Talk Medical Devices & Combination Products track
S0602 - Demystifying the EU AI Act – What will change for medical devices?
Wed, Mar 19, 2025 · 10:30–11:40 AM CET Boston 1-2 Room, Congress Center Basel
About this session
Currently, many rumours and myths concerning the EU AI Regulation are being openly shared and discussed in social media. This session aims to introduce the audience to the reality of the Regulation's ongoing implementation and will highlight key information and challenges from a medical devices perspective. A case study of a medical device using AI will illustrate requirements according to the current regulatory framework. Focus will be on discussion and clarifications regarding the AI Regulation's impact for digital medical devices.
Programme:
- 1. Implementing the EU AI Regulation - Introduction and Notified Body Perspective — Sebastian Fischer
- 2. The European AI Act in a Nutshell — Thorsten Stumpf
- 3. The EU AI Regulation and Medical Devices - What to Expect and When? — Rajarshi Banerjee
