MDCG 2024-15 is the first guidance document published by the Medical Device Coordination Group in December 2024. This document provides instructions on how to submit clinical investigation reports and summaries in the absence of EUDAMED.
Article 77(5) of the Medical Devices Regulation specifies the submission requirements for clinical investigations. Sponsors must submit a clinical investigation report to the Member States where the clinical investigation takes place. The report has to be submitted within 1 year after the investigation ends, or within 3 months if the investigation ends early or is temporarily halted. Reports must be submitted via EUDAMED. Additionally, Article 77(7) of MDR states that the summary and report must become publicly accessible via EUDAMED. This has to occur
a) before the device is registered under Article 29 and marketed, and
b) immediately upon submission in the case of an early termination or temporary halt.
Procedure for the publication of the clinical investigation reports and their summaries
The sponsors have to submit the reports and the related summaries to the competent authorities of the Member States where the investigation takes place. No changes will be performed by the Member States or the Commission, as the sponsor assumes full responsibility for the content of the documents, including ensuring confidentiality and data protection.
The competent authorities will label the documents as follows:
- For the clinical investigation report: CIV-ID – CIR
- For the clinical investigation report summary: CIV-ID – SCIR
The documents will be stored in a dedicated public CIRCABC directory called “MDR Clinical Investigation reports and their summaries”.
This procedure will stop applying when the EUDAMED module for clinical investigations will become mandatory.
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