Medtech Standards Request Advances – But Too Late For MDR/IVDR First Wave
The medtech sector may, at last, be one step closer to ensuring standards are drafted or revised under the EU’s MDR and IVDR. But delays have already meant industry has had to adopt “Plan B.”
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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.
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.
No one should underestimate the scale of the obstacles companies face trying to comply in time with the IVD Regulation by its 26 May 2022 deadline, especially now data is starting to emerge to highlight the size of the problem.