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    Periodic Safety Update Report

    Periodic Safety Update Report (PSUR)

    Periodic Safety Update Report (PSUR) is prepared throughout the lifetime of moderate to the high-risk device (Class IIa, IIb and III) by summarizing the results of Vigilance, PMS & PMCF data with any rationale and description of the CAPA taken which includes:

    • The conclusions of the benefit-risk determination;
    • The main findings of the PMCF; and
    • The volume of sales of the device and an estimated evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

    The PSUR must be conducted by setting out the conclusions of the benefit-risk determination, the main findings of the PMCF and the volume of sales of the device, and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

    PSUR

    MDR 2017/745 and Periodic Safety Update Report

    The Periodic Safety Update Report must be submitted to the Notified Body or the Competent Authority (upon request) during the conformity assessment and it is a compulsory part of the technical documentation as per article 86 of EU MDR 2017/745. It must also be updated as and when required.

    As per EU MDR article 86, the Periodic Safety Update Report must be prepared by the manufacturers of moderate and high-risk devices (class IIa, IIb, and III) and must be prepared for throughout the lifetime of the device, after it has been released to the market (as it requires PMS information).

    It must be submitted to the Notified body or competent authority at the time of conformity assessment and are part of the technical documentation. PSUR of class IIa device must be updated when necessary and every two years. PSUR of Class IIb and III must be updated at least annually.

    Periodic Safety Update Report Documentation

    There are no stages as such mentioned for PSUR in the EU MDR, however, following steps can be considered for writing a PSUR:

    • collection of all the information from the manufacturers such as PMS, PMCF, CAPAs was taken, benefit-risk conclusion, sales volume, characteristics of the user population, usage frequency of device;
    • review of the data collected;
    • documentation of the data collected in a PSUR template;
    • results of the analysis;
    • conclusion and final assessment.

    IMPORTANT

    PMS Report (PMSR) and PSUR are two different documents as per the MDR. Post Market Surveillance Record is for class I devices and Periodic Safety Update Report is for moderate and high-risk devices.

    The conclusion of PMSR will be based on the data collected from PMS of class I device and the CAPAs took for it whereas, the PSUR has a conclusion about the data collected from risk-benefit, PMCF.

    The volume of sales, usage frequency, and user population information, ultimately checking the safety and performance of the devices which can be input to documentation such as CER, RMF, IFU, and so on.

    Role of Consultants & Writers in PUSR Documentation

    A third-party consulting firm like I3CGLOBAL can help the medical device manufacturers to write the Periodic Safety Update Report acceptable to third parties well organized and searchable format after collecting all the relevant data such as conclusions of the PMS, benefit-risk determination, CAPAs taken with justification, information from sales volume, usage frequency, and user population information.

    We are capable of writing an organized, clear, and unmistakable Periodic Safety Update Report if the following data are provided by the medical device manufacturers:

    • Results from analyses of the PMS;
    • Conclusions from the analyses of the PMS;
    • Any rationale and description of CAPAs taken;
    • Conclusions of the benefit-risk determination;
    • Main findings of the PMCF;
    • Data of sales volume of the device;
    • Size and other characteristics of the of user population;
    • Information of usage frequency of the device

    Frequently Asked Questions