MedTech Europe responds to the European Commission’s targeted evaluation of Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Posted on 03.04.2025

MedTech Europe has contributed to the European Commission’s public consultations on EU rules on medical devices and in vitro diagnostics which closed on 21 March. This consultation marks an important milestone in moving towards a review and update of the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).

The European Commission will be evaluating, among other, how effective, efficient and proportionate the two regulations are in achieving a robust, transparent, predictable and sustainable regulatory framework which ensures a high level of safety and health.

In response, MedTech Europe’s Regulatory Affairs MDR/IVDR Working Groups prepared a comprehensive submission, aligning with the organisation’s vision for the future of the regulatory system.

Key elements of the response include:

• MedTech Europe 2024 Regulatory Survey Report
• Report on administrative burden under MDR/IVDR
• Governance of medical technologies in Europe
• Smooth transition to the mandatory use of EUDAMED Perspectives from manufacturers and specific paper on Clinical module implementation
• Submission of vigilance reports to Notified Bodies
• Exemption of routine blood draws from performance studies
• Urgent call for clarity in clinical discussions
• Digitalisation of technical documentation
• Call for EU to join the Medical Device Single Audit Program as a Full Member.

All MedTech Europe resources for targeted evaluation of IVDR and MDR can be accessed to our dedicated webpage: The Future of EU Medical Technology Regulatory System.

For more information, please contact Vaida Jukneviciute, Manager In Vitro Diagnostics.