The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Specific Devices.
It provides further clarification for vigilance reporting of Specific Devices to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This DSVG does not replace or extend any of those requirements.
This document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR and in Article 2(67) and (68) IVDR, in accordance with Articles 87 and 88 MDR and Articles 82 and 83 IVDR, which occurred with Specific Devices to the relevant Competent Authority.
MDCG 2024-1 - Device Specific Vigilance Guidance (DSVG) Template - January 2024
MDCG 2024-1 - Device Specific Vigilance Guidance (DSVG) Template - January 2024
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