Archives: Agenda

• Exploring the conjunction between medical devices and digital health
• What are the success factors?
• Dos and don’ts and best practice examples

• Understanding regulatory expectations
• Designing and conducting clinical investigations
• Balancing data sufficiency with practicality

Conducting medical device clinical trials in Europe and the UK presents unique challenges due to varying regulatory landscapes and operational complexities. This session highlights the key issues faced by researchers and companies in this region, including:

• Planning for varying local and regional regulatory requirements
• Coordinating operations across multiple countries
• Streamlining patient recruitment and data management

• Commercial pressure versus Clinical realities
• Managing the tripartite relationship between Sponsor, CRO and Site.
• Key drivers of failure (and success!)
• The changing clinical trial landscape: Adapting to new challenges

• Highlighting the main components of the act
• How the AI Act complements or adds to MDR requirements
• Balancing innovation with safety
• Strategies to navigate the AI Act