Navigating the EU AI act for medical devices: cross-border compliance strategies

In this session, Lisa Page and Tom Perkins from Penningtons Manches Cooper provide a practical overview of the regulatory challenges surrounding AI‑enabled medical devices, focusing on how overlapping EU and UK frameworks shape the path to market.

Key takeaways include:

• how the EU AI Act and the Medical Device Regulation (MDR) interact, including implications for risk categorisation, compliance duties, and approval pathways;
• practical considerations for manufacturers, with real‑world examples illustrating device classification and the expectations placed on high‑risk AI developers;
• cross‑border strategies for navigating contrasting regulatory approaches, particularly the EU’s prescriptive rules versus the UK’s pro‑innovation model, alongside issues around transparency and trade secrets.

Watch the full session below.