The MDCG has released a guidance document on the on the vigilance system for CE-marked devices DSVG 05 Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence. This follows the same format of the vigilance guidance documents that were released earlier this year concerning Devices for Cardiac Ablation, Coronary Stents and associated delivery systems, Cardiac Implantable Electronic Devices (CIEDs) and Breast Implants.
The aim of this guidance document is to harmonise vigilance reporting and provide guidance for manufacturers of Urogynaecological Surgical Mesh Implants. This document outlines the method to report incidents and serious incidents, in accordance with Articles 87 and 88 of the MDR, which occurred with these Specific Devices to the relevant Competent Authority.
The guidance provides a list of incidents related to the use of Urogynaecological Surgical Mesh Implants as well as their correct reporting mechanism. One thing to note is that the list provided in these guidance documents is not exhaustive. The guidance categorises the incidents based on their correct reporting mechanism, namely:
- Individual Serious Incidents
- Periodic Summary Reports
- Trend Reports
The guidance document can accessed using the following link
