MEDDEV 2.7.1rev42016附中文

MEDDEV2.71 revision 4 June 2016 Guidelines on Medical Devices Clinical Evaluation：A Guide for Manufacturers And Notified Bodies Under Directives 9342EEC and 90385EEC

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

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.

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对90/385/EEC和 93/42/EEC修正中的变更

（没规定实施时间）

MEDDEV2.71 revision 4 June 2016 Guidelines on Medical Devices Clinical Evaluation：A Guide for Manufacturers And Notified Bodies Under Directives 9342EEC and 90385EEC

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)

MEDDEV2.71 revision 4 June 2016 Guidelines on Medical Devices Clinical Evaluation：A Guide for Manufacturers And Notified Bodies Under Directives 9342EEC and 90385EEC

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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