MEDDEV 2.1-3 rev 3 2009 指导方针适用于有源植入式医疗器械的90-385-EEC号理事会指令,有关医疗器械的93-42-EEC号理事会指令.修改件3

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EUROPEAN COMMISSION

DG ENTERPRISE and INDUSTRY

Directorate F, Unit F3 “Cosmetics and medical devices”

MEDICAL DEVICES: Guidance document

Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal

substance or an ancillary human blood derivative

MEDDEV 2. 1/3 rev 3

GUIDELINES RELATING TO THE APPLICATION OF:

THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES

THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES

Foreword

The present Guideline is part of a set of Guidelines relating to questions of application of EC Directives on medical devices. This guideline is not legally binding, since only the

European Court of Justice can give an authoritative interpretation of Community law. It has been elaborated by an expert group including experts from Member States' Competent

Authorities, the Commission’ services, as well as industry trade associations. It is therefore intended that the document will provide useful guidance which should assist common

positions to be taken throughout the European Union. Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that

these guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions.

The present guideline provides non-exhaustive lists of examples of medical devices, accessories to medical devices and medicinal products. Further examples may be found in the

manual on borderline and classification in the Community Regulatory framework for medical devices, published on the European Commission website.1 Particular attention should be

paid to borderline cases between medical devices and herbal medicinal products. This issue may be further developed in this guidance in the near future.

Note: This document is a revision of an earlier document published in July 2001 as MEDDEV 2.1/3 rev 2. Some of the examples given in the MEDDEV 2.1/3 rev 2 have not been

included in the present Guideline. These examples will be further elaborated in the above mentioned manual on borderline and classification in the Community Regulatory framework

for medical devices.

This guidance incorporates the changes introduced by the Directive 2007/47/EC. 2 These changes have to be applied as of 21 March 2010.

1 http://ec.europa.eu/consumers/sectors/medical-devices/documents/borderline/index_en.htm

2 OJ L 247 , 21.09.2007

Ref. Ares(2015)2062695 - 18/05/2015

CONTENTS Pages

SECTION A. BORDERLINE MEDICAL DEVICES /MEDICINAL PRODUCTS

A.1. Introduction

A.2 General Principles

A.2.1 Medical devices

A.2.1.1 Definition of medical devices

A.2.1.2 Examples of medical devices

A.2.1.3 Definition of an accessory of a medical device

A.2.1.4 Examples of accessories of medical devices

A.2.2 Medicinal products

A.2.2.1 Definition of medicinal products

A.2.2.2 Examples of medicinal products

SECTION B. DRUG-DELIVERY PRODUCTS AND MEDICAL DEVICES INCORPORATING AS AN INTEGRAL PART, AN ANCILLARY

MEDICINAL SUBSTANCE OR AN ANCILLARY HUMAN BLOOD DERIVATIVE

B.1 Introduction

B.2 Drug-delivery products regulated as medicinal products

B.2.1 Examples of drug-delivery products regulated as medicinal products

B3 Drug-delivery products regulated as medical devices

B.3.1 Examples of drug-delivery products regulated as medical devices

B.4 Medical devices incorporating, as an integral part, an ancillary medicinal substance

B.4.1 Examples of medical devices incorporating, as an integral part, an ancillary medicinal substance

B.5 Medical devices incorporating, as an integral part, an ancillary human blood derivative

SECTION C. CONSULTATION PROCEDURE ON MEDICAL DEVICES INCORPORATING, AS AN INTEGRAL PART, AN ANCILLARY

MEDICINAL SUBSTANCES OR AN ANCILLARY HUMAN BLOOD DERIVATIVE

C.1 Purpose of the consultation procedure on medical devices incorporating, as an integral part, an ancillary medicinal substance or an

ancillary human blood derivative

C.2 Notified Body actions to initiate consultation process on medical devices incorporating, as an integral part, an ancillary medicinal

substance or an ancillary human blood derivative

C.3 Documentation to be provided by the Notified Body to the Competent Authority for medicinal products

C.4 Consultation process on medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human

blood derivative

SECTION D. PROCEDURES FOR THE REPORTING OF ADVERSE INCIDENTS 21

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标签： #医疗器械

摘要：

本文件为欧盟医疗器械领域的重要指导方针 MEDDEV 2.1-3 rev 3 2009，详细阐述了适用于有源植入式医疗器械的 90-385-EEC 号理事会指令，以及有关医疗器械的 93-42-EEC 号理事会指令及其修改件 3 的相关要求。该指导方针旨在为制造商、公告机构和监管当局提供统一的技术文件编制与审核标准，确保有源植入式医疗器械在欧盟市场中的安全性、性能及合规性。内容涵盖了医疗器械的符合性评估程序、临床评价要求、风险管理以及上市后监督等关键环节。对于从事有源植入式医疗器械研发、注册及质

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MEDDEV 2.1-3 rev 3 2009 指导方针适用于有源植入式医疗器械的90-385-EEC号理事会指令,有关医疗器械的93-42-EEC号理事会指令.修改件3

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