Counts here are a floor, never a total: they cover the 326 consultation files tracked so far (29,503 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
We very much welcome the European Commission’s willingness to further develop the MDR and to address existing challenges in the conformity assessment process. In particular, the proposed regulation aims at increasing the standardisation and transparency of notified body processes. However, in our view, this approach is too short.
Filed in German · English published by the European Commission
In principle, I welcome the Commission’s willingness to further develop the MDR. The authorisation of medical devices in Europe currently involves a lot of red tape, long processing times and high costs. The proposed regime can increase the transparency of conformity assessment.
Filed in German · English published by the European Commission
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