MDD指南,MEDDEV2.1.1-1994.04,医疗器械、附件、制造商的定义
EUROPEAN COMMISSION
DG ENTERPRISE
Directorate G
Unit 4 - Pressure Equipment, Medical Devices, Metrology
MEDICAL DEVICES : Guidance document
MEDDEV 2. 1/1
April 1994
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
Definition of "medical devices"
Definition of "accessory"
Definition of "manufacturer"
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LIST OF CONTENTS
I.FIELD OF APPLICATION - DEFINITIONS
1.Directive 93/42/EE on medical devices
2.Directive 90/385/EEC on active implantable medical devices1
3.Interface with other directives
- medical devices/medicinal products
- medical devices/electromagnetic compatibility2
- medical devices/personal protective equipment2
II.CLASSIFICATION OF MEDICAL DEVICES COVERED BY DIRECTIVE 93/42/EEC3
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玻尿酸功效III.CONFORMITY ASSESSMENT PROCEDURES(*):
1.CE-marking
2.Application
-Annex 5
-Annex 2分指手套
. Quality systems
. Examination of the design dossier
- Annex 3
3.Conduct of audits4
4.Format of decisions, design examination certificate
5.Technical Dossier
IV.CUSTOM MADE DEVICES(*):
V.DEVICES INTENDED FOR CLINICAL INVESTIGATIONS(*):
VI.MEDICAL DEVICE VIGILANCE(*):
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E OF LANGUAGES(*):
VIII.TRANSITIONAL PERIOD(*):
1e MEDDEV. 5/93 rev. 2
2e MEDDEV 13/93
3e MEDDEV.10/93 rev. 1
4e MEDDEV. 1/94
I.FIELD OF APPLICATION - DEFINITIONS
1.Directive 93/42/EEC on medical devices
1.1Definition of "medical devices"
a)devices - accessory
The definition of the term "medical device" together with the
definition of "accessory" is determinant for the delimitation of the field
of application of Directive 93/42/EEC. A slight difference exists
大蒜素肠溶胶囊between the definition in article 1(2) (a) of Directive 93/42/EEC and in
article 1(2) of Directive 90/385/EEC.
Following the latter directive, accessories are by definition medical
devices, whilst following Directive 93/42/EEC, a distinction is made
between "devices" and "accessories". Therefore within the meaning of
Directive 93/42/EEC, accessories are products in their own right and,
although being treated as devices (article 1(1)) do not follow, as a
general rule, the classification of related devices in conjunction with
which they are ud.
Accessories are therefore following Directive 93/42/EEC to be
classified in their own right.
张沄熙b)medical purpo
Medical devices are defined as articles which are intended to be ud
for a medical purpo. The medical purpo is assigned to a product
by the manufacturer. The manufacturer determines through the label,
the instruction for u and the promotional material related to a given
device its specific medical purpo. As the directive aims esntially at
the protection of patients and urs, the medical purpo relates in
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general to finished products regardless of whether they are intended
to be ud alone or in combination. This means that the protection
跳绳方法ensured by the directive becomes valid for products having a stage of
manufacture, where they are supplied to the final ur.
Following this concept, raw materials, components or intermediate掌心长痣
products are as such normally not medical devices. Such raw
materials may need to prent properties or characteristics which are
determinant for the safety and quality of finished devices. It is
therefore the responsibility of the manufacturer of finished devices to
lect and control by adequate means his raw materials or
intermediate products (e Annex I, ction 7.1; Annex II, ction 3.2;
Annex V, ction 3.2 of Directive 93/42/EEC)
Spare parts supplied for replacement of existing components of a
device, the conformity of which has already been established, are not
medical devices. If spare parts, however, change significantly the
characteristics or performances of a device with regard to its already
established conformity, such spare parts are to be considered as
devices in their own right.
c)customizing
The concept of "finished device" does not imply that a device when
reaching the final ur is already in a state ready for u. Prior to u
further preparatory processing, preparation, configuration,
installation, asmbling, adaptation or fitting to the needs of the ur
or patient may be required. Examples :
-sterilisation of medical devices supplied non-sterile
