The UK Government has accepted all 44 recommendations from the National Commission into the Regulation of AI in Healthcare. Alongside its response, the MHRA has opened applications for AI Airlock Phase 3, focusing on post-market surveillance and oversight throughout the lifecycle of AI-enabled medical devices.
At a glance
- The announcement: on 6 October 2026, the Government accepted all 44 recommendations.
- The direction: a more proportionate, risk-based and lifecycle-based approach to regulating AI-enabled medical devices.
- The initiative: AI Airlock Phase 3 will investigate practical regulatory challenges related to post-market surveillance.
- The next steps: draft guidance on Predetermined Change Control Plans by December 2026, followed by a consultation on device qualification and classification and an implementation roadmap by spring 2027.
- The distinction: these are policy and implementation commitments, not new regulatory obligations taking effect through the announcement.
What is the Government responding to?
The National Commission into the Regulation of AI in Healthcare published its recommendations on 10 September 2026.
Its remit extends beyond product regulation to accountability, transparency, clinical practice and organisational governance. This broader perspective recognises that the safe use of healthcare AI involves manufacturers, healthcare providers, professionals and patients.
The Government’s response accepts all 44 recommendations and identifies initial delivery priorities and next steps for developing the future regulatory framework.
Why the device lifecycle matters
A central theme is how to assess and oversee AI-enabled medical devices as they evolve after market entry.
Software updates, changing conditions of use and evidence collected in clinical practice can raise questions that an initial assessment alone cannot fully resolve.
The proposed direction therefore places greater emphasis on ongoing evidence generation and monitoring, alongside pre-market assessment. The practical challenge is how to maintain assurance of safety and performance as both the device and its operating environment change.
This approach also highlights the relationship between change management and post-market surveillance. Planned modifications and the evidence needed to evaluate their effects are closely connected throughout the device lifecycle.
PCCPs and the next regulatory steps
MHRA intends to publish draft guidance on Predetermined Change Control Plans (PCCPs) for public comment by December 2026.
The proposed approach would allow manufacturers to establish boundaries defining the scope of permissible changes, including for adaptive AI-enabled devices, while maintaining the device’s intended use.
The Government’s response also proposes including monitoring and reporting processes within PCCPs to support continued safety and performance as devices evolve.
By spring 2027, the MHRA also intends to launch a consultation on device qualification and classification. These concern whether a product qualifies as a medical device and how it is assigned to a regulatory class.
An implementation plan and roadmap are also expected by spring 2027, providing further details on responsibilities, timelines and deliverables.
These dates relate to planned regulatory activities, rather than manufacturer compliance deadlines.
What will AI Airlock Phase 3 explore?
AI Airlock is the MHRA’s regulatory sandbox: a collaborative programme designed to investigate regulatory challenges associated with AI-enabled medical devices.
Phase 3 prioritises post-market surveillance and lifecycle oversight, with particular attention to three areas:
- Deployment conditions: understanding how local infrastructure, clinical workflows, data quality and user interactions may affect device safety and performance.
- Different oversight environments: exploring how surveillance can identify and address safety or performance signals where clinical or organisational oversight varies, including remote or direct-to-consumer settings.
- Communication throughout the lifecycle: examining how information on performance, safety, updates and rollbacks can be communicated effectively to regulators, healthcare providers, professionals and patients.
For consideration in the first application review wave, the MHRA asks candidates to submit their applications before 31 October 2026. Applications will remain open afterwards, with another shortlisting period planned for spring 2027.
A webinar for prospective applicants is scheduled for 22 October 2026.
Participation in AI Airlock contributes to regulatory learning and the development of future guidance. It does not constitute regulatory approval, certification or permission to place a medical device on the market.
What changes now?
Acceptance of the recommendations does not, by itself, bring the proposed regulatory framework into force.
The Government’s response establishes a direction for future guidance, consultation and implementation. It does not replace the requirements currently applicable to medical devices.
In Great Britain, strengthened post-market surveillance requirements have already applied since 16 June 2025 to devices within their scope. These requirements apply to devices placed on the market or put into service from that date, subject to the relevant provisions and exceptions.
In Northern Ireland, medical devices remain subject to the applicable EU MDR and IVDR post-market surveillance framework.
The announced policy developments therefore remain distinct from the regulatory obligations already in force.
What happens next?
For medical device manufacturers, the relationship between change management and post-market evidence is particularly significant.
Software updates and the evaluation of their effects are connected aspects of lifecycle-based oversight. Evidence gathered during use can help determine whether a change achieves its objectives and whether additional action is needed.
The next developments include the MHRA’s draft PCCP guidance, the planned consultation on qualification and classification, and the findings emerging from AI Airlock Phase 3.
These developments will help clarify how the proposed lifecycle-based approach may translate into practical regulatory guidance, responsibilities and expectations for supporting evidence.
Official sources
- UK Government / MHRA — Government backs recommendations of NHS doctors-led AI Commission
- Government Response to the National Commission’s Recommendations on the Regulation of AI in Healthcare
- MHRA — AI Airlock Phase 3 application
- National Commission — Recommendations for a future regulatory framework
- MHRA — Medical devices: post-market surveillance requirements
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Informational note
This article is for informational purposes only and does not constitute regulatory, legal, technical or professional advice. For applicable requirements and procedures, please refer to the official texts and current documentation issued by the competent authorities.