The Medical Device Coordination Group (MDCG) has released the guidance document, MDCG 2025-5, “Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746,” dated June 2025. This document is pivotal for stakeholders involved in the implementation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Key features of the guidance include:
- Analytical vs Clinical Performance Studies: Provides a precise differentiation between these types of studies, facilitating appropriate methodological approaches.
- Sponsor Responsibilities: Clarifies the obligations of sponsors based on study type, including provisions related to academic research, ensuring comprehensive compliance and oversight.
- Regulatory Criteria: Establishes clear criteria for the necessity of applications or notifications to competent authorities, specifically concerning Articles 58(1), 58(2), and 70 of the IVDR.
- Companion Diagnostics and Left-over Samples: Offers specific guidance regarding the utilisation of companion diagnostics and the ethical use of left-over samples in research.
- Substantial Modifications Management: Delivers strategies for handling substantial modifications per Article 71 of the IVDR, supporting adaptability in evolving research initiatives.
Access the FULL GUIDANCE DOCUMENT HERE.
This document is essential for ensuring that performance studies meet regulatory expectations and contribute to the advancement of safe and effective diagnostic technologies within the EU framework.
If you require any assistance, you can contact us at: [email protected]
