SOP Vigilance

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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.

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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.

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Regulatory Context

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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.

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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.

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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.

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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.

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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.

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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.

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Example

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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.

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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

Causal Relationship Investigation: Investigation Team: Quality manager, software engineer, clinical specialist Evidence Collection:

• 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

Regulatory Reporting Decision:

• 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

Field Safety Corrective Action Implementation: FSCA Decision: Immediate software update required to fix calculation bug Field Safety Notice Content:

• 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

Follow-up and Effectiveness Monitoring:

• 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

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Q&A