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Is a European Devices Agency on the Horizon?

This article was originally published in SRA

Executive Summary

As European Union member states forge ahead to meet the December deadline for transposing the revised medical device directives into their national laws, the European Commission has announced that the entire regulatory system needs another overhaul1,2. The justification? That the current legal framework for medical devices “does not offer as high a level of protection of health as possible”.

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