EU AI Act and Medical Devices: New Compliance Deadline of August 2, 2028

Medical Device Global Market Access · Aug 11, 2026 · 5m

This episode covers the EU's postponement of the AI Act compliance deadline for high-risk AI medical devices to August 2, 2028. We discuss Regulation (EU) 2026/1744, explaining what this extension means for manufacturers navigating dual compliance under the MDR/IVDR and the AI Act. We offer practical steps for regulatory, quality, and market-access teams to effectively use this extra time to integrate compliance, engage with Notified Bodies, and strengthen their technical documentation. Key Questions: - What is the new EU AI Act compliance deadline for medical devices? - Which regulation…