MDCG issues guidance on the publication of medical device clinical trial reports in absence of EUDAMED |

In absence of EUDAMED the EU issued guidance with respect to the publication of medical device interventional study reports and summaries of Article 62 and 74.1 studies.

Noteworthy is that it is key to have one single ID, i.e. CIV-ID, and that the Competent Authority that generated it

“will transmit to the Commission the two documents as outlined above without undue delay after receiving them from the sponsor”

Thereafter the documents will be stored in a dedicated public CIRCABC directory that can be found with the following link:: https://circabc.europa.eu/ui/group/5bfd5ece-dc70-468c-b47d-8f871fe8405d/library/affe24c8-db4e-4e81-aedb-b555a0b395a4