Last updated: 2 July 2025
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The Government announced in its Regulatory Action Plan on the 17 March 2025 that the AI Airlock will run another phase during the 2025-2026 financial year.
Applicants can now apply to join the AI Airlock Phase 2 cohort.
Timeline of events
| Date | Event |
|---|---|
| 30 April 2024 | The MHRA set out its strategic approach to AI in response to a white paper published in 2023 by Government. |
| 9 May 2024 | The MHRA launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD). |
| 23 July 2024 | Following the launch webinar on 23 July 2024, candidates could apply to the MHRA to join the AI Airlock pilot. |
| 7 October 2024 | Cut off date for applications to the AI Airlock pilot |
| 17 March 2025 | The Government announced in its Regulatory Action Plan that the AI Airlock will run another phase during the 2025-2026 financial year. |
| April 2025 | The pilot phase of the AI Airlock ran until April 2025. |
| 23 June 2025 | AI Airlock phase 2 launched. Further information below. |
AI Airlock Background
The AI Airlock was established to proactively investigate the regulatory challenges of AI as a Medical Device. Working with key partners during the pilot phase and as it moves into phase 2, the programme is working towards key project outputs including an improved regulatory guidance for AIaMD.
You can read more on the background here and on the pilot phase in this post.
AI Airlock phase 2 call for applications
As of 23 June 2025, candidates can now apply to the MHRA to join the AI Airlock phase 2.
About the application process
The application process is designed to gather information about AI Medical Devices (AIaMD) and prototypes and evaluate their suitability for the AI Airlock sandbox.
The MHRA are are looking to recruit up to 4 candidates to form the next cohort that cover a wide range of regulatory issues, healthcare or clinical disciplines and levels of product and regulatory development.
How will candidates included in the programme benefit?
During the Airlock programme candidates will benefit from a unique collaboration of industry and regulatory experts, a bespoke testing plan and gain an improved understanding of the current regulatory framework.
Participation in the regulatory sandbox presents an opportunity for a proactive approach to AIaMD regulation, derisk the innovative products ahead of entering the market and may benefit candidate’s future routes to market.
What will outputs of the AIrlock programme include?
Outputs of the Airlock programme will include:
- project reports from each candidate team
- an Airlock Sandbox report of learnings to inform future guidance and implications for the regulatory framework
- a programme evaluation report sharing learnings on the use of regulatory sandboxes.
What is the application process?
Candidates should complete the application form (online) to submit a proposal to the AI Airlock. You can download the application template here.
- When preparing answers, please note character limits may apply for each section.
- Please complete this form before 14 July 2025 as applications beyond this date will not be considered.
- Companies of all sizes are invited to apply.
- The lead applicant may work with other companies or organisations.
- Following applications, candidates may be invited to a follow up shortlisting meeting, to share more information about their application, product, and regulatory challenge to be tested.
- Confidentiality and commitment agreements will be established between the Airlock programme and the phase 2 cohort candidates.
- Candidates may also be asked to share more information about their products or prototypes, where available, including:
- Evidence to demonstrate the basic principle of your idea.
- Evidence of relevant certification, regulatory and technical/clinical documentation.
- Details of the data access source.
What are the eligibility criteria?
The AI Airlock programme is available for medical devices as defined by the UK Medical Devices Regulation 2002, utilising AI or machine learning.
- The product manufacturer must be a legal entity and have the rights to market their product in the UK.
- Candidates will be asked to commit to working with the AI Airlock pilot programme for the duration.
The product:
- must have potential to deliver benefits for patients.
- or concept application is innovative.
- presents a regulatory challenge.
The proposal must be ready to be trialled. Applicants should be able to establish a plan for the Airlock sandbox for their product and commit resource to carrying out such plan. This should include a clear challenge to be addressed, high level objectives and include data access and quality management systems.
Further detail is available on this page.
About the AI Airlock testing environments
The AI Airlock has been designed to explore regulatory challenges within three different testing environments that can be utilised as part of the bespoke sandbox testing plan. They are:
- Simulation airlock – a roundtable focus group established to bring together key stakeholders and experts to address relevant focused questions, to gather perspectives and to move towards regulatory solutions in a safe space
- Virtual airlock – a digital testing space built into or around an AI system, where its functions can be explored safely
- Real-World airlock – involves testing in the actual environment where the AI product would eventually be used (e.g. a hospital) but carried out without impacting healthcare outcomes.
Further detail is available on this page.
Who are the AI Airlock partners?
The AI Airlock Partners comprise of the following organisations:
- MHRA
- Department of Health and Social Care (DHSC)
- Team AB – the Association of Approved Bodies for Medical Devices in the UK
About Fees & Funding
Is there a fee for application or participation in the programme?
There is no fee for application or participation in the AI Airlock programme.
The selection process and advice provided to applicants selected for the cohort from the consortium of the Airlock Partners will be free of charge.
Resource commitment between candidates and the MHRA
While there is no fee for the applicants throughout the programme there will be a resource commitment to be made between the candidates and the MHRA upon joining the Airlock. Candidates are expected to fund their own studies and delivery of any Airlock testing, including accessing relevant data sets.
What are the phase 2 testing timelines?
Phase 2 the AI Airlock will run until April 2026.
While each sandbox testing plan will be bespoke to the product and challenge, candidates should expect to complete their individual Airlock testing within 6 months.
MHRA webinar
You can view the MHRA webinar of 19 June 2025 titled AI Airlock Pilot The regulatory sandbox for AIaMD in healthcare at this link.
Below is a summary of the webinar as provided by Google Gemini.
This webinar discusses the AI Airlock, a regulatory sandbox designed to explore challenges in regulating AI as a medical device [00:03].
Key aspects of the AI Airlock:
- Purpose [05:43]: It serves as a safe space to test innovative products and services, generating evidence for products that might challenge current regulatory frameworks.
- MHRA’s Role [03:14]: The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medical devices meet safety, quality, and efficacy standards in the UK. The AI Airlock aligns with their MedTech strategy to improve regulation of novel areas like AI as a medical device [03:47].
- Pilot Program Insights [02:52]: The pilot program, launched in April 2024 [05:43], involved four candidates and explored regulatory challenges such as:
- Testing Environments [10:34]: The pilot utilized three testing environments:
- Simulation Airlock [10:41]: Workshops or roundtables to address focused questions and gather perspectives.
- Virtual Environment [11:15]: Testing models with real or synthetic data in a virtual setting.
- Real-World Environment [11:43]: Deploying products in hospitals to gather evidence while protecting clinical pathways.
- Phase 2 Strategy [45:02]: The next phase aims to “unlock” outputs from pilot case studies, feeding recommendations into regulatory changes and improving internal processes. It also seeks to “expand” through international collaboration, engaging more partners, and fostering internal MHRA collaboration [45:14].
- Application for Phase 2 [55:49]: Applications for the next round of candidates will open on Monday, June 23rd, and close in mid-July. The program is looking for candidates ready to work collaboratively and allow for transparent publication of findings [55:49].
Source: MHRA