EU AI Act & MDR/IVDR: Decoding the New Dual Compliance Roadmap for AI Medical Devices

This episode explores the critical intersection of the new European Union AI Act and the existing Medical Device and In-Vitro Diagnostic Regulations (MDR/IVDR). We unpack the challenges of dual compliance for manufacturers of AI-enabled medical devices and explain how the recent joint guidance from the Medical Device Coordination Group and the Artificial Intelligence Board (MDCG 2025-6 / AIB 2025-1) provides a much-needed roadmap for integrating these two complex regulatory frameworks. Key Questions: - What is the EU AI Act and how does it specifically impact medical device manufacturers? - How do the requirements of the AI Act overlap with the existing MDR and IVDR? - What new information must be included in your technical documentation for an AI-enabled device? - How should risk management under ISO 14971 be integrated with the AI Act's risk framework? - What are the new post-market monitoring obligations specifically for AI systems? - Will your current Notified Body be able to assess your device for AI Act compliance? - What are the key deadlines that manufacturers need to be planning for right now? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. We develop efficient regulatory strategies, act as your local representative in over 30 markets, and use powerful data tools to compile technical dossiers and monitor regulatory changes. To access global markets faster, visit us at https://pureglobal.com or contact [email protected]. Be sure to explore our FREE AI tools and extensive regulatory database at https://pureglobal.ai to support your compliance activities.