Guidance

AI Airlock Background

Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 23 June 2025

Documents

AI Airlock Background

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Details

We are updating medical device regulations and guidance for Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD) to address challenges and align with global standards.

Published 23 June 2025