Vigilance means to be watchful of the possible danger or difficulties. The medical device/ in vitro diagnostic medical device Vigilance System is designed to collect information on post-market incidents or adverse events related to medical devices / in vitro diagnostic medical device and, where appropriate, distribute or disseminate such information to prevent adverse events from recurring. This indicates that medical device/in vitro diagnostic 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 / in vitro diagnostic 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.

The placing of a medical device and an in vitro diagnostic medical device on the market is preceded by an evaluation of the residual risks related to quality, safety and performance. However, this evaluation shall continue throughout the entire lifecycle of the device, including the post-market period.

Post-market surveillance allows manufacturers to collect and analyze experiences of the actual use of medical devices / in vitro diagnostic medical devices. Based on the outcome of this analysis, further actions such as incident reporting to competent authorities, field safety corrective actions or safety warnings to users may be required.

Post-market surveillance activities are planned in the Post-market Surveillance Plan and the data is compiled in the Post-marketing Monitoring Report (for class I medical devices; and class A and class B for in vitro diagnostic medical devices) or the Periodic Safety Update Report (for class IIa, IIb and III medical devices; and class C and class D for in vitro diagnostic medical devices).

Our unit assists in the elaboration of PMS Plan with definition of actions and also the elaboration of PMSR or PSUR.