Stricter medtech rules gain EU panel vote, pushback from Eucomed

09/27/2013 | MassDevice.com (Boston)

A proposal to subject Class III medical devices in Europe to a tougher review process similar to the FDA's premarket-approval program has been approved by a European Commission panel. The move received pushback from Eucomed, which said the requirement would "not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe's 25,000 small and medium-sized device makers."

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