In June 2025, the Medical Device Coordination Group (MDCG) published a new guidance document on performance studies of in vitro diagnostic medical devices under Regulation…
Guidance on clinical investigation reports in EUDAMED absence
MDCG 2024-15 is the first guidance document published by the Medical Device Coordination Group in December 2024. This document provides instructions on how to submit…
New MDCG Guidance on content of the Investigator’s Brochure for clinical investigations under MDR
Recently the MDCG (Medical Device Coordination Group) published a guidance on the content of the Investigator’s Brochure for clinical investigations of medical devices (MDCG 2024-5).…
Guidance on content and structure of the clinical investigation report summary
According to Article 77 of the Medical Devices Regulation (MDR), the sponsor of a clinical investigation has to submit a report of the clinical investigation.…