Latest / Medical Device Global Market Access
EU Clinical Trial Blueprint: Unpacking the MDCG 2024-3 Guidance
This episode dissects the critical MDCG 2024-3 guidance issued in March 2024, which outlines the European Union's expectations for a Clinical Investigation Plan (CIP). We explore how this document harmonizes the EU MDR and ISO 14155:2020, establishing the best-practice blueprint for planning medical device studies. We break down the essential components your CIP must include, from the benefit-risk analysis and statistical design to data management and safety reporting, to ensure a successful regulatory submission. Key Questions: • What is the MDCG 2024-3 guidance, and why is it crucial for…
The skinny
The skinny isn't ready yet — notes appear once the transcript is processed.