FAQEU MDR

EU MDR FAQ PSUR

Under MDR Article 86, manufacturers of class IIa, class IIb, and class III devices prepare a periodic safety update report for each device and, where relevant, each device category or group.

A useful PSUR connects PMS data, PMCF findings, vigilance signals, benefit-risk conclusions, corrective actions, sales volume, and usage-population evidence.

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Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Questions
3

Structured answer sets in this page tree.

Primary sources
2

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated May 9, 2026
Overview

A PSUR is required for class IIa, class IIb, and class III medical devices under MDR Article 86. Class I devices use the separate post-market surveillance report in Article 85. The PSUR summarizes conclusions from the PMS plan, including benefit-risk conclusions, main PMCF findings, sales volume, user-population estimates, usage frequency where practicable, and any preventive or corrective actions.

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3 of 3 questions
Question 1

When a PSUR is required

Prepare a PSUR when the device is class IIa, class IIb, or class III. MDR Article 86 applies the duty to each device and, where relevant, to each category or group of devices.

Class IIb and class III PSURs must be updated at least annually. Class IIa PSURs must be updated when necessary and at least every two years. Except for custom-made devices, the PSUR is part of the technical documentation under Annexes II and III; for custom-made devices, it belongs with the Annex XIII documentation.

  • Class I: prepare the Article 85 post-market surveillance report, not an Article 86 PSUR.
  • Class IIa: PSUR required, update when necessary and at least every two years.
  • Class IIb and class III: PSUR required, update at least annually.
  • Class III and implantable devices: submit PSURs through the Article 92 electronic system to the notified body involved in conformity assessment.
  • Other PSUR devices: make the PSUR available to the notified body involved in conformity assessment and, on request, to competent authorities.
Citations
Regulation (EU) 2017/745 on medical devices

MDR Articles 85 and 86 distinguish class I PMS reports from PSURs for class IIa, IIb, and III devices and state the update cadence, technical-documentation placement, and notified-body handling.

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Review the PSUR evidence chain

Check the device class, PMS plan, PMCF evidence, vigilance inputs, benefit-risk conclusion, notified-body handling, and retained records before the next PSUR update.

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Question 2

What the PSUR should summarize

The PSUR is not a standalone narrative. It summarizes the results and conclusions of PMS data analysis gathered under the Article 84 PMS plan, together with the rationale and description of preventive or corrective actions.

Across the device lifetime, the PSUR must set out the conclusions of the benefit-risk determination, the main findings of PMCF, the device sales volume, an estimated evaluation of the size and characteristics of the user population, and usage frequency where practicable.

  • PMS analysis: complaints, feedback, trend data, serious incidents, non-serious incidents, field safety corrective actions, literature, databases, registers, and similar-device public information where relevant.
  • Benefit-risk link: explain whether PMS and vigilance data changed the benefit-risk determination or risk-management file.
  • PMCF link: summarize main PMCF findings and cross-reference the PMCF evaluation report where PMCF is performed.
  • Corrective-action link: state the rationale for preventive, corrective, or field safety corrective actions and track implementation.
  • Market-exposure link: include sales volume, population estimate, population characteristics, and usage frequency where practicable.
Citations
Regulation (EU) 2017/745 on medical devices

MDR Articles 83, 84, 86, 87, 88, 89, and Annex III ground the PSUR relationship to PMS, vigilance, trends, corrective actions, benefit-risk updates, PMCF, and technical documentation.

Question 3

Evidence to retain

Retain the evidence needed to reproduce the PSUR conclusions and the notified-body or authority review path. The file should show which PMS inputs were collected, how they were analyzed, what changed in benefit-risk or risk management, and which actions were opened or closed.

Because Annex III requires PMS technical documentation to be clear, organized, readily searchable, and unambiguous, keep PSUR evidence indexed against the device, Basic UDI-DI or internal device identifier, risk class, reporting period, PMS plan, PMCF plan or justification, and the technical documentation version.

  • Device scope: device identifiers, risk class, category or group rationale, custom-made status if relevant, and reporting period.
  • PMS inputs: complaints, user feedback, distributor and importer feedback, literature or register searches, similar-device public information, trend analyses, vigilance records, serious incidents, field safety corrective actions, and non-serious incident data.
  • PMCF records: PMCF plan, PMCF evaluation report, clinical-evaluation updates, and any justification for non-performance of PMCF.
  • Benefit-risk records: updated risk-management file, benefit-risk conclusion, thresholds or indicators used, and explanation of any new or changed risk signal.
  • Action records: preventive or corrective action rationale, field safety corrective action records, owner, status, effectiveness checks, and notified-body or competent-authority correspondence.
Citations
Primary sources

References and citations

EUDAMED - European Database on Medical Devices
webgate.ec.europa.eu
Referenced sections
  • Commission EUDAMED page identifying vigilance and post-market surveillance as one of the EUDAMED electronic-system modules.
"vigilance and post-market surveillance"
Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu
Referenced sections
  • MDR Annex III lists PMS-plan inputs and confirms that the PSUR and PMS report are part of post-market surveillance technical documentation.
"clear, organised, readily searchable and unambiguous"
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