European Commission launches ‘Call for Evidence’ on the future of the Medical Devices regulation and In Vitro Diagnostics Regulation
Posted on 02.10.2025
The European Commission has opened a ‘Call for Evidence’ on the future of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This is part of the ‘targeted revision’ initiative, which aims to streamline and future-proof the framework by reducing administrative burden, enhancing predictability and cost-efficiency and strengthening international competitiveness, while maintaining the highest standards of patient safety.
This ‘Call for Evidence’ is open-text only (4000 characters max.), with the possibility to upload a short file (max. 5 MB). There are no set questions to answer, but the Commission highlights key areas where we believe feedback is particularly important:
- reducing administrative and reporting burdens,
- improving the predictability and cost-efficiency of notified body assessments,
- making conformity assessment more proportionate for low- and medium-risk devices or special patient needs,
- enabling further digitalisation,
- streamlining governance procedures,
- promoting international cooperation and reliance,
- aligning the MDR/IVDR more effectively with other EU legislation.
The deadline to respond is 6 October 2025. This is one of the very few formal and last opportunities to contribute to the upcoming revision, and MedTech Europe will provide input.
For more information, please contact Merlin Rietschel, Senior Manager Medical Devices