The existing regulatory framework on medical devices dates back to the 1990s and consists of three Directives. Two new Regulations (Regulation (EU) 745/2017 on medical devices and Regulation (EU) 746/2017 on In Vitro diagnostic medical devices) were adopted in April 2017 and entered into force on 25 May 2017. The general application dates of the two Regulations are 26 May 2021 for medical devices and 26 May 2022 for In Vitro diagnostic medical devices, though different timelines apply for certain specific provisions.
These Regulations introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI).
The UDI system will facilitate easier traceability of medical devices, significantly enhance the effectiveness of the post-market safety-related activities for devices and allow for better monitoring by competent authorities. It will also help to reduce
medical errors and to fight against falsified devices. The use of the UDI system finally should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators.