# AI Airlock pilot cohort

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/4b2aa86a-00b3-4526-b62b-7f2f39ee80c1
Type: Guidance
Published: December 4, 2024
Updated: February 28, 2025

> The Medicines and Healthcare products Regulatory Agency (MHRA) launched the AI Airlock pilot to support developers of AI-based medical devices. Governed by the UK Medical Devices Regulation 2002, this initiative provides a collaborative environment for testing innovative technologies. As this document is a call for pilot participation rather than an enforcement report, it does not list specific company names, inspection dates, or violations. Instead, it outlines strict eligibility requirements for applicants. Manufacturers must be legally recognized entities with established rights to market their products in the United Kingdom. A primary required action for participants is a formal commitment to engage with the AI Airlock for the full duration of the pilot. The program focuses on bridging the gap between rapid software development and traditional medical device regulations. By participating, developers help shape future guidance for safe AI deployment in the healthcare sector. This summary confirms that no regulatory breaches were noted; rather, the document serves as a proactive framework for industry engagement and compliance with existing UK market standards.

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## Content

The AI Airlock pilot was open to applications from developers of medical devices that utilise AI, as defined by the UK Medical Devices Regulation 2002. The product manufacturer had to be a legal entity and must have the rights to market their product in the UK. They also have to commit to working with the AI Airlock for the duration of the pilot programme.

## Attachments

- [AI Airlock pilot cohort](/government/publications/ai-airlock-pilot-cohort/ai-airlock-pilot-cohort)