Establish Quality Management System
SOP Vigilance
Report serious incidents and safety events to regulatory authorities through systematic vigilance and field corrective action procedures.
Summary
Your Vigilance SOP establishes systematic processes for identifying, investigating, and reporting serious incidents and safety-related events to regulatory authorities while implementing field safety corrective actions to protect patients and users from device-related risks.Why is SOP Vigilance important?
Vigilance exists because regulators require immediate notification of serious safety events that could affect public health. It serves as a critical safety net that enables rapid response to device-related incidents, protecting patients from continued exposure to risks while allowing regulatory authorities to coordinate broader safety measures across the healthcare system. Your vigilance system demonstrates proactive safety management rather than reactive incident handling. It ensures that serious events are properly classified, investigated, and reported within strict regulatory timelines. This protects patients through rapid corrective actions while protecting your organization from regulatory enforcement actions and liability exposure.Regulatory Context
Under 21 CFR Part 803 (Medical Device Reporting):
- Mandatory reporting of deaths, serious injuries, and malfunctions
- 24-hour reporting for deaths, 10 days for serious injuries
- Must report device malfunctions that could cause serious injury or death
- Annual certification of MDR compliance required
- Integration with CAPA system for corrective actions
Special attention required for:
- Strict reporting timelines with severe penalties for non-compliance
- FDA MedWatch system submission requirements
- Manufacturer and user facility reporting obligations
- Field corrective action notification requirements to FDA
Guide
Your Vigilance SOP establishes rapid response systems for safety-critical events. Focus on creating efficient workflows that ensure regulatory compliance while enabling effective corrective actions to protect patients.Incident Classification and Assessment
Implement systematic classification procedures that distinguish between incidents, serious incidents, and serious public health threats. Create clear criteria and decision trees to ensure consistent classification across your organization. Include specific definitions for serious deterioration in health and causal relationship assessment. Establish rapid assessment procedures that evaluate potential device-relatedness within hours rather than days. Include escalation criteria for events requiring immediate regulatory notification and procedures for handling uncertainty in classification decisions.Causal Relationship Investigation
Develop structured investigation methodologies that systematically evaluate the relationship between device use and reported events. Include evidence collection procedures, expert consultation processes, and documentation requirements that support regulatory submissions. Create investigation timelines that balance thoroughness with regulatory reporting deadlines. Include procedures for submitting initial reports when investigations are incomplete and updating reports as additional information becomes available.Regulatory Reporting and Communication
Establish systematic reporting procedures for different regulatory jurisdictions with clear responsibility assignments and approval workflows. Create templates and checklists that ensure complete and accurate submissions within required timelines. Implement tracking systems that monitor reporting deadlines and provide early warnings for approaching submission dates. Include procedures for coordinating with multiple competent authorities and notified bodies when required.Field Safety Corrective Actions
Develop rapid response procedures for implementing field safety corrective actions when serious incidents require immediate intervention. Include decision criteria for different types of corrective actions and procedures for communicating with customers and users. Create Field Safety Notice templates and approval workflows that ensure consistent messaging while meeting regulatory content requirements. Include procedures for verifying customer receipt and implementation of corrective actions.Integration with Quality System
Connect vigilance activities to all relevant quality processes including CAPA, post-market surveillance, risk management, and change control. Establish clear triggers for initiating other quality processes based on vigilance findings. Include vigilance data in management review reporting and trend analysis. Use vigilance insights to inform product improvements, risk management updates, and regulatory strategy decisions.Example
Scenario
MedTech Solutions receives a report that their diabetes monitoring app provided incorrect glucose readings, leading to inappropriate insulin dosing and a patient hospitalization. They must quickly assess the incident, determine reportability, investigate the cause, and implement corrective actions while meeting strict regulatory reporting timelines.Vigilance Process Implementation
Incident Receipt and Initial Assessment:- Event: Patient hospitalized due to hypoglycemia after app displayed incorrect high glucose reading
- Source: Healthcare provider report through customer support
- Initial Classification: Potential serious incident (hospitalization = serious deterioration in health)
- Timeline: Quality team notified within 2 hours of receipt
- PRRC Notification: Immediate notification to Person Responsible for Regulatory Compliance
- Patient device logs and app version information
- Hospital medical records (with patient consent)
- Device performance data from same time period
- Similar complaint pattern analysis Findings: Software bug in glucose calculation algorithm affecting specific phone models Causal Assessment: Direct causal relationship established between device malfunction and patient harm
- Classification: Serious incident (hospitalization due to device malfunction)
- Reporting Timeline: 15 calendar days from awareness (EU MDR)
- Competent Authority: National authority where incident occurred
- Report Content: Incident details, investigation findings, corrective actions planned
- UDI numbers for affected app versions
- Clear description of malfunction and patient risks
- Specific actions required by users (immediate app update)
- Contact information for questions and support Distribution: All customers with affected app versions within 24 hours Verification: Customer acknowledgment tracking and update confirmation
- CAPA initiated for root cause analysis and systematic prevention
- Enhanced testing procedures implemented for future releases
- Customer feedback monitoring for similar issues
- Regulatory authority follow-up reporting as required
- Effectiveness verification through complaint monitoring and technical analysis
Q&A
What constitutes a serious incident requiring regulatory reporting?
What constitutes a serious incident requiring regulatory reporting?
A serious incident is any malfunction or deterioration that directly or indirectly led, might have led, or might lead to death, serious deterioration in health, or serious public health threat. Serious deterioration includes life-threatening illness, permanent impairment, hospitalization, or medical intervention to prevent serious harm. When in doubt, report the incident.
What are the reporting timelines for different types of incidents?
What are the reporting timelines for different types of incidents?
For EU MDR: serious public health threats (2 days), deaths/unanticipated serious deterioration (10 days), other serious incidents (15 days). For FDA: deaths (24 hours), serious injuries (10 days), malfunctions (30 days). Field Safety Corrective Actions must be communicated without undue delay in both jurisdictions.
How do I determine if there's a causal relationship between the device and an incident?
How do I determine if there's a causal relationship between the device and an incident?
Evaluate whether the incident involved device malfunction, deterioration in performance, inadequate manufacturer information, or undesirable side-effects. Consider temporal relationship, alternative explanations, and device-specific factors. Document your assessment rationale and when uncertain, err on the side of reporting.
What information must be included in Field Safety Notices?
What information must be included in Field Safety Notices?
Include relevant UDI numbers, manufacturer registration information, clear explanation of the malfunction and associated risks, specific actions required by users, and contact information. Content must be consistent across all markets and submitted to competent authorities for review except in urgent situations.
When do vigilance findings require CAPA initiation?
When do vigilance findings require CAPA initiation?
Initiate CAPA for all serious incidents to address root causes and prevent recurrence. Also consider CAPA for incident trends, systematic issues identified through vigilance, or when Field Safety Corrective Actions reveal broader quality system problems. Use your established CAPA qualification criteria.
How should vigilance activities be integrated with post-market surveillance?
How should vigilance activities be integrated with post-market surveillance?
Include vigilance data in post-market surveillance trending analysis and reporting. Use incident patterns to inform PMS plan updates and risk management decisions. Coordinate vigilance and PMS reporting to avoid duplication while ensuring comprehensive safety monitoring and regulatory compliance.