Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

Device Industry Aghast Over Proposed EU PMA Regulation

Posted by crimsonlanguage on 2013/09/26

On September 25th, a EU Parliament committee voted on proposed reforms to the device approval process – the results weren’t pretty for industry. Rather than the initial proposal to tighten control of Notified Bodies and begin unannounced facility inspections, the committee voted in favor of a centralized premarket approval process for high risk devices…similar to the U.S. system. A good overview is available at FierceMedicalDevices.

Not surprisingly, industry (including AdvaMed and Eucomed) are seriously concerned about approval delays that could harm manufacturers’ competitiveness…along with the ability of the EMA to manage the effort.

Stay tuned to this one – could be a significant change for EU device sales.


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