MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED

The Medical Device Coordination Group (MDCG) has published its latest guidance, MDCG 2024-15, addressing the management of clinical investigation reports and plain-language summaries in the absence of EUDAMED. This interim solution aims to maintain transparency and regulatory compliance until the European database becomes fully operational.

Key deadlines outlined in the guidance include submitting clinical investigation reports and plain-language summaries within one year of the investigation's conclusion or within three months for early terminations or temporary halts. Public access to these reports will align with device registration or default to one year after submission.

To bridge the gap left by the incomplete EUDAMED system, national procedures and the publicly accessible CIRCABC directory will serve as temporary platforms for sharing and publishing these essential documents.

This guidance reinforces compliance with MDR Article 77, emphasizing the importance of public accountability and trust in the regulatory process. Sponsors are encouraged to adapt to these temporary measures, leveraging the opportunity to enhance transparency and strengthen stakeholder confidence.