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    Periodic Safety Update Report

    Periodic EU MDR/IVDR report summarizing post-market surveillance findings.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Per EU MDR Article 86, the PSUR summarizes results and conclusions of analyses of post-market surveillance data, including main findings of the PMCF, the rationale and description of preventive and corrective actions, and the volume of sales.
    What the regulation says
    The Periodic Safety Update Report (PSUR) is a key post-market surveillance document required under the EU Medical Device Regulation (EU MDR) in Article 86. It provides a comprehensive summary of post-market surveillance data, including findings from Post-Market Clinical Follow-up (PMCF) and the rationale for preventive and corrective actions. The frequency of PSUR submission is risk-based, with Class IIb implantable and Class III devices typically requiring annual reports that are subject to assessment by a Notified Body.

    What this means in practice

    PSUR frequency depends on device classification. Class IIb implantable and Class III devices require annual PSURs assessed by Notified Bodies.

    Examples

    • A manufacturer of a Class III orthopedic implant submits an annual PSUR detailing field safety corrective actions implemented due to a higher-than-expected revision rate identified through vigilance data.
    • A company developing a Class IIb active implantable device includes a section in their PSUR outlining the results of their PMCF study, demonstrating the long-term efficacy of the device in a larger patient population.
    • A MedTech firm
    Common pitfalls
    • •Failing to integrate findings from all post-market surveillance activities, such as PMCF, into the PSUR is a common mistake.
    • •Submitting a PSUR that lacks clear justification for chosen preventive and corrective actions can lead to regulatory non-compliance.
    • •Incorrectly determining the submission frequency of the PSUR based on device classification or regulatory updates is a frequent error.
    • •Omitting quantitative data, such as sales volumes, or qualitative insights that support the conclusions in the PSUR will lead to an incomplete report.
    • •Not adequately linking the PSUR content to an updated risk-benefit assessment of the device can be a significant oversight.

    Frequently asked questions

    The primary purpose is to systematically report on the safety and performance of a MedTech device post-market, drawing conclusions from gathered surveillance data to ensure ongoing compliance and patient safety.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    EUR-Lex·1FDA·2
    1. 1
      EU MDR Article 86
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      FDA MAUDE Database
      Verified
      FDAaccessdata.fda.gov
    3. 3
      FDA Recalls - Medical Devices
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.