Further developing the safety and supply of medical devices, strengthening coordination and governance at EU level

The national authorities responsible for medical devices have adopted a consensus statement on the reform of the EU legal framework for medical devices and forwarded it to the European Commission. This consensus statement highlights the urgent need to address the issues of governance, coordination and centralisation at European level together with the European Commission.

On 24 June 2025, the authorities responsible for medical devices met for a workshop in Utrecht, attended by representatives of the European Commission as observers, to reflect on the importance and means of improving the coordination and governance of the regulatory system for medical devices at EU level in order to eliminate fragmentation and improve harmonisation and effective application in practice.

The aim was to discuss the need for reforms and the development of further support measures so that the EU regulatory framework described in the current EU medical device regulations can function in a more uniform, harmonised and effective manner in practice.

In their final statement, the authorities acknowledged the significant work done by the European Commission and reaffirmed their full commitment to continuing to support this work in addressing short- and medium-term priorities. At the same time, the authorities called for a detailed plan and resource assessment to further improve the governance model and examine how operational coordination and centralisation of certain tasks could benefit the system. The authorities called on the European Commission to comprehensively assess, address and further develop European legal provisions relating to governance and coordination, as well as the role of centralisation in the future development of the regulatory system.

Common goal: Ensuring safe care with innovative medical devices

The implementation of the European regulations on medical devices (MDR) and in-vitro diagnostics (IVDR) was the topic of a workshop organised by the authorities responsible for medical devices in the EU on 10th of July 2024. Together with representatives of the European Commission, current priorities, challenges and possible solutions for successful implementation were identified.

"Our common goal and priority is to ensure that patients in the EU continue to have access to safe care and innovative medical devices," said BfArM President Prof Karl Broich. "The rapid and successful implementation of the relevant European regulations is an important prerequisite here. We stand ready to support the Commission and work together to ensure that the regulatory system achieves its objectives and is applied efficiently in practice."

The results of this workshop form the basis for further work together with the European Commission. At the end of the meeting, the heads of the authorities signed an open letter to the European Commission, calling on it to prioritise the implementation of the EU Medical Devices Regulations.