• How EU MDR/IVDR complexity is delaying innovation, restricting market access, and pushing SMEs to prioritize non-EU pathways like the FDA
• The growing tension between securing funding and navigating Europe’s regulatory environment and what it means for the future of EU-based innovation
• Notified body bottlenecks, high costs, and limited capacity; are smaller companies being systematically disadvantaged?
• The rise of faster-moving markets like China and the implications for Europe’s position as a medtech leader
• Practical strategies for SMEs today, paired with a clear industry “wish list” for regulatory reform, harmonization, and political action