The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance
reporting and provide guidance for manufacturers of Urogynaecological Surgical
Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary
Incontinence.
It provides further clarification for vigilance reporting of Urogynaecological Surgical
Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary
Incontinence to the relevant Competent Authority and should be read in conjunction
with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) [1].
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, in accordance with Articles 87 and 88 MDR, which occurred
with Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse
repair and Stress Urinary Incontinence to the relevant Competent Authority…
