AI Airlock pilot cohort
Page summary:
An overview of the five technologies selected for the AI Airlock pilot.
Change made:
First published.
Time updated:
9:00am, 4 December 2024
MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach
Page summary:
The pilot scheme, AI Airlock, is designed to help test and improve the rules for AI-powered medical devices to ensure they reach patients quickly, safely and effectively.
Change made:
First published.
Time updated:
9:46am, 4 December 2024
Clinical investigations guidance
Page summary:
Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Change made:
Information about serious adverse event (SAE) has been updated.
Time updated:
9:51am, 4 December 2024
AI Airlock: the regulatory sandbox for AIaMD
Page summary:
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
Change made:
Press Release added ‘MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach’.
Time updated:
10:43am, 4 December 2024
