Vigilance Procedure

Evaluate serious incidents and field safety corrective actions under EU medical device vigilance with this editable Vigilance Procedure. It includes a decision tree and related forms for incident classification, reporting decisions, authority communication, follow-up and trend reporting.

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Supplied as four editable Microsoft Word documents (the procedure and three forms) in a digital download.

EU incident evaluation and vigilance decisions

The Vigilance Procedure provides instruction on requirements for reporting on serious incidents and field safety corrective actions. The Vigilance Procedure Includes vigilance decision tree and related forms.

The Vigilance Procedure, and applicable decision trees, will determine if the incident meets the three basic reporting criteria in order for an incident to be classified as reportable and provides instruction on how to report a reportable incident.

The vigilance process starts by assessing information about a potential incident or field safety issue. It covers evaluation of reportability, responsibilities for incident and trend reporting, communication with applicable authorities and coordination of field safety corrective actions. Records of the event, decision and follow-up remain connected to complaint handling and post-market surveillance, so a serious signal is not closed merely by filing an initial report.

Related processes include the Complaint Handling Procedure and the Remedial Action / Recall Procedure for field actions.

For analysis of recurring complaint signals, see the Complaint Trending Procedure. It and this vigilance procedure are included in the Complaint Handling Procedures Bundle.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read FDA MDR, EU Vigilance and Medical Device Recall Workflows for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Complaint Handling Procedures Bundle. Explore the bundle for the related documents.