Publication of Clinical Investigation Reports: The MDCG 2024-15 Guide Explained

On December 2, 2024, the MDCG (Medical Device Coordination Group) published MDCG 2024-15, titled “Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED”. This document offers temporary solutions for medical device manufacturers to publish Clinical Investigation Reports (CIRs) and their summaries while awaiting the full functionality of EUDAMED, as required by Regulation (EU) 2017/745 (MDR).

Regulatory Context

Regulation (EU) 2017/745 imposes several obligations on sponsors of clinical investigations, including:

• Article 77(5): Submit a full clinical investigation report and a summary understandable to the intended user within one year of the end of the clinical investigation or within three months in cases of early termination or temporary halt.
• Article 77(7): Make these reports publicly accessible via EUDAMED, no later than when the device is registered.

Since EUDAMED is not yet fully operational, MDCG 2024-15 provides practical alternatives to meet these requirements.

Key Measures in MDCG 2024-15

1. Submission of Reports to National Authorities

Sponsors must submit their reports and summaries to the competent authorities of the Member States where the investigations were conducted. These documents are transmitted in full, without modifications by either the national authorities or the European Commission. This means sponsors are fully responsible for the content, including confidentiality and data protection.

2. Publication via CIRCABC

Pending EUDAMED’s functionality, reports will be published through a public directory on the European platform CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens). This directory is accessible to everyone and includes:

• Clinical Investigation Reports (CIRs) with a unique identifier (CIV-ID).
• A tracking file containing key information: investigation title, sponsor, submission date, status, etc.

3. Temporary Validity

The guide will become obsolete once the EUDAMED module for managing clinical investigations is fully operational.

Links to Other MDCG Guidance and MDR Documents

MDCG 2024-15 is not standalone. It builds on other guidance documents and regulatory frameworks to ensure a smooth and coherent transition:

1. MDCG 2021-1 Rev. 1

• Provides recommendations for alternative technical solutions in the absence of EUDAMED.
• Specifies the national procedures to be followed for report submission.

2. MDCG 2021-20

• Explains how to generate the unique CIV-ID identifier, essential for tracking clinical investigations.

3. European Commission Guidance 2023/C 163/06

• Defines the required structure and format for clinical investigation report summaries.

4. ISO 14155:2020 (Good Clinical Practices)

• While not explicitly mentioned, this standard remains a key reference for ensuring international compliance in clinical investigations.

Key Points for Medical Device Manufacturers

The MDCG 2024-15 guide requires manufacturers and sponsors to:

• Ensure the quality and compliance of reports: No adjustments or redactions will be made after submission.
• Guarantee data confidentiality: Submitted information will be published as is.
• Efficiently manage national procedures: National requirements may vary and must be followed precisely.

Conclusion

MDCG 2024-15 offers a pragmatic solution to meet MDR requirements in the absence of EUDAMED. For manufacturers, it is essential to familiarize themselves with these new guidelines, work closely with national authorities, and leverage resources like ISO 14155 to ensure optimal compliance.

As the full implementation of EUDAMED approaches, this guide serves as a reminder that transparency and rigor remain at the core of regulatory expectations.

Need support in submitting or ensuring the compliance of your reports? Contact us for expert guidance tailored to your needs.