医疗器械协调小组(MDCG)比较了MDR和MEDDEV 2.7/1 Rev 4的医疗器械等同性评估 (MDCG 2020-5 "Clinical Evaluation - Equivalence: A guide for manufacturers and notified bodies",临床评估-等效性:制造商和公告机构指南)。MDCG 2020-5旨在通过比较来解决因欧洲医疗器械法规(2017/745)与MEDDEV 2.7/1 Rev 4中相...
MDCG 2020-5 Guidance on clinical evaluation – Equivalence 临床评价-等效性 中文 格式:DOCX 页数:18 上传日期:2021-12-23 10:37:38 浏览次数:410 1500积分 加入阅读清单 阅读了该文档的用户还阅读了这些文档 关于我们 关于道客巴巴 人才招聘 联系我们 网站声明 网站地图 APP下载...
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)...
a clinical evaluation in accordance with the MDR. It is the demonstration of equivalence6 that allows the manufacturer to let clinical data from an equivalent device enter the clinical evaluation process of the device in question for the purpose of confirmation of conformity with relevant general saf...
MDCG 2020-5 Guidance on Clinical Evaluation -Equivalence/临床评价-等效性指南。 指南中指出 进行临床研究是取得医疗器械安全及性能的临床数据的最直接方法,而临床数据亦可从以下获得: 1、临床研究或在科学文献中报道的研究,证明与该器械等价的器械。 2、发表在同行评议科学文献上的关于该设备或能证明与该设备等价...
基于MDCG 2020-13 Clinical Evaluation Assessment Report template临床评价评估报告(CEAR)模板,解析基于实质等同性器械的临床评价基本要求。 对于Regulation (EU)2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) 或 Medical Device Coordination Group (MDCG) 指导...
基于MDCG 2020-13 Clinical Evaluation Assessment Report template临床评价评估报告(CEAR)模板,解析基于实质等同性器械的临床评价基本要求。 对于Regulation (EU)2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) 或 Medical Device Coordination Group (MDCG) 指导...
MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence.pdf MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices.pdf MDCG 2020-7 Guidance on PMCF Plan Template.pdf MDCG 2020-8 Guidance on PMCF Evaluation Report Template.pdf ...
Guidance on PMCF evaluation PMCF 评价报告模 April 2020 report template 板的指南 MDCG 2020-7 Guidance on PMCF plan temp PMCF 计划模板的 April 2020 late 指南 MDCG 2020-6 Guidance on sufficient clinical 遗留器械充分临床 April 2020 evidence forlegacy devices 证据的指南 MDCG 2020-5 Guidance on cl...
中英文对照 MDCG-2020-1 医疗器械软件的临床评价MDR 性能评价IVDR指南.pdf,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) ofMedi