The MDCG 2025-5 FAQ offers essential guidance for sponsors of IVD performance studies. This article outlines key definitions, documentation routes, and common compliance issues. A must-read for CROs and manufacturers preparing for IVDR conformity.
The strategic role of performance studies under IVDR
Performance studies form the core evidence for demonstrating that an in vitro diagnostic medical device (IVD) meets the General Safety and Performance Requirements (GSPRs) set out in Annex I of the IVDR. MDCG 2025-5 delivers a long-awaited clarification of how these studies should be designed, documented, reported, and — if applicable — notified or authorised across Member States.
What types of studies are covered?
The guidance distinguishes between various types of performance studies, including:
analytical performance studies (sensitivity, specificity, linearity, etc.),
- clinical performance studies (predictive values, clinical accuracy),
- studies involving left-over samples,
- interventional performance studies,
- and investigations involving CE-marked devices used outside their intended purpose.
Each category carries different obligations in terms of ethics approvals, competent authority involvement, and documentation standards.
What must sponsors prepare and submit?
Depending on the type of study, sponsors may be required to:
- notify or seek prior authorisation from competent authorities,
- submit translated protocols and informed consent documents in multi-country trials,
- justify the intended purpose and design of the IVD under investigation,
- and document all amendments using harmonised procedures.
Sponsors should also ensure alignment with Article 58–77 IVDR and consult national requirements in cases of multicentre submissions.
Typical challenges and best practices
MDCG 2025-5 also addresses recurring challenges, such as:
- defining what constitutes a “substantial modification” during a study,
- clarifying sponsor and investigator roles in post-authorisation responsibilities,
- maintaining traceability of sample handling and data collection,
- and preventing duplication of submissions in parallel studies.
Summary
For IVD manufacturers and CROs, this FAQ document is more than a regulatory checklist — it is a map for planning compliant and efficient performance studies. Adopting these recommendations will also support long-term alignment with notified body expectations once conformity assessment begins.
