Coordination and management of medical device regulation at EU level New
Publication of a joint statement from the competent national EU authorities to the EU Commission
The competent national authorities have adopted a joint statement on the reform of the EU regulatory framework for medical devices and submitted it to the European Commission. The consensus statement underlines the urgent need to address the issue of governance and centralisation.
On 24 June 2025, the competent authorities and representatives of the European Commission met for a working meeting in Utrecht to discuss the importance and means of improving the coordination and governance of medical device regulation at EU level.
It is important to counteract fragmentation and therefore, in particular, to improve harmonisation and effective application in practice. The need for reform was discussed and the objective of developing further support options was addressed so that the EU regulatory framework described in the EU Medical Devices Regulation functions consistently, harmonised and effectively in practice.
With the joint statement, the authorities recognise the important work of the European Commission and reaffirm their determination to continue to support this work in addressing short and medium-term priorities.
At the same time, however, the authorities call on the Commission to provide a detailed plan and resource assessment to improve the governance model and explore the benefits of joint operational coordination and centralisation.
Link to the joint declaration.
