Vigilance

Vigilance is the post-market surveillance system mandated by the EU Medical Device Regulation (MDR 2017/745) for monitoring, reporting, and investigating serious incidents and safety issues involving medical devices. It ensures prompt identification and mitigation of device-related risks to protect patient and user safety.

What constitutes a Serious Incident?

A serious incident is any malfunction or deterioration of a device, or any inadequacy in labeling or instructions that:
- Led to death or serious deterioration in health
- Might lead to death or serious deterioration in health
- Led to or might lead to temporary or permanent injury

Vigilance Reporting Requirements:

Manufacturer Obligations:
- Report serious incidents to competent authorities
- Report Field Safety Corrective Actions (FSCA)
- Investigate incidents thoroughly
- Take corrective actions when needed
- Maintain vigilance database and records

Reporting Timelines:
- Death or imminent risk to life - Immediately (within 2 calendar days)
- Serious deterioration in health - Within 10 calendar days
- Other serious incidents - Within 15 calendar days
- Trend reporting - As soon as detected

Field Safety Corrective Actions (FSCA):

FSCAs are actions taken to reduce risk of death or serious deterioration in health:
- Recall - Return of device to manufacturer
- Modification - Changes to device or software
- Advice - Information to users about device use
- Reports must be submitted before or immediately after implementation

Field Safety Notice (FSN):
Communication to users and customers about:
- Nature of the safety issue
- Devices affected (models, serial numbers)
- Actions users must take
- Timeline for completion
- Contact information for questions

EUDAMED Integration:

All vigilance reports must be submitted through EUDAMED (European Database on Medical Devices):
- Electronic vigilance reporting module
- Centralized database for all EU countries
- Improved transparency and data sharing
- Public access to certain vigilance data

Competent Authority Actions:

National competent authorities may:
- Request additional information
- Conduct inspections
- Require additional corrective actions
- Issue safety communications
- Suspend or withdraw certifications

Key Differences from Other Regions:
- USA (FDA) - Medical Device Reporting (MDR)
- Canada - Mandatory Problem Reporting
- Australia (TGA) - Incident reporting scheme
- Japan (PMDA) - Adverse event reporting

Vigilance Documentation Requirements:
- Incident investigation reports
- Root cause analysis
- Risk assessment updates
- CAPA (Corrective and Preventive Actions)
- Trend analysis reports
- Communication records with authorities

Penalties for Non-Compliance:
- Fines up to €1 million or 7% of annual turnover
- Device recalls or market withdrawal
- Certificate suspension or revocation
- Criminal liability in severe cases

Effective vigilance ensures continuous device safety monitoring and rapid response to emerging risks throughout the product lifecycle.