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New EU Regs Will Offer No Reprieve From Borderline Classification Chaos

April 20, 2017, Medtech Insight

A post by Charlotte Ryckman on Covington's Inside Medical Device blog is quoted extensively in a Medtech Insight article regarding the impact of the new EU regulatory structure on the classification of borderline and combination products. According to the post, there is not enough clarity in the new medtech regulations around the definitions of the physical or chemical mode of action of a borderline or combination product to help determine whether it is a device (physical action) or medicine (chemical mode of action).

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