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:
Update to reflect that the pilot phase of the AI Airlock is complete, and that applications for phase 2 have now closed
Time updated:
1:53pm, 15 July 2025
MHRA CEO Lawrence Tallon welcomes Life Sciences Sector Plan
Page summary:
The Life Sciences Sector plan was released today (16 July 2025)
Change made:
First published.
Time updated:
10:30am, 16 July 2025
MHRA fees
Page summary:
Fees payable to the MHRA from 2025.
Change made:
Updated the following fees sections to reflect increases from 16 July 2025: 4. Blood banks: application fees for a Review Panel hearing5. Blood banks and other blood establishments: fees6. Blood facilities: contract laboratories fees9. Clinical investigations for devices: fees42. Medical Device Approved Body Fees44. Devices Regulatory Advice meeting (new section added)Also updated: Payment easements and waivers for small and medium companies
Time updated:
1:44pm, 16 July 2025
Clinical investigations for medical devices
Page summary:
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Change made:
Added link to updated SME information (relating to fees).
Time updated:
2:44pm, 16 July 2025
Register medical devices to place on the market
Page summary:
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Change made:
Statutory Registration fee increase to £261 from 16 July 2025Review Registration section updated to include Northern Ireland regulations
Time updated:
4:10pm, 16 July 2025
Five non-executive directors reappointed to the Medicines and Healthcare products Regulatory Agency Board
Page summary:
Two board members have been reappointed for two years, while three others have had their term extended by a year.
Change made:
First published.
Time updated:
9:38am, 17 July 2025
MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions
Page summary:
Points to consider when using real-world data in clinical studies
Change made:
Updated to reflect closing of consultation period
Time updated:
10:33am, 17 July 2025
CLOSED AI Airlock Phase 2 application
Page summary:
The call for applications for phase 2 of the AI Airlock is now closed.
Change made:
Updated to reflect that the call for applications for phase 2 of the AI Airlock is now closed.
Time updated:
3:02pm, 17 July 2025
