Periodic Summary Report (PSR) for Manufacturers of Medical Devices

Download a free template (MS Word)

The manufacturer's Periodic Summary Report (PSR) is associated with specific cases where there is a group of common and well-documented serious incidents, or field safety corrective actions with a known root cause. This report template is aligned with the EU MDR and aims to simplify the reporting process.

This periodic summary report enables manufacturers to:

  • Highlight results of an investigation
  • Analyze current trends
  • Underlain improvements made in comparison to past performance
8-step transition process from MDD to MDR

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