The article reveals the main aspects of the safety monitoring of medical devices, the correct implementation of safety monitoring of medical devices in organization and prevention of adverse events, associated with medical devices. Likewise the analysis of incoming to Roszdravnadzor information as the result of safety monitoring of medical devices is given.

The article conducts the analysis of the practice in the application of patient registers with implanted medical devices by regulatory authorities of various countries for vigilance of medical devices, as well as review of current patient registers their categories and applicability. In addition, the article review the recommendations of The International Medical Device Regulators Forum (IMDRF) on development, implementation and application methodology of patient registers.