EU Commission Proposes Package to Simplify Medical Device Regulations
Photo by Marek Studzinski on Unsplash
TL;DR: The European Commission proposed revisions to the EU's Medical Device Regulation and In Vitro Diagnostic Regulation to modernize and streamline the rules. The current regulations have caused bottlenecks, increased costs, fostered uncertainty, and led to slower approvals, potentially forcing product withdrawals from the European market.
Key takeaways
- The European Commission has proposed a comprehensive package of measures to streamline and modernize the European Union's regulations governing medical devices and in-vitro diagnostics
- This proposal entails a targeted revision of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR)
- This action addresses significant concerns that the current framework has created bottlenecks, increased costs, and fostered uncertainty
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