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.
Similar Posts
Clinical trials: Non-investigational medicinal products
Guidance on using non-investigational medicinal products in a clinical trial.
Common specification requirements for in vitro diagnostic devices
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
Guidance: AI Airlock Sandbox Pilot Programme Report
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
Field Safety Notices: 4 to 8 August 2025
List of Field Safety Notices from 4 to 8 August 2025.
Decision: Advertising Investigations: December 2025
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
Public advised to stop using some non-sterile alcohol-free wipes
UKHSA and MHRA are urging the public not to use 4 specified non-sterile alcohol-free wipe products due to the risk of infection associated with their use.