Audio Deep Dive: MDCG 2025-6 Explained - Navigating AI, MDR, and IVDR

About This Audio Session

This audio stream offers a vital discussion for anyone involved in the rapidly evolving field of Medical Device Artificial Intelligence (MDAI), particularly within the European Union's robust regulatory environment. Drawing on the latest guidance and frequently asked questions, this session provides a comprehensive overview of the intricate interplay between the Medical Devices Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR), and the new Artificial Intelligence Act (AIA).

Our discussion delves into key aspects of regulatory compliance for MDAI, including its scope of application and classification, with a particular focus on high-risk AI systems. We explore the stringent requirements for MDAI, covering essential elements such as comprehensive management systems (lifecycle, quality, and risk management), robust data governance practices (data quality, representativeness, and bias monitoring), and the critical need for detailed technical documentation.

Furthermore, the session addresses the paramount importance of transparency and human oversight, examining requirements for explainability, clear instructions for use, direct human interaction, informed consent, and traceability. We also highlight the crucial considerations for accuracy, robustness, and cybersecurity in MDAI.

Beyond foundational requirements, this audio stream navigates the complexities of clinical and performance evaluation for MDAI, outlining the specific criteria and processes for generating compelling clinical evidence. We also clarify the applicable conformity assessment procedures for high-risk MDAI under both the MDR/IVDR and AIA. The discussion extends to post-market responsibilities, detailing criteria for substantial modifications and significant changes, as well as ongoing post-market monitoring and surveillance. Finally, we address other pertinent questions, including those related to in-house MDAI development and training requirements for deployers.

This session aims to equip listeners with the necessary knowledge to confidently navigate the regulatory landscape for AI in medical devices in the EU.