EU AI Act: Navigating High-Risk Classification & Dual MDR/IVDR Compliance for Medical Devices

Medical Device Global Market Access · Mar 5, 2026 · 3m

This episode delves into the EU's new Artificial Intelligence Act and its significant impact on medical device manufacturers. We explore the "high-risk" classification for most AI-driven medical devices, the new compliance obligations that run parallel to existing MDR/IVDR requirements, and the critical timelines manufacturers must meet. We break down the challenges and strategies for navigating this dual regulatory framework, from data governance to human oversight. - What is the EU AI Act and why is it critical for MedTech companies? - How are AI-powered medical devices classified under…