On 16 December 2025, the European Commission put forward a proposal for a regulation to simplify the rules governing medical devices in the EU. The proposal forms part of a broader package of measures aimed at improving citizens' health and strengthening the resilience and competitiveness of the health sector. An evaluation of the current EU regulatory framework for medical devices concluded that it has led to unnecessary costs, administrative bottlenecks, regulatory uncertainty for companies, and delays in patient access to medical devices. The proposed revision seeks to address these challenges while ensuring that patient safety remains the highest priority, with faster access to safe and innovative devices. It also aims to reinforce the EU's competitiveness in the medical technology sector, by establishing a more coherent framework enabling companies to better respond to evolving market conditions, technological developments and patient needs. Source : © European Union, 2026 - EP Read more