is being distributed as a medical device These could also be called procedure packs or convenience kits Note Jurisdictions may differ in their definition of kit 10 April 2013 Page 14 of 34 563 564 565 566 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 592 593 594 595 596 597 598 599 600 601 602 IMDRF WG PD2 N7 R2 PAN Label Written printed or graphic information either appearing on the medical device itself or on the packaging of each unit or on the packaging of multiple devices INIL
72. plicable if a particular regulation requires that the label of the device contains a critical warning or contraindication associated with the use of the device e g a Labeled as containing latex Yes No Latex 9 Yes No b Labeled as containing DEHP Yes No etc DEHP 7 Yes No oo Fe Discontinuance information Information referring to products no longer placed on the market Date of discontinuance A 10 Rules for specific device types 10 10 1 Implants 10 1 HOLA KR Implants should follow the rules listed below 1 All unit packs of implants lowest level of packaging need to be identified AIDC marked with an UDI UDI DI UDI PD
73. roduct code should be globally unique at all levels of packaging UDI DI GS1 GTIN HIBC LIC ISBT If a lot number serial number software version number or expiration date appears on the label they should be part of the UDI PI If there is ALSO a manufacturing date on the label it does NOT need to be included in the UDI PI If there is only a manufacturing date on the label this should be used as the UDI PI UDLPI UDI PI UDLPI When a UDI is not assigned to the device at the level of its unit of use then a Unit of Use UoU UDI DI should be assigned to associate the use of a device with a patient for example a UoU UDI DI would be assigned to an individual electrode wh
74. s UDI In addition eliminating or reducing differences between regulatory authorities decreases the cost of gaining regulatory compliance 3 2 Purpose 3 2 A UDI unambiguously identifies a manufacturer s specific medical device A standardized UDI is part of the label documented in the UDID and used consistently throughout distribution and use should facilitate a number of patient safety benefits including UDIO 10 April 2013 Page 10 of 34 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 IMDRF WG PD2 N7 R2 UDI UDID
75. s The use of UDI System will facilitate and simplify the documentation of medical device use in various patient records including traditional as well as electronic health records and registries UDI UDI should also enable linkages of medical device information across various systems and across geographies UDI These applications of UDI could help identifying medical device problems and enhance comparative effectiveness UDI Other considerations essential for the successful development and implementation of a globally harmonized UDI System include UDI
76. to the hospital in a stainless steel box where the devices can be stored and sterilized by the hospital when needed After a procedure the hospital may replace used parts and re sterilize the box with its contents UDLDI L UDLPI UDI UDI 30 30 10 April 2013 Page 29 of 34 1201 1202 1203 1204 1205 1206 1207 1208 1209 1210 1211 1212 1213 1214 1215 1216 1217 1218 1219 1220 1221 1222 1223 1224 1225 1226 1227 1228 1229 1230 1231 1232 1233 1234 1235 1236 1237 1238 1239 1240 1241 1242 1243 IMDRF WG PD2 N7 R2 2 Medical device contents of Kits should ha
77. tructures operating platform architecture or new user interfaces or new channels for interoperability ek 3 Minor Standalone Medical Device Software revisions shall be identified with a new UDI PI Revision Minor Standalon fixes aesthetics UDLPI O e Medical Device Software revisions are generally associated with bug usability enhancements security patches or operating efficiency Note Minor Standalone Medical Device Software revisions shall not require a new UDI DI Minor revisions shall be identified by manufacturer specific identification methods
78. ulated new medical device 10 April 2013 Page 18 of 34 IMDRF WG PD2 N7 R2 734 735 UDI O 736 Ws 737 4 only the manufacturer can establish the UDI on the device or its packaging Reprocessors 738 of single use medical devices remanufacturers Own Brand Private Labelers are considered 739 the manufacturer of the reprocessed or remanufactured device and as such are also subject 740 to these requirements 741 UDI O 742 743 7 O 744 745 5 Manufacturer should provide UD
79. ve a UDI Carrier on their packaging or on the device itself O UDI CA Exemptions YI a Individual single use disposable medical devices within a Kit whose uses are generally known to the persons by whom they are intended to be used and which are not intended for individual use outside the context of the Kit do not require their own UDI Carrier UDI Example an unpackaged sterile syringe within a sterile Kit cannot be used for another procedure due to the lack of a sterile barrier once removed from the Kit O Medical devices that are normally exempted from having a UDI Carrier on the relevant level of packaging do not need to have a UDI Carrier when placed within a Kit
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