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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.

This article dedicated to the issues of state control over circulation of medical devices and typical violations detected by toxicity studies of medical devices. The article reviews the typical violations of mandatory requirements for various subjects of circulation of medical devices. The article specifically covers the reasons for decline of toxicological and sanitary chemical indicators when conducting toxicity studies of medical devices in the framework of state control.