Medical Devices Vigilance
In accordance with the Law on Medicines and Medical Devices (“Official Gazette of RS”, No. 30/2010), Medicines and Medical Devices Agency of Serbia is responsible for the organization and monitoring of the vigilance of marketed medical devices by gathering information on the quality, safety and efficiency of medical devices after their placement on the market, as well as the rate of known and discovery of new adverse reactions.
Adverse reaction reporting to medical devices is performed by reporters, as follows:
1. Manufacturer or medical device entry holder in the Register of Medical Devices;
2. Users of medical devices (health-care institutions, private practice, health-care professionals and patients);
3. Third parties (e.g. manufacturer’s distributor of medical equipment).
Adverse reactions to medical devices or suspected adverse reactions to medical device are reported using:
1. The form for reporting adverse reactions to medical devices for health-care institutions and health-care professionals;
2. The internationally standardized form for reporting adverse reactions to medical devices for manufacturers or medical device entry holder in the Register of Medical Devices (in Serbian and English language);
3. The form for reporting field safety corrective action (FSCA) for manufacturers (in Serbian and English language);
4. The form for reporting adverse reactions to medical device for other users of medical devices.