MDCG Guidance: Publishing Clinical Investigation Reports

The Medical Device Coordination Group (MDCG) has issued a new guidance titled ‘Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED’. This guidance will only be valid until the use of CI/PS EUDAMED module is mandatory. It provides a procedure on how to publish the clinical investigation reports by the sponsors to the Competent Authorities.

Key Requirements for Clinical Investigation Reporting Under MDR

The Medical Device Regulation (MDR) Article 77(7) mandates that summaries and clinical investigation reports must be made publicly available through EUDAMED within one year of the investigation ending, and before the device is marketed. If a clinical investigation is halted or terminated early, these documents must be published within three months. If a device isn’t registered within a year after the documents are entered into EUDAMED, they will be made public at that time (pursuant to Article 77(5) MDR).

MDCG 2021-1 Rev. 1 provides interim guidance until EUDAMED is fully operational, stating that information should be uploaded through national procedures and that clinical investigation (CI) reports and summaries should be published in a dedicated CIRCABC directory. The Commission’s guidance, 2023/C 163/06, outlines how to identify the summaries and reports, which will be submitted by sponsors to the competent authorities in the Member States where the clinical investigation was conducted. The Commission will publish the documents as submitted without any redactions, and sponsors are responsible for the content, including confidentiality and data protection issues. Legal interpretations of this guidance are ultimately determined by the Court of Justice of the European Union.

For more details, read the full MDCG 2024-15 guidance document here.

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