+7 (495) 025-05-85
105066, г. Москва, ул. Спартаковская, 24
Почтовый адрес: 105005, г. Москва, а/я 58
.................................................................................................................
Название / перевод рус
Companion Diagnostics Medical Device /
IMDRF/IVD WG/N64FINAL:2021 (formerly GHTF/SG1/N045:2008)
an IVD medical device, which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product, or (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product. NOTE 1: Companion diagnostics are essential for defining patients eligibility for specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers identifying subjects at a higher risk of developing an adverse reaction to the medicinal product in question or identifying patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective. Such biomarker or biomarkers can be present in healthy subjects and/or in patients. NOTE 2: Devices that are used to monitor treatment with a medicinal product in order to ensure that the concentration of relevant substances in the human body is within the therapeutic window are not considered to be companion diagnostics. (Regulation (EU) 2017/746 on in vitro diagnostic medical devices)В сообщении, пожалуйста, укажите известную информацию, касающуюся терминов глоссария