Targeted Simplification of Medical Devices Regulations - Commission Proposal COM(2025)1023
European Commission proposed targeted revision of medical devices regulations on December 16, 2025 to simplify rules, support digitalization, and promote innovation while maintaining patient safety. Proposal includes streamlined conformity assessment and modern adaptive framework for changing market conditions.
🔖 Status: pending-implementation
This reform is part of the European Commission's ongoing programme to modernise and strengthen the the EU medical device regulatory framework. Monitor the official source for updates on timelines, consultation opportunities, and implementation guidance. Where relevant, begin assessing potential impacts on your existing registrations, technical documentation, and compliance timelines so your organisation is prepared when the reform takes effect.
View official source ↗