What Next For Standards As CEN/CENELEC Reject MDR/IVDR Commission Request?
The timetable for developing harmonized standards under the EU’s Medical Device Regulation was already tight, even with new 2021 MDR application date. But it now looks untenable, even for the most urgently needed standards.
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The European Commission is optimistic that work on standards for the new EU medtech regulations will begin as soon as May. After previous setbacks, the medtech sector is pinning it hopes on the EU standards bodies, CEN and Cenelec, accepting the Commission’s latest proposal
Medtech companies selling in the EU will be keeping their fingers crossed that the European standards bodies will accept this third standards request from the Commission once the document is finalized.
Despite having its latest standards request formally rejected, the European Commission is determined to press ahead with proposals for new medtech standards under the new Medical Device Regulation – although the transition time is running out.