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:
Updated section on ‘Amendments’ to reflect changes to the process.
Time updated:
9:34am, 26 September 2024
Access Consortium: joint pipeline meetings
Page summary:
The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.
Change made:
Contact details have been updated.
Time updated:
1:05pm, 24 September 2024
Medical devices given exceptional use authorisations during the COVID-19 pandemic
Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Change made:
Updated ‘Open list’ entry for ‘The Heartware HVAD (model number 1104) System (DEU/012/2022/006)’ to reflect Expiry Date of 19 March 2025.
Time updated:
8:54am, 25 September 2024
MHRA opens applications from AI developers to join the AI Airlock regulatory sandbox
Page summary:
The MHRA, is calling for applications for manufacturers and developers of Artificial Intelligence (AI) medical devices, to join the AI Airlock regulatory sandbox.
Change made:
First published.
Time updated:
5:03pm, 23 September 2024
AI Airlock pilot call for applications
Page summary:
Apply now to join the AI Airlock pilot by the MHRA. Benefit from industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.
Change made:
First published.
Time updated:
10:00am, 23 September 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:
Added AI Airlock application documents to collection
Time updated:
10:00am, 23 September 2024
