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    Post Market Surveillance

    Post Market Surveillance Report For Medical Device

    Post Market Surveillance (PMS) is an activity carried out by the medical device manufacturers to actively and systematically gather, record, and analyze data received from the market, which can be used to ensure continued quality, safety, and performance throughout the lifetime of the medical device.

    PMS should be planned, established, documented, implemented, maintained, and updated for each medical device after it has been commercialized. The manufacturer should do so by considering the risk class and the type of device.

    Post Market Surveillance

    PMS and ISO 13485 Relationship

    The Post Market Surveillance (PMS) should be integrated into the company’s Quality Management System (ISO 13485) and should be built together to analyze the data on quality, performance, and safety of the device throughout its entire lifecycle. It should also be allowed to draw conclusions about this data and be linked to the company’s preventive and corrective action system.

     

    PMS could be ‘Reactive’ – responding after an event has occurred and is considered passive as they are largely data collection activities.

     

    PMS could be ‘Proactive’ – endeavors meant to anticipate and curtail events before they occur and are considered active as they give insights and data into the real-world performance of the device.

    REACTIVE Sources
    Customer complaints
    Literature reviews
    User feedbacks
    Maintenance/Service Reports
    Failure analysis
    In-house testing
    Device registries
    Social media
    PROACTIVE Sources
    Customer surveys
    PMCF or other post CE clinical trials
    Implant registries
    Expert user groups

    Post Market Surveillance Plan

    Post Market Surveillance (PMS) must be conducted by the manufacturer after proper and careful planning (PMS Plan) for data collection either Proactive or Reactive sources following a strict schedule. Once the PMS planning has been done, a PMS Report needs to be made showcasing the results of the data collected, along with information on any corrective and preventive actions which have been implemented.

    The PMS plan sets out the requirements for conducting the PMS activities. It is required for all devices except custom-made devices. It should be part of the Technical documentation. The PMS plan should address the collection and utilization of available information, in particular:

     

    • Information regarding serious incidents, including information from PSURs, and field safety corrective actions;
    • Records mentioning non-serious incidents and data on any undesirable side-effects;
    • Information from trend reporting;
    • Relevant specialist or technical literature, databases and/or registers;
    • Particulars including feedbacks and complaints, provided by users, distributors, and importers; and
    • Publicly available details about similar medical devices.

    The Post Market Surveillance Report or the PMSR has the record of all the PMS activities conducted as per the PMS Plan.

    PMS Report Documentation and Role of I3CGlobal Team

    • Guides manufacturers in conducting the PMS
    • Supports in drawing up the PMS plan;
    • Guides in conducting the PMS activities;
    • Provides well-structured PMS plan, procedure and report templates;
    • Identifies PMCF requirements from PMS data;
    • Analyzes the PMS data and drawing suitable conclusions.

    Frequently Asked Questions