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.
You may also be interested in...
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.
Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.
Despite COVID-19 distancing measures and fears that new notified body appointments would grind to a halt, there is now a new notified body for the EU Medical Device Regulation.