The Medicines and Medical Devices Agency of Serbia, in accordance with the Law on Medical Devices (“Official Gazette of the RS” No. 105/2017) and the Rulebook on Vigilance (“Official Gazette of the RS”, No. 3/2019), organizes and monitors the vigilance medical devices.
Medical device vigilance is a set of activities related to the collection, evaluation, understanding and response to the knowledge about the risks arising from the use or application of a medical device, and especially with regard to reporting incidents in order to improve and protect the health and safety of patients and users and other persons and, if necessary, to provide information that reduces the likelihood of recurrence of such incident in another place or that mitigates the consequences of that incident.
An incident is any malfunction or deterioration of characteristics or performance of a medical device, as well as inadequacy in labeling or instructions for use.
The applicable Law prescribes the obligation to appoint and report to the Agency a vigilance coordinator appointed by the healthcare institution. The vigilance coordinator informs the Agency and the manufacturer and/or the manufacturer’s authorized representative, of any incidents after the medical device has been marketed.
The Agency has established a system for coordinators of healthcare institutions in the medical device vigilance system in June 2022, and an IT solution related to the use of ePortal MS is to be used during registration.
Other ways of reporting an adverse reaction to a medical device: healthcare professionals, manufacturers and other users can report via a form – by email or by phone