MEDDEV 2.12-2 rev 2 2012 市场后续临床跟踪研究.制造商和公告机构指南(版本2)

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EUROPEAN COMMISSION

DIRECTORATE GENERAL for HEALTH and CONSUMERS

Consumer Affairs

Health technology and Cosmetics

MEDDEV 2.12/2 rev2

January 2012

GUIDELINES ON MEDICAL DEVICES

POST MARKET CLINICAL FOLLOW-UP STUDIES

A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

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 interest 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.

CONTENTS

1. Introduction ................................................................................................................................ 3

2. Scope .......................................................................................................................................... 4

3. References .................................................................................................................................. 4

4. Definitions.................................................................................................................................. 6

5. Circumstances where a post market clinical follow up study in indicated ................................. 8

6. Elements of a post-market clinical follow up study................................................................. 10

7. The use of study data ................................................................................................................ 12

8 The role of the notified body in post-market clinical follow up .............................................. 12

Preface

This document is intended to be a guide for manufacturers and Notified Bodies on

how to carry out Post-Market Clinical Follow-up (PMCF) studies in order to fulfil

Post-Market Surveillance (PMS) obligations according to Section 3.1 of Annex II,

Section 3 of Annex IV, Section 3 of Annex V, Section 3.1 of Annex VI or Section 4

of Annex VII of the Medical Devices Directive (93/42/EEC) and Section 3.1 of

Annex 2, Section 3 of Annex 4, Section 3.1 of Annex 5 of the Active Implantable

Medical Devices Directive (90/385/EEC). These Sections refer to requirements of

Annex X of Directive 93/42/EEC and Annex 7 of Directive 90/385/EEC, respectively.

Attention is drawn to paragraph 8 of Article 15 of Directive 93/42/EEC which spells

out the provisions of Article 15 that are not applicable to clinical investigations

conducted using CE-marked devices within their intended use.

Similarly when PMCF studies are conducted using CE marked devices within their

intended use, the provisions of section 2.3.5 of Annex X of Directive 93/42/EEC do

not apply. However, the provisions of Directive 93/42/EEC concerning information

and notification of incidents occurring following placing devices on the market are

fully applicable.

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标签： #临床 #制造

摘要：

MEDDEV 2.12-2 rev 2 2012 是欧盟医疗器械监管领域的关键指南文件，专门针对市场后续临床跟踪研究（PMCF）。该版本（版本2）为制造商和公告机构提供了详细的实施步骤与要求，帮助企业在产品上市后持续收集临床数据，以验证其安全性和性能。指南强调了PMCF在主动监测患者长期结果、识别潜在风险以及支持持续合规中的重要性，尤其适用于IIb类、III类以及植入类器械。通过遵循该指南，制造商能够有效规划研究方案、分析数据并提交报告，而公告机构则可依据统一标准进行评估。掌握MEDDEV 2.

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MEDDEV 2.12-2 rev 2 2012 市场后续临床跟踪研究.制造商和公告机构指南(版本2)

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