Vigilance Reporting

‍Vigilance Reporting is the mandatory systems and processes within a Quality Management System (QMS) used to identify, document, and report serious adverse events, malfunctions, and corrective actions related to marketed medical devices to regulatory authorities.

Vigilance Reporting is the systematic and timely notification to regulatory bodies (such as the FDA or EU competent authorities) of serious incidents, adverse events, and field safety corrective actions (FSCAs). This regulatory function is essential for continuous process improvement (CAPA) and is mandated to ensure patient safety and adherence to regulations like EU MDR Article 87 and FDA 21 CFR 803 (Medical Device Reporting - MDR).

Vigilance Reporting is a crucial component of postmarket activities, ensuring that device safety is monitored throughout the product lifecycle.

Integration within the Quality Management System (QMS)

Vigilance Reporting functions are tightly coupled with other core QMS processes, particularly Corrective and Preventive Action (CAPA) and Postmarket Surveillance (PMS).

• CAPA Integration: Vigilance reporting is integrated into CAPA Management Processes. This ensures that serious issues identified are systematically investigated, documented, and resolved.
• Traceability: Comprehensive documentation establishes a clear link between vigilance reports and resulting CAPA actions, thereby enhancing traceability during audits and regulatory inspections.

Regulatory Requirements: U.S. (FDA Medical Device Reporting - MDR)

The FDA mandates that manufacturers and user facilities report specific types of adverse events.

• Reportable Event Definition: An MDR reportable event reasonably suggests that a device has or may have caused or contributed to a death or serious injury. For manufacturers and importers, it also includes a malfunction where the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
• Definition of Serious Injury: A serious injury is defined as an injury or illness that is life-threatening, results in permanent impairment of a body function or damage to a body structure, or necessitates medical or surgical intervention to preclude such permanent damage.
• Timing of Reports:
  • Manufacturers must submit reports of individual adverse events no later than 30 calendar days after becoming aware of a reportable event (death, serious injury, or malfunction).
  • Manufacturers must submit a 5-day report if they become aware of a reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to public health.
  • User facilities (e.g., hospitals, ambulatory surgical facilities) must report device-related deaths to the FDA and the manufacturer, and serious injuries to the manufacturer (or FDA if the manufacturer is unknown), no later than 10 work days after becoming aware of the event.

Regulatory Requirements: European Union (EU MDR)

Vigilance requirements under the European Medical Device Regulation (EU MDR) are extensive:

• Mandate for Reporting: Vigilance reporting ensures compliance with EU MDR Article 87.
• Scope of Reporting: EU MDR requires the fulfillment of requirements for the reporting of serious incidents and field safety corrective actions as required by Article 10(13) and specified in Articles 87 and 88 of the Regulation.
• Manufacturer Obligations: Manufacturers must establish a robust CAPA system to manage nonconformities, complaints, and product recalls, with corrective and preventive actions taken as necessary.

Analogy for Understanding Vigilance Reporting

If the entire Quality Management System (QMS) is like a city's public safety infrastructure, then Vigilance Reporting is the mandated system of emergency calls and accident reports (Medical Device Reports).

A critical failure (a serious incident or malfunction likely to cause serious injury) triggers a mandatory report, similar to a 911 call going to the authorities (FDA/EU regulators) and dispatching aid (initiating a CAPA). This system ensures that all serious safety information is immediately centralized, allowing regulators to track device problems nationally or globally, coordinate responses (like recalls or field safety actions), and enforce systemic corrections.

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