This document provides essential guidelines for sponsors conducting clinical investigations under the MDR. It addresses how sponsors should submit clinical investigation reports and their summaries to the competent authorities of EU Member States while EUDAMED is not fully functional. The guidance emphasizes compliance with Article 77 of the MDR, ensuring public access to these documents and fostering transparency in the clinical evaluation of medical devices.

To facilitate this process, the document details the use of the publicly accessible CIRCABC directory as an interim solution for publishing these reports. It explains the requirements for preparing, labeling, and submitting the documents and outlines procedures for maintaining traceability and regulatory compliance. This guidance is particularly helpful for sponsors navigating regulatory obligations during the transitional phase, ensuring that clinical investigation data remain accessible and aligned with EU transparency goals.

 

 

Reference:
MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED

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