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    Post Market Surveillance

    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.

    Post Market Surveillance

    Post Market Surveillance 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 and ISO 13485 relationship

    The 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

    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:

     

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

    How to conduct Post Market Surveillance

    The PMS activity is conducted by the manufacturer after proper and careful planning (PMS Plan) of data collection from Proactive and 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, and information on any corrective and preventive actions which have been implemented.

    PMS Report

    The PMS 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.

    Post Market Surveillance

    What should the manufacturers do if there is a preventive or corrective action or both are identified during PMS?

    The manufacturers must implement appropriate measures and inform the Competent Authorities concerned or where applicable, to the Notified Bodies.

    What are the important aspects to be considered during PMS Planning?

    1. a proactive and systematic process to collect information;
    2. effective and appropriate methods to assess the collected data;
    3. suitable measures and threshold values that shall be used in the continuous reevaluation of the benefit-risk analysis and of the risk management;
    4. effective and appropriate methods and tools to examine complaints and analyze market-related experience collected in the field;
    5. methods and protocols to direct the events subject to the trend report;
    6. methods and protocols to interact effectively with competent authorities, notified bodies, economic operators and users;
    7. reference to procedures to fulfill the manufacturers’ obligations for PMS system, PMS plan, and Periodic Safety Update Report;
    8. systematic procedures to identify and begin appropriate measures including corrective actions;
    9. effective tools to detect and identify devices for which corrective actions might be necessary;
    10. a PMCF Plan per Annex III of MDR or a justification as to why a PMCF is not applicable

    What should the manufacturers do when a serious incident is identified, or a field safety corrective action is implemented during PMS?

    The manufacturers must report to relevant competent authorities when a serious incident is identified, or a field safety corrective action is implemented during PMS.

    What are some of the possible achievements of a manufacturer PMS system?

    Given below are some of the types of knowledge and feedback which can be achieved from a PMS system. Not every system will provide all the following, the manufacturer should decide which are the priorities.

     

    • detection of manufacturing problems
    • product quality improvement
    • confirmation (or otherwise) of risk analysis
    • knowledge of long-term performance/reliability and/or chronic complications
    • knowledge of changing performance trends
    • knowledge of performance in different user populations
    • feedback on indications of use
    • feedback on instructions for use
    • feedback on training needed for users
    • feedback on use with other devices
    • feedback on customer satisfaction
    • identification of vigilance reports
    • knowledge of manners in which the device is misused
    • feedback on continuing market viability

    What should the manufacturers do if there is a preventive or corrective action or both are identified during PMS?

    The manufacturers must implement appropriate measures and inform the Competent Authorities concerned or where applicable, to the Notified Bodies.

    What are the benefits of Post Market Surveillance?

    Data gathered from PMS could be used to:

    1. update benefit-risk determination and improve risk management process;
    2. update the clinical evaluation process;
    3. update summary of safety and clinical performance;
    4. for identification of needs of preventive, corrective or FSCA;
    5. for improving the usability, performance and safety of the device;
    6. to contribute to the PMS activity of other devices;
    7. to detect and report trends.
    8. The technical documentation should be updated accordingly.

    What should the manufacturers do if there is a preventive or corrective action or both are identified during PMS?

    The manufacturers must implement appropriate measures and inform the Competent Authorities concerned or where applicable, to the Notified Bodies.