Medical devices vigilance: the European approach.

Post market procedures have been foreseen within the medical device directives. This in turn, led to the preparation of the guidelines on a medical device vigilance system, which is actually the establishment of a recommended procedure to deal with reported adverse incidents. The medical device vigilance system provided a most valuable service to enhance safety of medical devices in the EU. However, a number of potential problems can arise during its implementation. Proper use of the vigilance system improves the protection of health, by reducing the likelihood of repeating the same type of incident.