What must a PSUR contain?

Summary of PMS data results and conclusions, rationale for preventive and corrective actions, conclusions of the benefit-risk determination, main PMCF findings, and volume of sales with an estimate of the user population (Article 86).

PSUR Template for EU MDR Article 86 (Word)

Q: How often is a PSUR required under the EU MDR?

Class IIb and III devices at least annually; Class IIa at least every two years. Class I manufacturers prepare a PMS report under Article 85 instead.

Q: Can several devices share one PSUR?

Yes, for a justified device group with the same intended purpose, technology and risk profile.

By Ishan Maharaj, Founder and Principal Consultant. Last reviewed 6 November 2026.

Short answer: a PSUR (periodic safety update report) template must follow Article 86 of the EU MDR: a summary of the results and conclusions of the post-market surveillance data analysis, the rationale and description of any preventive and corrective actions, the conclusions of the benefit-risk determination, the main findings of post-market clinical follow-up, and the volume of sales with an estimate of the size and characteristics of the population using the device. Our PSUR template (Word) ships in the EU MDR Technical Documentation & GSPR Kit ($149), alongside the PMS plan it reports against. The kit is included in the ISO 13485 Complete QMS Kit and listed in the ISO 13485 templates collection.

See the EU MDR kit in the ISO 13485 templates collection

What the PSUR template contains

Section	What you enter
Device and period	Device or device group, Basic UDI-DI, class, certificate, reporting period and the PMS plan revision the report follows.
Volume of sales and population	Units placed on the market by region, estimated users and usage frequency, with the method used to estimate.
PMS data summary	Complaints, serious incidents, trend reports, FSCAs, literature, registries and feedback against the thresholds in the PMS plan.
Preventive and corrective actions	Each action with rationale, CAPA reference and status.
Benefit-risk determination	Conclusion with reference to the risk management file (ISO 14971:2019 clause 10) and clinical evaluation report.
PMCF findings	Main findings of the post-market clinical follow-up plan, or the justification where PMCF is not applicable.
Conclusions and sign-off	Whether the benefit-risk remains acceptable, updates triggered to the risk file, clinical evaluation, IFU or technical documentation, and approval by the PRRC.

When a PSUR is required and how often

Manufacturers of Class IIa, IIb and III devices must prepare a PSUR for each device, or device group where justified. Class IIb and III reports are updated at least annually; Class IIa at least every two years. Class I manufacturers prepare a PMS report under Article 85 instead, which the kit's PMS report section covers. For Class III and implantable devices the PSUR is submitted to the notified body through Eudamed; for other classes it is made available to the notified body and, on request, to competent authorities.

How the PSUR connects to the rest of the QMS

The PMS plan defines the data sources, indicators and thresholds; the PSUR reports against them.
Complaint and vigilance records from the Complaint Handling, PMS and Vigilance Kit are the main input.
Conclusions update the risk management file (ISO 14971:2019 clause 10) and the clinical evaluation report.
Actions are tracked as CAPA and reported at management review (ISO 13485 clause 5.6.2).

Frequently asked questions

Can several devices share one PSUR?

Yes, for a device group where the grouping is justified, typically devices with the same intended purpose, technology and risk profile. The template has a grouping justification field.

What is the difference between a PSUR and a PMS report?

The PMS report (Article 85) applies to Class I devices and summarises PMS results and conclusions with a rationale for actions. The PSUR (Article 86) applies to Class IIa and above and adds the benefit-risk conclusion, PMCF findings and sales and population data.

Does the PSUR replace the PMCF evaluation report?

No. The PMCF evaluation report is a separate document in the clinical evaluation; the PSUR summarises its main findings.

Sources

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