ARTICLE SUMMARY:
Each month in Global Spotlight we provide market access facts from the country highlighted on the cover of Market Pathways' print issue. The June 2025 cover features the European Commission headquarters in Brussels. Here we spotlight points of interest for the EU Act Act and the Medical Device and IVD Regulations.
Artificial Intelligence Act
Authority: European AI Office
Leader: Lucilla Sioli, Director, AI Office
Points of Interest:
- The European Commission launched the AI Office, and related AI Board, to oversee implementation of the 2024-enacted AI Act.
- Starting August 2, 2027, most AI-enabled medical devices (”high-risk AI”) will be subject to new AI Act conformity assessment requirements.
- The AI Board endorsed its first document in June, on the “interplay” between the EU MDR and IVDR and the AI Act once the new requirements take effect.
MDR/IVDR
Authority: European Commission DG Sante D3 (Medical Devices Unit)
Leader: Flora Giorgio, Head of DG Sante D3
Points of Interest:
- The Commission published an Implementing Regulation to allow more devices to employ electronic instructions for use under the MDR beginning this month.
- It hopes to publish the results of a broader “targeted evaluation” of the MDR and IVDR by year’s end, expected to drive legislative reforms.
- Centralized governance will be a key focus of the evaluation, potentially leading to a new entity to oversee MDR/IVDR akin to the EU AI Office
