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
See also
Closely related context worth reading.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsAction 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.
EU MDR Essentials
· From this learning pathPeriodic 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.
European Database on Medical Devices.
Post-Market Mastery
· From this learning pathRemoval or correction of a marketed device that violates FDA law.
Process for receiving, evaluating, and responding to device complaints.
Systematic process to investigate and resolve quality issues and prevent recurrence.
Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.
IVDR Essentials
· From this learning pathEU-designated organization that assesses conformity of medical devices under MDR and IVDR.
IVDR equivalent of PMCF - ongoing collection of performance data for in vitro diagnostics.
Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81.
Static device identifier (DI) vs. dynamic production identifier (PI) within a UDI.
Primary references
3 sources- 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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