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...
• 总体结论 · Section A: Administrative particulars (notified body, manufacturer, product and clinical evaluation report reference) · Section B: Reviewers involved in the notified body assessment of the clinical evaluation · Section C: Device description, classification, clinical evaluation plan, inf...
Devices Medical Devices Coordination Group Document MDCG 2020-13 Contents Introduction 3 Scope3 Approach to Template 4 Template CEAR 6 Section A: Administrative particulars (notified body, manufacturer, product and clinical evaluation report reference) 6 Section B: Reviewers involved in the notified ...
总体来说，scientific validity的写作方法有点像md的clinical evaluation plan and report。普瑞君认为，在还没有更新的关于scientific validity指南推出之前，先按照md的meddev 2.7.1 ver4的要求来撰写，也是符合各大NB的评审要求的。以上的介绍，是适合绝对大部分已有同类型产品上市销售的情况。对于创新的IVD产品而言，...
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...
当临床获益符合了IVD产品预期用途,以及满足了IVDR Annex I列出的安全性能要求后,则能成为有意义的临床证据。至于临床证据的等级,则还需要根据证据的数量与质量去评估。具体临床证据等级评估也可以参考MDCG 2020-6 Guide of sufficient clinical evidence of legacy Devices。虽然是MD的指南,但小编认为也具有参考价值。
Medical Device Medical Device Coordination Group Document MDCG 2020-8 MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template 上市后临床跟踪(PMCF)评估报告模板 A guide for manufacturers and notified bodies 制造商和公告机构指南 April 2020 / ɪndɔrst/ This document has been...
MDR) / M performanceevaluation D (IVDR)临床评价(MDR) /性能评估(IVDR)的最终分析与结论 R The manufacturer should compile evidence, perform thebenefit-risk analysis and document the CLINICAL or PERFORMANCE EVALUATION andits output in the CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR)report...
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 ...