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    Post-Market Surveillance

    Activities to monitor device safety and performance after market release.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Post-Market Surveillance (PMS) comprises the systematic processes a manufacturer establishes to actively collect and review experience gained from devices placed on the market, in order to identify any need to apply corrective or preventive actions.

    What this means in practice

    PMS is required under EU MDR Articles 83-86 and IVDR Articles 78-81, and is embedded in FDA's Quality System Regulation (soon QMSR) through complaint handling (820.198), CAPA (820.100), and MDR reporting (Part 803). Under EU MDR, manufacturers must maintain a PMS plan proportionate to device risk (Article 84), covering active and reactive data collection: vigilance and serious incidents, trend reports (Article 88), user feedback, scientific literature, similar-device data, PMCF for Class IIa and above, and PMS reports (Class I) or PSURs (Class IIa+). Outputs feed the risk management file, technical documentation, clinical evaluation, and, where needed, corrective actions and field safety corrective actions (FSCA).

    Examples

    • A Class IIb implantable device team runs quarterly PMS reviews aggregating complaints, PMCF data, and literature searches, updating the RMF and PSUR annually.
    • A Class IIa SaMD manufacturer maintains an automated pipeline that ingests support tickets, app store reviews, and adverse-event reports into a single PMS dashboard reviewed monthly.

    Use cases

    1 scenario
    1

    PMS plan for a connected insulin pen cap

    Post-market team

    The PMS plan defines complaint trending, app analytics review, literature monitoring, and a registry partnership. Inputs feed a PSUR every two years and a continuously updated risk file.

    OutcomeAn emerging usability issue is detected within one quarter and fixed via a labeling change before it becomes a vigilance event.
    Common pitfalls
    • •Confusing PMS (proactive, plan-driven) with vigilance (reactive, incident-driven). MDR Article 83 explicitly distinguishes them; you need both.
    • •Under-scoping PMS to complaints only. MDR expects trend analysis, literature review, similar-device data, and PMCF results as well.
    • •Missing the trend reporting obligation. MDR Article 88 requires reporting statistically significant increases in non-serious incidents or expected side effects.
    • •Treating PMS as separate from the RMF. PMS outputs must be linked to risk analysis updates and, where relevant, to CAPA.

    Frequently asked questions

    PMS is the systematic, proactive process of collecting and analyzing all post-market data. Vigilance is the specific reactive process for reporting serious incidents and field safety corrective actions (FSCA) to competent authorities. Vigilance is one input to PMS.

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    Mentioned in recent activity

    12 entries
    NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107.
    Class I· 2026-02-27
    NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107
    Class I· 2026-02-27

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    Primary references

    3 sources
    Link health: 2 verified 1 unchecked· last checked 2026-06-20
    EUR-Lex·1European Commission·1FDA·1
    1. 1
      EU MDR Chapter VII (Post-Market Surveillance)
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      MDCG 2022-21 PSUR Template
      Unchecked
      European Commissionhealth.ec.europa.eu
    3. 3
      FDA Recalls - Medical Devices
      Verified
      FDAfda.gov

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