AI Airlock phase 2 call for applications

Candidates can now apply to the Medicines and Healthcare products Regulatory Agency (MHRA) to join the AI Airlock phase 2.

This application process is designed to gather information about AI Medical Devices (AIaMD) and prototypes and evaluate their suitability for the AI Airlock sandbox. We 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.

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.

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, and a programme evaluation report sharing learnings on the use of regulatory sandboxes.

Application process

Candidates should complete the application form to submit a proposal to the AI Airlock. When preparing answers, please note character limits may apply for each section. Please complete this form before 14 July 2025. We will be unable to consider applications beyond this date.

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.

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 has potential to deliver benefits for patients. Applicants can demonstrate that the product (or prototype) will provide a benefit to patients and public health as a medical device. The patient population that will be impacted by the product should be identified.
The product or concept application is innovative. The Airlock programme is looking to recruit AI as a Medical Device products that have the potential to be transformative in the healthcare system or are applied as a novel modification of existing technologies or clinical process.
The product presents a regulatory challenge. The Airlock provides a unique opportunity for products/ prototypes that provide examples of regulatory challenges experienced by Artificial Intelligence as a Medical Device products across the medical device lifecycle.
The proposal is 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.

In collaboration with the Airlock programme partners, the Airlock team will take a portfolio approach to selecting the final products for the second phase against these eligibility criteria.

While no product will be selected that does not fulfil the eligibility criteria, we will be selecting innovative products that will enable the AI Airlock programme to maximise the breadth of learning. Based on demand the programme may be able to establish reserve candidates and additional future cohorts.

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.

Simulation airlock is 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. This environment can be used for challenge areas that need cross-functional alignment / multi-stakeholder engagement or for conceptual products in early stages of development or where data access is not available or needed.

Virtual airlock is a digital testing space built into or around an AI system, where its functions can be explored safely. It allows testers to interact with the AI, feeding it information, checking how it responds, and inspecting how its internal processes work. It is designed to simulate real tasks, so teams can evaluate things like accuracy, reliability, and reasoning within the AI itself.

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. The AI is used alongside doctors and real patient data, following the usual clinical processes, but its outputs are not used to make real decisions about patients. Instead, the goal is to see how the AI performs in practice: how it fits into workflows, how accurate or helpful it is, and whether it’s safe and reliable in standard use.

These environments can be utilised in different ways depending on the regulatory challenges to be addressed as part of the testing plan which will be developed with the candidates during onboarding. Currently, applicants are required to provide their own access to a virtual or real-world environments and data for the testing in the Airlock.

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

The Airlock works across government departments to deliver its activities including with the Department of Science, Innovation and Technology via the Regulatory Innovation Office. The Information Commissioner’s Office (ICO) will also be supporting the MHRA AI Airlock via a referral service offering data protection by design advice to applicants. If you would like support, please indicate this during the application process.

Fees & Funding

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.

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.

Phase 2 testing timelines

The second phase of 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.

CLOSED AI Airlock Phase 2 application