MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements
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.
