On 18 June 2025, the European Commission (EC) released MDCG 2025-5, a comprehensive Q&A-style guidance document designed to help manufacturers, sponsors, and researchers navigate performance study requirements for in vitro diagnostic medical devices (IVDs) under the In Vitro Diagnostic Regulation (IVDR), Regulation (EU) 2017/746.
The document is particularly relevant for those involved in analytical and clinical performance studies, including manufacturers providing IVDs for use in performance studies that may be sponsored by other actors, and sponsors of combined studies involving medicinal products, IVDs, and/or other medical devices.
Purpose and Scope of the Guidance
This guidance aims to clarify:
- The definition and scope of performance studies under Article 2(42) of the IVDR
- The responsibilities of sponsors and manufacturers conducting such studies
- The submission and notification requirements to competent authorities
- The distinction between performance studies and clinical/laboratory methods (which are not regulated under the IVDR)
It also emphasizes that national ethical review requirements may vary and should be followed in parallel with regulatory submissions. The guidance is not exhaustive and should be used alongside other applicable EU regulations and standards.
Topics Covered in the Q&A Format
The Q&A guidance addresses over 50 regulatory questions encountered in performance studies, providing practical clarifications on study types, procedural responsibilities, documentation expectations, and cross-border coordination under the IVDR framework.
This detailed document helps unify interpretation across Member States while supporting compliance with performance study obligations under the IVDR:
Official Source: MDCG 2025-5 - Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 (June 2025)
Published by European Commission on 18 June 2025
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