Public Database for Clinical Investigation Report and Summaries

Where to store when the relevant EUDAMED module is still not ready

By Annette van Raamsdonk

When you read about a public database where manufacturers and sponsors need to file their clinical investigation report and the easily readable summary for the intended user/patient, you might think of EUDAMED.  However, as we wrote recently, certain modules of EUDAMED aren’t yet live. The module where the clinical investigation report and summary need to be stored, Module 6, the Clinical investigations/performance studies module (CI/PS module) is not yet available.

However some manufacturers already completed a clinical investigation, and the sponsor is required per Article 77(5) MDR to submit the report and summary to EUDAMED. To tackle this issue, the European Commission (EC) has created a dedicated public CIRCABC directory called “MDR Clinical Investigation reports and their summaries” which may be found under the following link:

https://circabc.europa.eu/ui/group/5bfd5ece-dc70-468c-b47d-8f871fe8405d/library/affe24c8-db4e-4e81-aedb-b555a0b395a4  

The reports and their summaries need to be submitted by the sponsors to the Competent Authorities (CA) of the Member States in which a clinical investigation was conducted. The CA will check that  the report and summary is filed on the dedicated CIRCAB page, where they are publicly available. Once the CI/PS module becomes mandatory, the CIRCAB page will no longer be available and becomes obsolete.

This and more is described in the recently released MDCG guidance, “MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED”.

We will keep you informed about any publications of this module and other modules of EUDAMED in the OJEU, making certain modules mandatory.