Vigilance: reporting incidents and corrective actions

Vigilance relates to the activities associated with detecting, assessing, understanding and preventing the dangerous adverse effects of medical devices. Vigilance is an element of post-market surveillance.

A manufacturer or its authorised representative is legally obliged to report serious incidents and corrective actions with medical devices. An example of a corrective action is the recall of a medical device. Reports are an important source of information for the Inspectorate's monitoring work. We monitor the safe operation and use of medical devices and in that context it is also important to weigh up the risks and benefits.