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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: 2020-01-26日期:Author:作者 :Reviewed by:审阅：Approved by:批准：vCompa ny公司Table of Content目录Page页码1. Gen eral details 总述 52. Descripti on of the device and its inten ded applicati on器械描述和预期用途53. Intendedth
2、erapeutic and/ordiagnosticindications and claims预期治疗和/或诊断说明和要求 64. Con textof the evaluati on and choice ofcli ni caldata types评估背景和临床数据类型的选择 65. Summary of the clinical data and appraisal总结临床数据和评价 86. Data an alysis数据分析 96.1. Performa nee性能9安全9产品文献和使用说明107. Con clusi ons结论io1. General details 总述Sta
3、te the proprietary name of the device and any code names assigned duringdevice developme nt.Iden tify the manu facturer(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. Descripti on of the device and its inten ded applicati on器械描述和预期用途Provide a con cise physical descripti on of the device, cr
4、oss referencing to releva ntsecti ons of the manu facturer' tech ni cal in formatio n as appropriate. Thedescription should cover information such as:materials, in clud ing whether it in corporates a medic inal substa nce (already on themarket or new), tissues, or blood products;the device comp
5、onen ts, in clud ing software and accessories;mecha ni cal characteristics; andothers, such as sterile vs. non- sterile, radioactivity etc.State the inten ded applicati on of the device,si ngle use/reusable; in vasive/nonin vasive; impla ntable; durati on of use or con tact with the body; orga ns, t
6、issues or body fluids con tacted by the device.Describe how the device achieves its inten ded 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. Inten ded th
7、erapeutic an d/or diag no stic in dicati ons and claims预期治疗和/或诊断说明和要求State the medical con diti ons to be treated, in clud ing target treatme nt group and diseases.Outli ne any specific safety or performa nee 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. Con text of the evalua
8、tio n and choice of cli nical data types评估背景和临床数据类型的选择Outli ne the developme ntal con text for the device. The in formatio n should in clude whether the device is based on a new tech no logy, a new cli ni cal applicati on of an existi ng tech no logy, or the result of in creme ntal cha nge of an exi
9、sti ng tech no logy.The amount of i nformatio n will differ accord ing to the history of the tech no logy.Where a completely new tech no logy has bee n developed, this secti on would n eedto give an overview of the developme ntal process and the points in thedevelopme nt cycle at which cli ni cal da
10、ta have bee n gen erated. For long sta ndingtech no logy, a shorter descripti on of the history of the tech no logy (withappropriate refere nces) could be used.Clearly state if the clinical data used in theevaluati on are for an equivale nt device.Ide ntify the equivale nt device(s) andprovide a jus
11、tificati on of the equivale ncy, cross-refere need to the releva ntnon-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
12、，参照相关非临床文献，以支撑观点。State the Esse ntial Requireme nts releva nt to the device in questi on, in particular,any special desig n features that pose special performa nee or safety concerns (e.g.prese nee of medici nal, huma n or ani mal comp onen ts) that were ide ntified in thedevice risk man ageme nt do
13、cume ntati on and that required assessme nt from acli ni cal 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 dataused for the evaluation. Where published scientific literatur
14、e has been used, provide a brief outl ine of the search in g/retrieval process, cross-refere need 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 cli nical data and appraisal总结临床数据和评价Provide a tabulation of the cli
15、nical data used in the evaluation, categorised accord ing to whether the data address the performa nee or the safety of the device in questi on. (Note: many in dividual data sets will address both safety and performa nee.) With in each category, order the data accord ing to the importa nee of their
16、contribution to establishing the safety and performance of the device and in relati on to any specific claims about performa nce or safety. Additi on ally, provide a brief outline of the data appraisal methods used in the evaluation, including any weighting criteria, and a summary of the key results
17、.提供一张评估中用到的临床数据的表格，按照数据是否关系到讨论的器械的性能或安全来分类。(注：许多单独的数据与安全、性能都相关。)每个类别中，数据的排列依据它们对于该器械 安全和性能的重要性，以及与性能和安全有关的任何特别要求的相关方面。此外，简要描述评 估中使用的数据评价方法，包括任何权重标准，和重要结论的总结。Include full citations for literature-based data and the titles and investigationcodes (if releva nt) of any cli ni cal in vestigati on reports
18、.包括任何临床研究报告的基于文献的数据，题目和研究编码（如果相关）的完整引用信息。Cross-refere nee the entry for each piece of data to its locati on in themanu facturer' tech ni cal docume ntati on.每条数据的记录与其在生产商技术文档中的位置应相互对应。6. Data an alysis数据分析6.1. Performanee性能Provide a description of the analysis used to assess performanee.描述用于性能评估
19、的分析方法。Identify the datasets that are considered to be the most important in contributing to the dem on strati on of the overall performa nce of the device and, where useful, particular performa nce characteristics. Outli ne why they are con sidered to be pivotal and how they dem on strate the perfor
20、ma nce of the device collectively （e.g. consistency of results, statistical significance, clinically significance of effects）.识别那些被认为是论证了器械总体性能和特殊性能特点的最重要的数据。概述这些数据为何被 认为是关键数据，它们如何共同论证了器械的性能（比如结论的连贯性，统计的显著性，疗效 的临床重要性）。6.2. Safety 安全Describe the total experience with the device, including numbers and
21、 characteristics of patients exposed to the device; and duration of follow-up of device recipie nts. 描述器械的全部使用经验，包括使用此器械的患者的数量和特点；以及跟踪器械使用情况的持 续时间。Provide a summary of device-related adverse eve nts, pay ing particular atte nti onto serious adverse eve nts.总结与器械有关的不良事件，特别注意严重不良事件。Provide specific co
22、mme nt on whether the safety characteristics and inten dedpurpose of the device requires training of the en d-user.要特别讨论，是否会因为器械的安全特性和预期用途，须对最终用户进行培训。6.3. Product Literature and Instructions for Use产品文献和使用说明State whether the manu facturer' proposed product literature and In structi ons forUse ar
23、e con siste nt with the cli ni cal data and cover all the hazards and othercli ni cally releva nt in formati on that may impact on the use 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。7. Con clusi ons结论Outl ine clearly the con clusi ons reached about the safety and performa
24、 neeof the device from the evaluati on, with respect to the inten ded use of thedevice. State whether the risks identified in the risk managementdocume ntati on have bee n addressed by the cli ni cal data.For each proposed cli ni cal in dicati on state whether:the cli ni cal evide nee dem on strates
25、 con formity with releva nt Esse ntialRequireme nts;the performa nee and safety of the device as claimed have bee n established;andthe risks associated with the use of the device are acceptable whe n weighed aga inst the ben efits to the patie nt.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。感谢下载!欢迎您的下载，资料仅供参考