Vigilance

The term “vigilance system” refers to a system for reporting and evaluating serious incidents and safety corrective actions in the field. The purpose of the vigilance system is to enhance the level of protection of the lives and health of patients, users, and other individuals in connection with the use of devices by reducing the likelihood of recurrence of the same or similar type of serious incident elsewhere. This should be achieved by evaluating reported serious incidents and, if appropriate, disseminating information that can be used to prevent their recurrence or mitigate their consequences.

More information about vigilance can be found in Articles 87 to 92 of the Medical Devices Regulation (Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC, as amended (hereinafter referred to as “MDR”), Articles 82 to 87 of the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, as amended (hereinafter referred to as “IVDR”), and Sections 48 to 50 of Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices (hereinafter referred to as “the Act on Devices”) as amended.