MHRA: Guidance on the vigilance system

This guidance document gives advice to manufacturers on the notification of adverse incidents involving implantable neurostimulators under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of the Active Implantable Medical Devices Directive 90/385/EEC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System, and the MHRA’s Directives Bulletin 3 ‘Guidance on the operation of the EU vigilance system in the UK’.