Strengthened UK PMS Requirements Coming: Are You Ready?
April 2, 2025 – Do you have medical devices on the market in the UK ? If so, take note: new, strengthened Post-Market Surveillance (PMS) requirements are coming into force in June 2025.
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 introduce several important updates. While these regulations closely align with the EU regulations, there are some key differences, including:
- New definitions specific to PMS processes
- Enhanced reporting obligations for serious incidents
- Clearer details on PMS system requirements
- Detailed requirements for Field Safety Corrective Actions (FSCAs), and Field Safety Notices (FSNs).
- More stringent periodic review mandates for PMS data
What Does This Mean for You?
If you market medical devices in the UK, you may need to update your PMS procedure to ensure compliance with these evolving requirements. Ensuring your Post-Market Surveillance system meets the latest standards is critical to maintaining market access and regulatory compliance.
Need Help Navigating the Changes?
If this feels overwhelming, if you’re short-staffed, or if you’re unsure where to begin, PASB MedTech Solutions is here to help. We specialize in streamlining quality management systems so that your processes work for you—not against you.
Reach out today for expert guidance and support!
📩 Email us at info@pasbtech.com or fill in the contact form on the right to get started.