MHRA launches "AI Airlock": new regulatory sandbox for medical devices based on Artificial Intelligence
The MHRA (Medicines and Healthcare products Regulatory Agency) has officially launched the AI Airlock, an innovative initiative in the form of a regulatory sandbox to support the development, validation, and regulatory assessment of Artificial Intelligence Medical Devices (AIaMD) in the United Kingdom.
This new collaborative space aims to accelerate the market entry of AI-based solutions, while ensuring product safety, performance, and regulatory compliance.
What is the AI Airlock?
The AI Airlock is a controlled regulatory testing environment where manufacturers of medical devices with AI can interact directly with the MHRA and clinical and academic partners to:
Explore compliance models adapted to complex and dynamic algorithms;
Test approaches to clinical evidence, continuous validation, and post-market surveillance;
Discuss ethical, equity, and algorithmic explainability issues;
Trial personalized regulatory pathways before formal submission.
Who is this initiative for?
The AI Airlock is intended for developers and manufacturers of AIaMD with products in advanced stages of development that:
Use adaptive machine learning models based on real clinical data;
Face evaluation challenges due to the continuous evolution of the algorithm;
Intend to access the UK market with robust evidence and in compliance with UKCA requirements.
Contact us to assess whether your product is eligible for the AI Airlock and how to accelerate your regulatory pathway in the United Kingdom.
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