Recasting Legislation

The EU Member States are currently implementing the most recent set of amendments to the EU Medical Devices Directives, and manufacturers continue to determine the likely impact of these for their products. However, this has not prevented the European Commission from proposing a "recast" of the existing legislative framework in order "to improve and strengthen the legal framework for the regulation of medical devices in Europe".

In this article, Elisabethann Wright examines some elements of the European Commission's proposal, their suitability and their potential impact.


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