Commission To Submit Yet Another European Standards Request – In Early 2021
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.
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The European Commission has a pacey line-up of meetings for the rest of 2020 to help companies achieve compliance with the Medical Device Regulation by next May.
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.
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.