European Commission To Cast Its Own Critical Eye Over MDR And IVDR

The commission expects to reach its conclusions before the end of 2025. This will signal what regulatory changes the EU medtech sector can expect thereafter.

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The medtech industry and notified bodies have been increasingly vocal about the failures in the EU’s Medical Device and IVD Regulation over the last few years. Now the European Commission has pledged to take stock of the situation and listen to the views of stakeholders.

The commission has promised a public consultation on the MDR and IVDR in the third quarter of 2024, following a...

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