Current approaches to product marking
Page summary:
Guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors.
Change made:
First published.
Time updated:
7:00am, 3 February 2025
MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapies
Page summary:
The draft MHRA guidance aims to clarify and streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles
Change made:
First published.
Time updated:
9:06am, 3 February 2025
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’.
Time updated:
2:13pm, 3 February 2025
Digital mental health technology: qualification and classification
Page summary:
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
Change made:
First published.
Time updated:
2:43pm, 3 February 2025
Digital mental health technologies guidance launched to help manufacturers and safeguard users
Page summary:
New guidance helps manufacturers navigate medical device regulations and protect users of digital mental health technologies.
Change made:
First published.
Time updated:
3:30pm, 3 February 2025
Software and artificial intelligence (AI) as a medical device
Page summary:
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Change made:
Added link to guidance on digital mental health technology: qualification and classification.
Time updated:
4:32pm, 3 February 2025
