Report outlines proposed changes to EU medtech regulation

04/17/2013 | Clinica (subscription required)

A draft report released Monday by the European Parliament details proposed changes to medical device regulation in Europe, including creating both centralized and decentralized premarket approval processes for medical devices and making it difficult for device makers to classify their products as single use. The proposals indicate a difficult regulatory road ahead for medtech and could draw opposition from the industry, according to this article.

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