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This guidance document gives advice to manufacturers on the notification of adverse incidents involving breast implants under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC and Commission Directive 2003/12/EC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System, which are under revision at the time of writing.
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.
This is the third edition of a document first published in 1999.
Breast implants - guidance on the vigilance system 
