Introduction
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). 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.
What should be reported
Individual serious incident
Periodic summary reporting
Trend reporting
MDCG 2024-1-5 - Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence (
MDCG 2024-1-5 - Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence (June 2024)
health.ec.europa.eu
