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This guidance document gives advice to manufacturers on the notification of adverse incidents involving coronary stents under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of the Medical Devices Directive 93/42/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.
Coronary stents - guidance on the medical devices vigilance system 
