On Wednesday 3 June, ahead of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) on 16 June, the permanent representatives of the Member States to the European Union (Coreper I) took stock of progress on the proposal for a regulation to simplify the rules applicable to medical devices and in vitro diagnostic medical devices (EUROPE 13848/11).
According to a document dated 28 May seen by Agence Europe, the proposal, presented by the European Commission on 16 December last year as part of its legislative package on health, is intended to ease the administrative constraints weighing on the sector while preserving a high level of public health protection and patient safety.
According to the European Commission, the entry into application of the current regulations on medical devices has led to supply shortages and the withdrawal from the market of certain critical devices. Despite several extensions of the transitional periods, an evaluation carried out in 2024 and 2025 showed that several difficulties remained unresolved, with consequences for product availability, the competitiveness of European manufacturers and innovation in medical technologies
This includes, in particular, adapting regulatory requirements to the actual level of risk presented by devices, making certification procedures more predictable and less costly, and improving coordination between national authorities and notified bodies.
Calls for clarification on EMA’s role and several provisions of the text. According to the report by Cyprus Presidency of the Council of the EU, the Member States expressed a favourable view of the objectives of simplification, reducing administrative burdens and supporting innovation. Nevertheless, several issues - such as the expanded role entrusted to European Medicines Agency (EMA) to support the Medical Device Coordination Group (MDCG) - will still be the subject of discussions before the adoption of a common EU Council position.
Several Member States expressed a wish for a more precise definition of the respective responsibilities of the two structures.
As regards the introduction of a definition of “devices based on a well-established technology”, which could benefit from more appropriate requirements, the Member States expressed their support for this point, while nevertheless calling for further details on the criteria chosen.
Several EU countries also called for certain lighter procedures planned for innovative devices or those intended for rare diseases to be extended to other categories, in particular paediatric devices.
Moreover, discussions will also focus on the costs associated with strengthening the control of notified bodies, on the fee reductions envisaged for micro-enterprises and small businesses, and on certain empowerments granted to European Commission.
Lastly, several delegations support the objective of putting in place a single regulatory framework for medical devices including artificial intelligence, in order to avoid this encroaching on the provisions of the Artificial Intelligence Act. Discussions will nevertheless continue on taking European cybersecurity requirements into account. (Original version in French by Nithya Paquiry)