dimarts, 1 d’abril del 2014

Medtech makers warn on new EU rules | MassDevice.com On Call




Medical device makers say they're worried that new regulations in the European Union will slow approvals.






MassDevice.com On Call


MASSDEVICE ON CALL — Medical device makers that relocated to Europe to take advantage of its easier path to approval are worried about new European Union rules, the Financial Times reports.


Companies such as Middle Peak Medical, which is developing a mitral valve implant, moved some of their operations to the EU to escape the FDA's more-stringent approval protocols. But the new EU rules could take a bite out of that advantage, they worry.




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