The Medicines and Healthcare products Regulatory Agency (MHRA) is set to play a central role in implementing the government’s response to the National Commission into the Regulation of artificial intelligence (AI) in Healthcare.
Following ministers’ acceptance of all 44 recommendations, the regulator will develop a more lifecycle-based approach for AI-enabled medical devices. The intention is to assess how devices perform in real clinical settings over time, rather than depending primarily on a single pre-market assessment, according to the organisation.
The MHRA has opened applications for Phase 3 of its AI Airlock regulatory sandbox. The programme will focus on post-market surveillance, bringing developers, healthcare partners and regulators together to test methods for monitoring AI tools once deployed.
By December 2026, the MHRA expects to issue draft guidance on managing changes to AI-enabled devices as they adapt or are updated. It will also consult next year on how such products should be qualified and classified.
The first AI Airlock Phase 3 participants are expected to be selected in November 2026.