All terms
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 scenario1
PMS plan for a connected insulin pen cap
Post-market teamThe 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.
Cross-references
Related terms
Shared paths + categoryPost-Market
Periodic Safety Update Report(PSUR)
Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
Post-Market Mastery · adjacent
Post-Market
Field Safety Corrective Action(FSCA)
Action taken to reduce a risk of serious deterioration in health associated with a device.
Post-Market Mastery
Post-Market
Medical Device Vigilance
Reporting and management of serious incidents and field safety corrective actions.
Post-Market Mastery
Quality & Risk
Corrective and Preventive Action(CAPA)
Systematic process to investigate and resolve quality issues and prevent recurrence.
Post-Market Mastery
Post-Market
Post-Market Clinical Follow-up(PMCF)
Proactive collection of clinical data on a CE-marked device to confirm safety and performance.
Same category
Regulatory
EU Medical Device Regulation(MDR)
Regulation (EU) 2017/745 governing medical devices in the European Union.
Latest in MedTech
Primary references
3 sourcesLink health: 2 verified 1 unchecked· last checked 2026-06-20
EUR-Lex·1European Commission·1FDA·1
- 1EU MDR Chapter VII (Post-Market Surveillance)VerifiedEUR-Lexeur-lex.europa.eu
- 2MDCG 2022-21 PSUR TemplateUncheckedEuropean Commissionhealth.ec.europa.eu
- 3FDA Recalls - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.