PSUR (periodic safety update report)

Under the EU MDR, a Periodic Safety Update Report is the manufacturer's periodic conclusion on the benefit-risk balance of a device, based on post-market data.

EU MDR Article 86 requires a PSUR for class IIa, IIb and III devices. It summarizes the results and conclusions of the analyses of post-market surveillance data, including a rationale and description of any preventive and corrective actions taken. Class I devices use a post-market surveillance report under Article 85 instead. The update cycle depends on the class. Check the current article text before you set a calendar reminder, because the interval is regulatory, not a software default.

The PSUR is not the CAPA log and it is not the vigilance report for a single incident. It is the periodic argument that you still understand the device's benefit and risk. Weak PSURs repeat last year's text. Useful ones cite complaints, trend data, CAPA, literature and any field action.

HAVGATE can hold the complaint trends, audit results and CAPAs that feed the report. It does not generate a regulatory PSUR template as a published feature. Write the report from those records and file it with your technical documentation.