[2025-09-08] (Open access) The European Commission launched a call for evidence on September 8, 2025, to prepare a targeted revision of European regulations on medical devices (MD) and in vitro diagnostic medical devices (IVDD).
The call for evidence is available in all European Union (EU) languages. You will need to log in to your account to respond (or create an account if you don’t already have one).
Already, since 2024 (see previous network article), the Commission has been carrying out a targeted evaluation of the effectiveness, efficiency, relevance, coherence and added value of European regulations. Not surprisingly, the targeted assessment revealed that application of the regulations is complex: stricter requirements, limited resources of notified bodies, insufficient preparation by many manufacturers – all factors that could lead to a potential shortage of devices.
The initiative aims to maintain the smooth functioning of the internal market while guaranteeing a high level of patient protection. It also aims to strengthen the competitiveness of the European Union by promoting innovation and patient access to a wider range of devices. The targeted revision aims to :
- simplify existing rules,
- make conformity assessment requirements more proportionate to risks,
- improve the predictability and cost-effectiveness of notified body certification processes,
- reduce the administrative burden and support digitization and international cooperation, while maintaining the overall structure of the regulatory framework,
- streamline procedures, including those related to governance. As we’ve seen, governance has become an increasingly important topic in recent months (see this network article, for example).
The Commission believes that this revision will reduce compliance costs, speed up the arrival of new devices on the market and make the European Union more attractive to investors.
Stakeholders, whether competent authorities, notified bodies, economic operators, healthcare professionals, industrialists, associations, patients, regulatory experts, researchers, learned societies, etc., are invited to submit their contributions by October 6, 2025 (midnight, Brussels time). The impact of the initiative will be monitored through existing reporting and monitoring mechanisms.
We can only welcome the continuation and continuity of the European Commission’s initiatives, and hope to see these potential simplifications come to fruition soon.
Article written by Lam-Xé NOEL, Managing Director of DM Experts SAS