Description: The EU’s AI Act will have been adopted by the date of the Euro Convergence 2024 and its transitional period will have started by then. It will be crucial for companies in the medical technology and in vitro diagnostics field to understand the implications for the AI Act, which will impose an additional horizontal layer of AI technology specific regulation on medical devices and IVDs already regulated under the AI Act. As a consequence both devices that are already CE marked as device as new devices that are also in scope of the AI Act need to be CE marked under this new EU regulation in addition to MDR or IVDR CE marking. This session will provide an overview of how the AI Act and the MDR/IVDR dovetail, where the overlaps are, where the diferences are and how to set up and execute an effective transition stratgegy for various types of AI, including foundation models.
Learning Objectives:
Understand the AI Act in general terms and the concepts of it that apply to medical devices and IVDs.
Understand how the AI Act interacts with other EU legislation and the overlap mechanisms of the AI Act work.
Define transition strategies for existing and new medical devices / IVDs for compying with the. AI Act and the MDR/IVDR simultaneously.
