Skip to main content
NSF Home

MDCG 2025-6: EU Commission publishes FAQ on interplay between MDR, IVDR and AI Act

Date
June 26, 2025
Category

EU Regulations

Description

The MDCG 2025-6 guidance document, jointly adopted by the Medical Device Coordination Group and the Artificial Intelligence Board, describes how the EU's draft legislation on artificial intelligence (AIA) complements the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).

Key takeaways:

  • High-risk Medical Device AI (MDAI) systems must comply with both MDR/IVDR and AIA.
  • The AIA introduces new requirements for data governance, transparency, human oversight, and post-market monitoring.
  • Manufacturers can integrate AIA obligations into existing MDR/IVDR processes to reduce burden and ensure compliance.

While the document consolidates key regulatory expectations for Medical Device AI (MDAI)—including risk classification, data governance, transparency, and post-market monitoring—it does not introduce new obligations beyond those already established in the AIA and MDR/IVDR.

For those already familiar with both regulations, this FAQ-style document serves more as a structured reference than a source of new insights. Nevertheless, it may be helpful for aligning internal interpretations or engaging new stakeholders.