MDCG 2024-15: Guidance on the Publication of the Clinical Investigation Reports and Their Summaries in the Absence of EUDAMED

The Medical Device Coordination Group (MDCG) has issued guidelines for publishing clinical investigation reports and summaries in the absence of full EUDAMED functionality. Key aspects of the guidelines include:

Submission and Accessibility

• Submission Requirements: Sponsors must ensure compliance with submission protocols, including accurate labeling and tracking of documents.
• Public Accessibility: Timelines are provided for making reports and summaries publicly accessible through alternative mechanisms.

Confidentiality and Document Management

• Confidentiality Responsibilities: Sponsors are responsible for ensuring the protection of confidential content while adhering to transparency requirements.
• Document Storage: Documents are stored in a public directory using the CIRCABC platform for access and reference.

Roles of Member States

• Management and Transmission: Member States are responsible for handling and transmitting documents to ensure compliance with MDCG standards.

Special Conditions

• Immediate Publication: In cases of early termination of clinical investigations, documents must be published immediately.
• Document Validity: Guidelines remain applicable until EUDAMED becomes fully operational and mandatory.

These guidelines ensure transparency, accessibility, and regulatory compliance in managing clinical investigation reports and summaries during the transitional phase.

Region: EU Harmonized (27 Markets)

Source: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en?filename=mdcg_2024-15_en.pdf