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

This guide explains the procedure for publishing clinical investigation reports and their summaries, in the absence of Eudamed. It specifies: 

• • • The procedures for submission of clinical investigation reports and their summaries by sponsors to the competent authorities  
    • The labelling of these documents by the competent authorities  
    • Publication of these documents by the Commission in the dedicated public CIRCABC directory