Episode Details

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 officially postponed the application date? - How does the AI Act interact with the MDR and IVDR for high-risk devices? - What are the key requirements for AI systems under the AI Act? - How should manufacturers update their Quality Management System for AI compliance? - What steps should be taken to prepare technical documentation for a dual conformity assessment? - Why is early engagement with Notified Bodies crucial for AI-enabled devices? - What does the AI Act require regarding data governance and transparency? Sources: - https://www.dlapiper.com/en/insights/publications/2026/07/life-sciences-news-in-italy-july-2026 How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex requirements like the EU AI Act and MDR/IVDR. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers, reducing time to market. We act as your local representative and provide continuous regulatory monitoring to ensure ongoing compliance. Whether you're a startup or a multinational, we streamline your path to global market access. Learn more about our free AI tools and global device database at https://pureglobal.ai, or contact us at info@pureglobal.com and https://pureglobal.com to accelerate your market entry.