| Theme | Vigilance |
| Target Audience | Manufacturers |
| Products concerned | Specific devices : cardiac ablation, coronary stents, cardiac implantable electronic devices, breast implants |
| Documents mentioned |
MDR (EU) 2017/745 – articles 87 et 88, 92 IVDR (EU) 2017/746 – articles 82, 83, 87 MDCG 2023-3 MDCG 2021-1 MDCG 2022-12 |
The purpose of this guide is to harmonise vigilance reports and provide guidance to manufacturers of specific devices.
It provides further clarification on how to report to the relevant competent authority :
- serious incidents
- the periodic safety report
- trend reports
This document 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), which it does not replace.
4 documents, each dealing with a specific device, have thus been published:
- MDCG 2024-1-1 – DSVG 01 on Cardiac ablation for cardiac ablation devices
- MDCG 2024-1-2 -DSVG 02 on Coronary stents for coronary stents
- MDCG 2024-1-3 – DSVG 03 on Cardiac implantable electronic devices (CIEDs) for electronic cardiac implants
- MDCG 2024-1-4 – DSVG 04 on Breast implants for breast implants