All terms
Medical Device Vigilance
Reporting and management of serious incidents and field safety corrective actions.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Vigilance is the regulatory process by which manufacturers report serious incidents and field safety corrective actions involving CE-marked devices to the relevant Competent Authorities. Equivalent obligations apply under FDA's Medical Device Reporting (MDR) regulation in 21 CFR Part 803.What this means in practice
Vigilance feeds back into PMS, risk management, and CAPA. Timeliness of reporting is closely scrutinized by regulators.Use cases
1 scenario1
Serious incident with a surgical robot
Vigilance officerA patient injury linked to a robot's instrument is reported to the manufacturer. Within 10 days, an initial vigilance report is filed in EUDAMED; a Field Safety Corrective Action follows with a software update and FSN to all users.
OutcomeCompetent authorities accept the FSCA; further incidents are prevented and the trend closes out in subsequent PSURs.
Cross-references
See also
Closely related context worth reading.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
European Commission·2FDA·1
- 1
MDCG Vigilance GuidanceVerifiedEuropean Commissionhealth.ec.europa.eu
- 2
EUDAMED Public SiteVerifiedEuropean Commissionec.europa.eu
- 3
FDA MAUDE DatabaseVerifiedFDAaccessdata.fda.gov
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