EU Commission Confidence on MDR Meets Growing List of Challengers

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ARTICLE SUMMARY:

EU member country leaders are increasingly alarmed that Europe will not be ready to stand up the new Medical Device Regulation next May, as more notified bodies drop out. But the Commission insists the deadline is “realistic and achievable” and points to its progress.

There barely seems to be a week without news underscoring reasons to worry about the planned May 2020 implementation of the EU Medical Device Regulation (and even the May 2022 date for the IVD Regulation). And each week, it becomes more difficult to understand how the European system will be ready for the big change without many products at least temporarily dropping off the market, or without individual EU countries stepping in on a piecemeal basis to help fill the gaps.

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