MEDDEV2.7.1ver.3临床评价报告样本(中文)
MEDDEV 2 12-2 Chinese
EUROPEAN COMMISSION 欧盟委员会DG ENTERPRISE DG企业Directorate G 董事会GUnit 4 - Pressure Equipment, Medical Devices, Metrology第4单元-压力设备、医疗器械、计量学医疗器械指南该指南是指实施医疗器械EC指令中所遇到问题的系统指南中的一个。
这些指令与指南之间没有法律效益的关联。
这些指南是通过与各个利益方（包括主管当局，委员会服务机构，行业以及其他利益相关方）进行详尽的征询后谨慎起草的，在这个过程中，草稿有被传阅，相关的建议在文件中加以采纳。
因此，此文件体现了医疗器械各相关方代表的立场。
CEC 临床评估小组5月18日, 2004年医疗器械指令之上市后临床跟踪前言：PMCF的基本原因和目标本文件的目的是指为制造商和通告机构就如何执行PMCF, 和履行上市后监督义务提供指导性意见。
参照医疗器械指令附录II 3. 1, 附录IV 3. 附录V 3, 附录VI 3.1 附录VII 4 (增加参阅AIMDD)。
虽然临床证据是上市前符合性评定程序的基本要素，但重要的是要认识到，这些上市前临床调查存在局限性。
虽然在上市前阶段已经收集了广泛的数据，但是并不能保证制造商能够察觉到不常见的并发症或问题，而这些问题只有在医疗器械被大范围的使用和长期运行后才会显现。
作为医疗器械制造商的质量体系，或上市后监督体系的一个部分，关键就是需识别和调查销售后的医疗器械在使用过程中所具有的风险。
制造商应建立上市后监督系统，并且对每一个产品或产品类都应有明确的PMS（上市后监督）策划。
因此，选择PMCF(上市后临床跟踪)看起来是实现此目的的一个方法。
通过建立一个长期的安全跟踪评审程序和侦查一些可能出现的风险，它可以使病人获得新的疗法，而这些风险仅仅依赖上市前的临床调查（仅仅要求相对很短的时间跟踪）和根据产品经验或产品警惕性都是不能完全充分地察觉到的。
(完整)医疗器械临床试验病例报告表
(完整)医疗器械临床试验病例报告表编辑整理：尊敬的读者朋友们：这里是精品文档编辑中心，本文档内容是由我和我的同事精心编辑整理后发布的，发布之前我们对文中内容进行仔细校对，但是难免会有疏漏的地方，但是任然希望（(完整)医疗器械临床试验病例报告表）的内容能够给您的工作和学习带来便利。
同时也真诚的希望收到您的建议和反馈，这将是我们进步的源泉，前进的动力。
本文可编辑可修改，如果觉得对您有帮助请收藏以便随时查阅，最后祝您生活愉快业绩进步，以下为(完整)医疗器械临床试验病例报告表的全部内容。
编号:□□□□患者姓名拼音缩写：□□□□产品名称＊＊＊*＊(商品名：＊＊＊)的安全性和有效性研究病例报告表(Case Report Form,CRF）患者姓名拼音缩写：□□□□试验编号:□□□□医院名称:研究者签名：申办单位：上海＊*****有限公司病例报告表填写要求1、所有记入本手册的数据需对照原始资料进行核查2、用签字笔填写，中文字应清晰可辨，英文字母需大写3、每格填写一个字,不适用的空格，请填“/"4、选择项请打“√"5、填写错误修改时，用单线划掉,切毋涂抹，原字迹需清晰可辨，并签名和注明修改时间6、患者的姓名不得出现在本病例报告表中，患者姓名拼音缩写四格需填满，两字姓名填写两字拼音前两个字母，三字姓名填写三字首字母及第三字二字母，四字姓名填写每一个字的首子母。
举例：张红ZHHO，张红旗ZHQI 欧阳予黄 OYYH.7、日期填写为：□□□□年□□月□□日。
一、入选标准：1、年龄18～65岁，性别不限；□是□否2、创面面积小于体表面积的50%；□是□否3、签署知情同意书; □是□否如以上任何答案为“否”，则该病人不能入选二、排除标准：1、年龄小于18岁或大于65岁；□是□否2、有严重心、脑、肝、肾功能不全的患者；□是□否3、严重营养不良的患者;□是□否4、创面面积大于体表面积50%的患者；□是□否5、有精神疾病的患者以及无自知力、不能确切表达者。
MEDDEV 2.7.1_REV 3_医疗器械指南_中文版
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10 在评估临床评价资料过程中公告机构的角色…………
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10.1 设计档案的检查
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10.2 作为质量体系程序一部分的评价
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10.3 公告机构特定程序和专门知识 Nhomakorabea24
附件....................................................................................................................……
关于上市后行动，制造商被期望执行和保持监督程序，日常监测器械的临床性能 和安全，作为质量管理体系的一部分。上市后监督的范围和性质应适用于该器械 以及它的预期用途。使用由此程序(比如安全报告, 包括不良事件报告; 出版文献 的结果, 任何进一步的临床调查和正式的上市后监督研究等)生成的资料, 制造商 应通过临床评价定期评审器械的性能，安全和利害评估，并相应地更新临床证 据。这个持续的临床评价过程应允许制造商根据当地的报告要求，以及任何对器 械的利害评估有重要影响或需要对关于禁忌症，注意事项或说明书要做出更改的 任何信息，与符合性评估机构和监管当局进行交流。
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2.0 范围................................................................................................................................ 6
3.0 参考文献........................................................................................................................ 7
MEDDEV 2 12-2 Chinese
EUROPEAN COMMISSION 欧盟委员会DG ENTERPRISE DG企业Directorate G 董事会GUnit 4 - Pressure Equipment, Medical Devices, Metrology第4单元-压力设备、医疗器械、计量学医疗器械指南该指南是指实施医疗器械EC指令中所遇到问题的系统指南中的一个。
这些指令与指南之间没有法律效益的关联。
这些指南是通过与各个利益方（包括主管当局，委员会服务机构，行业以及其他利益相关方）进行详尽的征询后谨慎起草的，在这个过程中，草稿有被传阅，相关的建议在文件中加以采纳。
因此，此文件体现了医疗器械各相关方代表的立场。
CEC 临床评估小组5月18日, 2004年医疗器械指令之上市后临床跟踪前言：PMCF的基本原因和目标本文件的目的是指为制造商和通告机构就如何执行PMCF, 和履行上市后监督义务提供指导性意见。
参照医疗器械指令附录II 3. 1, 附录IV 3. 附录V 3, 附录VI 3.1 附录VII 4 (增加参阅AIMDD)。
虽然临床证据是上市前符合性评定程序的基本要素，但重要的是要认识到，这些上市前临床调查存在局限性。
虽然在上市前阶段已经收集了广泛的数据，但是并不能保证制造商能够察觉到不常见的并发症或问题，而这些问题只有在医疗器械被大范围的使用和长期运行后才会显现。
作为医疗器械制造商的质量体系，或上市后监督体系的一个部分，关键就是需识别和调查销售后的医疗器械在使用过程中所具有的风险。
制造商应建立上市后监督系统，并且对每一个产品或产品类都应有明确的PMS（上市后监督）策划。
因此，选择PMCF(上市后临床跟踪)看起来是实现此目的的一个方法。
通过建立一个长期的安全跟踪评审程序和侦查一些可能出现的风险，它可以使病人获得新的疗法，而这些风险仅仅依赖上市前的临床调查（仅仅要求相对很短的时间跟踪）和根据产品经验或产品警惕性都是不能完全充分地察觉到的。
MEDDEV 2.7.1 ver.3 临床评价报告样本(中文)
临床评价报告数字X射线摄影系统: Xxxx 系列编制:批准:1.器械概述产品名称:产品型号:制造商：2.器械及预期用途描述2.1 预期用途：数字X射线摄影系统，用于生成人体解剖组织的放射线图像。
设计本系统的目的是在所有一般用途的诊断程序中替代放射线胶片/ 屏幕系统。
本设备不用于乳腺X 射线成像应用。
2.2 器械描述: 按医用电气设备的安全分类属于Ⅰ类B型间歇加载连续运行固定式设备，诊断患者时人体与摄影床和探测器部分接触。
本X射线摄影系统功能组成有以下几部分构成。
3.预期诊断适应症本设备需要在隔离室内对需要诊断人体解剖组织的放射线图像的患者进行拍摄。
不适用于乳腺X 射线成像应用。
孕妇及儿童应遵守医师的诊断并了解放射拍片的危害。
4.临床评价背景及临床资料类型的选择4.1 产品研发背景：1895年X射线被发现。
20世纪10-20年期间开始有常规X射线机在临床上应用。
70年代末开始，数字化技术在X射线机成像系统上不断得到应用。
DR（digital radiography）成像技术是80年代末实现的X射线直接成像技术，由DR所获得的图像，其每一个像元都来自于相应的数字化探测单元，正是这些排列有致的阵列实现了X射线的数字化成像。
因此，Xxxx系列数字X射线摄影系统的成像技术已经非常成熟，关于数字X射线摄影系统的研究以及评价分析的文献，及器械相关的不良事件等资料应很丰富。
足以说明数字X射线摄影系统成像在临床应用中安全性和有效性。
4.2临床评价阶段概述临床评价阶段按照以下流程图划分并进行临床评价：*符合协调标准的要求可以认为能充分满足相关的基本要求基于Xxxx 系列数字X射线成像系统临床评价计划中的拟评价内容及以下检索协议进行文献检索。
4.3文献检索应依据以下协议进行：a)文献检索的范围：涵盖数字X射线摄影系统的安全，性能及不良事件等信息的文献。
b)方法(i) 文献检索日期：(ii) 文献检索人员：xxxx(iii) 检索涵盖的时期范围：近２０年关于数字X射线摄影设备的安全、性能及不良事件信息。
MEDDEV2.7.1（中文版翻译）
MEDDEV2.7.1（中文版翻译）MEDDEV.2.7.12003年4月医疗器械指南临床数据评价：制造商和认证机构指南说明本指南为一系列与EC—医疗器械指令应用问题相关的指南中的一部分。
并不具有法律约束力。
该指南在经过与各个利益方（主管机构、欧盟委员会服务处、工业、其他有兴趣的团体）进行深入协商之后谨慎拟定而成，期间对中期草案进行了传阅，而且部分意见还为本文件所采纳。
因此，本文件反映出了来自医疗器械行业的利益团体代表所持的立场。
Commission européenne, B-1049 Bruxelles / Europese Commissie, B-1049 布鲁塞尔–比利时. 电话：（32-2）299.11.11. 传真：（32-2）296 70 13. 电子邮件：entr-medical-**************.int1. 引言与目的本文件之主要目的是为制造商提供审核和分析临床数据方面的指导意见，并且在当认证机构对制造商临床数据评价进行审核的时候，作为90/385/EEC（AIMD）[1]和93、42、EEC（MDD）[2]所规定的符合性评估程序的一部分提供给认证机构。
本文件还通过提供期望方面的指导意见给予制造商一定帮助。
2. 背景制造商必须按照指令中的规定，论证其预期目的和就其实现的安全性与性能所做出的声明。
根据一般规律，上述论证需要临床数据的支持（附录X，MDD 1.1）MDD附录X和AIMD附录7中所述的临床数据评价与以下规定之间存在密切关系：MDD 附录I：通用要求第1节和第3节；AIMD附录1：通用要求第1节和第2节。
还应注意附录I之I.6（MDD）和附录1之1.5（AIMD）。
3. 术语解释在本指南中：3.1 临床数据是指与器械临床安全和性能各方面有关的数据。
必须包括来自以下来源的数据：（i）与待评估器械市场经验有关的已发表和（或）未发表数据；或能够证明与上述待评估器械等价的类似器械；或（ii）相关器械的前瞻性临床研究；或（iii）临床研究结果，或针对能够证明与上述待评估器械等价的类似器械的科技文献报道的其他研究结果。
医疗器械：适用于制造商和公告机构的临床评估指南(中英文对照)
EUROPEAN COMMISSIONDG Internal Market, Industry, Entrepreneurship and SMEs Consumer,Environmental and Health TechnologiesHealth technology and Cosmetics日用消费品化妆品和医疗器械GUIDELINES ON MEDICAL DEVICES 医疗器械指南NoteThe present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical Devices. They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts where circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interest parties in the medical devices sector. These guidelines incorporate changes introduced by Directive 2007/47/EC amending Council Directive 90/385/EEC and Council Directive 93/42/EEC.本指南为一系列与EC—医疗器械指令应用问题相关的指南中的一部分。
MEDDEV.2.7.1 09版_医疗器械指南_中文版
欧盟委员会企业和工业总署日用消费品化妆品和医疗器械MEDDEV. 2.7.1版本.32009年12月医疗器械指南临床评价:制造商和公告机构指南本指南为一系列与CE—医疗器械指令应用问题相关的指南中的一部分。
并不具有法律约束力。
该指南在经过与各个利益方（主管当局、服务委员会、行业委员会、其他利益相关团体）进行深入协商之后谨慎拟定而成，期间对中期草案进行了传阅，而且部分意见还为本文件所采纳。
因此，本文件反映出了来自医疗器械行业的利益团体代表所持的立场。
本指南包含了指令 2007/47/EC，90/385/EEC和93/42/EEC中的变更，并从2010年3月21日开始实施。
2010年3月21日前的过渡时期应逐步地实施该指南。
注:本文件是MEDDEV 2.7.1 03年4月版的修订版。
本文件是在2007年6月29日发表在 上的GHTF 指南SG5/N2R8:2007 临床评价的基础上起草的。
目录前言 (4)1.0 引言 (5)2.0 范围 (6)3.0 参考文献 (7)4.0 定义 (7)5.0 临床评价总原则 (9)6.0 临床评价的资料/文件材料来源(阶段1) (12)6.1 通过文献搜索生成的资料126.2 通过临床经验生成的资料136.3 临床调查得出的资料147.0 临床资料的鉴定(阶段2) (16)8.0 临床资料的分析(阶段3) (17)9.0 临床评价报告 (18)10 在评估临床评价资料过程中公告机构的角色 (19)10.1 设计档案的检查2010.2 作为质量体系程序一部分的评价2310.3 公告机构特定程序和专门知识24 附件 (27)A: 文献检索报告的可能格式28 B: 文献检索报告中编制文献筛选和选择的可能方法29 C: 有助于标准编制的一些例子30 D: 一种可能的鉴定方法32 E: 临床评价报告的一种可能格式34 F: 公告机构临床评价检查表37前言这些有关临床评价的指南是一系列医疗器械指南的一部分，由制造商，公告机构和国家主管当局根据相关医疗器械指令促成的一个共同方法。
MEDDEV 2.7-4 临床调查-制造商和公告机构的指南
Ref. Ares(2015)2067487 - 18/05/2015 EUROPEAN COMMISSIONDIRECTORATE GENERAL for HEALTH and CONSUMERSConsumer AffairsCosmetics and Medical DevicesMEDDEV 2.7/4December 2010GUIDELINES ON MEDICAL DEVICESGUIDELINES ON CLINICAL INVESTIGATION:A GUIDE FOR MANUFACTURERS AND NOTIFIEDBODIESNoteThe present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical Devices. They are legally not binding. The Guidelines have been carefully draftedthrough a process of intensive consultation of the various interest parties (competent authorities,Commission services, industries, other interested parties) during which intermediate drafts wherecirculated and comments were taken up in the document. Therefore, this document reflects positionstaken by representatives of interest parties in the medical devices sector.CONTENTS1 Introduction (3)2 Scope (3)3 References (4)4 Definitions (5)5 General Principles When Considering the Need for a Clinical Investigation (6)6 General Principles of Clinical Investigation Design (7)7 Ethical Considerations for Clinical Investigations (10)1 IntroductionThese guidelines are based on the guidance document SG5/N3:2010 of the Global Harmonization Task Force. They are adapted to the requirements on clinical investigations laid out in annex 7 of directive 90/385/EEC and in annex X of directive 93/42/EEC as amended by directive 2007/47/EC. The clinical investigations shall be performed as described in these annexes.They reflect the consensus view of the various interested parties with regard to clinical investigations under the above-mentioned medical devices directives.What is a clinical investigation?A clinical investigation is defined as “any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety and/or performance of a medical device.” (SG5/N1:2007).The undertaking of a clinical investigation is a scientific process that represents one method of generating clinical data.What is the objective of a clinical investigation?The objective of a clinical investigation is to assess the safety and clinical performance of the device in question and evaluate whether the device is suitable for the purpose(s) and the population(s) for which it is intended (EN ISO 14155-1:2009).How is a clinical investigation conducted?EN ISO 14155-1:2009 Clinical Investigation of Medical Devices for Human Subjects - General Requirements details the general requirements for the conduct of clinical investigations and EN ISO 14155-2:2009 Clinical Investigation of Medical Devices for Human Subjects - Clinical Investigation Plan contains detailed information about the procedure and contents of a clinical investigation plan. Clinical investigations must take into account scientific principles underlying the collection of clinical data along with accepted ethical standards surrounding the use of human subjects. The clinical investigation objectives and design should be documented in a clinical investigation plan.2 ScopeThe primary purpose of this document is to provide guidance in relation to:• when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Requirements; and• the general principles of clinical investigations involving medical devices.Given the wide diversity of medical devices and their associated risks, this document is not intended to provide comprehensive guidance for clinical investigations of specific medical devices.The guidance contained within this document is intended to apply to medical devices generally and to combination products regulated as medical devices. It is not intended to cover in vitro diagnostic medical devices. Additionally, this document was drafted primarily to address the use of Clinical Investigations to support clinical evaluation and a conformity assessment procedure. Some aspects of this document may apply to studies conducted following commercial release of a device. A separate guidance document specifically addresses post-market clinical follow-up (MEDDEV 2.12/2: Clinical Evaluation - Post Market Clinical Follow-up).3 ReferencesDirective 90/385/EEC, as amended by Directive 2007/47/ECDirective 93/42/EEC, as amended by Directive 2007/47/ECInterpretative DocumentsMEDDEV 2.7.1 Rev. 3; December 2009Clinical Evaluation: A Guide for Manufacturers and NotifiedBodiesMEDDEV 2.7.1, Appendix 1; December 2008Evaluation of Clinical Data – A Guide for Manufacturers andNotified Bodies – Appendix 1: Clinical Evaluation of CoronaryStentsMEDDEV 2.7.2; December 2008Guide for Competent Authorities in Making an Assessment ofClinical Investigations NotificationMEDDEV 2.12/2; May 2004Clinical Evaluation - Post Market Clinical Follow-upGHTF final documentsSG5/N1:2007 Clinical Evidence – Key definitions and ConceptsSG5/N2:2007 Clinical EvaluationHarmonized/International standardsEN ISO 14155-1: 2009Clinical investigation of medical devices for human subjects – Part1 General requirementsEN ISO 14155-2: 2009Clinical investigation of medical devices for human subjects – Part2 Clinical investigation plansEN ISO 14971: 2009Application of risk management to medical devicesOther ReferencesWorld Medical Association – Declaration of Helsinki - Ethicalprinciples for medical research involving human subjects4 DefinitionsClinical Data:The safety and/or performance information that is generated fromthe use of a device. Clinical data are sourced from:— clinical investigation(s) of the device concerned; or— clinical investigation(s) or other studies reported in thescientific literature, of a similar device for which equivalenceto the device in question can be demonstrated; or— published and/or unpublished reports on other clinicalexperience of either the device in question or a similar devicefor which equivalence to the device in question can bedemonstrated.Clinical Evaluation:The assessment and analysis of clinical data pertaining to a medicaldevice to verify the clinical safety and performance of the devicewhen used as intended by the manufacturer.Clinical Evidence:The clinical data and the clinical evaluation report pertaining to amedical device.Clinical Investigation:Any systematic investigation or study in or on one or more humansubjects, undertaken to assess the safety and/or performance of amedical device.Clinical Investigation Plan:Document that states the rationale, objectives, design and proposedanalysis, methodology, monitoring, conduct and record-keeping ofthe clinical investigation.Clinical Performance:The ability of a medical device to achieve its intended purpose asclaimed by the manufacturer.Clinical Safety:The absence of unacceptable clinical risks, when using the deviceaccording to the manufacturer’s Instructions for Use.Conformity Assessment:The systematic examination of evidence generated and proceduresundertaken by the manufacturer, according to Article 9 of directive90/385/EEC and Article 11 of directive 93/42/EEC, to determine thata medical device is safe and performs as intended by themanufacturer and, therefore, conforms to the EssentialRequirements according to Annex 1 of directive 90/385/EEC andAnnex I of directive 93/42/EEC.Device intended for Clinical Investigation:any device intended for use by a duly qualified medical practitionerwhen conducting investigations as referred to in Sections 2.1 ofAnnex 7 of directive 90/385/EEC and section 2.1 of Annex X ofdirective 93/42/EEC in an adequate human clinical environment. Endpoint: Indicators measured or determined to assess the objectives of a clinical investigation, prospectively specified in the clinicalinvestigation plan. (EN ISO 14155_2:2009, modified)Residual Risk: Risk remaining after risk control measures has been taken (EN ISO 14971:2009).Risk Management:The systematic application of management policies, procedures andpractices to the tasks of analysing, evaluating, controlling andmonitoring risk (EN ISO 14971:2009).5 General Principles When Considering the Need for a ClinicalInvestigationClinical EvaluationAccording to Annex 1.I.5a of directive 90/385/EEC and Annex I.I.6a of directive 93/42/EEC demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7/Annex X of the respective directive.As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in sections I.1 and I.3 of annex I of directive 90/385/EEC and in sections I.1 and I.2 of annex I of directive 93/42/EEC under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section I.5/I.6 of Annex I of directives 90/385/EEC and 93/42/EEC respectively, must be based on clinical data.The kind and amount of clinical data needed will primarily depend on the specifics of the clinical claims with regard to clinical performance, considerations of clinical safety, including determination of undesirable side-effects and on risk management output, namely determination of residual risks and favorable benefit/risk ratio. Some factors that may typically influence the specificity/extent of clinical datarequirements are listed in section 6 of this guidance. Different clinical claims/intended purposes of a device may often necessitate different clinical data. For example, in the case of the closure of the heart defect patent foramen ovale, clinical performance/safety data and benefit/risk-considerations may vary in different intended purposes such as stroke prevention or migraine crisis prevention.Conducting a proper clinical evaluation will demonstrate which clinical data are necessary, which clinical data can be adequately supplemented by other methods, such as literature search, prior clinical investigations, clinical experience or by using suitable clinical data from equivalent1 devices, and which clinical data remain to be delivered by clinical investigations (see MEDDEV 2.7.1 Rev.3: “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies”).The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. New such data as well as considerations for new or changed intended purposes need updating of the clinical evaluation and may indicate necessity of additional clinical investigations.When must/should a clinical investigation be undertaken?The Conformity Assessment process for active implantable medical devices as well as for class III and implantable medical devices requires that a clinical investigation is undertaken unless it is duly justified to rely on existing data (section 1.2 of Annex 7 of directive 90/385/EEC and section I.1a of Annex X of directive 93/42/EEC ). Any such justification will have to be based on a proper clinical evaluation.Depending on clinical claims, risk management outcome and on the results of the clinical evaluation, clinical investigations may also have to be performed for non-implantable medical devices of classes I, IIa and IIb.Additional clinical investigations may be feasible to corroborate the existing clinical evidence with regard to aspects of clinical performance, safety, benefit/risk-ratio or to determine relative effectiveness and safety with suitable comparators.6 General Principles of Clinical Investigation DesignAny clinical investigation must:• be part of the clinical evaluation process;• follow a proper risk management procedure to avoid undue risks;• be compliant with all relevant legal and regulatory requirements;• be appropriately designed (see below);• follow appropriate ethical principles (see Section 7).1 The concept of equivalency encompasses technical, biological and clinical equivalency.Basic legal and administrative provisions given in directives 90/385/EEC and 93/42/EECArt. 4 of the two directives require that Member States shall not create any obstacle to devices intended for clinical investigation being made available to medical practitioners or authorized persons for that purpose if they meet the conditions laid down in Article 10/15 and in Annex 6/VIII of the respective directives. These devices shall not bear the CE marking.Art. 10/15 of the directives contain the administrative provisions for clinical investigations, Annex 6/VIII respectively the contents and provisions for the statement and documentation required.Annexes 7/X, sections 2.2 relate to ethical provisions, sections 2.3 specify basic methodological aspects of clinical investigations.Further legal and regulatory/administrative requirements may be valid at national/regional level.Factors to Influence Clinical Data RequirementsThe design of the clinical investigation, including the study objectives and statistical considerations, should provide the clinical data necessary to address relevant aspects of clinical performance, safety, including undesirable side-effects as well as the residual risks identified in the risk management process. Some factors that may influence the extent of clinical data requirements include, but are not limited to, the following:• type of device and/or regulatory classification;• novel technology/relevant previous experience;• clinical application/indications;• nature of exposure to the product, e.g.: surface contact, implantation, ingestion;• risks inherent in the use of the product, e.g.: risk associated with the procedure;• performance claims made in the device labeling (including instructions for use);• component materials and substances;• disease process (including severity) and patient population being treated;• demographic, geographic and cultural considerations (e.g.: age, race, gender, etc.);• potential impact of device failure;• period of exposure to the device;• expected lifetime of the device;• availability of alternative treatments and current standard of care; and• ethical considerations.Considerations for Device Study DesignsSome of the factors that need to be considered in the study design include, for example:• clear statement of objectives• appropriate subject population(s)• minimization of bias (e.g., randomization, blinding)• identification of confounding factors (e.g., concurrent medications, co-morbidities)• choice of appropriate controls (e.g., cohort, sham, historical), where necessary• design configuration (e.g., parallel, crossover, factorial)• type of comparison (e.g., superiority, non-inferiority, equivalence) Investigations should be planned in such a way as to maximize the clinical relevance of the data while minimizing confounding factors. Possible study designs include: • randomized controlled trials• cohort studies• case-control studies• case seriesThese are further explained in Appendix C of the document MEDDEV 2.7.1 Rev. 3 on Clinical Evaluation.In designing the study, statistical considerations should be prospectively specified and should be based on sound scientific principles and methodology. Care must be taken in developing a statistical plan that includes consideration of, for example, the following:•endpoints that are clinically relevant, clearly defined and assessed at a specified time point2• a testable hypothesis• statistical significance levels, power• sample size justification2 See e.g. critical aspects of end point definition for regulatory trials [D.B. Kramer et al, American Journal of Therapeutics 17, 2-7 (2010)]• analysis methodology (including sensitivity and poolability analysis)The design should ensure that the statistical evaluation derived from the investigation reflects a meaningful, clinically significant outcome.Discussion with a competent authority or a notified body may be appropriate when there is uncertainty as to whether the proposed clinical investigation plan is sufficient.Conduct of Clinical InvestigationsA properly conducted clinical investigation, including compliance to the clinical investigation plan and local laws and regulations, ensures the protection of subjects, the integrity of the data and that the data obtained is acceptable for the purpose of demonstrating conformity to the Essential Requirements. EN ISO 14155 outlines good clinical practice for clinical investigations of medical devices.Final Study ReportThe outcome of a clinical investigation has to be documented in a final study report (Annex 7/X, section 2.3.7 of directives 90/385/EEC and 93/42/EEC) This then forms part of the clinical data that is included in the clinical evaluation process and ultimately becomes integrated into the clinical evaluation report (see MEDDEV 2.7.1 Rev. 3) for the purposes of conformity assessment. The structure of a final study report is proposed in EN ISO 14155-1:2009.7 Ethical Considerations for Clinical InvestigationsIn their sections 2.2 of Annex 7/Annex X, directives 90/385/EEC and 93/42/EEC require: “Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly. It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Helsinki Declaration. This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results.”As a general principle, “the rights, safety and wellbeing of clinical investigation subjects shall be protected consistent with the ethical principles laid down in the Declaration of Helsinki” (EN ISO 14155-1:2009).It is ethically important in deciding to conduct a clinical investigation that it should generate new data and answer specific safety and/or performance questions that remain unanswered by the current body of knowledge. The desire to protect human subjects from unnecessary or inappropriate experimentation must be balanced with the need to protect public health through the use of clinical investigations where they are indicated. In all cases, however, care must be taken to ensure that the necessary data are obtained through a scientific and ethical investigational process that does not expose subjects to undue risks or discomfort. The rights, safety and well-being of subjects are paramount and appropriate trial design and conduct is essential to generate meaningful data.。
meddev2.7.1(英文版)
EUROPEAN COMMISSIONENTERPRISE DIRECTORATE-GENERALSingle Market : regulatory environment, standardisation and New ApproachPressure equipment, medical devices, metrologyMEDDEV. 2.7.1April 2003GUIDELINES ON MEDICAL DEVICESEVALUATION OF CLINICAL DATA :A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIESNoteThe present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical devices. They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interest parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interest parties in the medical devices sector.Commission européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel – Belgium.Version 2003-03-27EVALUATION OF CLINICAL DATA:A GUIDE FOR MANUFACTURERS AND NOTIFIEDBODIES1.Introduction and purposeIt is the primary purpose of this document to provide guidance to Manufacturers on reviewing and analysing clinical data and to Notified Bodies when reviewing the manufacturers evaluation of clinical data as part of the conformity assessment procedures required by 90/385/EEC (AIMD) [1] and 93/42/EEC (MDD) [2].This document will also assist manufacturers, by providing guidance on what is ex-pected.2.BackgroundThe manufacturer must demonstrate that his intended purpose(s) and claim(s) made in relation to safety and performance are achieved, as referred to in the Directives. As a general rule, such demonstration will require clinical data (Annex X, 1.1 of MDD).Evaluation of clinical data as described in Annex X of the MDD and Annex 7 of the AIMD is particularly relevant to assessment of conformity with essential requirements given in MDD Annex I: General Requirements, sections 1 and 3 and AIMD Annex 1: General requirements, sections 1 and 2. Attention should also be paid to Annex I,I.6 (MDD) and Annex 1, I.5 (AIMD).3.Explanation of termsFor the purpose of this document:3.1 Clinical data is data which is relevant to the various aspects of the clinical safety and performance of the device. This must include data obtained from:(i) published and/or unpublished data on market experience of the devicein question; or a similar device for which equivalence to the device inquestion can be demonstrated; or(ii) a prospective clinical investigation(s) of the device concerned; or(iii) results from a clinical investigation(s) or other studies reported in the scientific literature of a similar device for which equivalence to thedevice in question can be demonstrated.3.2.The Evaluation of clinical data is the process by which clinical data from all se-lected sources (literature, results of clinical investigations and other) is as-sessed, analysed and deemed appropriate and adequate to establish conformity of the device with the pertinent essential requirements of the Directive as they relate to safety and performance, and to demonstrate that the device performs as intended by the manufacturer. The outcome of this process is a report which includes a conclusion on the acceptability of risks and side effects when weighed against the intended benefits of the device.4.Clinical data to be provided by the manufacturerThe Active Implantable Medical Devices Directive and the Medical Devices Directive state that as a general rule, and in particular in the case of implantable devices, active implantable devices and devices in Class III, evidence of the clinical performance and safety of a medical device is provided by means of clinical data, which is supplied by the manufacturer in accordance with Annex X (MDD) or Annex 7 (AIMD). The decision as to whether clinical data is necessary however must be taken for every device on the basis of the type of data required to demonstrate compliance with the relevant Essential Requirements, the claims being made for the device in question and the risk management assessment. All the conformity assessment procedures leading to CE marking, address the issue of clinical evaluation by the manufacturer. In the case of Annexes II and III, the Notified Body is involved. Clinical evaluation is based on the assessment of the risks and the benefits, associ-ated with use of the device, through either:(i) a compilation of relevant scientific literature, that is currently availableas well as, where appropriate, a written report containing a critical evaluation of this compilation (the "literature route"); or(ii)the results of all the clinical investigations relevant to the device in question (the "clinical investigation route"); or(iii) a combination of (i) and (ii) above. Where the clinical evaluation is based on such a combination, it should include an overall assessment. This assessment should take account of market experience, if available. It is important that the manufacturer relates the data to the specific device, having regard to the hazards identified (see 4.2).The manufacturer must demonstrate whether the available data is sufficient to establish conformity with the Directive, having regard to:(i) the demonstration of equivalence of the device to which the datarelates and the device(s) for which conformity is being assessed, andso the applicability of the findings to the device being assessed (seesection 4.3.1 (i)d) ); and(ii) the adequacy of the data in addressing the relevant aspects of Directive conformity.4.1. Manufacturer’s statement on the clinical data used to affix the CE markingThe manufacturer should include in the technical documentation a simple statement on the clinical data used to affix the “CE” marking. The statement should make clear whether that clinical data was obtained from the published literature or the results of clinical investigations or a combination of both. Where data relates to other devices, the statement should indicate analogy with which device(s) and how equivalence was established. The full clinical data used for CE marking should be included within the technical documentation.4.2.Identification of aspects of safety and performance to be addressedthrough clinical dataThe manufacturer is required by the Directive to perform a risk analysis. A risk analysis is important in helping the manufacturer identify known or reasonably fore-seeable hazards associated with use of the device, and decide how best to estimate the risks associated with each hazard1. From the results of the risk analysis, the manufacturer lays out how each risk is addressed and decides on the acceptability of risks when weighed against the intended benefits.The risk analysis includes technical and clinical aspects relating to the particular device concerned. It should distinguish between aspects associated with:(i)the medical procedure for which the device is intended;eg the risks versus benefits associated with extracorporeal lithotripsy ascompared with conventional (surgical and non-surgical) methods ofkidney stone removal.(ii)the technical solutions adopted;eg the risks versus benefits associated with different technologies ofextracorporeal lithotripsy such as those involving generating shockwaves with electric sparks (electrohydraulic method), with anelectromagnetic generator or a piezoelectric system.(iii)aspects specific to the design and use of the particular device concerned;1The loss/absence of the performance of a given device as claimed by the manufacturer and which could result in the loss of benefit of a treatment may be considered a hazard.eg the risks versus benefits associated with the shock wave couplingmethod, size of the focal zone, the stone localisation and targetingsystem (X-ray, ultrasound) and the trigger methodThis distinction should be used to identify the type and specificity of clinical data needed. Where the available data is not sufficient to address the identified clinical hazards relating to one or more of the above aspects, a clinical investigation(s) will be needed (see also section 4.4.1). The objectives of the clinical investigation(s) should focus on those aspects not sufficiently addressed by the available data. The manufacturer should also set out the intended benefits of the device and relate those to the accepted benefits associated with the generally acknowledged “state of the art”4.3.Literature routeDue regard needs to be paid to the extent to which the published data are relevant and applicable to the relevant characteristics of the device under assessment and the medical procedure for which the device is intended.A literature review should be performed by person(s) suitably qualified in the relevant field, knowledgeable in the “state of the art” and able to demonstrate objectivity.4.3.1RequirementsWhen the manufacturer's clinical evaluation to be submitted to the Notified Body takes the form of a review of the relevant scientific literature, the following requirements should be fulfilled:(i) Methodologya)GeneralA protocol for the identification, selection, collation and review of relevantstudies should be written and preferably be based on recognised practice for systematic review for literature.b)ObjectiveThe objective of the literature review should be clearly defined. The types of studies that are relevant to the objective of the literature review should be specified, taking into account the already well established knowledge of the device.c)Identification of dataData should be taken from recognised scientific publications. Unpublished data should also be taken into account in order to avoid publication bias.The literature review should state:·the sources of data and the extent of the searches of databases or other sources of information;·the rationale for the selection/relevance of the published literature;·the reasons for believing that all relevant references, both favourable and unfavourable, have been identified;·the criteria for exclusion of particular references together with a justification for this exclusion.Note: possible data sources for a systematic literature review are for example:· medical and paramedical databases· technical papers from relevant Standards Committees·foreign language literature·“grey literature” (theses, internal reports, non peer review journals, the internet, industry files)·references listed in primary sources·other unpublished sources known to experts in the field (obtained by personal communication)·raw data from published trials (obtained from personal communication)d)Relevance of dataA literature review should clearly establish the extent to which the literaturerelates to the specific characteristics and features of the device under consideration.If the published studies do not directly refer to the device in question, the following must apply.·The manufacturer must demonstrate equivalence in all the following essential characteristics with the device, which is the subject of thepublished reports. Equivalence means:Clinical:-used for the same clinical condition or purpose;-used at the same site in the body;-used in similar population (including age, anatomy, physiology);-have similar relevant critical performance according to expectedclinical effect for specific intended use.Technical:-used under similar conditions of use;-have similar specifications and properties eg tensile strength,viscosity, surface characteristics-be of similar design;-use similar deployment methods (if relevant);-have similar principles of operationBiological:-use same materials in contact with the same human tissues orbody fluids;To be equivalent, the devices should have similarity with regard to the clinical, technical and biological parameters with special attention to the performance, principles of operation and materials; or if there are differences identified, an assessment and demonstration of the significance these might have on safety and performance must be set out.For example we can consider the case where the device under consideration and the device referred to in the published studies do not have the same principles of operation ie the new device has a new principle of operation.Since a new mechanism of action does not necessarily result in a new clinical benefit, demonstration of the clinical benefit of the new device has to be generated by data resulting from a specifically designed clinical investigation since the 2 devices cannot be considered equivalent.·The manufacturer must be able to demonstrate the adequacy of the data in addressing the aspects of conformity set out in the objectivee)Assessment of clinical dataThe literature review should make clear the significance that is attached to particular references based on a number of factors. These include:·the relevance of the author’s background and expertise in relation to the particular device and/or medical procedure involved.·whether the author’s conclusions are substantiated by the available data·whether the literature reflects the current medical practice and the generally acknowledged “state of the art “ technologies.·whether references are taken from recognised scientific publications and whether or not they have been reported in peer reviewed journals·the extent to which the published literature is the outcome of a study/studies which have followed scientific principles in relation to design,for example, in having demonstrable and appropriate endpoints, inclusionand exclusion criteria, an appropriate and validated number of patientssubmitted, carried out for an appropriate duration, providing evidence andanalysis of all adverse incidents, deaths, exclusions, withdrawals andsubjects lost follow-up and identifying an appropriate statistical plan ofanalysis.Ideally, evidence should be generated from a clinical trial (controlled if appropriate), properly designed cohort/case controlled study, well documented case histories or sequential reports conducted by appropriate experienced experts, whether in relation to the device itself or an equivalent device. If unpublished data is being included in the assessment, the literature review will need to weigh the significance that is attached to each report.The evidence should not consist of:·isolated case reports;· random experience;·reports lacking sufficient detail to permit scientific evaluation (including lack of accepted and validated statistical design if this is relevant to the design of the intended study);· unsubstantiated opinions.(ii) Critical evaluation of the literatureThe literature review should contain a critical evaluation of the literature. This critical evaluation should:·be written by a person suitably qualified in the relevant field, knowledgeable in the “state of the art” and able to demonstrate objectivity;·contain a short description of the medical device, its intended functions, description of the intended purpose and application of use;·contain an analysis of all the available data considered, both favourable and unfavourable;· establish the extent to which the literature relates to the specific characteristics and features of the device being assessed, taking due accountof the extend of similarity between the device(s) covered by the literature and the device under assessment;·demonstrate that those aspects of the use of the device, including performance, addressed in the clinical part of the risk analysis are met as claimed by the manufacturer, and that the device fulfils its intended purpose as a medical device;·analyse the identified hazards, the associated risks and the appropriate safety measures of patients, medical staff and third parties involved in the study/studies, for example by reference to the manufacturer’s risk analysis (see also ISO14155-2);·contain a risk analysis relevant to the device design, materials and procedures involved, taking into account any adverse events, results of post-market surveillance studies, modifications and recalls (if known) (see also ISO14155-2);·contain a description of the methods of weighting of different papers and the statistical methods of analysis employed taking into account the assessment methods, the type and duration of study and the heterogeneity of the population included within the study. Particular attention should be given in circumstances where there are repeated publications on the same group of patients by the same authors in order to avoid overweighting the experience;·include an analysis of the market experience of the same or similar devices, including the results of post-marketing studies, post-market surveillance and short- and long-term adverse events;·contain a list of publications appropriately cross-referenced in the evaluation;·if the clinical data relates to an equivalent device, contain a statement that equivalence with all the relevant characteristics has been demonstrated;·include a conclusion with a justification, including an assessment of any probable benefit to health from the use of the device as intended by the manufacturer, against probable risks of injury or illness from such use taking account of the “state of the art”. If applicable, the findings should be compared with other studies covering the same field of application. These studies may involve other modalities, including alternative medical devices, medical therapy, surgery or other accepted health care methods provided they employ methods which are generally accepted as being common practice. The conclusions should make clear how the objectives of the literature review have been met and identify any gaps in the evidence necessary to cover all relevant aspects of safety and performance.Note 1:conclusions should be relevant in the field of use,indications, contra-indications and instructions for use intended by themanufacturerNote 2:the critical evaluation should be signed and dated by theauthor4.3.2 Conclusions from Analysis of Literature ReviewAs a result of a literature review, the Notified Body needs to be able to answer the following:· that the manufacturers’ conclusions are valid;·that the data, taken together with the available pre clinical data, is sufficient to demonstrate compliance with the essential requirementscovering safety and performance of the device in question under normalconditions of use; or·identify gaps in the demonstration of compliance with the relevant essential requirements or in the demonstration of equivalence that needaddressing through the means of a specifically designed clinicalinvestigation(s); and·that the claims made in the device labelling are substantiated by the clinical data taken together with the pre-clinical data.The manufacturer’s report of the literature review should be written in a format that enables the Notified Body to answer the questions above.4.4Clinical investigations route4.4.1.Need for clinical investigation(s)When reviewing the manufacturer’s evaluation of clinical data and whether or not a clinical investigation(s) is needed as part of this, due regard should be paid to NB-MED/2.7/R1 [5].4.4.2.Conduct of clinical investigationsWhere the results of clinical investigation(s) form part of the clinical data, the clinical investigations should comply with the relevant sections of Annex X MDD or Annex 7 AIMD. Compliance with the EN 540 [3] carries the presumption that the design, conduct and monitoring of the clinical investigation(s) conforms with the requirements of these Annexes. Whilst not carrying such a presumption of conformity, other equivalent standards may be used.2[4]4.4.3Requirements2Where justified, the Notified Body may require further information to assess the manufacturers clinical investigation data.When the manufacturer’s clinical evaluation to be submitted to the Notified Body takes the form of presentation and analysis of results from a specifically designed clinical investigation(s) involving the device in question, the following requirements should be fulfilled.(i) Identification of Relevant DocumentsThe following documents must be requested:·copy of the Protocol submitted to the Competent Authority for which no grounds for objection were raised;·copy of the letter of “no objection” from Competent Authority/Authorities (if available), together with comments made (was this a first submission to aCompetent Authority? If rejected, a copy of the original “grounds forobjection” should be requested);·copy of the Ethics Committee opinion(s) and comments (was this the first submission to Ethics Committee? If previously rejected, a copy of theletter of objection should be requested);·copy of the signed and dated final report.(ii) Information to be checkedThe following must be checked in all cases.·Letter of “no objection” from the Competent Authority(ies)·Clinical Investigation Plan (CIP): Is the CIP used for the clinical investigation the same as that submitted to the Competent Authority?Particular attention should be paid to:-number of patients entered-objectives of investigation(s) (in particular which Essential Requirements are being addressed)-duration of investigation(s) and patient follow up (short and long term)-end points in terms of diagnostic tools and patient assessment-inclusion and exclusion criteria;·If parameters, especially those mentioned above, are not as set out in the original CIP, the rationale for non adherence (particularly important to notewhether inclusion numbers and duration of study are cut short);·Identification of any changes to CIP and rationale for any such changes (important to ensure Competent Authority was notified of changes, if thisis relevant);·Where the clinical investigation(s) was performed outside the EU, the manufacturer must demonstrate that the use of the device (includingclinical practice and techniques) and patient population are equivalent tothose for which the device will be used within the EU (if relevant).(iii) FinalReportThe contents of the Final Report should always be checked and should contain the following informationa) SummaryA structured abstract should be provided, presenting the essentials of thestudy, including:·title of investigation(s);·identification of the medical device(s), including names, models as relevant for complete identification;·name of sponsor;· statement indicating whether the investigation(s) was performed in accordance with CEN/ISO Standards;·objectives;·subjects;·methodology;·investigation(s) initiation and completion dates, including date of early termination, if applicable;·results;·conclusions;·authors of report;·date of report.b) IntroductionA brief statement placing the study in the context of the development of themedical device in question and an identification of guidelines followed inthe development of the Protocol.c) Materials and methods· devicedescription;·summary description of the device and its intended use, together with any modifications performed during the investigation;·Clinical Investigation Plan summary.d)Summary of the clinical investigation planThis should be accompanied by any modification described. The summaryshould include a brief description of:·the clinical investigation objectives;·the investigation design;·type of investigation;·investigation end points;· ethical considerations;· subject population;· inclusion/exclusion criteria;· sample size;·treatment and treatment allocation;· investigation variables;· concomitant medications/treatments;·duration of follow up;·statistical analysis including investigation hypothesis or pass/fail criteria, sample size calculation, statistical analysis methods.e) ResultsThis section should contain summary information with a description of the analysis and results including:·the investigation initiation date;·investigation completion/suspension date;·the disposition of patients/devices;·the patient demographics;·clinical investigation plan compliance;·the analysis to include safety report, including a summary of all adverse events and adverse device events seen in the investigation,including a discussion of the severity, treatment required, resolutionand assessment by the investigator of relation to treatment;performance or efficacy analysis; any sub group analysis for specialpopulation; a description of how missing data, including patients lostto follow up or withdrawn, were dealt with in the analysis.f) Discussions and conclusionsThese should contain:·the performance and safety results of the study;·the relationship of risks and benefits;·clinical relevance and importance of the results, particularly in the light of other existing data and discussion of comparison with “state of the art”;·any specific benefits or special precautions required for individual subjects or at risk groups;·any implications for the conduct of future studies.g) SignatureThe final report should be signed off by the sponsor, the co-ordinating clincal investigator (if appointed) and principal investigator at each centreh) Annex to the reportThere should be an Annex to the report containing the following:· clinical investigation plan, including amendments.· list of investigators and their institutions;· list of other parties involved;· list of monitors;· list of statisticians, if applicable;· list of Ethics Committees and their approval letters.4.4.4Independent AnalysisAn assessment and analysis carried out by an independent and unbiased expert in the field should always be considered, particularly if in-house expertise is not available.4.4.5Conclusions from Analysis of Clinical Investigation DataAs a result of a review and analysis of the data generated by a specifically designed clinical investigation(s), the Notified Body needs to be able to answer the following:·that any identified pass/fail criteria of the investigation(s) have been mete.g. 98% of patient implanted with a hip prosthesis have no devicerelated adverse events at 2 years ;·that the results and conclusions of the clinical investigation(s) have demonstrated that compliance with the identified relevant essentialrequirements;· that the claims made in the device labelling are substantiated by clinical data when taken together with the relevant pre-clinical data;and· that the risk analysis has demonstrated that the risks associated with the use of the device as set out by the manufacturer is acceptablewhen balanced against the benefits to the patient.5.0The Role of the Notified BodyWith regard to the evaluation of clinical data the Notified Body has different roles depending on the conformity assessment procedure followed.As part of the design/type examination under Annexes II.4 or III, the Notified Body assesses the clinical data assembled by the manufacturer and the manufacturer’s evaluation and the validity of the conclusions drawn. (see 5.1)。
MEDDEV-2.7.1 Rev4(最新附中文2016)
EUROPEAN COMMISSIONDG Internal Market, Industry, Entrepreneurship and SMEsConsumer, Environmental and Health TechnologiesHealth technology and Cosmetics备注：中文翻译中的临床调查=临床研究，评估=评价、设备=器械、数据=资料MEDDEV 2.7/1 revision 4June 2016GUIDELINES ON MEDICAL DEVICES 医疗器械指南CLINICAL EVALUATION:A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EECNoteThe present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical Devices. They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts where circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interest parties in the medical devices sector. These guidelines incorporate changes introduced by Directive 2007/47/EC amending Council Directive 90/385/EEC and Council Directive93/42/EEC.本指南为一系列与CE—医疗器械指令应用问题相关的指南中的一部分。
医疗器械临床评价报告模板
医疗器械临床评价报告XXXXXXXXXXX临床评价报告一、概述我公司（XXXXXXXX）研制开发的 XXXXXXXXXXX 供临床XXXXXXX 用。
根据《医疗器械分类目录》的规定，XXXXXXXXXXX 为第二类 XXXXXXXX 器械，类别代号为：XXXXXXXX。
目前国内已有多个同类产品注册上市，广泛应用多年，其临床上的安全性、有效性早已得到确认。
二、产品设计本产品XXXXXXXX。
三、工作原理XXXXXXXXXXX 的工作原理是按无菌操作要求，撕开注射器单包装，去掉注射器保护套，抽取、溶解或配制药液用。
四、市场概况现在市场销售的同类产品主要有XXXXXXXXXXX 等。
这些产品在使用过程未发生过任何意外事故的报道；其中本公司的XXXXXXXXXXX 产品与国内厂家工作原理基本相同。
XXXXXXXXXXX 为列入《免于进行临床试验的医疗器械目录》产品，现将申报产品与《目录》所述内容进行对比以判定申报产品是否为列入《目录》产品。
申报产品与《目录》产品的对比表注：支持性资料是指申报产品与《目录》产品的差异性对申报产品的安全有效性不产生影响的理由和依据，可以附件的形式提供。
第 3 页共9 页五、对比产品选择现以与同类已上市产品进行对比评价，说明我公司产品在临床使用的安全性、有效性。
选择与我司产品类似，且同样按二类医疗器械产品注册的**** XXXXXXXXXXX。
六、主要对比情况说明第 4 页共9 页第 5 页共9 页第7 页共9 页七、与XXXXXXXX 有限公司产品对比结果通过上述对本公司产出的XXXXXXXXXXX 和 XXXXXXXX 有限公司生产的产品作对比分析，两款产品在工作原理、产品材质、结构组成、主要技术性能指标、消毒/灭菌方法、预期用途、是否家庭使用等方面均相似或一致，此两款产品为实质性等同产品。
八、中国政府已批准同类产品在境内上市的查询文件经从国家食品药品监督管理局官方网站 /数据查询，共有该类产品信息：国产 XXXXXXXXXXX6 条，现随机摘录其中产品结构、性能原理与本公司基本一致的、已注册的部分产品如下：九、国内外同类产品临床文献资料。
医疗器械风险管理报告
风险管理报告产品名称/商标：XXXXX产品产品型号/系列：XXXX文件编号：XX-XX-01文件版本：Ver A.0编制：日期：审核：日期：批准：日期：文件修订记录Revision Record目录第一章综述 (1)第二章风险管理评审输入 (2)第三章风险管理评审 (3)第四章风险管理评审结论 (4)附录1 风险评价和风险可接受准则附录2 XXXX产品安全性特征问题清单附录3 XXXX产品初始危害分析（PHA）附录4 XXXX产品初始风险评价和控制方案附录5 XXXX产品风险评价和风险控制措施记录表第一章 综 述1．产品简介1.1 工作原理见整机控制框图，XXXX 产品利用单片机控工作模式XXX 状态，由用户根据患者的情况进行选择。
选择“XXX1”模式时，……。
选择“XXX2”模式时，……。
1.2 功能结构本机设电源开关、XX 键、XX 键、XX 键，具有计数显示、XX 指示、工作状态指示、XX 模拟显示等功能。
1.3 工作顺序打开电源开关，机器处于待机状态：工作状态指示灯亮，计数显示为“00”。
选择“XXX1”或“XXX2”模式后，按下XX 键，机器开始工作：……。
1.4 产品组成XXXX 产品产品主要由气泵、控制电路、换向阀、容器、电磁阀组等组成。
1.5 产品预期用途：适用于医疗机构作……。
1.6 产品工作机理：XXXX 产品产品以气泵为动力源，利用空气压缩原理，通过气压和液压的转换，形成正压和负压……1.7 产品预期使用寿命：根据本产品的结构特性确定其预期使用寿命为X 年。
1.8 产品的基本性能 1) 流量：2) 压力设定范围：XXkPa ～XX kPa 3) 电 源：～220V ，50Hz 4) 输入功率：XXX VA 5) 电击防护类型：Ⅰ类设备 6) 电击防护程度：B 型应用部分 7) 外壳防护等级：IPX0 8) 运行模式：连续运行9) 熔丝管：RF1 5×20/ F500mAL 10) 噪音：≤65dB(A) 1.9 软件功能提供三个按键、一个位置检测和一个压力检测输入接口，用于启/停、“XXX1”和“XXX2”模式的选择、启动程序、检测换向阀的位置、监测管道内的压力状况并给出工作状态指示。
临床试验—病例表
甘露聚糖肽注射液辅助治疗恶性肿瘤的安全性和有效性的随机、双盲、与安慰剂平行对照、多中心临床再评价试验病例报告表（Case Report Form）受试者姓名缩写□□□□药物编号：□□□试验中心编号：□□试验开始日期年月日填表说明1．请用签字笔填写，字迹应清晰,易于辨认。
2．受试者姓名按汉语拼音首字母缩写靠左对齐填写。
3．在所有选择项目中，请在相应的方框中划“×” ;疼痛强度（PI）和疼痛缓解度等数字表示项目请在选择的相应数字上画圈“○”.4．每项填写内容务必准确,不得随便涂改，如发现填写内容有误,应在原记录上划单横线,在旁边写明正确内容，并注名修改者及日期。
不要用任何方式（橡皮、涂改液等)涂抹原记录。
5．不要改变病例报告表的格式，如发现表中没有位置填写记录者希望记录的资料时，请将有关信息记录于后面的空白附页中，并保留以上记录副本.6．知情同意书一般为患者签名.如患者有特殊情况,可由患者法定代理人签名。
试验观察流程图入组筛选表1．受试者应为：♦年龄：18 —70岁癌症患者(一般情况尚好,可适当放宽）♦性别不限♦预计生存期2个月以上的住院患者♦疼痛强度为中到重度，评分≥4♦并符合一下条件之一（请在符合的项目上画圈）1）入选前1周内曾使用XX，日剂量为40—60mg，疼痛强度可缓解到≤2；2）入选前1周内曾使用其它镇痛药，其全日剂量相当于40—60mgXX剂量,疼痛强度可缓解到≤2♦非放疗期或疼痛部位为非照射部位♦间歇期的化疗者，应由主管医生确认化疗后无止痛作用♦该患者是否同意参加本试验，并已签署知情同意书如以上任何一个答案为“否”,此受试者不能参加2．受试者排除标准：♦本研究开始前4周内曾参加过其他临床试验♦正在服用或本试验开始前2周内曾服用MAO抑制剂者(如优降宁、苯乙肼等)♦24小时内用过XX类镇痛药，或5日内用过XXX♦癌痛骨转移患者，近4周内接受同位素内放疗或/和双磷酸盐类药物治疗♦呼吸抑制、（肺)气道阻塞或组织缺氧♦胆道疾病♦心脏疾患(即Ⅱ级和Ⅱ级以上心功能)♦血压高于正常值♦血液系统疾病♦肝、肾功能明显异常(即指标高于正常值一倍以上）♦脑部疾病,判定能力异常♦XX药耐受、过敏，或曾在使用时因不良反应停药♦药物及∕或酒精滥用♦孕妇或哺乳期妇女如以上任何一个答案为“是",此受试者不能参加结论:该患者是否符合上述要求,同意入组是□□□□□□□□是□□□□□□□□□□□□□□□否□□□□□□□□否□□□□□□□□□□□□□□□医生签名:＿＿＿＿＿＿日期＿＿＿＿年＿＿＿月＿＿＿日病历简况1.1检查日期：年月日。