European Medical Device Regulatory Framework: Competent authorities call for reform and centralisation

On 14 July 2025, the Competent Authorities for Medical Devices (CAMD) and the Head of Medicines Agency (HMA) – including those from Germany and the Netherlands –, together with representatives from 17 EU and EEA Member States, the European Commission (participating as an observer), issued a joint statement advocating for significant reforms to the EU regulatory framework for medical devices. The statement highlights the need for improved coordination, governance, and centralisation of regulatory activities in the EU to address fragmentation and enhance harmonisation across the EU. It is a further element in the current broad discussion of reform, in particular of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

Key Recommendations

The authorities identify several priorities for reform:

1. Enhanced Coordination and Governance: A scientifically grounded and well-supported governance model at the EU level is needed to ensure a more effective and harmonised application of medical device regulations across Member States.
2. Centralisation of Regulatory Activities: A more centralised and cohesive structure is recommended to provide predictability, clarity, and consistency in regulatory requirements, supporting both patient safety and the global competitiveness of the EU medical technology sector.
3. Proportionate and Adaptive Approaches: Future regulations should be patient-centred and adaptable, enabling timely access to medical technologies while maintaining high safety standards.
4. Simplification and Burden Reduction: The existing regulations should be simplified and clarified to improve efficiency, predictability, and stability in the sector, with particular attention to supporting micro-enterprises and ensuring equitable access.
5. Sustainable Resourcing and Funding: Investment in sufficient resources at both EU and national levels, underpinned by a sustainable and transparent funding model, is deemed essential for a well-functioning regulatory system.

Next Steps

The authorities acknowledge ongoing efforts by the European Commission to implement short-term measures and conduct the targeted evaluation of the regulatory framework. They call for a detailed plan and resource assessment to further improve governance and explore the benefits of operational centralisation. The statement also recognises the potential role of a central agency in providing scientific, technical, and regulatory support, and in reinforcing a stable knowledge base.

The authorities conclude that legislative support beyond the current regulations is required to achieve effective reform. They reaffirm their commitment to supporting the European Commission’s work on both immediate and long-term priorities, urging a comprehensive assessment of governance, coordination, and centralisation in the future development of the EU medical device regulatory system.

Comments

The statement reflects growing recognition that the current Medical Devices Regulation/In Vitro Diagnostic Medical Devices Regulation, while strengthening safety standards, has created implementation challenges that threaten EU competitiveness in the global medical technology sector—concerns that align with broader EU discussions about regulatory burden hindering innovation. Notably, this marks an escalation from previous regulatory authority statements focused on implementation issues to an explicit call from competent authorities for structural reform and centralisation.