This document represents a transposition of the views of the Global Harmonisation Task Force (GHTF) on what constitutes a reportable incident into the European vigilance guidance. The Guidelines have in addition to the Medical Devices Directive and Active Implantable Medical Devices Directive been extended to include the reporting of adverse incidents involving in vitro diagnostic medical devices (IVDs).
This document is a draft working document of an earlier document published in March 1998 as MEDDEV 2.12/1 - rev. 3
The document can be downloaded from DGM's homepage, it is found under "Documents" in the index.