Breakout

Breakout #2: Horizontal Legislation in EU, A Complex Growing Web of Supporting Legislation

Thursday, April 23, 2026

11:30 AM - 12:30 PM East Coast USA Time

Location: Franklin CD - 2nd Floor

Moderator(s)

Gert Bos

Executive Director & Partner
Qserve Group
Kim Trautman

Expert
Medical Device, IVD and Combo Product Expert

Speaker(s)

Philippe Auclair

Senior Consultant
AKRA Team
Fabien Roy

Partner
Arnold & Porter
Andreas Stange

Senior Vice President, Regulatory and Quality
TUV SUD
Cécile van der Heijden

Attorney-at-law
Axon Lawyers

The EU is continuing to add horizontal legislation to the maze of legal requirements that also affect the medical device industry. Critical topics include data, security, AI, and environment. The session will highlight some essentials, focusing on priority, handling conflicting requirements and an outlook to the future.