Journey Step 6 of 6

Step 6: Maintain dual compliance

Step 6 of 6

Ongoing dual compliance requires:

  • Maintaining PMS systems for both GB (UK MDR PMS requirements) and NI (EU MDR PMCF and PSUR requirements)
  • Vigilance reporting to MHRA (for GB incidents via MORE) and the relevant EU authority (for NI incidents via EUDAMED)
  • Keeping both sets of technical documentation current
  • Renewing certificates with both UK Approved Bodies and EU Notified Bodies before expiry

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.

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