Europe – Guidance on the vigilance system for CE-marked medical devices : Cardiac Implantable Electronic Devices

1. Introduction

This document provides guidance for manufacturers of Cardiac Implantable
Electronic Devices. It outlines specific scenarios that should be considered when
determining if an incident is reportable. This document should be read in conjunction
with DSVG00: Introduction to Device Specific Vigilance Guidance.

The aim of this guidance is to complement the requirements of the Active Implantable
Medical Devices Directive [1] and the MEDDEV [2] and should be read in conjunction
with the aforementioned. Device specific guidance does not replace or extend these
requirements.

2. What Incidents Should Be Reported

The following table details Cardiac Implantable Electronic Devices examples
indicating what should be reported as device performance problems that caused or
contributed to the incident. The examples are for illustrative purposes only and do not
constitute an exhaustive list…