Russian Federation
Russian Federation
Russian Federation
GRNTI 76.35 Прочие отрасли медицины и здравоохранения
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.
patient register, implanted medical devices, the post-marketing clinical monitoring, the adverse event of medical device, vigilance of medical devices
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