Announced 6 Oct 2026 · Sources checked
What did the government accept?
The National Commission, convened by the MHRA in September 2025 as an independent advisory body, published its recommendations on 10 September 2026 after what the government calls a year-long UK-wide evidence exercise involving more than 12,000 patients, clinicians and members of the public. Professor Alastair Denniston chaired the Commission; Professor Henrietta Hughes, the Patient Safety Commissioner for England, was deputy chair.
Health Innovation Minister James Frith’s response, published 6 October, accepts every recommendation. The government says current medical-device rules, built around the UK Medical Devices Regulations 2002, are “not fit for purpose” for today’s AI products. The replacement it describes is proportionate, risk-based and lifecycle-based, with less reliance on a single pre-market assessment.
That is a policy commitment, not a finished legal rewrite. Secondary legislation, consultations and guidance still have to be written. Buyers who already struggle to assign governance owners will not get a new statutory checklist tomorrow.
What are the ten priority areas?
The HTML response groups the next year of work under three Commission themes. Under proportionate lifecycle regulation: modernise the framework for AI-enabled devices; deliver equitable access, with attention to underserved groups; shift toward stronger post-market assurance; and enable safer iteration and earlier access, including predetermined change-control plans, staged authorisation and sandboxes.
Under system-wide responsibility: describe the operating conditions needed for safe deployment; build readiness and workforce AI literacy, including an AI Readiness Toolbox from DHSC and NHS England with the devolved departments; and clarify accountability, reporting and redress with CQC, NHS Resolution, professional regulators and the Patient Safety Commissioner.
Under trust, transparency and predictability: increase public engagement and tell patients when AI is used in their care; make regulatory pathways easier to navigate; and align MHRA, NICE and the Health Research Authority on evidence and on when AI work counts as research. A cross-system Programme Board will meet quarterly. An implementation roadmap is promised by Spring 2027, with annual progress updates.
How will device rules change?
Recommendation 1 commits the MHRA to consult, by Spring 2027, on qualification and classification of software and AI-enabled devices, then to use secondary legislation. The consultation is meant to clarify when a product is not a medical device, including some administrative, wellbeing and decision-support software. Teams that evaluate vendors should treat that line as unfinished: today’s qualification guidance still applies until it is updated.
Recommendation 6 is nearer. The MHRA intends to issue draft guidance on Predetermined Change Control Plans by December 2026, describing boundaries for allowable change, including adaptive devices, without listing every future modification in advance. Staged authorisation pathways, in which a tool could be used in the NHS under supervision while more real-world evidence is gathered, are to be explored rather than switched on.
Scotland’s health secretary said Scotland will set out its own response in due course and already has interim guidance, with an AI policy framework due later this year. Wales and Northern Ireland welcomed the UK-wide work and said they will keep working with the MHRA. “Accepted in full” is therefore not the same as identical implementation in every nation.
What is AI Airlock Phase 3?
AI Airlock is the MHRA’s regulatory sandbox for AI as a medical device. After a pilot and Phase 2, Phase 3 has three further years of government funding; the application page says the current phase is funded until April 2029. There is no fee to apply or take part. Participants are expected to fund their own studies and data access. A webinar for applicants is scheduled for 22 October 2026 at 10:00.
The stated priority is post-market surveillance and lifecycle oversight. The application table asks how manufacturers can capture deployment-context factors, how monitoring should work where clinical oversight is thin, including direct-to-consumer and higher-autonomy tools, and how performance, safety, updates and rollbacks are communicated across the system. Proposals outside that theme can be filed as expressions of interest, but priority goes to post-market work.
Applicants can be asked to use three environments: a simulation airlock (roundtables), a virtual airlock (digital testing with real or synthetic data), and a real-world airlock that watches a tool beside clinicians on retrospective data, outside live patient decisions. Typical engagements are described as 6–12 months. Outputs are intended to be public: tools, frameworks, project reports and sandbox reports.
When do applications close?
They do not close in November. The application page, published 6 October, says the window stays open year-round until the page is updated. Applications are reviewed in waves. To be considered in the current wave, apply before 31 October 2026. Later applications roll into the next wave, with a further shortlisting period in Spring 2027. The press notice says the first wave of innovators will be selected in November 2026.
That is a correction worth keeping straight. An earlier line on the news page talked about applications closing in November; the dedicated application page is the operational rule. Eligibility includes a patient or system benefit, an innovative regulatory question, and a testing plan the applicant can resource.
What should readers do with this?
Manufacturers who already have an AI-enabled device can apply if they have a post-market question worth testing. NHS and trust teams should watch the December PCCP draft and the Spring classification consultation before rewriting procurement. Patients are promised more say and clearer routes to redress; those mechanisms are not specified in the October documents. Our guide to verifying AI answers remains the practical habit at the bedside while the framework is built.
The government’s own caveat is the one to keep: accepting 44 recommendations is the start of delivery. Until secondary legislation and guidance exist, UK MDR 2002 and today’s MHRA software guidance still govern what may be placed on the market.
Common questions
Has the law already changed?
No. The government accepted the recommendations and set timelines. The MHRA still has to consult, issue guidance and, for some items, use secondary legislation.
Do Airlock applications close in November 2026?
No. The application page keeps the window open year-round. 31 October 2026 is the cut-off for the first review wave. Selection of that wave is planned for November.
Is Airlock a shortcut to a CE or UKCA mark?
The MHRA describes it as a sandbox that generates evidence for future guidance and policy. It is not described as a substitute for device approval.
What to remember
The UK has accepted a lifecycle model for healthcare AI and opened a three-year Airlock focused on post-market surveillance. Treat December’s change-control draft and next spring’s classification consultation as the first test of whether the 44 acceptances become operable rules.
Sources & further reading
How this story was made
Written by Kristian Kostov with AI assistance and checked against the linked sources. Company performance claims are attributed to the company. Analysis reflects AiLookout’s interpretation; we have not independently tested the products discussed. Cover photography is illustrative and does not depict the specific announcement or product.
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