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Vigilance system

Medical Device Vigilance is a system of reporting and evaluating Field Safety Corrective Actions (FSCA), the main purpose of which is to improve the health and safety of patients, users and others by reducing the likelihood of a recurrence of an incident at another location. This should be achieved by evaluating reported incidents and, where appropriate, disseminating information that can be used to prevent such recurrence or to mitigate the consequences of the incidents in question.


On 26.05.2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 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 ("MDR") and Act No. 89/2021, on medical devices and amending Act No 378/2007 Coll., on pharamaceuticals and amending certain related acts (Act on Pharmaceuticals), as amended (hereinafter referred to as "Act No 89/2021 Coll.") entered into force.


With the entry into force of the MDR and Act No 89/2021 Coll., there are changes in the obligations for economic operators in the area of pre-marketing and post-marketing of medical devices.


For more information on vigilance of medical devices, see Articles 87-92 of the MDR and Articles 48-50 of Act No 89/2021 Coll.


The area of in vitro diagnostic medical devices falls within the scope of Act No. 268/2014 Coll. on in vitro diagnostic medical devices effective as of 26 May 2021.