New EU Regs Will Offer No Reprieve From Borderline Classification Chaos

Challenges will persist for borderline and combination products under the new EU regulatory structure so manufacturers need to continue to pay close attention when determining the classification of these products.

Despite the clarifications surrounding the definition of a medical device under the forthcoming EU Medical Device Regulation and the elaborated procedure on borderline decisions that is to come, complex qualification questions are likely to persist when these new rules come into effect.

That is the view of Charlotte Ryckman and Dr Anna Wawrzyniak at the law firm Covington and Burling,...

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