Image source: Guillaume Périgois on Unsplash
In the last few years, we have repeatedly reported on the EU Medical Devices Regulation. This included recommendations for action in preparation and how regulatory affairs positions can be filled.
Now, both the European Parliament and the European Council have adopted the EU Commission's proposal to extend the transition period for the recertification of existing products. Previously, the deadline was 26 May 2024. Products with a higher risk do not have to be recertified until the end of 2027 and products with a medium to low risk until the end of 2028.
The extension is subject to certain conditions and applies, for example, to:
Since the regulation was adopted, SMEs in particular have seen a major challenge in its implementation. The additional bureaucratic hurdles and the lack of regulatory affairs staff have been cited as the biggest point of criticism. Now, additionally, hospitals have warned of possible bottlenecks as there are not enough places for the certification of medical devices.
The extended transition period is intended to ease the bottleneck situation.
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