Last updated: 23 September 2024
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On 9 May, the MHRA launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD).
On 30 April, the MHRA set out its strategic approach to AI in response to a white paper published in 2023 by Government.
- This pilot project is a key part of that approach.
- It will help the Agency to identify and address the challenges for regulating standalone AI medical devices (AIaMD), initially seeking out and supporting 4-6 virtual or real-world projects through simulation.
- This will allow the Agency to test a range of regulatory issues for these devices when they are used for direct clinical purposes within the NHS.
The AI Airlock
The regulatory sandbox model is a recognised mechanism to help address novel regulatory challenges across sectors.
- The AI Airlock is a world-leading version in healthcare, designed to assist in safe development and deployment of AIaMDs, and this project will follow that robust process so manufacturers can deliver what is required to ensure the real-world viability of these devices.
- The MHRA’s regulatory AI Airlock takes into account evidence-based work produced by other bodies with a similar focus and the Agency will work collaboratively with the NHS AI Lab and the Department of Health and Social Care (DHSC).
- AIaMD products are deployed via NHS infrastructure, making the Devolved Nations crucial to regulatory discussions around deployment and post-market surveillance.
- The findings from this partnership between government, regulators and industry will inform future AI Airlock projects and influence future UK and international AIaMD guidance, including how we work with UK Approved Bodies on UKCA marking and with trusted regulatory partners on international recognition of medical devices.
Who are the AI Airlock Partners?
The AI Airlock Partners comprise of the following organisations:
- MHRA
- Department of Health and Social Care (DHSC)
- NHS AI Lab
- Team AB – the Association of Approved Bodies for Medical Devices in the UK
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.
AI Airlock pilot call for applications
Following the launch webinar on 23 July 2024, candidates can now apply to the MHRA to join the AI Airlock pilot.
- The application process is designed to gather information about AI Medical Devices (AIaMD) and prototypes and evaluate their suitability for the AI Airlock pilot.
- The MHRA is looking to recruit 4-6 candidates to form the pilot 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 future routes to market.
- Outputs of the Airlock programme will include Project Reports from each candidate project team, an Airlock Sandbox report of learnings to inform future guidance and implications for the regulatory framework, and a programme evaluation report sharing learning on the use of regulatory sandboxes.
What are the eligibility criteria for the pilot?
The criteria in brief are:
- The AI Airlock pilot programme is available for medical devices as defined by the UK Medical Devices Regulation 2002, utilising AI.
- The product:
- manufacturer must be a legal entity and have the rights to market their product in the UK.
- has potential to deliver benefits for patients
- or concept application is innovative
- presents a regulatory challenge
The proposal is ready to be trialed.
More detailed information on the criteria is available on this page.
Who can apply for the pilot?
Companies of all sizes are invited to apply. The lead applicant may work with other companies or organisations.
What about fees and funding?
- There is no fee for application or participation in the AI Airlock pilot.
- The selection process and advice provided to applicants selected for the pilot from the consortium of the Airlock Partners will be free of charge.
- While there is no fee for the applicants throughout the pilot 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.
The pilot Application process
- Candidates should complete the application form and return to the aiairlock@mhra.gov.uk mailbox to submit a proposal to the AI Airlock.
- When preparing answers, please note character limits may apply for each section.
- Please return your completed application form before 7 October 2024.
What happens once an application is submitted?
Following applications, candidates may be invited to a follow up shortlisting meeting to share more information about:
- their application
- product
- regulatory challenge to be tested
Confidentiality and commitment agreements will be established between the Airlock programme and the pilot cohort candidates. Candidates may also be asked to share more information about 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.
When will the pilot phase run until and what are the pilot testing timelines?
- The pilot phase of the AI Airlock will run until April 2025.
- While each sandbox testing plan will be bespoke to the product, candidates should expect to complete their individual Airlock testing within 6 months.
- This timeframe is aligned with emerging global best practices.
Further information
- MHRA webinar 23 July 2024
Source
Collection: AI Airlock: the regulatory sandbox for AIaMD – MHRA
Guidance: An AI Airlock pilot call for applications – MHRA