Life Sciences AI Summit – Europe

As AI becomes integral to medical devices, the EU regulatory framework is evolving to address new compliance and safety challenges. This webinar will focus on two key initiatives currently under development — the Digital Omnibus (AI) and the targeted revisions of the MDR and IVDR — and will discuss how these proposals aim to streamline requirements, strengthen data access, and more explicitly integrate AI into sector‑specific product legislation.

The webinar speakers, Ulrich Juknat and Roland Wiring, will explore industry concerns around overlapping obligations, unclear definitions, and the risk of delays due to dual compliance and limited notified body capacity. While the legislative texts are still in the EU decision‑making process and therefore not yet ready for concrete implementation examples, the webinar will illustrate how the proposed changes could affect manufacturers in practice.

Attendees will gain practical insight into how these developments will impact regulatory strategy, conformity assessment, and market access for AI-driven medical technologies.