Double regulated? The AI Act and MDR in Medtech: clash or balance?

The European AI Act and the MDR are both designed to ensure safety and transparency, but their simultaneous application to medical AI devices presents complex challenges. Manufacturers face duplicate conformity assessments, overlapping documentation requirements, and unclear responsibilities. This presentation highlights where the regulations reinforce and conflict with each other. We discuss how startups and established players can strategically navigate the two frameworks without slowing down innovation. Finally, we offer practical tools for compliance and market access in a rapidly evolving MedTech landscape.

Speaker: Kevin Veldman