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This guidance document gives advice to manufacturers on the notification of adverse incidents involving artificial heart valves under the medical devices vigilance system. It is intended to facilitate the uniform application and implementation of the Medical Devices Directive 93/42/EEC1. It is supplementary to, and should be read in conjunction with, the European Commission guidelines on a medical devices vigilance system, and MHRA Directives Bulletin 3 - Guidance on the operation of the EU vigilance system in the UK.
To obtain information on device related incidents, the Medical Devices Directive requires manufacturers to have procedures in place for systematic review of experience gained from device usage in the post-production phase. These review systems are particularly important in helping to ensure the continuing safety of artificial heart valves, because their long term performance cannot reliably be predicted from information obtained from pre-market clinical investigations or short term use.
Note: This is an update to the document first published in 1998 by the Medical Devices Agency.
Artificial heart valves - guidance on the vigilance system 
