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UK MHRA: "AI Airlock" The Regulatory Sandbox for AIaMD

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced (09 May, 2024) the “AI Airlock - The Regulatory Sandbox for AIaMD” a regulatory sandbox designed specifically for Artificial Intelligence as a Medical Device (AIaMD).

AIaMD stands for Artificial Intelligence as a Medical Device. It refers to medical devices that incorporate artificial intelligence technologies to perform tasks related to the diagnosis, treatment, or management of health conditions.

These devices use algorithms and machine learning models to analyze data, make predictions, and support clinical decision-making.

The AI Airlock is a pioneering regulatory sandbox created by the MHRA to support the development and deployment of AIaMD. It provides a controlled environment where developers can test their AI medical devices under real-world conditions while navigating regulatory requirements.

It will enhance understanding and accelerate solutions to novel regulatory challenges for AIaMD. The MHRA AI Airlock project is currently in progress and a call for product applications will be issued shortly.

The AI Airlock differs from other regulatory sandboxes in that it requires collaboration across a wide range of healthcare regulatory, governance, and assurance organizations. AI Airlock combines expertise within MHRA with expertise from key partners including UK Approved Bodies, NHS, and other regulators using real-world products. A short-term analysis of the results will contribute to future AI Airlock phases, and a long-term analysis will inform MHRA policy and guidance regarding demonstrating regulatory compliance.

Objectives of the AI Airlock

  • Facilitate Innovation: Encourage the development of innovative AI solutions in the medical device sector.

  • Ensure Safety and Compliance: Provide guidance and oversight to ensure AIaMDs meet regulatory standards.

  • Collaborative Environment: Foster collaboration between developers, regulators, and other stakeholders.

The pilot project will address a variety of regulatory challenges across different medical device products and healthcare disciplines. Key focus areas include:

  • Detecting and reporting product performance errors (including drift) and failure modes in post market surveillance data.

  • Increased automation and decision-making responsibilities within clinical workflow and producing pre-market evidence of safety.

  • Breaking down the complexities of generative AI based medical devices.

The AI Airlock helps developers bring cutting-edge AI medical devices to market while ensuring they meet stringent safety standards.

For more detailed information, you can explore the full MHRA guidance on the AI Airlock here.


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