MDCG 2021-5 Rev.1 -Guidance on standardisation for medical devices(医疗器械标准化指南).pdf 27页内容提供方:柒笙 大小:507.04 KB 字数:约8.56万字 发布时间:2024-08-03发布于广西 浏览人气:30 下载次数:仅上传者可见 收藏次数:0 需要金币:*** 金币 (10金币=人民币1元)MD
Sections 2.2-2.6 give an overview of some requirements that depend on the class of the device. For detailed and exhaustive provisions on each topic, refer to the MDR, as well as to dedicated 4 guidancewhereavailable . 第2.2-2.6节概述了一些取决于器械类的要求。关于每个主题的详细和详尽的规定,...
MDCG 2021-5 Guidance on standardisation for medical devices(翻译)医疗器械标准化指导意见 导言:范围和...
修改前:Rule 3 covers a range of devices as reflected in its indents (a)-(m). Devices falling under Rule 3 (when not classified as Class D according to rules 1 & 2) are to be classified in class C,irrespective o...
MDCG 2020-16 rev.3 IVDR体外诊断医疗器械分类规则指南 Guidance on Classification Rules for in vitro Diagnostic Medic.pdf,医疗器械协调小组文 MDCG 2020-16 rev.3 关于 Regulation (EU) 2017/746 下 体外诊断医疗器械分类规则的指导 2024 年7 月 本文件已获 Regulation
This is however not necessary for other Class I devices, as it is not required by the MDD (Annex VII) and as there is no certificate from a notified body to which the issued Declaration of Conformity is related. Guidance on the content of the Declaration of Conformity can be found, ...
近日,MDCG发布了今年第二份指南 Guidance on general principles of clinical evidence for In Vitro Diagnosticmedical devices(IVDs)。题目虽是和 “clinical evidence” 有关,但实际内容是包含了 Scientific Validity,analytical performance 以及 clinical performance。
For further guidance on the assessment of ‘similar’, see also section 4 of this document. MDR要求在证明等同性时应考虑技术特性,包括待评价器械和假定“在类似的使用条件下使用”的等同器械。然而,MEDDEV 2.7/1 rev.4规定了技术特征应在相同条件下的使用。使用条件在待评价器械与假定等同器械之间没有临床...
首先MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical Devices 这个指南是针对IVDR的,并不是对IVDD的,如果IVDD对试剂的样本量有要求,那么应该发布CTS (common technical specification),而不是发布MDCG guidance (IVDR确定完后应该发布CS, common specification), 然而因为...
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