MDCG 2021-5 Rev.1 -Guidance on standardisation for medical devices(医疗器械标准化指南).pdf,Medical Devices Medical Device Coordination Group Document MDCG 2021-5 Rev. 1 MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices Revision 1 – Ju
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...
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,...
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I...
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...
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
2022年2月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG)“MDCG 2022-4关于根据MDD或AIMDD认证所涵盖器械的MDR第120条过渡条款的适当监督指南”(MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates...
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。
13 For class I devices in scope of this guidance document, the involvement of a notified body is not required. 14 Not all Union harmonisation legislation requires the intervention of a notified body (e.g. the Low Voltage Directive and the Toys Directive. 15 The name and address of the ...
内容提示: Medical Device Medical Device Coordination Group Document MDCG 2020-6 MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC A guide for manufacturers and notified bodies April 2020 This document...