European Union’s Proposed Regulations Governing Medical Devices Raise Multiple Concerns for US Manufacturers

On September 25, 2013, the European Parliament Committee on the Environment, Public Health and Food Safety (“ENVI”) voted on draft Regulations including a proposal concerning high risk medical devices, raising concerns among US manufacturers. Expectations that a more restricted process in Europe could undermine the development of domestic medical devices appear increasingly well-founded, but the entire story has yet to be played out overseas. At issue is an attempt by the European Union (“EU”) to close loopholes that allowed breast implants made with industrial-grade silicone…
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