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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
Jul 24, 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 Jul 24, 2026
Overview

A 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 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 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 is part of the technical documentation under Annexes II and III; for custom-made devices, it belongs with the Annex XIII documentation.

Article 86 requires electronic submission for class III and implantable devices through the Article 92 system, but the EUDAMED Vigilance/ module is still in development as of 24 July 2026. Until it becomes mandatory and available, manufacturers should follow the current notified-body and competent-authority arrangements rather than claim that an EUDAMED upload has been completed.

  • Class I: prepare the Article 85 post-market surveillance report, not an Article 86 .
  • Class IIa: required, update when necessary and at least every two years.
  • Class IIb and class III: required, update at least annually.
  • Class III and implantable devices: prepare the for the Article 86(2) route and follow the current notified-body and competent-authority process until the EUDAMED Vigilance/ module becomes available.
  • Other devices: make the PSUR available to the notified body involved in conformity assessment and, on request, to competent authorities.

When is a required under the EU MDR?

A is required for class IIa, class IIb, and class III devices. Class IIb and class III PSURs are updated at least annually; class IIa PSURs are updated when necessary and at least every two years. Class I devices instead have the Article 85 post-market surveillance report.

Who receives the under MDR Article 86?

Article 86(2) assigns class III and implantable-device PSURs to the Article 92 electronic system for notified-body review and evaluation. The Commission currently lists the EUDAMED Vigilance/ module as in development, so manufacturers must use the current notified-body and competent-authority arrangements until that module becomes mandatory and available. For other devices, the manufacturer makes the PSUR available to the notified body 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 summarizes the results and conclusions of 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 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.

  • 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 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 conclusions and the notified-body or authority review path. The record should show which 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 technical documentation to be clear, organized, readily searchable, and unambiguous, keep 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.
  • 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

European Commission - EUDAMED overview
health.ec.europa.eu
Referenced sections
  • Current Commission source identifying Vigilance and post-market surveillance as an EUDAMED module and listing it as in development.
"Vigilance and post-market surveillance (in development)"
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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