MDCG provides guidance on clinical investigation reports during EUDAMED transition

The European Commission’s Medical Device Working Group (MDCG) has issued guidance on publishing and maintaining clinical investigation reports for medical devices until they can be submitted to the European database on medical devices (EUDAMED). While EUDAMED is being set up, sponsors are asked to upload the information to the EU’s Communication and Information Resource Centre for Administrations, Businesses and Citizens (CIRCABC) directory.

The guidance outlines expectations for submitting clinical investigation reports and their summaries. The EU Medical Device Regulation (MDR) calls for sponsors to submit their clinical investigation report to the member state where their research is conducted within a year of the clinical investigation being completed or within three months of it being terminated early or paused.

Sponsors will be required to submit a summary of the report via EUDAMED where it will become publicly available before being placed on the EU market. All the EUDAMED modules, however, have not been launched and the guidance gives a temporary solution to the MDR requirements.

Under MDCG 2021-1 Rev. 1, which provides guidance on what to do while EUDAMED is being set up, sponsors should upload relevant clinical research information based on respective national procedures. Furthermore, clinical investigation reports and summaries should be shared using the CIRCABC directory.

“According to article 77(5) and MDCG 2021-1 Rev. 1, the reports and their summaries will be submitted together by the sponsors to the competent authorities of the Member States in which a clinical investigation was conducted and will be published by the Commission in the form they are submitted to the Member States,” said MDCG. “No redaction will be performed by the Member States or the Commission, the sponsor bearing all the responsibility for the content of the documents including confidentiality and data protection.”

The guidance details how to label and track documents in the system and how they will be managed and stored. More specifically, the guidance states that clinical investigation documents will be stored in the CIRCABC platform under a directory titled “MDR Clinical Investigation reports and their summaries.”

“A dedicated tracking file listing the CI reports and their respective summaries uploaded in the library will be placed in the root of the dedicated CIRCABC directory and kept up to date by the Commission,” said MDCG. “The membership of this directory is the same as for the MDCG CIE Working Group.”

“For the general public, as the CIRCABC directory is publicly accessible, anybody interested in consulting and downloading its content will be able to do so without the need to become a member,” the group added.

However, after the EUDAMED clinical investigation/performance studies (CI/PS) module for clinical investigation reports and summaries is fully operational, MDCG said the guidance will cease to be applicable and become obsolete.

MDCG guidance

MDCG provides guidance on clinical investigation reports during EUDAMED transition

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