UK Moves to Regulate AI Medical Devices by Sector
The MHRA signals a sector‑specific AI regulatory approach after the national commission, diverging from the EU AI Act.
The UK Health and Social Care Secretary announced that the Medicines and Healthcare products Regulatory Agency (MHRA) will adopt a sector‑specific regulatory framework for AI medical devices, a move that eschews the more sweeping EU AI Act. The national commission’s recommendation, released last year, prompted the MHRA to outline a tiered risk‑based system that will apply AI‑powered diagnostic, therapeutic, and monitoring devices within defined clinical classes. The framework is designed to allow manufacturers to demonstrate compliance on a product‑by‑product basis, with the possibility of a 12‑month transitional period for existing devices. While the UK will not enact a single AI Act, the MHRA’s approach will still require detailed evidence of safety, efficacy, and data governance—an area that may impose new supply‑chain scrutiny on firms with multinational operations. Firms should review the draft guidance, assess their clinical‑risk exposure, and consider engaging with the MHRA before the upcoming review deadline to avoid regulatory gaps and potential market delays.