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MEDDEV 5
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WORKING DOCUMENT
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
- Field of application of Directive 90/385/EEC -
Note
The present first draft for a Guidelines Document has been elaborated
taking account of various comments and questions addressed to the Commission by Member
States and parties concerned. It forms a support for the subjects to be discussed and
requires further elaboration subsequent to such discussions.
The various parts of the guidelines will at the present stage of
preparation, be subject to separate circulation and discussion.
INTRODUCTION
These guidelines should be read in conjunction with the Directive
90/385/EEC relating to active implantable medical devices and the Directive 93/42/EEC
relating to medical devices. They provide a practical support for the uniform application
of these Directives. The guidelines deal with specific issues in the context of the
aforementioned Directives. They are therefore of complementary nature to the general
vade-mecum relating to the application of New Approach Directives.
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 devices
3. Interface with other directives (*):
- medical devices/medicinal products
- medical devices/electromagnetic compatibility
- medical devices/personal protective equipment
II. CLASSIFICATION OF MEDICAL DEVICES COVERED BY DIRECTIVE
93/42/EEC(*):
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 audits
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(*):
I. FIELD OF APPLICATION
I. 2. DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES
The Directive 90/385/EEC covers the placing on the market and putting
into service of "active implantable medical devices".
2.1. Active implantable medical device
A product falls within the field of application of the Directive if it
complies with the definition given in this Directive. That means, it must be a
"medical device" as defined which is, at the same time, both "active"
and "implantable"
2.1.1 The "device" definition within the
meaning of Directive 90/385/EEC relates to a product intended by the manufacturer for a
medical purpose "whether used alone or in combination, together with any accessories
or software for its proper functioning". The medical purpose may be achieved either
by a "stand alone device" or as a result of several devices acting each in
combination with the other as part of a system. Where the medical purpose is achieved by a
system, each element of the system may be regarded as a medical device. The device
definition may consequently apply to the system as such or to interchangeable parts
intended to form a system together with other devices, therefore for the purposes of the
Directive on Active Implantable Medical Devices each part belonging to such system is
covered by the Directive regardless of whether such part on its own is "active",
"active implantable" or not.
Examples of AIMDs :
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a) - implantable pulse generator for pacing including the electrode
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- implantable pulse generator without electrode
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- electrode
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b) - implantable drug administration device with or without catheter
- catheter for implantable drug administration device
2.1.2. For the purpose of the Directive 90/385/EEC a medical
device is active if it "relies for its functioning on a source of electrical
energy or any source of power other than that directly generated by the human body or
gravity. This includes, for instance, devices activated by means of pressure unless this
effect is achieved by energy resulting from the body of the patient. The definition
implies that the function of the device involves using the source of power to perform
useful work. The mere transmission of heat, light, pressure or vibration does not mean
that a device is active.
Examples :
- a hydrocephalus pressure relief allowing release of cerebro-spinal
fluid when a spring is overcome is not "active". Even where the setting of the
spring can be adjusted by electro-magnetic means, it remains non-active as the medical
function of the device is to relieve pressure, not to be adjusted,
- a drug delivery device in which the drug is driven from a reservoir
by means of a stored energy source (spring, fluid, gas, etc...) is "active"
- an intravascular cathether containing a fibre-optic bundle connected
to an external light source may be used to measure pressure or other characteristics of
blood if some quality of the light can be changed by the blood characteristic and
detected. Although the system as a whole depends on a power source to achieve its medical
function (the measurement of a blood characteristic) the invasive element is not
"active" as it does no more than transmit light
- a cochlear implant activated by an external power transmitter is
regarded as "active" as the implanted component clearly depends on a power
source for its function and its purpose is to convert the power it receives into
electrical signals which trigger appropriate sensory channels in the brain, i.e. it
performs useful work.
2.1.3. An active medical device is defined as
"implantable" if it is "totally or partly introduced, surgically or
medically, into the human body or by medical intervention into a natural orifice, and
which is intended to remain after the procedure".
The Directive has been conceived for active devices for which a
potential high risk may be inherent due to the fact that they are totally or partly
implanted into the body. Such devices may present hazards in particular with regard to
impossibility of maintenance, calibration or control and problems relating to the ageing
of materials, as mentioned in several essential requirements of Annex 1 to the Directive.
The attribute "implantable" has therefore to be interpreted bearing in mind
those hazards typical for implantable devices.
For the aforementioned reasons, an external drug infusion pump, although for long-term or
permanent use, which is connected to a catheter "partially introduced" into the
body is not considered as an active implantable device.
One of the essential characteristics of an implantable device is its relatively long-term
use. Distinction is to be made between an intended use of a device which is permanent or
long-term in the order of several months compared to a temporary use during a given
medical intervention. An external pacemaker, including its electrode, used for an interim
process is thus not considered as "remaining after the procedure". The same
applies to the use of an intra-aortic balloon pump. For the purpose of the Directive
90/385/EEC, the term "procedure" is to be interpreted as a process of diagnosis,
monitoring or treatment which may last for some days, generally in hospital, and not
necessarily exclusively relating to an operation carried out in the theatre in the course
of which the device is placed in the body.
2.2. "Accessories" to an active implantable medical
device are by definition "active implantable medical devices" and
therefore covered by the Directive 90/385/EEC. This does not presuppose that the
attributes "active" and "implantable" must be necessarily met by a
product called "accessory". It is sufficient that a product in its intended
purpose is ancillary to the purpose of an active implantable medical device in such a way
that it enables the device to be used in accordance with the intended device purpose or
that it enhances the purpose of a device as intended by the device manufacturer.
Following this a programmer or an external transmitter intended for activating or
controlling the implantable part of the device is covered by the definition of
"active implantable medical device".
2.3. exemplative list of active implantable medical devices
The subsequent list contains examples of types of devices which are normally
covered by Directive 90/385/EEC :
1. implantable cardiac pacemakers
2. implantable defibrillators
3. leads, electrodes, adaptors for 1. and 2.
4. implantable nerve stimulators
5. bladder stimulators
6. sphincter stimulators
7. diaphragm stimulators
8. cochlear implants
9. implantable active drug administration device
10. catheters, sensors for 9.
11. implantable active monitoring devices
12. programmers, software, transmitters.
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