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What Next For Standards As CEN/CENELEC Reject MDR/IVDR Commission Request?

 
• By Amanda Maxwell

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.

Blocked

European standards bodies CEN and CENELEC were due to submit their joint work program to the European Commission today. But that is not happening.

The standards bodies rejected the European Commission’s Medical Device Regulation (MDR) and IVD Regulation (IVDR) standardization request on 16 June,...

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