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1、 医疗器械临床评估-中英文翻译 Table of Content 目录 Page 页码 1.General details 总述.5 2.Description of the device and its intended application 器械描述和预期用途.5 3.Intended therapeutic and/or diagnostic indications and claims 预期治疗和/或诊断说明和要求.5 4.Context of the evaluation and choice of clinical data types 评估背景和临床数据类型的选择.6 5.Su
2、mmary of the clinical data and appraisal 总结临床数据和评价.6 6.Data analysis 数据分析.错误!未定义书签。6.1.Performance 性能.错误!未定义书签。6.2.Safety 安全.错误!未定义书签。6.3.Product Literature and Instructions for Use 产品文献和使用说明.7 7.Conclusions 结论.8 CLINICAL EVALUATION REPORT for Product XXXX 临床评估报告 产品 Document No.XXXXXXXX 文件编号：Version
3、:1.0 版本 Date:2021-08-31 日期 Page 页码 5 of 8 1.General details 总述 State the proprietary name of the device and any code names assigned during device development.Identify the manufacturer(s)of the device.描述器械的商品名，以及在器械研发过程中使用的任何编码。识别器械的生产商。2.Description of the device and its intended application 器械描述和预期
4、用途 Provide a concise physical description of the device,cross referencing to relevant sections of the manufacturers technical information as appropriate.The description should cover information such as:materials,including whether it incorporates a medicinal substance(already on the market or new),ti
5、ssues,or blood products;the device components,including software and accessories;mechanical characteristics;and others,such as sterile vs.non-sterile,radioactivity etc.State the intended application of the device,single use/reusable;invasive/non invasive;implantable;duration of use or contact with t
6、he body;organs,tissues or body fluids contacted by the device.Describe how the device achieves its intended purpose.对该器械进行简明的物理描述，适当参照生产商技术信息的相关章节。此描述应包含的信息，如：材料，包括是否含药（已经上市的或全新的）、组织或血液产品；器械组成，包括软件和附件；机械特征；和 其他，如灭菌，非灭菌，放射能等等。描述器械的预期用途，一次性使用/多次使用；侵入/非侵入；可植入；使用持续时间或与人体接触；器械接触的器官，组织或体液。描述器械如何达到它的预期用途。3
7、.Intended therapeutic and/or diagnostic indications and claims 预期治疗和/或诊断说明和要求 State the medical conditions to be treated,including target treatment group and diseases.Outline any specific safety or performance claims made for the device 描述使用时的医学条件，包括目标治疗群体和疾病。概述器械的任何特殊安全或性能要求。CLINICAL EVALUATION REP
8、ORT for Product XXXX 临床评估报告 产品 Document No.XXXXXXXX 文件编号：Version:1.0 版本 Date:2021-08-31 日期 Page 页码 6 of 8 4.Context of the evaluation and choice of clinical data types 评估背景和临床数据类型的选择 Outline the developmental context for the device.The information should include whether the device is based on a new
9、technology,a new clinical application of an existing technology,or the result of incremental change of an existing technology.The amount of information will differ according to the history of the technology.Where a completely new technology has been developed,this section would need to give an overv
10、iew of the developmental process and the points in the development cycle at which clinical data have been generated.For long standing technology,a shorter description of the history of the technology(with appropriate references)could be used.Clearly state if the clinical data used in the evaluation
11、are for an equivalent device.Identify the equivalent device(s)and provide a justification of the equivalency,cross-referenced to the relevant non-clinical documentation that supports the claim.概述器械的发展历史。内容应包括器械是否基于新技术，是否基于现有技术的新临床应用，或者是现有技术增量变化的结果。根据该技术的历史，信息量将有所不同。如果是一项全新技术发展起来，本章须概述发展过程和发展周期中产生临床数
12、据的节点。如果是常规技术，须简短描述该技术的历史（须适当引用）。明确指出，评估中使用的临床数据是否来自等同器械。识别等同器械，并给出等同的理由，参照相关非临床文献，以支撑观点。State the Essential Requirements relevant to the device in question,in particular,any special design features that pose special performance or safety concerns(e.g.presence of medicinal,human or animal components)
13、that were identified in the device risk management documentation and that required assessment from a clinical perspective.陈述有关讨论的器械的基本要求，特别是，任何导致特殊性能或安全特性（如药，人体或动物组织的使用）的特殊设计已经在器械风险管理文件中被识别过，并从临床的角度进行了必要的评估。Outline how these considerations were used to choose the types of clinical data used for the
14、evaluation.Where published scientific literature has been used,provide a brief outline of the searching/retrieval process,cross-referenced to the literature search protocol and reports.概述这些需要考虑的因素如何用来选择评估中用到的临床数据的类型。如果引用已出版的科学文献，请简要描述检索/回溯过程，参照文献检索草案和报告。5.Summary of the clinical data and appraisal 总
15、结临床数据和评价 Provide a tabulation of the clinical data used in the evaluation,categorised according to whether the data address the performance or the safety of the device in question.(Note:many individual data sets will address both safety and performance.)Within each category,order the data according
16、to the importance of their contribution to establishing the safety and performance of the device and in relation to any specific claims about performance or safety.Additionally,provide a brief outline of the data appraisal methods used in the evaluation,including any weighting criteria,and a summary
17、 of the key results.5.1.5.2.Product Literature and Instructions for Use 产品文献和使用说明 State whether the manufacturers proposed product literature and Instructions for Use are consistent with the clinical data and cover all the hazards and other clinically relevant information that may impact on the use
18、of the device.声明生产商提到的产品文献和使用说明书是否与临床数据一致，并包含所有风险和其他可能影响到器械使用的相关的临床信息。6.Conclusions 结论 Outline clearly the conclusions reached about the safety and performance of the device from the evaluation,with respect to the intended use of the device.State whether the risks identified in the risk management d
19、ocumentation have been addressed by the clinical data.For each proposed clinical indication state whether:the clinical evidence demonstrates conformity with relevant Essential Requirements;the performance and safety of the device as claimed have been established;and the risks associated with the use of the device are acceptable when weighed against the benefits to the patient.简明概述从评估延伸到器械安全和性能的结论，同时考虑器械的预期用途。描述临床数据是否涉及了从风险管理文件中识别出的风险。对于每个提到的临床说明，须声明：临床证据是否论证了符合相关基本要求；如同所声称的，是否已确定器械的性能和安全；以及 与患者的受益相权衡，与器械使用相关的风险是否是可接受的。