MHRA outlines plans for AI medical device regulation and closer links with US FDA
The Medicines and Healthcare products Regulatory Agency (MHRA) announced plans on 19 October 2026 to change how it regulates artificial intelligence (AI) and software in healthcare. Speaking ahead of the AdvaMed 2026 conference, the UK agency outlined flexible rules that track AI medical devices throughout their lifespan. These devices can update and change as they learn from new health data. To manage this, the MHRA is creating a dedicated Centre for AI and Digital Health. It is also testing products in controlled environments called regulatory sandboxes, such as its AI Airlock scheme and regional trials with NHS London and Manchester University NHS Foundation Trust. The UK government accepted all 44 recommendations of a doctor-led independent commission supporting this lifecycle approach. The agency is also hiring a liaison officer based in Washington, D.C., to work with the US Food and Drug Administration (FDA). This news helps patients understand how emerging AI tools in medical care will be monitored for safety.
What was announced
The MHRA set out its strategy for AI and medical technology regulation at the AdvaMed 2026 conference. Key parts of the announcement include:
- Creating a new MHRA Centre for AI and Digital Health.
- Expanding the AI Airlock regulatory sandbox, which tests AI medical devices in real health settings alongside NHS London and Manchester University NHS Foundation Trust.
- Recruiting a Regional Deputy Director of US Partnerships based in Washington, D.C. This officer will act as a dedicated liaison to the US FDA under the MHRA-FDA Pioneer Programme.
- Increasing reliance and recognition routes for medical devices approved by trusted international regulators, including the FDA.
- Adopting all 44 recommendations from the independent National Commission into the Regulation of AI in Healthcare.
What it means
Medical devices driven by AI differ from traditional medical equipment because software updates and adapts over time. A single static check before a product enters the market is often not enough. The MHRA is shifting toward lifecycle regulation, which monitors software safety continuously as products evolve.
By placing a dedicated official in Washington, D.C., the MHRA aims to work more closely with US regulators. This link could help technology developers navigate approvals in both countries more easily. However, the MHRA confirmed that both the UK and US agencies will continue to make independent decisions on medical device approvals.
What the announcement does not tell us
The announcement leaves a number of operational details unstated:
- It does not give an launch date or budget for the new MHRA Centre for AI and Digital Health.
- It does not specify which FDA-approved devices will qualify for faster recognition routes in the UK.
- It does not detail the exact legislative changes the MHRA plans to put before Parliament for medical device reform.
- It does not state how many AI medical devices are currently enrolled in the AI Airlock sandbox.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is gov.uk: Medicines and Healthcare products Regulatory Agency’s own. Always check the original before acting on anything here.
UK’s Medicines and Healthcare products Regulatory Agency (MHRA) sets out its next phase of MedTech and AI regulation to US industry leaders at AdvaMed 2026.
Opens www.gov.uk
More from gov.uk: Medicines and Healthcare products Regulatory Agency
- MHRA sets out approach to strengthen patient and public involvement and engagement in medicines and medical device regulation5 November 2026
- MHRA guidance on its assessment of non-clinical data generated outside OECD system4 November 2026
- Clinical trials for medicines: Inclusion and Diversity Plan pilot findings published3 November 2026
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