Status of the AI Act & Standards | European SaMD Meetup

The EU AI Act and its impact on medical devices are becoming increasingly important as the regulatory and standards landscape continues to evolve. In this European SaMD Meetup, experts discuss the current status of the AI Act, expectations for Notified Bodies, and the development of standards supporting its implementation. The session explores the evolving relationship between the EU AI Act and the standards landscape, with a focus on CEN-CENELEC JTC 21 and ISO/IEC JTC 1/SC 42, as well as what manufacturers of AI-enabled medical devices should be preparing for now. Whether you work in Regulatory Affairs, Quality, Software Development, Clinical Affairs, AI Governance, Medical Devices, or Digital Health, this meetup provides practical perspectives on the regulatory and standards developments shaping AI-enabled medical devices. Chapters 0:00 Welcome and agenda 5:40 Daniela Seneca (BSI): the AI Act from the notified body perspective 6:23 The New Legislative Framework 10:22 The Blue Guide, conformity assessment and harmonised standards 21:01 AI Act scope and risk classification 31:40 AI Act timelines and AI literacy 36:35 Notification codes and the MDR proposal 39:34 How AI is assessed under the MDR today 42:32 Common gaps in technical documentation 45:07 Q&A with Daniela 46:09 Leon Doorn (MedQAIR): from SC 42 to JTC 21 47:40 ISO/IEC JTC 1/SC 42 and its standards 51:14 Why ISO 31000-based risk management falls short for the AI Act 53:54 CEN-CENELEC JTC 21 and its working groups 56:08 EN 18286 and EN 18228 58:21 Q&A: ISO 14971 and fundamental rights risks 1:01:23 The digital omnibus and the MDR/IVDR proposal 1:03:52 Cybersecurity standard and what to watch 1:06:16 Getting involved in standardisation 1:11:03 Closing discussion 🎤 Speakers • Daniela Seneca Regulatory Lead | BSI Discussion on the current status of the AI Act and its implications and expectations for Notified Bodies. • Leon Doorn CEO & Co-Founder | MedQAIR Discussion on the current status of CEN-CENELEC JTC 21 and ISO/IEC JTC 1/SC 42 standards. 🎙️ Host • Ivo Flipse Co-Founder | MedQAIR About European SaMD European SaMD is a community dedicated to Software as a Medical Device (SaMD), Healthcare AI, Digital Health, and medical device innovation. Our meetups bring together regulators, researchers, clinicians, startups, and industry experts to discuss emerging technologies, regulatory developments, and real-world implementation of AI in healthcare. 📅 Join our upcoming meetups: https://www.meetup.com/european-samd/ 👍 If you found this session valuable, please Like, Subscribe, and Share this video with colleagues working in Healthcare AI, Medical Devices, Regulatory Affairs, and Digital Health.