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
Required under EU MDR Articles 83–86 and embedded in FDA's quality system. Outputs include PSUR, PMS reports, trend reports, and updates to the risk management file.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.
Cross-references
Follows
Comes after in a typical workflow or lifecycle.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
EUR-Lex·1FDA·1European Commission·1
- 1
EU MDR Chapter VIIVerifiedEUR-Lexeur-lex.europa.eu
- 2
FDA Recalls - Medical DevicesVerifiedFDAfda.gov
- 3
EUDAMED Public SiteVerifiedEuropean Commissionec.europa.eu
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