Released by the European Commission's Medical Device Coordination Group (MDCG), this document is of great importance 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: it provides a precise differentiation between these types of studies, facilitating appropriate methodological approaches.
- Sponsor Responsibilities: it clarifies the obligations of sponsors based on study type, including provisions related to academic research, ensuring comprehensive compliance and oversight.
- Regulatory Criteria: it 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: it offers specific guidance regarding the utilisation of companion diagnostics and the ethical use of left-over samples in research.
- Substantial Modifications Management: it delivers strategies for handling substantial modifications per Article 71 of the IVDR, supporting adaptability in evolving research initiatives.
For full details, access the official document here
