Extension of transitional periods for MD – Further to the implementation of European Regulation (EU) 2017/745 & 746, thousands of medical devices are currently pending certification, a situation which is raising great fears of a widespread shortage in Europe. In particular, the lack of notified bodies, the recent pandemic, and the geopolitical context of the Ukraine war with its resulting disruptions to raw material supply are to blame.
To avoid a catastrophic situation for the many patients whose health depends on vital medical devices, the European Parliament and Council recently put forward a proposal to extend the transitional period. The proposal was adopted by the European Commission on 16 February, 2023. The deadlines have thus been extended to 31 December 2027 for high-risk Class II and IIb MD, and to 31 December 2028 for low-risk Class I and IIa devices. For safe in vitro diagnostic medical devices, the withdrawal of the May 2025 ‘sale’ date will prevent devices which are already on the market from being excluded.
While the adoption of this proposal clearly provides breathing space for MD manufacturers awaiting certification from notified bodies, companies who are lagging behind in their transition must pursue their efforts without delay. Initial actions to be implemented include the Quality Management System, technical files and the compilation and recording of production information and data, in addition to MD traceability and the recording and storing of Basic UDI and UDI-DI data. The traceability and analysis of dynamic data are two particularly sensitive areas which require specific solutions.
To facilitate this task, our experts are at your side to provide practical solutions for the traceability and management of dynamic data, while taking your regulatory requirements into account. Contact us now.
The amending regulation can be downloaded or read on line.
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