Vigilance of the Market

Vigilance means to be watchful of the possible danger or difficulties. The medical device Vigilance System is designed to collect information on post-market incidents or adverse events related to medical devices and, where appropriate, distribute or disseminate such information to prevent adverse events from recurring. This indicates that medical device manufacturers must have a dedicated system in place for the management of vigilance activities. It is the manufacturers or the European Authorized Representatives’ obligation to notify the Competent Authority in case of any incident with their devices. In the regulatory unit, we help manufacturers to implement medical device Vigilance Systems in compliance with all legal and regulatory requirements and also support incident reporting as well as incident investigation and further actions implementation.