Guide to the Vigilance System for Medical Devices
01 August 2012
This guide describes the Irish Medicines Board’s (IMB) vigilance system for medical devices as required by the relevant Articles of Directives 93/42/EEC, 90/385/EEC, and 98/79/EC, and additionally outlines how the system operates in Ireland.
This document has been updated.
Guide to the Vigilance System for Medical Devices
A version of the document with changes tracked is attached below.
Guide to the Vigilance System for Medical Devices with changes tracked