[EU] MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)

1. Introduction

Article 77(5) MDR requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, irrespective of the outcome of the clinical investigation. Furthermore, the clinical investigation report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by means of EUDAMED.

 

Article 77(7) MDR require that the summary and the clinical investigation report shall become publicly accessible through EUDAMED at the latest when the device is registered in accordance with Article 29 and before it is placed on the market. In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission. If the device is not registered in accordance with Article 29 within one year of the summary and the report having been entered into EUDAMED pursuant to Article 77(5) MDR, they shall become publicly accessible at that point in time. These are the timelines for publication under this SOP.

 

MDCG 2021-1 Rev. 1 “Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional” indicates that concerning Article 77(5) “The upload of the relevant information should take place via the respective national procedures applicable to clinical investigations”. Regarding paragraph 7 of the same Article it indicates that the “CI reports and the respective summary reports should be shared and published via the use of a dedicated publicly available CIRCABC directory.”

 

The Commission guidance on the content and structure of the summary of the clinical investigation report (2023/C 163/06) provides appropriate means of identifying the summaries of the CI reports. The same principles are used for identifying the CI reports. 

 

 

MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024) - European Commission

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

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