Coordination and governance of the regulatory system for medical devices at the EU level: publication of a consensus statement from the EU Competent Authorities to the EU Commission

By Mina Blaess / On July 11th, 2025 / In Events, Health, Regulatory

National Competent Authorities have endorsed a consensus statement and shared it with the European Commission on the reform of the EU regulatory framework for medical devices. This consensus statement outlines the urgent need, and also the clear momentum, to address the topic of governance and centralisation.

On June 24th, 2025, Competent Authorities gathered in a workshop in Utrecht, with representatives from the EU Commission participating as an observer, to reflect on the importance and means of improving the coordination and governance of the regulatory system for medical devices at EU level to help address fragmentation and enhance harmonisation and effective application in practice.

The purpose was to discuss the need to reform and develop further supports to allow the EU regulatory framework described under the current EU Medical Device Regulations to work in a more consistent, harmonised and effective way in practice.

With this statement, the authorities recognised the significant work being undertaken by the European Commission and reaffirmed their strong commitment to continue to support this work in addressing short and medium term priorities. At the same time the authorities called on the need for a detailed  plan and resource assessment to improve the governance model and to examine the potential ways that operational coordination and centralisation could benefit the system; the authorities called on the Commission to fully assess, address and develop the provisions relating to governance and coordination and the role of centralisation in the future regulatory system development.

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