Changing Regulatory Landscape in the EU: The Commission's Draft Medical Devices Directive Proposal

The Commission's draft Medical Devices Directive proposal is a long-awaited document, reflecting several years of review of the current EU medical device regulatory system. It tightens clinical data requirements, increases the authority of EU member states concerning classification changes and health measures, and clarifies procedures between medical device "notified bodies" and pharmaceutical regulatory bodies (the European Medicines Agency or national-level agencies).