MedTech Terms
    The authoritative reference
    All terms
    Post-MarketPost-Market & Safety

    Post-Market Surveillance Plan

    Documented plan describing PMS activities, data sources, methods, and review frequency.

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

    Definition

    MDR Annex III requires a PMS Plan covering proactive and reactive collection of clinical data, complaints, registries, literature, similar-device data, and trend analysis. Drives PSURs, PMS Reports, and PMCF Plans. The plan must also set out methods to assess the data, indicators and thresholds for benefit-risk reassessment, methods for complaint and trend analysis, communication with authorities and users, and links to CAPA and the PMCF plan. It is part of the technical documentation under Annex III and is reviewed by notified bodies. Under the IVDR, the equivalent plan covers post-market performance follow-up instead of PMCF.
    What the regulation says
    The EU Medical Device Regulation (MDR) 2017/745, specifically Article 84 and Annex III, mandates that manufacturers establish, document, implement, and maintain a Post-Market Surveillance (PMS) Plan. This plan is an integral part of the technical documentation for a device and outlines the proactive and systematic process for collecting, recording, and analyzing data on the quality, performance, and safety of a device throughout its entire lifecycle. The FDA similarly expects manufacturers to have a robust system for post-market surveillance under 21 CFR Part 820.

    What this means in practice

    A weak PMS Plan is a recurring Notified Body finding; reviewers want to see specific, measurable activities - not boilerplate.

    Examples

    • A manufacturer includes in their PMS Plan a commitment to conducting annual surveys of 100 clinical users to gather feedback on device performance.
    • The PMS Plan specifies utilizing a national implant registry to track the long-term integrity and failure rates of a prosthetic device.
    • A software as a medical device (SaMD) manufacturer outlines quarterly reviews of publicly available app store data and cybersecurity incident reports as part of their proactive surveillance activities.
    Common pitfalls
    • •A common pitfall is creating a generic PMS Plan that lacks specific, actionable tasks and measurable outcomes.
    • •Failing to integrate lessons learned from PMS activities back into risk management and device design is a significant oversight.
    • •Not allocating sufficient resources, both human and financial, to execute the PMS Plan effectively can lead to non-compliance.
    • •Misinterpreting "proactive" surveillance as merely collecting complaints, rather than actively seeking data, is a frequent mistake.
    • •Ignoring data from "similar devices" or publicly available information can result in an incomplete understanding of post-market risks.

    Frequently asked questions

    The primary purpose is to systematically monitor the safety and performance of a medical device once it is on the market, ensuring its continued compliance with regulatory requirements and identifying any emerging risks.

    Related terms

    Grouped by theme
    Cited by

    Where this term appears across MedTech Terms.

    Ecosystems (1)

    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. 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
      MDR Annex III
      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

    Inline markers like [1] jump to the matching reference above.