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: