MEDDEV 2.7-1 rev 4 2016 医疗器械临床评估指南：93-42-EEC 和 90-385-EEC 指令下的制造商和公告机构指南（修订版 4）

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MEDDEV 2.7/1 revision 4 page 1 of 65

EUROPEAN COMMISSION

DG Internal Market, Industry, Entrepreneurship and SMEs

Consumer, Environmental and Health Technologies

Health technology and Cosmetics

GUIDELINES ON MEDICAL DEVICES

CLINICAL EVALUATION:

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 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.

MEDDEV 2.7/1 revision 4

June 2016

Ref. Ares(2016)3047772 - 29/06/2016

MEDDEV 2.7/1 revision 4 page 2 of 65

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. Introduction.........................................................................................................................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 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. 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 evaluate 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 considerations.....................................................................................................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

MEDDEV 2.7/1 revision 4 page 3 of 65

A1. Demonstration of equivalence..........................................................................................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

A5.2. 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. Conformity 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 requirement 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..................................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 3)..........................................................................................................57

A12.3. Evaluation as part of quality system related procedures..................................................61

A12.4. Notified body specific procedures and expertise..............................................................62

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标签： #评估 #临床 #医疗器械

摘要：

本指南文档《MEDDEV 2.7-1 rev 4 2016 医疗器械临床评估指南》是欧盟委员会发布的权威性指导文件，旨在为制造商和公告机构提供在欧盟医疗器械指令93-42-EEC及有源植入式医疗器械指令90-385-EEC框架下进行临床评估的详细方法和标准。修订版4强调临床评估应基于持续的数据收集和科学文献评价，明确要求制造商制定并更新临床评估计划（CEP）、临床评估报告（CER）及相关安全性和性能数据。文档详细阐述了等同性论证、文献检索策略、数据评价、上市后临床跟踪（PMCF）以及临床证据等级

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MEDDEV 2.7-1 rev 4 2016 医疗器械临床评估指南：93-42-EEC 和 90-385-EEC 指令下的制造商和公告机构指南（修订版 4）

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