Medical Device Vigilance System in Portugal

1. Overview

The National Vigilance System of Medical Devices in Portugal consists of rules and resources for systematically collecting and evaluating information on medical device safety to protect public health through appropriate measures. It includes the competent authority (INFARMED), manufacturers, authorized representatives, distributors, healthcare providers, professionals, users, and notified bodies where applicable. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/vigilance-system-of-medical-devices

2. INFARMED's Role

INFARMED manages the system by establishing procedures for incident information, receiving and evaluating reports, informing manufacturers, ensuring investigations and preventive actions, conducting studies on performance and safety, proposing recommendations, disseminating information, providing training, collaborating with other authorities, and notifying the European Commission in recall cases. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/vigilance-system-of-medical-devices

3. Manufacturer's Obligations

Manufacturers must communicate contact details for vigilance issues, report incidents and corrective actions in Portugal or from non-EEA countries if based in Portugal, maintain post-marketing review processes, investigate incidents, propose corrective measures, provide additional information to authorities, and collaborate on system improvements. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/vigilance-system-of-medical-devices

4. Definition of Reportable Incidents

Incidents include malfunctions, failures, deteriorations, labelling inaccuracies leading to death or serious health deterioration; indirect harm from medical decisions; technical or medical reasons prompting corrective actions; and other noteworthy information. In doubt, always report. Serious public health threats involve imminent multiple deaths or illnesses requiring immediate action, like HIV or Creutzfeldt-Jakob transmission risks. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/vigilance-system-of-medical-devices

5. Who Should Report Incidents

Manufacturers report all Portuguese incidents to INFARMED. Distributors ensure known Portuguese incidents are reported. Users (professionals, patients, or companions) may voluntarily notify INFARMED. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/vigilance-system-of-medical-devices

6. Reporting Deadlines

Initial reports: 2 days for serious public health threats, 10 days for death or high health risk, 30 days otherwise. Final reports within 10 days of investigation completion, with follow-ups as agreed. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/vigilance-system-of-medical-devices

7. Manufacturer Actions Upon Incident Notification

Investigate causes, recover devices if needed (with decontamination info), review batch documentation, compile similar cases, justify no action based on risk analysis, and implement corrective actions except recalls. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/vigilance-system-of-medical-devices

8. Field Safety Corrective Actions

Submit corrective action reports, Portuguese notices, response forms, user lists, and conclusion dates to INFARMED. For recalls, provide reconciliation reports. Deadlines: 2 days before implementation (immediate for threats). Conclusion info on agreed date. Documentation sent by manufacturer, representative, or distributor. Source: https://www.infarmed.pt/web/infarmed-en/medical-devices/vigilance-system-of-medical-devices

9. Important Notes

The system emphasizes timely reporting and collaboration to minimize risks and ensure device safety.