The UK Medicines and Healthcare products Regulatory Agency (MHRA) outlined its evolving approach to artificial intelligence (AI) and medical device regulation at AdvaMed 2026, highlighting lifecycle-based oversight, regulatory sandboxes and closer cooperation with the US Food and Drug Administration (FDA). The plans build on the MHRA 2030 Strategy, published on 14 October 2026, and aim to support innovation while maintaining patient safety.
MHRA 2030 strategy and centre for AI and Digital Health
The MHRA’s 2030 Strategy set out plans to modernise regulation in response to advances in AI, personalised medicine and medical technology. For medical devices, the agency outlined plans to develop an adaptive framework for AI as a medical device (AIaMD), establish a dedicated Centre for AI and Digital Health, improve device data and traceability, and expand reliance and recognition pathways with trusted international regulators. The strategy aims to establish a global standard for safe and agile regulation of AI and medical technology by 2030, supporting timely patient access to innovative technologies while strengthening safety protections.
On 6 October 2026, the UK Government accepted all 44 recommendations made by the independent National Commission into the Regulation of AI in Healthcare. The government’s response sets out initial implementation priorities, including a more proportionate, risk-based and lifecycle-oriented approach to AI regulation. It also establishes a programme board to coordinate implementation across government and the wider health system.
AI Airlock and NHS partnerships
The MHRA is testing its evolving regulatory approach through AI Airlock, a regulatory sandbox for AI-enabled medical devices. On 6 October 2026, the agency opened applications for Phase 3, which focuses specifically on post-market surveillance and the safe management of AI-enabled devices throughout their lifecycle. The programme brings together developers, regulators and healthcare partners to examine how devices can be monitored after deployment and to generate evidence for future regulatory guidance and policy. The first participating innovators are expected to be selected in November 2026.
The initiative is complemented by regional partnerships, including NHS London and Manchester University NHS Foundation Trust, which provide healthcare settings for testing innovative technologies and generating evidence to inform future regulatory approaches. The programme is intended to help the regulator address the challenges posed by AI-enabled devices that may change throughout their lifecycle, while giving developers greater clarity on regulatory requirements.
Jessica Paulsen, MHRA Deputy Director for AI and Software, said:
“AI is changing medical technology, and regulation must keep pace. In the UK we are moving from policy into practice, using initiatives like AI Airlock to build a more proportionate, lifecycle-based approach. “These are global technologies, so close collaboration with the FDA and other regulators will be critical to giving innovators greater clarity while maintaining strong protections for patients.”
MHRA–FDA Pioneer Programme
The MHRA–FDA Pioneer Programme, announced in June 2026, established a framework for dedicated liaison roles within both regulatory agencies. The programme is designed to strengthen day-to-day collaboration, scientific exchange and coordination on emerging regulatory challenges, including AI and medical devices. Both agencies retain independent decision-making authority. The initiative builds on existing UK–US cooperation. At AdvaMed 2025, the MHRA outlined ambitions to strengthen regulatory alignment with the FDA, reduce transatlantic barriers to market access and explore greater use of international reliance pathways, including for medical devices already approved by the FDA. The MHRA has also launched recruitment for a Regional Deputy Director of US Partnerships, based in Washington, D.C. The role is intended to serve as the agency’s dedicated liaison to the FDA under the Pioneer Programme and to strengthen scientific and regulatory cooperation between the two countries.
Wider medical device regulatory reform
Alongside its work on AI and international collaboration, the MHRA is progressing broader medical device reforms. These include improvements to post-market surveillance and proposed legislative changes intended to make the regulatory framework more responsive to technological developments. The Government’s response to the National Commission also sets out further regulatory work: the MHRA plans to issue draft guidance by December 2026 on managing changes to AI-enabled medical devices and to consult in 2027 on their qualification and classification. The measures form part of the agency’s wider effort to modernise medical device regulation while maintaining patient protections and supporting innovation.
