AIB 2025-1 & MDCG 2025-6 Guidance: Interplay between the MDR/IVDR and the AI Act

The Medical Device Coordination Group (MDCG) and the Artificial Intelligence Board (AIB) have jointly released this new guidance document, offering practical insights into the interplay between the MDR, IVDR, and the AI Act.

This FAQ-style guidance provides practical answers for manufacturers, competent authorities, and notified bodies on how to align with the three regulations.

Key topics covered:

• Qualification of high-risk AI systems in the medical field;
• Integration of AI Act requirements into existing quality systems and technical documentation;
• Post-market monitoring obligations;
• Managing bias, ensuring transparency, and enabling human oversight.

This document aims to support a more consistent and coordinated approach to compliance for manufacturers of AI-powered medical devices, particularly as the AI Act obligations are set to apply from August 2027.

DOWNLOAD THE AIB 2025-1 & MDCG 2025-6 GUIDANCE