mhra
MHRA opens AI Airlock Phase 3 applications with focus on post-market surveillance
AI Airlock Phase 3 prioritises post-market surveillance and lifecycle oversight for AI-enabled medical devices, with year-round applications assessed in scheduled waves.
What Changed
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened applications for AI Airlock Phase 3. The regulatory sandbox’s current priority is post-market surveillance (PMS) and lifecycle oversight for AI-enabled medical devices.
Applications remain open year-round until the page is updated to announce closure. Assessment will take place in scheduled review waves, with rolling onboarding. Submissions received after a scheduled review will generally move to the next wave.
Who Is Affected
Organisations of all sizes may apply, and a lead applicant can partner with other companies or organisations. The process gathers information about candidates, including manufacturers’ AI-enabled devices and prototypes, to assess suitability.
Expressions of interest outside the current priorities are welcome, although aligned proposals receive priority. Selection considers patient benefit, innovation, a regulatory challenge, and readiness to test with sufficient resources.
Regulatory and Technical Implications
The three priority topics address deployment-context factors such as infrastructure, workflows, data quality and user interaction; PMS in settings with varying clinical or organisational oversight; and effective communication of performance, safety, updates and rollbacks. These are presented as programme challenge areas and goals.
Testing options include stakeholder simulation workshops, virtual testing with real or synthetic data, and observation in real-world settings outside patient pathways. In the latter environment, outputs are not used for actual patient decisions. Projects are intended to generate public regulatory tools, frameworks or best practices.
Manufacturer Actions
Applicants should describe their challenge, hypothesis or goal, high-level testing plan and data-access needs, and identify resources for delivery. Candidates may be invited to a shortlisting meeting and asked for supporting evidence, relevant certification, technical or clinical documentation, and information about data sources. Confidentiality and commitment agreements will be established with participants.
Application and participation are free, but candidates are expected to fund their studies, testing and relevant dataset access. Applicants seeking data protection by design advice through the Information Commissioner’s Office referral service should indicate this during application.
Confirmed Dates
The page displays a publication date of 6 October 2026. For the current review wave, it requests applications before 31 October, without explicitly stating the year in that sentence. This is not the overall application closing date: submissions remain open, with a subsequent shortlisting period planned for spring 2027.
The current phase is funded until April 2029. Individual testing or engagement plans are generally expected to run within 6–12 months, tailored to the product and challenge.
Official Source
The MHRA’s GOV.UK guidance, “AI Airlock Phase 3 application,” provides the application form, eligibility criteria, testing arrangements and funding information. Both an online form and a Word version are listed.
https://www.gov.uk/government/publications/ai-airlock-phase-3-application
Source and related services
Guidance: AI Airlock Phase 3 application ↗Source date: 06/10/2026
This news provides general information and does not replace device-specific legal or conformity assessment advice.