Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) will outline its developing approach to AI-enabled medical devices at a Boston conference Tuesday, as it prepares guidance for products that can change after deployment.
The panel at AdvaMed’s MedTech Conference is scheduled for 9:30–10:30 a.m. ET, Tuesday, Oct. 20. MHRA Deputy Director for AI and Software Jessica Paulsen and U.S. Food and Drug Administration (FDA) official Rick Abramson are listed as participants.
Britain’s government on Oct. 6 accepted all 44 recommendations from an independent commission on AI regulation in health care. The commission urged regulators to assess devices throughout their working lives because AI performance can change after an initial review. Accepting the recommendations did not put new rules into effect.
In its 2030 strategy, released Oct. 14, the MHRA proposed adaptable oversight for AI medical devices and the creation of the MHRA Centre for AI and Digital Health. It also calls for improved device data and traceability. The agency is accepting applications for AI Airlock Phase 3, which focuses on monitoring AI-enabled devices after they enter use.
The MHRA says its approach is intended to help patients gain faster access to safe technologies while giving developers clearer regulatory expectations. A London regulatory sandbox aims to select up to 10 AI medical-device manufacturers. A Manchester partnership launched Sept. 2 will test health technologies in National Health Service settings.
The MHRA and FDA announced reciprocal liaison roles June 15 to support scientific exchange. Both agencies said they would retain authority over their own regulatory decisions. In an MHRA statement issued ahead of the conference, Paulsen said cooperation with other regulators would give developers greater clarity while maintaining protections for patients.
The government plans a consultation on the qualification and classification of AI medical devices in 2027 and a full implementation roadmap by spring 2027. The next scheduled policy step is draft MHRA guidance by December 2026 on managing changes to AI-enabled devices.
