Article 77(5) MDR requires that sponsors submit to 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.
The clinical investigation report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. The report and summary shall be submitted using EUDAMED.
Article 77(7) MDR requires 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 has been entered into EUDAMED under Article 77(5) MDR, they shall become publicly accessible at that point in time.
In the absence of EUDAMED, the documents will be stored in a public CIRCABC directory called “MDR Clinical Investigation reports and their summaries”
The MDCG 2024-15 “Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED” provides more detail.
The performance studies reports and their summaries will be published later.