UK Backs Continuous Monitoring of AI Medical Devices

UK Backs Continuous Monitoring of AI Enabled Devices

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The government has accepted a recommendation that AI-enabled medical devices be assessed and monitored throughout their working life, rather than relying on one-time assessments. It is one of 44 recommendations from the National Commission into the Regulation of AI in Healthcare, led by NHS doctors, that ministers have accepted in full.

The Medicines and Healthcare products Regulatory Agency (MHRA) said its AI Airlock phase 3 programme, supported by multi-year funding from the Department of Health and Social Care, would put this principle into practice immediately. The programme will work with developers, regulators, and healthcare partners to test how AI devices can be safely monitored and managed for post-market surveillance after deployment, generating insights, evidence, and solutions that will directly inform future MHRA guidance and policy.

Applications are now open for developers of eligible AI-enabled medical devices, with a webinar for prospective applicants taking place on 22 October. The MHRA will also issue draft guidance by December 2026.

The commission was launched by the MHRA in September 2025 to advise government on a future regulatory framework for AI in healthcare. It published its recommendations on 10 September. The commission considered not only the regulation of safe and effective software and AI-enabled medical devices, but also wider issues such as accountability, transparency, clinical practice, organisational governance, and system-wide level assurance.

Clinicians have expressed practical and ethical concerns about AI, particularly over patient confidentiality and medicolegal liabilities, and called for clearer AI guidance and oversight. The commission aimed to support the government’s ambition “to make the NHS the most AI-enabled healthcare system in the world”. The government said the reforms aim to ensure patients benefit from safe, effective, and trusted AI more quickly, while maintaining robust safeguards as technologies evolve.

What the Recommendations Mean for Clinicians

The MHRA also published a series of explainers setting out what the new recommendations mean for healthcare providers, industry, patients, and the public.

According to the explainers, healthcare providers would get better evidence and clearer information about what AI tools do, their benefits and limitations, and how they perform in real-world care. The MHRA said that clinicians’ professional judgement “stays central”, with AI designed around clinical practice, supporting their expertise and decision-making, not replacing it.

Clinicians would also have clearer responsibilities, better support, and greater clarity about their own role and the responsibilities of manufacturers and healthcare organisations. Training would be matched and relevant to that role and the AI technologies they use, with easier ways to provide feedback, raise concerns, and support ongoing monitoring.

Reaction to the Government’s Decision

Lawrence Tallon, MHRA chief executive, said he welcomed the government’s acceptance of the commission’s recommendations in full. “The independent National AI Commission, led by NHS doctors, has given us a clear and ambitious blueprint for how we make the UK the best place to get AI products to patients safely, quickly and in a way that maintains public trust.”

Professor Alastair Denniston, chair of the National Commission, said the response showed that “government has listened, not just to the commission, but to the more than 12,000 patients, clinicians and members of the public who shaped our recommendations”.

James Frith MP, under-secretary of State for Health Innovation, said in a foreword to the government’s response:

“AI-enabled products, when deployed correctly and with proportionate safeguards, can support better outcomes for patients, free up professionals’ time, and support the development and expansion of promising UK-based manufacturers.”

Steve Bates, executive chair of the Office for Life Sciences, said the government’s response would help to “accelerate the safe development, scaling and adoption of AI technologies.”

Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.

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Summary

The UK government has fully accepted 44 recommendations from the National Commission into the Regulation of AI in Healthcare, emphasizing the need for continuous assessment and monitoring of AI-enabled medical devices beyond initial approval. This shift from one-time evaluations to ongoing surveillance aims to ensure safety, efficacy, and trust as these technologies evolve in clinical practice. The Medicines and Healthcare Products Regulatory Agency (MHRA) will implement this approach through its AI Airlock phase 3 program, which focuses on post-market surveillance by collaborating with developers, regulators, and healthcare providers to refine future guidance and policies. Applications are now open for AI developers, with draft guidance expected by December 2026. The commission’s recommendations address not only regulatory frameworks but also broader concerns such as accountability, transparency, and clinical governance. Clinicians have raised ethical and practical issues, including patient confidentiality and liability, underscoring the need for clearer oversight. The MHRA has published explainers to clarify the implications for healthcare providers, emphasizing that AI tools should support, not replace, clinical judgment. Clinicians will receive better evidence on AI performance, clearer delineation of responsibilities, and tailored training to integrate AI effectively into practice. Government and industry leaders have welcomed the recommendations, viewing them as a step toward establishing the UK as a leader in safe, innovative AI deployment in healthcare. The reforms aim to accelerate the adoption of AI while maintaining robust safeguards, ultimately improving patient outcomes and operational efficiency. This initiative reflects a commitment to balancing innovation with accountability, ensuring AI technologies align with clinical needs and public trust. For radiologists and healthcare professionals, this signals a structured approach to AI integration, with ongoing monitoring and support to enhance diagnostic and decision-making processes.