This Device Specific Vigilance Guidance (DSVG) aims to harmonize vigilance reporting and provide guidance for manufacturers of specific devices. The document outlines procedures for reporting incidents and serious incidents, as defined in the MDR and IVDR, to the relevant Competent Authority.

Manufacturers are responsible for assessing each event and ensuring compliance with statutory reporting requirements. For information and clarification on what constitutes a serious incident and for details on how to apply the reporting timelines of the MDR, please refer to MDCG 2023-3.

This document provides examples of device-related problems and complications, which manufacturers can use clinical references or guidelines to identify. It also refers to IMDRF terminologies for categorizing adverse event reporting. Manufacturers should consult the most recent version of IMDRF adverse event codes for accurate reporting.



MDCG 2024-1 - Device Specific Vigilance Guidance (DSVG) Template

MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices