According to Article 77 of Regulation (EU) 2017/745 on medical devices (MDR), clinical investigation reports and their summaries in lay language shall be made publicly accessible via the European EUDAMED database.

As EUDAMED is not yet fully functional, publication is carried out temporarily in accordance with MDCG Guidance 2024-15 through a central public repository managed by the European Commission.

According to Article 77(5) and MDCG 2021-1 Rev. 1, the reports and their summaries shall 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. 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 directory of clinical investigation reports and their lay summaries (CIR/SCIR) is publicly accessible under the following link:

CIRCABC Directory “MDR Clinical Investigation reports and their summaries”

The following information is published:

• Title and status of the clinical investigation (e.g. completed, early termination)
• Name of the sponsor and, where applicable, the funding entity
• Date of submission and CIV-ID
• Clinical investigation report in accordance with Article 77(5) MDR
• Summary in lay language in accordance with Article 77(5) MDR

Publication takes place:

• no later than one year after the end of the investigation, or
• within three months in the case of early termination or temporary halt.

Further guidance is provided in the following documents:

• MDCG 2024-15 Guidance on publication of CI reports (PDF)
• Commission Guidance on CI Summary Reports (2023/C 163/06)