Medical Device Vigilance
Reporting and management of serious incidents and field safety corrective actions.
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 scenarioSerious 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.
Cross-references
Related terms
Shared paths + categoryAction taken to reduce a risk of serious deterioration in health associated with a device.
FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
Activities to monitor device safety and performance after market release.
Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
Mandatory European conformity mark for medical devices placed on the EU market.
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
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Primary references
3 sources- 1MDCG Vigilance GuidanceVerifiedEuropean Commissionhealth.ec.europa.eu
- 2EUDAMED Public SiteVerifiedEuropean Commissionec.europa.eu
- 3FDA MAUDE DatabaseVerifiedFDAaccessdata.fda.gov
Inline markers like [1] jump to the matching reference above.