MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
The Medicines and Healthcare products Regulatory Agency (MHRA) has released official guidance to help medical device manufacturers prepare for the updated Post-Market Surveillance (PMS) requirements, effective June 16, 2025.
What is PMS?
PMS is a mandatory system designed to monitor devices on the market, identify risks, and ensure safe usage throughout their lifecycle.
Key Updates from MHRA Guidance
1. Enhanced data collection: Continuous monitoring of quality and safety.
2. Shorter reporting timelines:
– 2 working days for public health threats.
– 10 working days for deaths or serious injuries.
– 15 working days for other serious incidents.
3. Mandatory periodic summaries: Early identification of safety issues.
4. Risk mitigation and communication: Clear guidance for managing risks and protecting users.
MHRA recommends:
– Applying the guidance immediately.
– Collaborating with trade associations for further support and feedback.
Need Support?
Our team is here to assist you in meeting the new PMS requirements. Contact us for personalized advice.
