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Simply stated, Unique Device Identification or UDI is the bar-coding of all IVDs on the European market using a standard format. It will be supported by a database which provides users and regulators quick access to information about the coded device. In contrast to the current In Vitro Diagnostics Directive (IVDD) which doesn’t mention UDI, the requirements associated with the introduction of UDI in the EU are present in many of the Articles and Annexes of the new European Union In Vitro Diagnostics Regulation (EU IVDR). However, UDI is not a new topic. UDI is another example where the EU IVDR simply brings European regulations up to date and into line with device and IVD regulations elsewhere in the world. The US FDA published its final rule on UDI as far back as 2013. Similar to the approach taken in the USA, the UDI requirement will be phased in also in Europe over several years. According to Article 10 of the new EU IVDR, UDI ranks among the basic obligations for all IVD manufacturers, just like fulfilling essential requirements or creating Technical Documentation. Article 24 contains the mandate to establish a UDI system for Europe, Article 25 contains the requirement to establish a UDI database and Article 26 requires Manufacturers to register their UDI in the database. While the specific data elements which make up the individual device UDI are listed in Part B of Annex VI. Concerning the timing of the introduction of the basic UDI (Device Identifier) required for the documentation: Any Manufacturer wishing to comply with the new EU IVDR can and should develop the basic UDI for their device without delay. The UDI is required for the new Technical Documentation (Annex II), for the new EU Declaration of Conformity (Annex IV) and for the new registration data (Annex VI, Part A). However, manufacturers need not wait for the European system to be developed. Annex II, 1.1(b) says the device UDI based on “a” UDI system, rather than specifying the European UDI system. The interpretation being that the new Technical Documentation, the new EU Declaration of Conformity and the new registration can all be prepared based another UDI system, the system used in the USA for example. This is further supported by Article 110 (10) (Transitional provisions) which also confirms, prior to the designation of a UDI entity for the EU, formats published by GS1 AISBL, HIBCC and ICCBBA will also be recognised. In contrast to the introduction of the basic UDI (Device Identifier) in the Technical Documentation, on the Declaration of Conformity and in the registration data. The introduction of the full UDI on labelling, which includes the production data, is in stages similar to the approach taken by the FDA. According to Article 113 (c); the UDI labelling will be required for Class D devices from 26th May 2023. UDI labelling will be required for Class C and B devices from 26th May 2025. UDI labelling will be required for Class A devices from 26th May 2027. For additional information on UDI see the IMDRF UDI guidance document of December 2013. |