Planning clinical evidence for US and EU medical device market entry: Key strategic decisions  

When a medical device’s risk profile requires clinical investigations, early decisions regarding clinical evidence requirements, study design, market prioritization and regulatory engagement it can significantly influence development timelines, regulatory acceptance and overall US and EU market entry strategy. Since clinical investigations are complex, time-consuming, and expensive, strategic planning early in design and development is essential.

This webinar examines key strategic decisions involved in planning clinical evidence for US and EU medical device market entry. Topics include identifying clinical evidence requirements during design and development, determining which safety and performance requirements need clinical data, evaluating when multi-stage clinical investigations may be needed and addressing differing US and EU expectations for clinical evidence quality and acceptability.

The webinar will also discuss how market prioritization and interactions with FDA and EU Notified Bodies may influence clinical evidence strategy.

Attendees will gain a practical framework for planning clinical evidence strategies that support effective and efficient US and EU medical device market entry.

Key takeaways:

• Key considerations for identifying US and EU clinical evidence requirements early in design and development
• Key considerations in determining which safety and performance requirements need clinical data
• When multi-stage clinical investigations may be needed (e.g., first-in-human, pilot, pivotal)
• When to prioritize US vs. EU market entry and how that decision impacts clinical evidence strategy
• How to address differing US and EU expectations for clinical evidence quality and acceptability
• When and how to engage FDA and EU Notified Bodies as part of clinical evidence strategy