A guidance document has been released on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED. To offer some background to this guidance document, Article 77(5) of the MDR mandates that sponsors submit a clinical investigation report to the Member States where the clinical investigation was conducted within one year of its conclusion, or within three months if the investigation is halted or terminated early. The report must be accompanied by an easily understandable summary for the intended users, and both must be submitted via EUDAMED.
Article 77(7) requires that both the report and the summary become publicly accessible through EUDAMED once the device is registered (under Article 29), and before it is placed on the market. If the investigation is ended early or temporarily halted, they must be made public immediately after submission. If the device isn’t registered within a year, the report and summary should be made publicly available at that time. These are the key timelines for publication.
MDCG 2021-1 Rev. 1 outlines that submissions for Article 77(5) should follow national procedures for clinical investigations, while for Article 77(7), the reports should be shared via the CIRCABC directory until EUDAMED is fully operational. The Commission guidance (2023/C 163/06) details how clinical investigation summaries should be structured and identified.
The guidance document can be accessed using the following link
