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…
MDCG Guidance on Clinical Investigation Plan
The Medical Devices Coordination Group (MDCG) released in March 2024 a new guidance on the content of the clinical investigation plan for clinical investigations of…
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.…