EU Regulations Catch-Up: Where Things Stand One Year from Lift Off

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Europe’s new Medical Device Regulation is scheduled to activate next May, but the necessary frameworks are far from ready. Still, progress has picked up a bit in recent months. Here’s a quick look at recent steps forward and remaining barriers.

Some late-May progress in the designation of notified bodies under the looming European Medical Device Regulation (MDR) added a touch of brightness to an overall bleak picture for device companies.

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