Unique Device Identifier (UDI) Guidance Document
Table of Contents 1.0 Introduction .................................................................................................................................... 3 2.0 Key Objectives .............................................................................................................................. 3 3.0 Responsibilities ............................................................................................................................. 3 4.0 Definitions ...................................................................................................................................... 4 5.0 General requirements of the UDI ............................................................................................... 5 6.0 Specific requirements of the UDI ............................................................................................... 6 7.0 European database on medical devices (EUDAMED)............................................................ 7 8.0 UDI Database................................................................................................................................ 8 9.0 Specific Rules ............................................................................................................................. 10 Appendix: References from 2017/745 EU MDR ........................................................................... 11
1.0 Introduction Unique Device Identifier (UDI) is defined in a series of characters which is created in order to identify a device. The new regulation EU MDR 2017/745 introduces the UDI system which is similar to the Global Regulatory Data Standards. It is hard to achieve a single worldwide UDI database although, in the near future several regional regulators will adopt UDI standards. The UDI system is aiming to improve the safety and accurate the reporting. Also, its purpose is to monitor the corrective actions and have more efficient IDs (fewer counterfeits). According to EU MDR 745/2017, only if the device is assigned to the UDI system can be released on the market. It is the manufacturer's obligation to assign the device in the UDI system and comply with the essential requirements. The aim of this guidance is to illustrate the manufacturer to the UDI system and define its obligations in regard to the UDI system. The UDI system includes the UDI database which part of the EUDAMED (European database on medical devices) and is illustrated in this document.