Journey Step 4 of 5

Step 4: Investigate and implement corrective actions

Step 4 of 5

After your initial report:

  • Conduct a root cause investigation
  • Submit follow-up reports to MHRA as new information emerges
  • Implement corrective and preventive actions (CAPA)
  • If other devices on the market may be affected, initiate a Field Safety Corrective Action (recall, modification, or additional warnings)
  • Issue a Field Safety Notice to users and distributors

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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