Key points: 

• The UK and EU are taking distinct but converging approaches to regulate clinical investigations involving medical devices (MDs) and in vitro medical devices (IVDs), with pilots and process refinements aiming to reduce burden and improve harmonisation 
• Sponsors continue to face significant challenges in navigating overlapping regulatory frameworks, particularly when studies span multiple countries or involve combination products 

To read more key points and the session summary, login as a member or register for free using the links below.