PSUR Requirements and Process

The PSUR is a summary of the results of post-market surveillance activities as well as the conclusions that manufacturers have drawn from those results. If the manufacturer has taken any corrective or preventive actions (CAPAs), a description and rationale for the actions must also be included in this report.

The Periodic Safety Update Report is part of a device’s technical documentation, and it has to be updated throughout the device’s lifecycle. The PSUR is initially submitted to a Notified Body during the device’s conformity assessment audit, but from then on it must be updated either annually or biennially.

This Whitepaper discusses about:

• Article 86 (Periodic Safety Update Report)
• Article 83 (Post-market surveillance system of the manufacturer)
• Article 84 (Post-market surveillance plan)
• Article 87 Vigilance (Reporting of serious incidents and field safety corrective actions)
• Article 88 (Trend Reporting)
• Article 89 (Analysis of serious incidents and field safety corrective actions)
• Annex III (Technical Documentation On Post-Market Surveillance)