MHRA

What the MHRA does

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the United Kingdom. It is an executive agency sponsored by the Department of Health and Social Care. Its listed address is in London. Its stated responsibilities include:

• ensuring that those products meet standards of safety, quality and efficacy
• securing their supply chain
• enabling innovation that benefits public health

The agency came into existence on April 1, 2003 through a merger of the Medicines Control Agency and the Medical Devices Agency, according to an editorial in The BMJ. In March 2025 the government announced Lawrence Tallon as chief executive, to begin the role from April 1, 2025. He was to succeed Dame June Raine, who had led the agency since 2019. For 2025-26, the MHRA reported approving 921 medicinal products, including 39 new medicines.

Why it matters for AI in medicine

Some AI products fall within the UK Medical Devices Regulations 2002, the government's October 2026 response to an advisory commission says. It says the MHRA is the competent regulatory authority for medical devices. The same paper says those regulations are not fit for purpose, because AI has developed considerably since they were drafted.

The agency's AI work predates that paper. In October 2023 it published five guiding principles for predetermined change control plans with the U.S. Food and Drug Administration and Health Canada. On May 9, 2024 it launched AI Airlock, a regulatory sandbox for AI as a medical device. In April 2026 it said the Department of Health and Social Care had allocated £1.2 million a year for 2026 to 2029 to the program. On September 26, 2025 it launched the National Commission into the Regulation of AI in Healthcare. The commission is an expert, non-statutory advisory body chaired by Professor Alastair Denniston.

Recent developments

• October 6, 2026: The government accepted all 44 of the commission's recommendations in a policy paper published by the MHRA. The same day, the agency opened applications for AI Airlock phase 3, which focuses on post-market surveillance.
• September 10, 2026: The commission published its recommendations. They include staged authorizations for new AI models and continuous real-world monitoring of AI-enabled devices. STAT reported that health authorities worldwide are trying to work out how to keep reviewing AI products that change after they are authorized.
• July 29, 2026: The MHRA published guidance, developed with NHS England, on ambient voice technology products, often called AI scribes. It says products intended solely to transcribe or summarize clinical conversations, draft letters or suggest clinical codes for clinician review are not regulated as medical devices. It says those intended to support diagnosis or treatment are. The agency said the guidance does not change the law.

What to watch

• Draft guidance on predetermined change control plans, which the response says the MHRA intends to issue by December 2026.
• A consultation on how software and AI devices are qualified and classified, which the response says the MHRA intends to launch by spring 2027. The response says an implementation plan and roadmap will be published by then.
• The first AI Airlock phase 3 participants, which the MHRA said will be selected in November 2026.
• Capacity. Jennifer Dixon, chief executive of the Health Foundation, commented in the MHRA's September 10, 2026 announcement. She said the real test will be whether the NHS has the capacity, skills and systems to implement and monitor AI safely and effectively at the scale needed.