MDCG 2020-5 Guidance on clinical evaluation – Equivalence 临床评价-等效性 中文 下载积分: 1500 内容提示: 本文件已得到 2017/745 年《法规》(欧盟)第 103 条设立的医疗器械协调小组(MDCG)的批准。 MDCG 由所有会员国的代表组成,由欧洲联盟委员会代表担任主席。该文件不是欧洲联盟委员会的文件,不能被视...
This MDCG guidance does not introduce any new requirements. 本MDCG指南没有引入任何新的要求。 The demonstration of equivalence does not remove the requirement to always conduct a clinical evaluation in accordance with the MDR. It is the demonstration of equivalence that allows the manufacturer to le...
The conditions of use shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance between the device in question and the device presumed to be equivalent. For further guidance on the assessment of ‘similar’, see also section 4...
MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2020-1 医疗器械协调小组文件 MDCG2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation(IVDR) ofMedicalDevice Software 医疗器械软件的临床评价 (MDR)/性能评价 (IVDR)指 南 March2020 2020.03 This document has been endorsed by...
Medical Device Medical Device Coordination Group Document MDCG 2020-5 MDCG 2020-5 Clinical Evaluation - Equivalence A guide for manufacturers and notified bodies April 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU)...
The MDCG provides guidance on various aspects of the MDR, including classification of medical devices, conformity assessment procedures, clinical evaluation, post-market surveillance, and vigilance. The group also publishes guidance documents and recommendations to help manufacturers, notified bodies, and ...
Guidance on safety reporting 临床试验安全报告 in clinical investigationsAppe 指南 May 2020May ndix: Clinical investigation su 附录:临床试验总 2020 mmary safety report form 结安全报告表 MDCG 2020-8 Guidance on PMCF evaluation PMCF 评价报告模 April 2020 report template 板的指南 MDCG 2020-7 Guidan...
-“The current knowledge/ state of the art in the corresponding medical field, such as applicable standards and guidance documents, information relating to the medical condition managed with the device and its natural course, benchmark devices, other devices and medical alternatives available to the ...
内容提示: Medical Device Medical Device Coordination Group Document MDCG 2020-8 1 MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template A guide for manufacturers and notified bodies April 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) ...
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...