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Just in – MedTech Europe’s vision for the future of Europe’s medical technology regulations

Posted on 09.11.2023

Reform should address the three key areas of efficiency, innovation and governance, all while maintaining the framework’s established high level of device safety and performance. In its position paper, MedTech Europe calls for a comprehensive reform to make the IVD and MD regulations work for patients and European health systems.

This call follows the many and growing indications that new and existing products will struggle to reach European patients and health systems in a timely manner. Structural issues within the regulatory framework for medical technologies, are resulting in unpredictability and delays, dampening innovation, and undermining confidence in the long-term viability of the framework. Left unaddressed, such issues will increasingly impact patients and health systems in Europe and erode the influence of Europe’s valued CE-marking system.

The vision is accompanied by recommended solutions to help start the conversation between all impacted stakeholders on the needed steps to reform the current system.  

While MedTech Europe believes that a targeted and comprehensive reform is needed to tackle the structural issues in the medical technology regulatory system, we remain committed to working with all stakeholders on finding short-term solutions to the ongoing implementation of the regulations, for example through implementing acts, guidance, best practice or other means.

For more information, please contact Petra Zoellner, Director IVDR – MDR.