The first MDCG guidance document released for 2024 is concerning the vigilance systems for Specific CE-Marked devices. The aim of this guidance document is to harmonise vigilance reporting and provide guidance for manufacturers of Specific Devices. This document outlines the way to report incidents and serious incidents, in accordance with Articles 87 and 88 MDR and Articles 82 and 83 IVDR, which occurred with Specific Devices to the relevant Competent Authority.
The specific devices that are mentioned in this guidance document are the following:
- Devices for Cardiac Ablation
- Coronary Stents and associated delivery systems
- Cardiac Implantable Electronic Devices (CIEDs)
- Breast Implants
The guidance provides device related problem examples for each of the reporting mechanisms listed below. One thing to note is that the list provided in these guidance documents is not exhaustive.
- Individual Serious Incidents
- Periodic Summary Reports
- Trend Reports
Links to reference documents
The guidance document can be accessed using the following link
The ancillary guidance’s concerning the specific devices can be accessed using the links below;
DSVG 01: Devices for Cardiac Ablation
DSVG 02: Coronary Stents and associated delivery systems
