New MDCG Guidelines: Publication of Clinical Investigation Reports Without EUDAMED

Publishing clinical investigation reports is a crucial aspect of compliance with MDR regulations. In the absence of a fully functional EUDAMED system, MDCG 2024-15 provides guidelines enabling alternative solutions. This article outlines the applicable procedures and how to ensure compliance.

Responsibilities of clinical investigation Sponsors

Under Article 77(5) MDR, sponsors are required to submit clinical investigation reports and their summaries to the competent authorities of the Member States where the investigations were conducted. These documents must be submitted within one year of the conclusion of the clinical investigation or within three months in cases of early termination. It is critical that the summary is presented in terms that are easily understandable to the intended user, ensuring accessibility even for those without advanced medical expertise. Sponsors bear full responsibility for the content of the documents, including compliance with confidentiality and data protection requirements. Failure to meet these obligations may result in sanctions, such as delays in placing the device on the market. Sponsors must also ensure that their submissions adhere to MDR’s technical documentation guidelines.

Alternative procedures for publishing Clinical Investigation Reports

Given the lack of a fully functional EUDAMED system, MDCG 2021-1 Rev. 1 introduces alternative measures for the publication of clinical investigation reports. During this transitional period, sponsors must use national procedures, which may vary across Member States and require thorough knowledge of local regulations. To promote transparency, data is published in a publicly accessible digital repository, CIRCABC, enabling wide access to clinical investigation outcomes. This system allows medical professionals, regulators, and the public to access the information without the need for registration or login. Although this alternative minimizes barriers to information access, it demands precise and timely action from sponsors and national authorities. These measures are vital to maintaining continuity in the publication of data despite delays in EUDAMED implementation.

Document labeling and tracking process

Every clinical investigation report and its summary must be labeled with a unique identifier (CIV-ID), ensuring effective tracking of the documents. CIV-ID is generated as per MDCG 2021-20 guidelines during the clinical investigation registration process. Labeling involves appropriate notations, such as “CIV-ID – CIR” for the complete report and “CIV-ID – SCIR” for its summary. This system facilitates streamlined document management and eliminates duplication risks, thereby preventing potential confusion in the publication process. Furthermore, national authorities are tasked with reporting the receipt date of these documents, ensuring transparency and monitoring compliance with deadlines. A well-structured labeling process is foundational for seamless collaboration between sponsors, Member States, and the European Commission.

Responsibilities of Member States

Competent authorities in Member States play a pivotal role in publishing clinical investigation reports. Upon receiving the documents from sponsors, they must forward them to the European Commission without undue delay while ensuring compliance with formal requirements. Reports related to early terminations or halts must be published immediately upon receipt, enhancing transparency in cases requiring special attention. Member States also manage communication with the Commission to avoid duplication and provide updates on the status of submitted documents. In specific scenarios, such as investigations conducted under Article 82 MDR, reporting obligations depend on national requirements. Cooperation between Member States and the Commission is essential for efficient document management during this transitional period.

Public accessibility and document storage

Reports and summaries are stored in the publicly accessible CIRCABC digital repository, which anyone can access without registration. Member States are responsible for promoting this platform through their websites and other communication channels. The European Commission regularly updates the repository and adds new documents in accordance with submissions received. To enhance usability, a tracking file listing all documents is maintained and updated regularly. This approach ensures better organization and management of documentation while reinforcing the transparency of the regulatory system.

Significance of the guidelines for the industry

MDCG 2024-15 serves as an invaluable resource for sponsors and regulators, bridging the gap created by the absence of a functional EUDAMED system. The guidelines establish uniform standards for report publication during the transitional period, minimizing discrepancies and inconsistencies across Member States. By harmonizing publication procedures, the guidelines enhance transparency and trust in clinical investigation results, which is crucial for end-users, regulators, and the medical device industry. The document also emphasizes sponsors’ accountability for preparing documentation that adheres to data protection and confidentiality standards. Implementing these principles is fundamental to advancing the regulatory system and bringing safe, effective medical devices to market.

Conclusion

MDCG 2024-15 provides essential support to sponsors in publishing clinical investigation reports compliant with MDR. Through the use of the CIRCABC repository and harmonized publication procedures, transparency and regulatory compliance are assured. Organizations involved in clinical investigations should thoroughly review these guidelines to avoid non-compliance and contribute to the development of safe and effective medical devices.