Guidance: AI Airlock Phase 3 application

AI Airlock Phase 3 application

The call for applications for phase 3 of the AI Airlock is now open.

AI Airlock phase 3 call for applications

Candidates can now apply to the Medicines and Healthcare products Regulatory Agency (MHRA) to join the AI Airlock. Please submit applications using this portal – Application Portal

This application process is designed to gather information about candidates (including their AI enabled Medical Devices and prototypes, if they are a manufacturer) and evaluate their suitability for the AI Airlock sandbox.

The application window will remain open year-round, and applicants may submit an application at any time until this page is updated to indicate that the call has been closed. Applications will be evaluated in scheduled review waves and onboarded on a rolling basis. Applications submitted after a scheduled review will generally be carried forward to the next review wave.

Current areas of focus

The current priority regulatory challenge area is Post-Market Surveillance (PMS) and oversight across the lifecycle for AI enabled Medical Devices. Specific focus will be given to projects that address the priority topics set out below:

If you see a challenge area you are interested in exploring or addressing with the programme, and you have sufficient information to support hypothesis development and testing, please complete the relevant section of the form.

We are also open to expressions of interest from outside of these key focus areas. If there is a challenge you’d like to explore within the AI Airlock which does not fit into the PMS and lifecycle oversight challenge area, we would encourage you to submit your proposal using the form above and selecting the “Express interest in another regulatory focus area” option in the form.

These expressions will help to inform future priorities for the programme which we will update in due course, however, please note that priority will be given to proposals that align with current areas of focus.

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. Organisations of all sizes are invited to apply. A lead applicant may partner 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 participating organisations. 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 a data access source, as relevant.

Phase 3 testing timelines