MEDDEV271 Rev4最新附中文.docx

1、MEDDEV271 Rev4最新附中文EUROPEAN COMMISSION DG Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies Health 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 4 June 2016 GUIDELINES ON MEDICAL DEVICES 医疗器械指南 CLINICAL EVALUATI

2、ON: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC 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 t

3、hrough 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 ta

4、ken 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

5、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对90/385/EEC和 93/42/EEC修正中的变更 （没规定实施时间） MEDICAL DEVICES DIRECTIVES CLINICAL INVESTIGATION CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC Index 1. Int

6、roduction. 4 2. Scope . 4 3. References . 4 4. Definitions. 5 5. Abbreviations. 8 6. General principles of clinical evaluation . 9 6.1. What is clinical evaluation? . 9 6.2. When is clinical evaluation undertaken and why is it important?. 10 6.2.1. Clinical evaluation undertaken for the development

7、of a medical device . 10 6.2.2. Clinical evaluation for initial CE-marking . 11 6.2.3. Updating the clinical evaluation . 11 6.3. How is a clinical evaluation performed? . 13 6.4. Who should perform the clinical evaluation? . 14 7. Definition of the scope of the clinical evaluation (Stage 0) . 15 8.

8、 Identification of pertinent data (Stage 1). 17 8.1. Data generated and held by the manufacturer . 17 8.2. Data retrieved from literature. 18 9. Appraisal of pertinent data (Stage 2) . 19 9.1. General considerations. 19 9.2. The appraisal plan . 20 9.3. Conduct of the appraisal. 20 9.3.1. How to eva

9、luate methodological quality and scientific validity . 20 9.3.2. How to determine the relevance of a data set for the clinical evaluation. 24 9.3.3. How to weight the contribution of each data set. 26 10. Analysis of the clinical data (Stage 3). 27 10.1. General considerations. 27 10.2. Specific con

10、siderations. 27 10.3. Where demonstration of conformity based on clinical data is not deemed appropriate . 29 11. The clinical evaluation report (CER, Stage 4) . 29 12. The role of the notified body in the assessment of clinical evaluation reports. 31 Appendices. 32 A1. Demonstration of equivalence

11、. 32 A2. When should additional clinical investigations be carried out?. 34 A3. Device description - typical contents . 35 A4. Sources of literature . 36 A5. Literature search and literature review protocol, key elements . 37 A5.1. Background to the literature search and the literature review . 38 A

12、5.2. Objective. 38 A5.3. Methods. 39 A6. Appraisal of clinical data - examples of studies that lack scientific validity for demonstration of adequate clinical performance and/or clinical safety . 39 A7. Analysis of the clinical data - compliance to specific Essential Requirements . 41 A7.1. Conformi

13、ty assessment with requirement on safety (MDD ER1 / AIMDD ER1). 41 A7.2. Conformity assessment with requirement on acceptable benefit/risk profile (MDD ER1 / AIMDD ER1) . 42 A7.3. Conformity assessment with requirement on performance (MDD ER3 / AIMDD ER2) . 46 A7.4. Conformity assessment with requir

14、ement on acceptability of undesirable side-effects (MDD ER6 / AIMDD ER5) . 47 A8. Devices for unmet medical needs - aspects to consider . 48 A9. Clinical evaluation report - proposed table of contents, examples of contents. 49 A10. Proposed checklist for the release of the clinical evaluation report

15、 . 54 A11. Information on declarations of interests. 56 A12. Activities of notified bodies . 56 A12.1. Notified body assessment of clinical evaluation by conformity assessment route . 56 A12.2. Examination of a design dossier (Annex II.4; Annex 2.4) or of a type examination dossier (Annex III; Annex

16、 3). 57 A12.3. Evaluation as part of quality system related procedures . 61 A12.4. Notified body specific procedures and expertise . 62 1. Introduction 介绍 Pursuant to 依据 - section 6a of Annex I to Directive 93/42/EEC (amended by Directive 2007/47/EC) and to - section 5a of Annex 1 to Directive 90/38

17、5/EEC (amended by Directive 2007/47/EC), the demonstration of conformity with Essential Requirements for a medical device must include a clinical evaluation, which is conducted in accordance with Annex X to Directive 93/42/EEC or with Annex 7 to Directive 90/385/EEC. MDD 指令93/42/EEC (amended by Dire

18、ctive 2007/47/EC) 附录I的6a部分和 MDD指令90/385/EEC (amended by Directive 2007/47/EC) 附录I的5a部分 和医疗器械的基本要求一致性的证明必须包含临床评价，根据Directive 93/42/EEC的附录10和Directive 90/385/EEC的附录7来指导。 This document promotes a common approach to clinical evaluation for medical devices regulated by directives 90/385/EEC and 93/42/EEC

19、. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question. Therefore, this guidance is not intended to impose device-specific requirements. 这个文件提供了按directives

20、 90/385/EEC and 93/42/EEC规定开展医疗器械临床评价的一般途径，不包含体外诊断试剂。 This document uses the terms must, shall, have to where these terms are used in the Directives. Should is used in other instances. 本文档使用了术语“必须”、“应当”、“必须”这些术语使用的指令。“应该”在其他情况下使用。 2. Scope范围 This guide is not legally binding; only the text of the Directives is authentic in