# Vigilance Reporting | Botable Glossary

https://www.botable.ai/glossary/vigilance-reporting

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## Summary

Vigilance Reporting is the mandatory QMS process for identifying, documenting, and reporting serious adverse events, malfunctions, and corrective actions for marketed medical devices to regulatory authorities, including requirements under FDA 21 CFR 803 and EU MDR Article 87. The page explains integration with CAPA and post-market surveillance and outlines U.S. and EU reporting obligations and timelines.

## Audience

quality and regulatory professionals (medical device industry)

## Prompts this page answers

- What is vigilance reporting for medical devices and how does it fit into a QMS?
- What are the FDA MDR reporting timelines for manufacturers and user facilities?
- What EU MDR articles relate to vigilance reporting and field safety corrective actions?
- How does vigilance reporting integrate with CAPA and post-market surveillance?

## Purpose

Define and explain the concept of vigilance reporting within medical device quality systems and summarize relevant U.S. and EU regulatory requirements.

## Highlights

- Vigilance Reporting is the mandatory process in a QMS to notify regulators of serious incidents, adverse events, and field safety corrective actions.
- U.S. FDA MDR: manufacturers must report individual adverse events within 30 calendar days; a 5-day report is required for events that necessitate remedial action to prevent substantial public health harm; user facilities must report deaths and serious injuries within 10 work days as specified.
- EU requirements: vigilance reporting ensures compliance with EU MDR Article 87 and related Articles 10(13), 87, and 88 for serious incidents and field safety corrective actions.
- Vigilance reporting is integrated with CAPA and post-market surveillance to ensure traceability and corrective action.

## How to cite

Credit Botable Glossary (Vigilance Reporting) and link to https://www.botable.ai/glossary/vigilance-reporting.

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- vigilance reporting
- FDA 21 CFR 803
- EU MDR Article 87
- medical device reporting (MDR)
- CAPA
- post-market surveillance

## Key entities

- **Food and Drug Administration (FDA)** (organization): U.S. regulatory authority referenced in relation to 21 CFR 803 (Medical Device Reporting).
- **EU MDR (European Medical Device Regulation)** (other): European regulation referenced (Article 87, Articles 10(13), 87, 88).
- **CAPA (Corrective and Preventive Action)** (other): QMS process cited as integrated with vigilance reporting.
- **Medical Device Reporting (MDR)** (other): Term used to describe FDA-required reporting (21 CFR 803).

## Metadata

- Type: article