医疗器械临床评估_中英文翻译

1、CLINICAL EVALUATION REPORT临床评估报告For Product: XXXX产品:xxxxDocument No. XXXXXXXX文件编号Version: KO版本:Date: 04/12/2020日期:Author:作者:Reviewed by:审阅:Approved by:批准:vpany公司Table of Content目录Page页码1 General details 总述2、Description of the device and its intended application 器械描述与预期用途Intended thera peutic and/or

2、diagnostic indications and claims预期治疗与/或诊断说明与要求35、Context of the evaluation and choice of clinical data types 评估背景与临床数据类型得选择3Summary of the clinical data and appraisal 总结临床数据与评价6、Data analysis 数据分析PerformanceSafety6、3、5Product Literature and Instructions for Use 产品文献与使用说明7、Conclusions 结论1. General d

3、etails 总述State the proprietary name of the device and any code names assigned during device deretopmeHt Identify the mamt/acturer(s) of the device描述器械得商品名、以及在器械研发过程中使用得任何编码.识别器械得生产商2. Description of the device and its intended application 器械描述与预期用途Provide a concise physical description of the device

4、、cross referencitif； to relevant sections of the manufacturers technical utformatioit as appropriate、 The description shouid cover information such as:materials, including whether it incorporates a medicinal substaitce (already on the market or new), tissues, or blood producfs;the device poncnfs、ind

5、itding software and accessories;mechanical characteristics; andothers, such as sterile vs、 tion-sterite, radioactivity etc State the intended application of the device, single nse/rettsabie; invasive/non invasive; implantable; duration of use or contact with the body; organs tissues or body fluids c

6、ontacted by the device Describe how the device achieves its intendedpurpose 对该器械进行简明得物理描述、适当鑫照生产商技术信息得相关章节此描述应包含得信息、如: 材料包括就是否含药(已经上市得或全新得人组织或血液产品;器械组成包括软件与附件;机械特征;与其姒如灭菌、非灭菌放射能等等。描述器械得预期用途一次性使用f多次使用;侵入/非侵入;可植入使用持续时间或与人体接舷 器械接触得器官，组织或体液 描述器械如何达到它得预期用途。3. Intended therapeutic and/or diagnostic indica

7、tions and claims 预期治疗与/或 诊断说明与要求State the medical conditions to be treated, including target treatment group and diseases、Outline atty specific safety or p erforntaiice claims made for the device描述使用时得医学条件,包括目标治疗群体与疾病.概述器械得任何特殊安全或性能要求.4. Context of the evaluation and choice of clinical data types 评估

8、背景与临床数 据类型得选择Outline the developmental context for the device The information should include whether the device is based on a new technology a new clinicai application of an existing technology, or the result of incremental change of an existing technology The amoitiit of information will differ acc

9、ording to the history of the technolo、 Where a p letely new technology has been developed, this sectioH would need to give an overview of the deveiopmental p rocess and the po ints in the deveiopmetit cycle at which clinical data have been generated For long standing technology, a shorter descriptio

10、n of the history of the technology (with appropriate references) could be used dearly state if the clinicai data used in the evaiuation are for an equivalent device、 Identify the equivalent deviceis) and proride a Justificatio/t of the equivalency cross-referenced to the relevant non-clinicai docume

11、ntation that supports the claim概述器械得发展历史。内容应包括器械就是否基于新技术就是否基于现有技术得新临床应用、 或者就是现有技术增量变化得结果.根据该技术得历史信息量将有所不同。如果就是一项全新 技术发展起来本章须格述发展过程与发展周期中产生临床数据得节点如果就是常规技术须筒 短描述该技术得历史须适当引用八明确指出、评估中使用得临床数据就是否来自等同器械.识 别等同器减并给出等同得理由、参照相关非临床文就以支挥观点。State the Essential Requirements relevant to the device in question, in p

12、artieu/ar, any special design features that pose special p e/formance or safety concerns 仗、g. presence of medicinal human or anima I po nents) that were identified in the device risk management documentation and that required assessment from a elinicat perspective 陈述有关讨论得器械得基本要求特别就是、任何导致特殊性能或安全特怕如药、

13、人体或动物组 织得使用)得特殊设计已经在器械风险管理文件中被识别过并从临床得角度进行了必要得评 估。Outtbie how these considerations were used to choose the types of clbtical data used for the evabtatioH Where published scientific literature has been used, provide a brief outline of the searchinf/retrieval process, cross-referenced to the literatur

14、e search protocol and reports 概述这些需要考虔得因素如何用来选择评估中用到得临床数据得类型.如果引用己出版得科学 琢请简要描述检索/回溯过程参照文献检索草案与报告。5. Summary of the clinical data and appraisal 总结临床数据与评价Provide a tabuiation of the clinical data used in the evaluation categorised according to whether the data address the petfonnance or the safety of

15、the device bt question、 (Note: many individual data sets will address both safety and performance J Within each category order the data according to the importance of their contribution to establishing the safety and performance of the device and in relation to any specific claims about p erfonnaitc

16、e or safety Additionally p rovide a brief outline of the data appraisal methods used in the evaluation, inciutiing any weighting criteria and a summary of the key results.提供一张评估中用到得临床数据得表格、按照数据就是否关系到讨论得器械得性能或安全来分 类(注:许多单独得数据与安全.性能都相关。)每个类别中、数据得排列依据它们对于该器械安 全与性能得重要性以及与性能与安全有关得任何特别要求得相关方面。此外、简要描述评估中使

17、用得数据评价方法、包括任何权重标准,与重要结论得总结.Indude fuH citations for literature-basetl tiata and the titles and inrestifiation codes (if relevant) of any clinical investigation reports、包抵任何临床研究报告得基于文献得数抵題目与研究编碑如果相为得完整引用信息. Cross-reference the entry far each p iece of data to its location in the manufacturers technic

18、al documentation、每条数据得记录与其在生产商技术文档中得位置应相互对应6. Data analysis 数据分析6.1. Performance 性能Provide a description of the analysis used to assess per/ormance、 描述用于性能评估得分析方法。Identify the datasets (hat are considered to be the most important in contributing to the demonstration of the overatl perjbrntaitce of t

19、he device and, where useful, particular performance characteristics. Outline why they are considered to be pivotal anti how they demonstrate the p erformance of the device collectively 2 .g consistency of results, statistical significance, cHnically significance of effects) 识别那些被认为就是论证了器械总体性能与特殊性能特点

20、得最重要得数据。概述这些数据为何 被认为就是关键数据,它们如何共同论证了器械得性能(比如结论得连贯性、统计得显著性，疗效 得临床S要性几6.2. Safety 安全Describe the total experience with the device, including manbers and characteristics of patients exposed to the device; and duration offollowup of device recipients 描述器械得全部使用经验、包括使用此器械得患者得数量与特点;以及跟踪器械使用情况得持续 时间.Provide

21、 a summary of device-related adverse events, p aybtg p articular attention to serious adverse events.总结与器械有关得不良事件,特别注意严重不良事件,Provide specific ment on whether the safety characteristics and intended pttrpose of the device requires training of the end-user要特别讨论就是否会因为器械得安全特性与预期用途、须对最终用户进行培训。6.3. Produc

22、t Literature and Instructions for Use 产品文献与使用说明State whether the manufacturers p roposed product literature attd Instructions for Use are consistent with the clinical data and cover all the hazards and other clinically relevant utfbrntatio/t that may impact on the use of the device 声明生产商提到得产品文献与使用说明书就是否与腦床数据一致、并包含所有风险与其她可能 影响到器械使用得相关得临床信息7. Conclusions 结论Ont