Following the global trend in handling the traceability of medical devices, the EU Commission has clearly defined the requirements for implementation of a Unique Device Identification (UDI) System in the final text of the new EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, published at the beginning of May. Both legislative acts describe similar requirements for the two types of devices, with only the implementation timelines differing.

The UDI system and the compliance requirements for all medical device industry stakeholders are described in several articles and annexes throughout the MDR. The widespread appearance of the UDI through the legislative text reflects the complexity of the UDI system, and it comes from the multiple regulatory processes that are affected and would have to incorporate UDI information in the future. These processes impose new requirements on all actors of the supply chain, from manufacturers down to healthcare professionals, with the involvement of notified bodies (NB) and competent authorities (CA). The final goal: to improve patient safety through better traceability and transparency.

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