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This guidance document gives advice to manufacturers on the notification of adverse incidents involving cardiac ablation catheters (CACs) under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC as amended by 2007/47/EC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System , and MHRA’s Directives Bulletin 3, Guidance on the operation of the EU vigilance system in the UK.
The relevant Medical Devices Directives require medical device manufacturers to notify Competent Authorities of certain adverse incidents under what is known as the ‘vigilance system’. The purpose of the vigilance system, as outlined in section 3 of the European Commission Guidelines on a Medical Devices Vigilance System, is to protect patients and others by reducing the chance of the same types of adverse incident being repeated within the European Economic Area (EEA).
This document details what should be reported and the reporting process.
Cardiac ablation catheters - guidance on the vigilance system 
