COVID-19 test validation approved products
Page summary:
Find out which COVID-19 test products have been approved.
Change made:
Updated ‘Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations’ CSV file.
Time updated:
10:34am, 30 July 2025
Our governance
Page summary:
The main decision-making, executive and managerial bodies at the Medicines and Healthcare products Regulatory Agency (MHRA).
Change made:
Published board papers and recording for ‘MHRA Board Meeting held in public on 8 July 2025’.
Time updated:
3:03pm, 30 July 2025
MHRA outlines intent to speed up patient access to innovative medical devices
Page summary:
Statement of Policy Intent sets out initial thinking on a new Early Access service to help patients benefit sooner from innovative medical devices that address unmet clinical needs.
Change made:
First published.
Time updated:
9:30am, 31 July 2025
Statement of Policy Intent: Early Access to Innovative Medical Devices
Page summary:
The MHRA’s initial plans on an Early Access service, which will be developed further throughout 2025.
Change made:
First published.
Time updated:
9:42am, 31 July 2025
MHRA Safety Roundup: July 2025
Page summary:
Summary of the latest safety advice for medicines and medical device users
Change made:
First published.
Time updated:
2:42pm, 31 July 2025
If you have any questions about the medical content in this email, contact MHRA on info@mhra.gov.uk
Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance
Page summary:
Advice for manufacturers of DMHTs that qualify as software as a medical device (SaMD) on understanding new post marketing surveillance rules and examples of how they apply.
Change made:
First published.
Time updated:
3:45pm, 1 August 2025
Digital mental health technology
Page summary:
The Wellcome Trust has funded a 3-year project focusing on effective regulation and evaluation of digital mental health technology.
Change made:
Added link in ‘Guidance’ section to ‘Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance’
Time updated:
3:45pm, 1 August 2025
