June 2026 saw the publication of the AI Airlock Phase 2 Programme Report by the MHRA, which provides information on the insights and subsequent recommendations from Phase 2 of the initiative. Phase 2 builds upon the initial pilot programme launched in 2024, a regulatory sandbox used to address the challenges that come with regulating medical devices that incorporate artificial intelligence.
Phase 2 worked with several candidates and focused on three specific areas in applying the current frameworks onto AI-enabled medical devices (AIaMDs) that pose difficulty, namely predetermined change control plans and post-market surveillance, performance evaluation and scope of intended purpose and validation, as these were originally designed with static devices in mind.
The report detailed five key insights, such as the need to ensure devices, particularly those with generative AI and large language models, stay within their intended purpose. The Airlock highlighted how these devices, in the absence of guardrails, start to exhibit functionalities beyond what they were originally designed for. Other such findings include the need for adequate human oversight, something we saw reflected in the National Commission’s call for evidence, and grounding the acceptance criteria and thresholds for Predetermined Change Control Plans (PCCPs) in clinical relevance.
Following Phase 2 recommendations were shared with the National Commission, whose recommendations to the Medicines and Healthcare products Regulatory Agency (MHRA) on evolving the current regulatory framework will likely impact the design of Phase 3 of the Airlock programme. Regarding the Phase 2 report, the recommendations called for guidance development for pre-determined change control plans and performance metrics for AI-powered In Vitro Diagnostics (IVDs). The intended purpose and software qualification guidance was also recommended to be updated to reflect the evolving device landscape. Considerations in the report were not limited to just the MHRA but also extended to manufacturers and approved bodies.
The Department for Health and Social Care (DHSC) has already given £3.6 million of funding to the AI Airlock to develop the programme and the regulatory sandbox concept further, aiming to tackle increasingly more complex regulatory challenges. The report detailed strong stakeholder feedback to the programme; however, it was noted that translating the findings into tangible guidance and policy changes will be crucial to the long-term success of the programme.
AI Airlock was not the only sandbox announcement from the MHRA last week, with Science Minister Lord Vallance announcing an AI Sandbox for medicines development during London Tech Week, supporting the delivery of safer medicines to patients. This new sandbox will allow companies and researchers to test AI tools in understanding the safety of a drug in a controlled environment. Work is expected to begin in the Summer of 2026 between the regulator, industry and academia.
Furthermore, a joint initiative between the MHRA, NHS England and London Health Innovation Networks announced a London-specific regulatory sandbox, known as London Region I. Up to 10 AI medical device providers will be selected in the initial phase to work alongside the NHS in London to deploy technologies in live clinical settings, under the watch of the MHRA, providing a controlled environment to generate real-world evidence on their safety and effectiveness of the technologies.
The three initiatives indicate a strong interest from the MHRA to allow regulation to enable innovation, work collaboratively with researchers and evolve with the changing technologies, a sentiment echoed by the Chief Executive, Lawrence Tallon, who in response to the new medicines sandbox stated, ‘by working directly with developers and researchers, we can help create the right environment for innovation to thrive and cement the UK’s position as a world leader in life sciences’.
