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 3

III. CONFORMITY ASSESSMENT PROCEDURES(*):

1. CE-marking
2. Application
- Annex 5
- Annex 2
. 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(*):

VII. USE OF LANGUAGES(*):

VIII. TRANSITIONAL PERIOD(*):

1 see MEDDEV. 5/93 rev. 2
2 see MEDDEV 13/93
3 see MEDDEV.10/93 rev. 1
4 see MEDDEV. 1/94

I. FIELD OF APPLICATION - DEFINITIONS

1. Directive 93/42/EEC on medical devices

1.1 Definition of "medical devices"

a) devices - accessory

The definition of the term "medical device" together with the

Accessories are therefore following Directive 93/42/EEC to be

b) medical purpose

Medical devices are defined as articles which are intended to be used

Following this concept, raw materials, components or intermediate

Spare parts supplied for replacement of existing components of a

c) customizing

The concept of "finished device" does not imply that a device when

- sterilisation of medical devices supplied non-sterile
- assembling of systems
- configuration of electronic equipment
- preparation of a dental filling
- fitting of contact lenses
- adaptation of prosthesis to the needs of the patient.

The aforementioned activities are normally not manufacturers

A particular consideration in this context needs to be given for the

This applies essentially to dental alloys, dental ceramics, modular

d) medical - toiletry purpose

The definition of "medical device" should be understood to include

- tooth brushes, dental sticks, dental floss;
- baby diapers, hygiene tampons;
- contact lenses without corrective function intended to

Examples for products, where depending on the circumstances, a

e) aids for handicapped persons

In the case of equipment intended for alleviation of or compensation

- acoustic signals at traffic lights,
- special water taps, toilet equipment for handicapped

f) software

The following distinction can be made : software influencing the

- calculation of anatomical sites of the body,
- image enhancing software intended for diagnostic

There is no medical purpose in the case of software used for

g) multipurpose products

Products with a multiple purpose which may be used occasionally in a

- multipurpose PC, printer, scanner, ...
_ magnetoscope, screen.

1.2 Definition of "accessory"

The question whether a product is a "device" or a "accessory" has not

The definition of "accessory" requires that the accessory is specifically

Examples for accessories depending on defined circumstances of

devicerelated

1.3 Definition of "manufacturer"

Users in-house manufacturing

The Directive defines a manufacturer as the natural or legal person

The reason for this link with the placing on the market is that the directives aims to subject to its protection requirements the transaction of a device from the sphere of a manufacturer towards the public. The directive does not provide any specific provisions for the case where a device is manufactured by the user (for example, a hospital) without being transferred to another person. The decision to which extent such in-house manufacturing activities by hospitals are subjected to legal requirements, belongs therefore to the national legislator. This relates however exclusively to such in-house manufacturing activities where a device remains within the users, but not to cases where, for example, a hospital produces orthopaedic devices for use with patients.

(Partial information is quoted as below, for full version of this Guidelines, please click the Highlighted headings below)

GUIDELINES FOR THE CLASSIFICATION OF MEDICAL DEVICES

1. PURPOSE AND PHILOSOPHY OF MEDICAL DEVICE CLASSIFICATION
2. PRACTICAL RELEVANCE OF CLASSIFICATION
2.1. General requirements
2.2. Conformity assessment
2.3. Clinical data
2.4. Labelling
2.5. Miscellaneous
3. HOW TO CARRY OUT CLASSIFICATION
3.1. Basic definitions
3.2. Application rules
3.3. How to use the rules and the decision tree
3.4. Practical example
3.5. Handling of interpretational problems
4. EXPLANATIONS OF INDIVIDUAL RULES
4.1. Graphical summary - Guidance chart
4.2. General explanation of rules/Practical issues/Examples
APPENDICES:
1. Annex IX of the Medical Device Directive

PART 2: GUIDELINES FOR THE CLASSIFICATION OF MEDICAL DEVICES

ALL information is cited from:

EUROPEAN COMMISSION DG ENTERPRISE
Directorate G Unit 4 - Pressure Equipment, Medical Devices, Metrology
MEDICAL DEVICES : Guidance document