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Overview
Artificial intelligence is rapidly becoming part of medical device software, while the regulatory and standards landscape continues to evolve.

This European SaMD Meetup will focus on the current status of the EU AI Act and the standards supporting its implementation, with perspectives from notified body, industry and regulatory experts.

We will explore what the latest AI Act developments mean for medical devices and how relevant standards are progressing across the European and international standardisation landscape.

The discussion will cover the implications and expectations for Notified Bodies, developments within IEC TC 62, the SNAIG roadmap, and the current status of CEN-CENELEC JTC 21 and ISO/IEC JTC 1/SC 42 standards. JTC 21 is developing European AI standards intended to support the AI Act, while also drawing on international work from SC 42.

The meetup is intended for professionals working across regulatory affairs, quality, software development, clinical affairs, AI governance, medical devices and digital health.

Agenda
Introduction (5–10 minutes) – Host (Ivo Flipse)

  • Welcome and introduction to the meetup
  • Current status of the AI Act and its relevance to medical devices
  • Overview of the standards landscape supporting AI Act implementation

Session 1 (10–15 minutes + Q&A) – Daniela Seneca (Regulatory Lead, BSI)

  • Implications and expectations for Notified Bodies regarding the AI Act
  • Status of the AI Act

Session 2 (10–15 minutes + Q&A) – Dominik Kowalski (Senior Project Manager, Regulatory Compliance, Brainlab / SNAIG)

  • Overview of IEC TC 62 standards
  • SNAIG roadmap update

Session 3 (10–15 minutes + Q&A) – Leon Doorn (CEO, Co-Founder, MedQAIR)

  • Status of CEN-CENELEC JTC 21 standards
  • Status of ISO/IEC JTC 1/SC 42 standards

Panel Discussion (20–30 minutes)

  • How the AI Act and standards are evolving together
  • Notified Body expectations and conformity assessment
  • IEC TC 62, JTC 21 and SC 42: how do the different standards activities fit together?
  • What manufacturers should be preparing for now
  • Open questions and practical challenges for AI-enabled medical devices

Conclusion (5 minutes)
Wrap-up, discussion, and key takeaways.

Event Date & Time
21 September 2026 – 7:30 PM–9:30 PM CET

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