Key Changes In Commission’s Latest Draft EU Standards Request To CEN/Cenelec
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.
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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.
The European Commission has at last officially requested that CEN and CENELEC develop and update urgently needed standards to support the MDR and IVDR. The pressure is now on the national European standards bodies to press on with the necessary work.
There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussion at the Council of the EU have now added to this drive.