Periodic Safety Update Report (PSUR)

What is a Periodic Safety Update Report?

A Periodic Safety Update Report, or PSUR, is a recurring post-market surveillance report required by Article 86 of the EU Medical Device Regulation. It summarizes the results and conclusions drawn from post-market data and explains preventive or corrective actions taken by the manufacturer.

A PSUR is not the post-market surveillance plan itself. The plan defines how data will be collected and assessed; the PSUR records important outputs and conclusions from that work over a defined reporting period.

Which medical devices require a PSUR?

Manufacturers of Class IIa, IIb and III medical devices prepare PSURs for each device and, where relevant, for a category or group of devices. Class I devices generally use the post-market surveillance report described in Article 85 rather than an Article 86 PSUR.

Grouping must be justified. Devices should not be combined merely to reduce reporting work when their intended purposes, technologies or risk profiles make a shared safety analysis misleading.

What must an EU MDR PSUR contain?

Throughout the device’s lifetime, the PSUR presents conclusions from benefit-risk determination, the main findings of post-market clinical follow-up and relevant sales and usage information. This includes sales volume and an estimate of the population using the device, together with usage frequency where practicable.

The report should connect these data to identified signals, trends, complaints, incidents, field actions and resulting preventive or corrective measures. The European Commission’s MDCG 2022-21 guidance provides a common structure and interpretation.

How often must a PSUR be updated?

Class IIb and Class III PSURs are updated at least annually. Class IIa PSURs are updated when necessary and at least every two years. A significant safety issue can require action before the routine reporting date; the PSUR cycle does not delay vigilance reporting or an urgent field safety corrective action.

How does a PSUR connect to PMS and PMCF?

The PSUR is one output of the manufacturer’s wider PMS system. PMCF findings feed the report, and PSUR conclusions can trigger changes to risk management, clinical evaluation, labeling or corrective actions.

For operational requirements, see our EU MDR and IVDR post-market surveillance guide and EU PMCF services.