MDCG 2025-5 Q&A on Performance Studies under Regulation (EU) 2017/746

The Medical Device Coordination Group (MDCG) has just released a Q&A document providing regulatory clarification on performance studies for in vitro diagnostic medical devices (IVDs), with a focus on Articles 57 to 77 of the IVDR.

Key highlights include:

• Clear differentiation between analytical and clinical performance studies;
• Sponsor responsibilities depending on the type of study (including academic research);
• Criteria for when an application or notification to competent authorities is required (Articles 58(1), 58(2), and 70);
• Specific guidance on companion diagnostics and the use of left-over samples;
• Management of substantial modifications under Article 71 IVDR.

A useful document to read for RA/QA teams involved in the development, validation, or market access of IVDs in the EU.

DOWNLOAD THE MDCG 2025-5