First Harmonized Standards Published For Both MDR And IVDR
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.
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The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.
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.
Standards harmonized under the EU medical device directives may have more longevity than originally expected, given the delay in the readiness of standards that can be used in the context of the forthcoming Medical Device Regulation.