Public advised to stop using certain non-sterile alcohol-free wipes
Page summary:
Due to risk of infection, non-sterile alcohol-free wipes are not appropriate for the treatment of injuries, wounds or on broken skin, nor for cleaning of intravenous lines.
Change made:
First published.
Time updated:
2:00pm, 4 August 2025
COVID-19 test validation approved products
Page summary:
Find out which COVID-19 test products have been approved.
Change made:
Published update for ‘Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations’.
Time updated:
2:55pm, 4 August 2025
MHRA begins recruitment for new digital roles at Leeds hub to drive innovation and smarter regulation
Page summary:
New jobs to strengthen innovation, safety and smarter regulation across the UK health and life sciences sector.
Change made:
First published.
Time updated:
4:44pm, 4 August 2025
Field Safety Notices: 28 July to 1 August 2025
Page summary:
List of Field Safety Notices from 28 July to 1 August 2025.
Change made:
First published.
Time updated:
9:46am, 5 August 2025
If you have any questions about the medical content in this email, contact MHRA on info@mhra.gov.uk
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:
Revised wording in the ‘Payment for a clinical investigation’ section to remove reference to ‘amendments to a clinical investigation’.
Time updated:
4:42pm, 5 August 2025
MHRA MedRegs blog – Summer 2025
Page summary:
Updates on regulatory reform and plans to support innovation.
Change made:
First published.
Time updated:
10:00am, 6 August 2025
New review highlights untapped potential of the vaginal microbiome in women’s health
Page summary:
The microscopic bacteria living in women’s bodies could be a powerful tool for personalised, non-invasive treatment and earlier diagnosis.
Change made:
First published.
Time updated:
5:01am, 7 August 2025
MORE Submissions – user reference guide
Page summary:
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
Change made:
Updated the PSR submission process to reflect the resumption of uploads via the MORE portal. Revised the SAE section to include additional guidance on Quarterly Safety Reports (QSRs).
Time updated:
12:29pm, 7 August 2025
MHRA designated as WHO-Listed Authority: a milestone for UK life sciences and global health
Page summary:
WHO recognition affirms MHRA’s commitment to regulatory excellence, innovation and global collaboration
Change made:
First published.
Time updated:
8:20am, 8 August 2025
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:
Updated to fix typo in paragraph AI Airlock Pilot cohort
Time updated:
2:46pm, 8 August 2025
