CE Marking (CE Mark) for active implantable medical devices: EU Council Directive of 20 June 1990 (90/385/EEC)

Brief Introduction of
Directive 90/385/EEC
Active Implantable Medical Devices

COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)

This directive has been amended by the following Council Directives:

1. 92/59/EEC of 29 June 1992 (General Product Safety);
2. 93/42/EEC of 1993 (Medical Devices);
3. 93/68/EEC of 22 July 1993 (CE Marking directive).

Other Related CE Publications:

1. 93/42/eec: Directive of Medical Devices
2. 2001 Guidelines for Classification of Medical Devices
3. Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec.
4. 98/79/ec: Directive of In Vitro Diagnostic Medical Devices
5. Guidelines to Medical Devices Vigilance System

* The term 'EC Mark' or 'CE Mark' appeared in this directive is out of date and has been officially replaced by term 'CE Marking' in 1993 in the CE Marking directive 93/68/EEC.

Article 1

1. This Directive shall apply to active implantable medical devices.

2. For the purposes of this Directive, the following definitions shall apply:
(a)
'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:
- diagnosis, prevention, monitoring, treatment or alleviation of disease or injury,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means;
(b)
'active medical device' means any medical device relying 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;
(c)
'active implantable medical device' means any active medical device which is intended to be totally or partially 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;
(d)
'custom-made device' means any active implantable medical device specifically made in accordance with a medical specialist's written prescription which gives, under his responsibility, specific design characteristics and is intended to be used only for an individual named patient;
(e)
'device intended for clinical investigation' means any active implantable medical device intended for use by a specialist doctor when conducting investigations in an adequate human clinical environment;
(f)
'intended purpose' means the use for which the medical device is intended and for which it is suited according
to the data supplied by the manufacturer in the instructions;
(g)
'putting into service' means making available to the medical profession for implantation.
3. Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (6), as last amended by Directive 87/21/EEC (7), that substance shall be subject to the system of marketing authorization provided for in that Directive.
4. Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 65/65/EEC, that device must be evaluated and authorized in accordance with the provisions of this Directive.
5. This Directive constitutes a specific Directive within the meaning of Article 2 (2) of Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (8).

Article 2

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8

Article 9

1. In the case of devices other than those which are custom-made or intended for clinical investigations, the manufacturer must, in order to affix the CE mark, at his own choice:
(a) follow the procedure relating to the EC declaration of conformity set out in Annex 2; or
(b)
follow the procedure relating to EC type-examination set out in Annex 3, coupled with:
i(i) the procedure relating to EC verification set out in Annex 4, or
(ii)
the procedure relating to the EC declaration of conformity to type set out in Annex 5.
2. In the case of custom-made devices, the manufacturer must draw up the declaration provided for in Annex 6 before placing each device on the market.
3. Where appropriate, the procedures provided for in Annexes 3, 4 and 6 may be discharged by the manufacturer's authorized representative established in the Community.
4. The records and correspondence relating to the procedures referred to in paragraphs 1, 2 and 3 shall be in an official language of the Member State in which the said procedures will be carried out and/or in a language acceptable to the notified body defined in Article 11.

Article 10

Article 11

Article 12

1. Devices other than those which are custom made or intended for clinical investigations considered to meet the essential requirements referred to in Article 3 must bear the EC mark of conformity.
2. The EC mark of conformity, as shown in Annex 9, must appear in a visible, legible and indelible form on the sterile pack and, where appropriate, on the sales packaging, if any, and on the instruction leaflet.
It must be accompanied by the logo of the notified body responsible for implementation of the procedures set out in Annexes 2, 4 and 5.
3. The affixing of marks likely to be confused with the EC mark of conformity shall be prohibited.

Article 13
Where it is established that the EC mark has been wrongly affixed, in particular, in respect of devices:
- that do not conform to the relevant standards referred to in Article 5, should the manufacturer have opted for conformity therewith,
- that do not conform to an approved type,
- that conform to an approved type which does not meet the relevant essential requirements,
- regarding which the manufacturer has failed to fulfil
his obligations under the relevant EC declaration of conformity,
the notified body shall take appropriate measures and forthwith inform the competent Member State thereof.

Article 14

Article 15

Article 16

Article 17

ANNEX 1 ESSENTIAL REQUIREMENTS

I. GENERAL REQUIREMENTS
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
8.
Devices must be designed and manufactured in such a way as to remove or minimize as far as possible:
- the risk of physical injury in connection with their physical, including dimensional, features,
- risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,
- risks connected with reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure and acceleration,
- risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment,
- risks connected with ionizing radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Directive 80/836/Euratom (;), as amended by Directives 84/467/Euratom ($) and 84/466/Euratom (=),
- risks which may arise where maintenance and calibration are impossible, including:
- excessive increase of leakage currents,
- ageing of the materials used,
- excess heat generated by the device,
- decreased accuracy of any measuring or control mechanism.
(;) OJ No L 246, 17. 9. 1980, p. 1.
($) OJ No L 265, 5. 10. 1984, p. 4.
(=) OJ No L 265, 5. 10. 1984, p. 1.
9.
The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in I. 'General requirements', with particular attention being paid to:
- the choice of materials used, particularly as regards toxicity aspects,
- mutual compatibility between the materials used and biological tissues, cells and body fluids, account being taken of the anticipated use of the device,
- compatibility of the devices with the substances they are intended to administer,
- the quality of the connections, particularly in respect of safety,
- the reliability of the source of energy,
- if appropriate, that they are leakproof,
- proper functioning of the programming and control systems, including software.
10.
Where a device incorporates, as an integral part, a substance which, when used separately, is likely to be considered to be a medicinal product as defined in Article 1 of Directive 65/65/EEC, and whose action in combination with the device may result in its bioavailability, the safety, quality and usefulness of the substance, account being taken of the purpose of the device, must be verified by analogy with the appropriate methods specified in Directive 75/318/EEC (;), as last amended by Directive 89/341/EEC ($).
11.
The devices and, if appropriate, their component parts must be identified to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices and their component parts.
12.
Devices must bear a code by which they and their manufacturer can be unequivocably identified (particularly with regard to the type of device and year of manufacture); it must be possible to read this code, if necessary, without the need for a surgical operation.
13.
When a device or its accessories bear instructions required for the operation of the device or indicate operating or adjustment parameters, by means of a visual system, such information must be understandable to the user and, as appropriate, the patient.
14.
Every device must bear, legibly and indelibly, the following particulars, where appropriate in the form of generally recognized symbols:
14.1.
On the sterile pack:
- the method of sterilization,
- an indication permitting this packaging to be recognized as such,
- the name and address of the manufacturer,
- a description of the device,
- if the device is intended for clinical investigations, the words: 'exclusively for clinical investigations',
- if the device is custom-made, the words 'custom-made device',
- a declaration that the implantable device is in a sterile condition,
- the month and year of manufacture,
- an indication of the time limit for implanting a device safely.
14.2.
On the sales packaging:
- the name and address of the manufacturer,
- a description of the device,
- the purpose of the device,
- the relevant characteristics for its use,
- if the device is intended for clinical investigations, the words: 'exclusively for clinical investigations',
(;) OJ No L 147, 9. 6. 1975, p. 1.
($) OJ No L 142, 25. 5. 1989, p. 11.
- if the device is custom-made, the words: 'custom-made device',
- a declaration that the implantable device is in a sterile condition,
- the month and year of manufacture,
- an indication of the time limit for implanting a device safely,
- the conditions for transporting and storing the device.
15.
When placed on the market, each device must be accompanied by instructions for use giving the following particulars:
- the year of authorization to affix the CE mark,
- the details referred to in 14.1 and 14.2, with the exception of those referred to in the eighth and ninth indents,
- the performances referred to in section 2 and any undesirable side effects,
- information allowing the physician to select a suitable device and the corresponding software and accessories,
- information constituting the instructions for use allowing the physician and, where appropriate, the patient to use the device, its accessories and software correctly, as well as information on the nature, scope and times for operating controls and trials and, where appropriate, maintenance measures,
- information allowing, if appropriate, certain risks in connection with implantation of the device to be avoided,
- information regarding the risks of reciprocal interference (*) in connection with the presence of the device during specific investigations or treatment,
- the necessary instructions in the event of the sterile pack being damaged and, where appropriate, details of appropriate methods of resterilization,
- an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the essential requirements.
The instruction leaflet must also include details allowing the physician to brief the patient on the contra-indications and the precautions to be taken. These details should cover in particular:
- information allowing the lifetime of the energy source to be established,
- precautions to be taken should changes occur in the device's performance,
- precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, etc.,
- adequate information regarding the medicinal products which the device in question is designed to administer.
16.
Confirmation that the device satisfies the requirements in respect of characteristics and performances, as referred to in I. 'General requirements', in normal conditions of use, and the evaluation of the side effects or undesirable effects must be based on clinical data established in accordance with Annex 7.
(*) 'Risks of reciprocal interference' means adverse effects on the device caused by instruments present at the time of investigations or treatment, and vice versa.

ANNEX 2 EC DECLARATION OF CONFORMITY

ANNEX 3 EC TYPE-EXAMINATION

ANNEX 4 EC VERIFICATION

ANNEX 5 EC DECLARATION OF CONFORMITY TO TYPE

ANNEX 6 STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES

ANNEX 7 CLINICAL EVALUATION

ANNEX 8 MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED

ANNEX 9 CE MARK OF CONFORMITY

Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:-

What is CE marking (CE mark)?

The CE marking logo (Free download CE mark logo)

Download of the EC Rep symbol/logo

CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content

What is a manufacturer? What are the responsibilities of a manufacturer?

Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer?

Why is CE marking called "European passport"?

Does my product need CE Marking in order to be sold/exported on/to the European Market?

How to obtain CE Marking for my product?

How can Wellkang Tech Consulting help me to obtain CE Marking for my product?

Wellkang can be your Authorized Representative in Europe for CE Marking purpose !

Complete list of all CE Marking Directives and Guidelines to Directives