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EU Parliament Considers More Stringent Medical Device Regulations

EU Parliament committee continues debate on medical device regulations, focusing on pre-market approval, scrutiny of notified bodies and post-market surveillance.

The EU Parliament’s Environment, Public Health and Food Safety Committee continued to discuss possible changes to Europe’s medical device regulations at its March 20 meeting.

Continuing the argument from the committee’s Feb. 26 meeting, Dagmar Roth-Behrendt of Germany, the rapporteur of the committee, advocated that a more extensive pre-market approval process should be created for Europe. “I want to have a centralized pre-market authorization for the highest class [of medical devices],” she said in her opening remarks

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