EU Authorities Urge Medical Device Regulatory Reform

In July 2025, medical device competent authorities from 17 European countries convened in Utrecht to issue a unified Consensus Statement urging significant reforms to the EU medical device regulatory framework (MDR/IVDR). With participation from the European Commission and hosted by the Dutch Ministry of Health, the meeting emphasized the urgent need for improved coordination, centralization, and governance within the EU regulatory system.

Key Recommendations Include

• Establishing a more centralized and cohesive governance structure to ensure harmonized and predictable application of MDR/IVDR requirements.
• Enhancing regulatory clarity, efficiency, and scientific support, including a potential central agency to reinforce EU-wide regulatory science.
• Implementing proportionate, patient-centered, and adaptive approaches to facilitate access to innovative technologies while maintaining safety.
• Investing in sustainable funding models and sufficient resources at both national and EU levels.
• Simplifying regulatory processes and reducing burdens, especially for micro-enterprises and SMEs.

The authorities stress that the success of these EU medical device reforms’ hinges on appropriate legislative support, beyond current MDR/IVDR provisions. They also called on the European Commission to develop a clear roadmap and resource assessment to enable effective governance and centralized operations—particularly for vigilance, notified body oversight, and regulatory advisory services.

This consensus marks a pivotal moment in the evolution of EU medical device regulation, with authorities aligned on the need for structured, science-based improvements to better serve both public health and innovation.

How Can MedEnvoy Support 

We actively monitor these regulatory developments and support our clients in staying up to date with key changes, ensuring they remain compliant and informed every step of the way.

If you have questions about how these EU medical device reform changes affect your products – or need expert support to ensure continued compliance in the EU – MedEnvoy is here to help. We simplify regulatory complexity, helping you stay focused on innovation and patient outcomes. 

We encourage you to reach out to our regulatory experts here.