GovWire

AI Airlock pilot call for applications:

Following the launch webinar on 23 July 2024, candidates can now apply to the Medicines and Healthcare products Regulatory Agency (MHRA) to join the AI Airlock pilot.

This application process is designed to gather information about AI Medical Devices (AIaMD) and prototypes and evaluate their suitability for the AI Airlock pilot. We are 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 learnings on the use of regulatory sandboxes.

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 7October 2024.

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 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.

Eligibility Criteria

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. 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 pilot 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. We will categorise the products on receipt of the applications and select the first cohort from the submissions. Based on demand the programme may be able to establish reserve candidates and additional future cohorts.

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 Commissioners 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 theAI Airlockpilot. The selection process and advice provided to applicants selected for the pilot from the consortium ofthe 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.

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

If you would like to ask any questions, please email aiairlock@mhra.gov.uk

Further information is also available on the launch webinar recording.

Further information is also available on the launch webinar recording

AI Airlock data protection and privacy information