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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Work is progressing towards publications of an updated list of standards to support implementation of the EU’s new medtech regulations.
After a long delay, the EU’s first harmonized standards under the MDR and IVDR are trickling through ̶ but the standards situation is still far from ideal.
The EU’s Medical Device Regulation applies in just over a month’s time and the IVD Regulation in just over a year. But the standards underpinning them are way behind. Will they get the green light at last?