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...
2020年7月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG)“MDCG 2020-13临床评价的评估报告模板”( MDCG 2020-13 Clinical evaluation assessment report)。目的是提供CEAR报告模板,以记录临床评估过程。本模板可应用于MDR附录 IX第4节和附录X第3节。此外,它还可用于根据附录 IX第2.3节和3.5节和附录XI A部分...
Medical Devices Medical Devices Coordination Group Document MDCG 2020-13 MDCG 2020-13 Clinical evaluation assessment report template July 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is compose...
MDCG 2020-13 临床评估报告模板(31页) MDCG 2020-13 Clinical evaluation assessment report template 范围 该模板适用于MDR附件IX第4节和附件X第3节。它还适用于根据附件IX第2.3和3.5节以及附件XI(A)第10节以抽样方式对IIa / IIb类设备进行的技术文档评估。与临床评估评估有关的方面也载于附件VII的第4.5.5...
MDCG 指南清单2022年
MDCG 指南清单2022年 Clinical investigation and evaluation?临床试验及评价 Reference编号 Title名称中文名称 Publication发布时间 MDCG 2020-13 Clinical evaluation assessment report template 临床评价评估报告模板 July 2020 MDCG 2020-10/2 MDCG 2020-10/1 Guidance on safety reporting in clinical investigations...
2.3.Pre-clinicalevaluation13 2.3.1.Generalrecommendationsregardingpre-clinicalevaluation13 2.3.2.Specificrecommendationsregardingpre-clinicalevaluation15 .Indesigncalculations15 .Benchtesting-“horizontal”tests(validforanydevice)15 .1.Performancetests15 .2.Reliabilitytests16 .3.Interoperabilityandcompatibilitytests...
6.PerformanceEvaluation13 6.1.Performanceevaluationprocess13 6.2.Theroleofriskmanagementinperformanceevaluation15 6.3.PerformanceEvaluationPlan18 6.4.ScientificValidity20 6.5.AnalyticalPerformance23 6.6.ClinicalPerformance24 6.7.Clinicalperformancestudies26 6.8.PerformanceEvaluationReport27 ...
临床评价等同性指南：MDCG 2020-5 md_mdcg_2020_5_guidance_clinical_evaluation_equivalence https:/...
such producer will become the legal manufacturer in its own right. This means that the manufacturer will need to fulfil all requirements of the MDD (e.g. including the need to draw up the technical documentation and clinical evaluat...