欧盟临床评价指导原则

临床试验临床试验评价指导文件,临床评价范围,数据鉴别,评估、文献检索、评价报告

Ref.Ares(2016)3047772-

29/06/2016 EUROPEAN COMMISSION欧盟委员会

DG Internal Market,Industry,Entrepreneurship and SMEs

Consumer,Environmental and Health Technologies

Health technology and Cosmetics

卫生技术和化妆品

MEDDEV2.7/1revision4

June2016

GUIDELINES ON MEDICAL DEVICES

医疗器械指南

CLINICAL EVALUATION:临床评价

A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

UNDER DIRECTIVES93/42/EEC and90/385/EEC

基于93/42/EEC和90/385/EEC指令适用于制造商和

公告机构的指南

Note

The 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 Directive2007/47/EC amending Council Directive90/385/EEC and Council Directive

93/42/EEC.

本指南是欧盟医疗器械指令相关应用问题指南的一部分。该指南并不具有法律约束力。这一指南是在严格咨询了各利益相关方（主管部门、服务委员会、企业和其它利益团体）后认真起草的，在此期间对中期草案进行了传阅并采纳了部分建议。因此，

本指南反映了医疗器械行业利益团体所代表的立场。本指南整合了由2007/47/EC指令对90/385/EEC和93/42/EEC指令修订

产生的变更。

MEDDEV2.7/1revision4page1of65

临床试验临床试验评价指导文件,临床评价范围,数据鉴别,评估、文献检索、评价报告

Appraisal of pertinent data (Stage 2)相关数据评估（阶段2） (19)

General considerations 总则 (19)

The appraisal plan 评估计划 (20)

Conduct of the appraisal 评估进行 (20)

How to evaluate methodological quality and scientific validity 如何评价方法质量和科学有效.20

How to determine the relevance of a data set for the clinical evaluation 如何确定数据集相关性24

How to weight the contribution of each data set 如何衡量每一数据集权重 (26)

10.Analysis of the clinical data (Stage 3)临床数据分析（阶段3）..............................................27General considerations 总则...................................................................................................27Specific considerations 具体细则...........................................................................................27Where demonstration of conformity based on clinical data is not deemed appropriate .. (29)

10.1.10.2.10.3.11.12.The clinical evaluation report (CER,Stage 4)临床评价报告（阶段4） (29)

The role of the notified body in the assessment of clinical evaluation reports..................31Appendices 附录.. (32)

MEDDEV 2.7/1revision 4page 2of 65MEDICAL DEVICES DIRECTIVES

CLINICAL INVESTIGATION

医疗器械临床试验指南

CLINICAL EVALUATION:临床评价

A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

UNDER DIRECTIVES 93/42/EEC and 90/385/EEC

基于93/42/EEC 和90/385/EEC 指令适用于制造商和公告机构的指南

Index

目录

1.

2.

3.

4.

5.Introduction 前言....................................................................................................................4Scope 范围...........................................................................................................................4References 参考文献............................................................................................................4Definitions 定义......................................................................................................................5Abbreviations 缩写词..............................................................................................................86.6.1.6.2.6.2.1.6.2.2.6.2.3.6.3.General principles of clinical evaluation 临床评价一般原则 (9)

What is clinical evaluation?什么是临床评价 (9)

When is clinical evaluation undertaken and why is it important?何时开展和为什么重要 (10)

Clinical evaluation undertaken for the development of a medical device.为开发展开评价 (10)

Clinical evaluation for initial CE-marking 为首次CE 认证进行临床评价 (11)

Updating the clinical evaluation 临床评价更新 (11)

How is a clinical evaluation performed?如何进行临床评价 (13)

Who should perform the clinical evaluation?由谁执行临床评价 (14)

6.4.7.Definition of the scope of the clinical evaluation (Stage 0)定义临床评价的范围（阶段0） (15)

8.8.1.8.2.Identification of pertinent data (Stage 1)相关数据鉴别（阶段1） (17)

Data generated and held by the manufacturer 制造商生成和掌握的数据 (17)

Data retrieved from literature 文献检索数据...........................................................................189.9.1.9.2.9.3.9.3.1.9.3.2.9.3.3.

临床试验临床试验评价指导文件,临床评价范围,数据鉴别,评估、文献检索、评价报告

A1.A2.A3.A4.Demonstration of equivalence 等同性证明........................................................................32When should additional clinical investigations be carried out?何时需开展新的临床试验34Device description -typical contents 器械描述-代表内容................................................35Sources of literature 文献来源..........................................................................................36A5.Literature search and literature review protocol,key elements 文献检索和审评方案，关键要素37

Background to the literature search and the literature review 文献检索和文献审评背景.38Objective 目标...................................................................................................................38Methods 方法............................. …… 此处隐藏：46515字，全部文档内容请下载后查看。喜欢就下载吧 ……