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  • MDR post-market surveillance requirements

    The MDR pays more attention to the post-market surveillance requirements, and the interested parties need to establish:

    Post-market surveillance system;

    Vigilance system;

    Post-market clinical tracking system;

    Risk management system.


    Based on the above systems, considering the device risk category, it is required to form:

    Post-market surveillance report;

    Periodic safety update report;

    PMCF report;

    Safety and clinical performance summary.


    All of these shall be reflected in the quality management system and technical documentation.