The MDR and The AI Act: A Match Made in Heaven or The Odd Couple?

Description: As the dust continues to settle on MDR implementation, the AI Act has now arrived, bringing with it a wave of additional considerations for those medical devices that will now also be regulated as ‘high-risk AI systems’. Integrating compliance with AI Act requirements into the existing EU frameworks that already regulate devices (including software medical devices) will require a constructive, collaborative, and possibly quite creative approach from regulators, manufacturers, and notified bodies.

This session will consider the AI Act and the MDR side by side identifying key areas of compatibility, or in some cases, conflict between the two frameworks. A multidisciplinary approach will also be central to understanding and accommodating AI tools within the ever-evolving EU regulatory system applicable to medical devices. For that reason, the session will include perspectives from panelists drawn from the life sciences and AI sectors with legal, academic, and industry backgrounds. Panelists will be invited to not only outline what they feel are the most important challenges in integrating the MDR and the AI Act in the short, medium, and long terms but also to canvas their views and possible solutions with their co-panelists and the audience.

The goal is to trigger a lively interactive discussion during a time when the AI Act will have entered into force, with standards being published, governance structures becoming operational, and a confirmed timeline for implementation set out. Attendees will leave the session equipped with a deeper understanding of the impact of the AI Act on the medical device industry, and the most important areas of agreement and ongoing debate in this complex area.

Note: this proposal is premised on the AI Act having been adopted in advance of the conference. That final text and any guidance issued at that point would be considered and discussed by the panel.