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    PSUR (IVDR Specific)

    Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

    Definition

    Under IVDR Article 81, Class C and D IVDs require a PSUR updated at least annually; Class A and B IVDs instead keep a post-market surveillance report under Article 80. PSURs summarize PMS data, benefit-risk re-evaluation, sales volumes, and PMPF status. For Class D devices, the PSUR is submitted through EUDAMED to the notified body, which adds its evaluation; for Class C, it is made available to the notified body. PSURs include conclusions on benefit-risk, main findings of post-market performance follow-up (PMPF), sales volumes and an estimate of the population using the device. MDCG 2022-21 covers both MDR and IVDR PSURs.
    What the regulation says
    The EU IVDR (Regulation (EU) 2017/746) mandates the preparation of A Periodic Safety Update Report (PSUR) as a post-market surveillance document for certain classes of in vitro diagnostic (IVD) devices. Specifically, Article 81 outlines the requirements for PSURs, detailing their content and submission frequency to Notified Bodies, where applicable. The PSUR serves to update the competent authorities on the post-market performance and safety of an IVD throughout its lifecycle.

    What this means in practice

    Closely linked to the Summary of Safety and Performance (SSP) for high-risk IVDs and reviewed by Notified Bodies for Class C/D devices.

    Examples

    • A manufacturer of a Class C IVD for cancer biomarkers submits its annual PSUR to its Notified Body, detailing post-market complaints, vigilance cases, sales data, and the status of its PMPF plan.
    • An IVD company developing a Class B diagnostic for infectious diseases prepares a PSUR every two years, summarizing data from user feedback, literature reviews, and an updated benefit-risk assessment.
    • A manufacturer of a Class D IVD used for blood screening updates its PSUR with new clinical evidence and a re-analysis of adverse event trends observed in the field.
    Common pitfalls
    • •Confusing the PSUR frequency requirements between IVD classes can lead to non-compliance.
    • •Failing to include a comprehensive benefit-risk re-evaluation in the PSUR is a common deficiency.
    • •Inadequate data collection for post-market surveillance (PMS) will result in an incomplete PSUR.
    • •Omitting the PMPF (Post-Market Performance Follow-up) status update renders the PSUR deficient.
    • •Assuming Class A devices never require any form of post-market surveillance reporting is incorrect, even if a PSUR is not mandated.

    Frequently asked questions

    The primary purpose of an IVDR PSUR is to report on the post-market safety and performance of an IVD, including any changes to its benefit-risk profile, and to confirm its continued compliance with the regulation.

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    Sources

    3 sources

    Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2
    Link health: 3 verified· last checked 2026-06-20
    EUR-Lex·1FDA·2
    1. 1
      IVDR Article 81
      Tier 1 Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      FDA MAUDE Database
      Tier 2 Verified
      FDAaccessdata.fda.gov
    3. 3
      FDA Recalls - Medical Devices
      Tier 2 Verified
      FDAfda.gov

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