Journey Step 4 of 5

Check 4: Is your PMS system up to date?

Step 4 of 5

Confirm your PMS system meets the enhanced requirements in force from 16 June 2025:

  • Do you have a documented PMS plan?
  • Are you proactively collecting safety data (not just waiting for complaints)?
  • Are you monitoring for trends?
  • Are your PMS records retained for the correct period (10 years general, 15 years implantable)?

Post-market surveillance for medical devices

How to establish and maintain a post-market surveillance system for medical devices on the GB market under the enhanced requirements in force from 16 June 2025. Covers PMS plans, proactive data collection, trend analysis, summary reporting, Field Safety Corrective Actions, and data retention periods.

Read the guide →