The EU medical device regulatory framework (Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746) is at a pivotal moment.
Fragmentation, inefficiencies, and inconsistent application of rules are undermining the goals of safety, innovation, and timely access.
This paper proposes a future governance model that integrates centralised support mechanisms, enhanced scientific and regulatory coordination, and sustainable funding.
It draws on the July 2025 EU Commission Communication “European Commission’s Life Sciences Strategy” , the July 2025 Consensus Statement of CAMD/HMA2 and notified bodies’ input in the MDCG Annex VII / governance workshops on 20 February, 3 April and
4 June 2025.
Notified Body Perspective on Future Governance in the EU Medical Device Sector