MEDDEV 2.7-2 revision 2 2015 临床研究申请在指令 93-42-EEC 和 90-385-EEC 下进行有效验证评估的指南

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EUROPEAN COMMISSION

DG Internal Market, Industry, Entrepreneurship and SMEs

Consumer, Environmental and Health Technologies

Health technology and Cosmetics

GUIDELINES ON MEDICAL DEVICES

GUIDELINES FOR COMPETENT AUTHORITIES

FOR MAKING A VALIDATION/ASSESSMENT OF A

CLINICAL INVESTIGATION APPLICATION

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 2.7/2 revision 2

September 2015

Ref. Ares(2015)4243818 - 12/10/2015

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MEDICAL DEVICES DIRECTIVES

CLINICAL INVESTIGATION

GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A

VALIDATION/ASSESSMENT OF A

CLINICAL INVESTIGATION APPLICATION

Index

0. PREFACE

1. INTRODUCTION

2. SCOPE

3. REFERENCES

4. DEFINITIONS

5. ETHICAL CONSIDERATIONS

6. VALIDATION

7. ASSESSMENT

8. DECISION ON APPROVAL/AUTHORIZATION

9. INFORMATION TO BE EVALUATED DURING THE CONDUCT OF A

CLINICAL INVESTIGATION AND AT THE END

9.1 Suspension of a Clinical Investigation

9.2 Termination, Temporary Halt, Clinical Investigation

Report

9.3 Follow-up

APPENDICES

1a: List of the standards applied in full or in part

1b: Matrix of Essential Requirements applicable to IMD

2: Guidance notes on medical devices incorporating a medicinal substance

having ancillary action

3: Guidance on medical devices which require sterilization

4: Guidance on clinical investigations of active devices

5: Guidance on clinical investigations of software

6: Guidance on medical devices incorporating tissues of animal origin

7: Clinical investigation application form

8: Clinical investigation validation checklist

9: Clinical investigation assessment checklist

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0. PREFACE:

These guidelines on the validation/assessment of a clinical investigation application are part

of a set of Medical Device Guidelines that, according to the relevant Annexes of the Medical

Devices Directives, promote a common approach in clinical investigation validation and

assessment procedures by Competent Authorities charged with safeguarding public health.

The guidelines are regularly updated according to regulatory developments. The latest

version of the guidelines should always be used. This revision of the previous version has:

• modified the structure to align with the structure of other Medical Device Guidelines

and to better reflect the relevant Directives and take note of the harmonized standard

EN ISO 14155;

• provided some basic criteria to promote a harmonized approach in clinical

investigation assessment among Member States and further the understanding of the

requirements of Directive 93/42/EEC concerning medical devices and Directive

90/385/EEC relating to active implantable medical devices as amended by Directive

2007/47/EC;

• rephrased some paragraphs to reflect the above listed changes;

• introduced new Appendices to standardize specific procedures or provide checklists.

These guidelines are not legally binding. It is recognised that under given circumstances, for

example as a result of scientific developments, an alternative approach may be possible or

appropriate to comply with the legal requirements.

Nevertheless, due to the participation of the aforementioned interested parties and of experts

from National Competent Authorities, it is anticipated that the guidelines will be followed within

the Member States and, therefore, support uniform application of relevant EU Directive

provisions and common practices within Member States.

However, only the text of the Directives constitutes legal requirements. On certain issues not

addressed in the Directives, national legislation may be different from these guidelines.

1. INTRODUCTION

These guidelines are addressed to Competent Authorities responsible for

validation/assessment of clinical investigation applications referred to in article 10 of Council

Directive 90/385/EEC1 and in article 15 of Council Directive 93/42/EEC2, as amended.

However roles of Competent Authorities (CAs) may vary between Member States, and other

bodies, such as Ethics Committees, are involved in the assessment/approval process of

clinical investigations mentioned above, according to national regulations. Competent

Authorities shall encourage the use of these guidelines by all the Ethics Committees and

other possible national bodies involved in the assessment of clinical investigational

application, according to national law.

Competent Authorities shall ensure that the information submitted in the application pursuant

to annex 6 of Directive 90/385/EEC or annex VIII of Directive 93/42/EEC, contains the items

listed below (if appropriate) and is adequate in detail.

It is also important to ensure that the clinical investigation plan shall include documented

procedures and a study design in accordance with the provisions of Section 2 of Annex 7 of

Directive 90/385/EEC or Section 2 of Annex X of Directive 93/42/EEC. Furthermore it is

important that the clinical investigation plan correctly reflects the clinical evaluation as

planned by the manufacturer/sponsor.

1 Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable

medical devices, last amended by Directive 2007/47/EC of the European Parliament and of the Council.

2 Council Directive 93/42/EEC concerning medical devices, last amended by Directive 2007/47/EC of the European

Parliament and of the Council.

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摘要：

本指南文档《MEDDEV 2.7-2 revision 2 2015 临床研究申请在指令 93-42-EEC 和 90-385-EEC 下进行有效验证评估的指南》是欧盟医疗器械监管框架下的核心指南之一，重点阐述了如何依据旧版医疗器械指令（93/42/EEC 和 90/385/EEC）对临床研究申请进行有效验证与评估。文档适用于制造商、公告机构及临床评估人员，旨在确保临床研究设计符合伦理与法规要求，并能为产品安全性与性能提供充分证据。内容涵盖研究方案的结构要求、数据完整性检查、风险分析整合、以及验

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MEDDEV 2.7-2 revision 2 2015 临床研究申请在指令 93-42-EEC 和 90-385-EEC 下进行有效验证评估的指南

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