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1、CLINICAL EVALUATION REPORT临床评估报告For Product: XXXX产品： XXXXDocument No. XXXXXXXX文件编号Version: 1.0版本 :Date: 2020-03-04日期 :Author:作者 :Reviewed by:审阅 :Approved by:批准 :CLINICAL EVALUATION REPORT forProduct XXXX临床评估报告产品Table of Content目录Document No. XXXXXXXX文件编号：Version: 1.0版本Date: 2020-03-04日期Page 页码1.Gene
2、ral details总述32.Description of the device and its intended application器械描述和预期用途. 33.Intendedtherapeuticand/ordiagnosticindicationsandclaims预期治疗和 /或诊断说明和要求34.Contextoftheevaluationandchoiceofclinicaldatatypes评估背景和临床数据类型的选择35.Summary of the clinical data and appraisal总结临床数据和评价46.Data analysis数据分析56.1.
3、 Performance性能56.2. Safety 安全56.3. Product Literature and Instructions for Use产品文献和使用说明57.Conclusions结论62 / 6Page 页码2 of6CLINICAL EVALUATION REPORT forProduct XXXX临床评估报告产品Document No. XXXXXXXX文件编号：Version: 1.0版本Date: 2020-03-04日期1.General details总述State the proprietary name of the device and any cod
4、e 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器械描述和预期用途Provide a concise physical description of the device, cross referencing to relevant sections of the manufacturer
5、s 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), tissues, or blood products;the device components, including software and accessories; mechanical characteristics
6、; andothers, 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 the body; organs, tissues or body fluids contacted by the device.Describe how the device achieves its
7、 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.Intended therapeutic and/or diagnostic indications and claims预期治疗和 /或诊断说明和要求State the medical co
8、nditions 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。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 devi
9、ce. The information should include whether the device is based on a new technology, a new clinical application of an existing technology, or the result of incremental change of an existing technology. The amount of information will differ3 / 6Page 页码3 of6CLINICAL EVALUATION REPORT forProduct XXXX临床评
10、估报告产品Document No. XXXXXXXX文件编号：Version: 1.0版本Date: 2020-03-04日期according to the history of the technology. Where a completely new technology has been developed, this section would need to give an overview of the developmental process and the points in the development cycle at which clinical data hav
11、e 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 are for an equivalent device. Identify the equivalent device(s) and provide a justification of
12、 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。Sta
13、te 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) that were identified in the device risk management documentation and that required as
14、sessment 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 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 repor
