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 tools creates complex challenges. Manufacturers face dual conformity assessments, overlapping documentation requirements, and unclear responsibilities. At the exhibition Industriële Elektronica, Kiwa will present highlights where the regulations reinforce each other, but also where they conflict. We discuss how startups and established players can strategically navigate both frameworks without slowing innovation. Finally, we provide practical guidance for compliance and market access in a rapidly evolving Medtech landscape.

Interested to know more? Come to our presentation and visit our booth, we are there to support you.