Special edition in Slovenian Chapter 13 Volume 010 P. 154 - 173 

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)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commission (1),

In cooperation with the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas in each Member State active implantable medical devices must give patients, users and other persons a high level of protection and achieve the intended level of performance when implanted in human beings;

Whereas several Member States have sought to ensure that level of safety by mandatory specifications relating both to the technical safety features and the inspection procedures for such devices; whereas those specifications differ from one Member State to another;

Whereas national provisions ensuring that safety level should be harmonized in order to guarantee the free movement of active implantable medical devices without lowering existing and justified levels of safety in the Member States;

Whereas harmonized measures must be distinguished from measures taken by Member States to manage the financing of public health and sickness insurance schemes directly or indirectly concerning such devices; whereas, therefore, such provisions do not affect the right of Member States to implement the abovementioned measures in compliance with Community law;

Whereas maintaining or improving the level of protection achieved in Member States constitutes one of this Directive's essential objectives as defined by the essential requirements;

Whereas rules governing active implantable medical devices can be confined to those provisions needed to satisfy the
OJ No C 149, 18. 6. 1990.
essential requirements; whereas, because they are essential, these requirements must replace corresponding national provisions;

Whereas, in order to facilitate proof of conformity with these essential requirements and to permit monitoring of that conformity, it is desirable to have Europe-wide harmonized standards in respect of the prevention of risks in connection with the design, manufacture and packaging of active implantable medical devices; whereas such standards harmonized at European level are drawn up by private-law bodies and must retain their status as non-mandatory texts; whereas, to that end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as being the competent bodies to adopt harmonized standards in accordance with the general guidelines for cooperation between the Commission and these two bodies, signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by either or both of these bodies, as instructed by the Commission pursuant to the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (4), as last amended by Directive 88/182/EEC (5), and under the abovementioned general guidelines;

Whereas evaluation procedures have to be established and accepted by common accord between the Member States in accordance with Community criteria;

Whereas the specific nature of the medical sector makes it advisable to make provision for the notified body and the manufacturer or his agent established in the Community to fix, by common accord, the time limits for completion of the evaluation and verification operations for the conformity of devices,

HAS ADOPTED THIS DIRECTIVE:

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
Member States shall take all necessary steps to ensure that the devices referred to in Article 1 (2) (c) and (d) may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly implanted, maintained and used in accordance with their intended purposes.

Article 3
The active implantable medical devices referred to in Article 1 (2) (c), (d) and (e), hereinafter referred to as 'devices', must satisfy the essential requirements set out in Annex 1, which shall apply to them account being taken of the intended purpose of the devices concerned.

Article 4
1. Member States shall not impede the placing on the market or the putting into service within their territory of devices bearing the CE mark.
2. Member States shall not create any obstacles to:

- devices intended for clinical investigations being made available to specialist doctors for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,

- custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement referred to in that Annex.

These devices shall not bear the CE mark.
3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices do not conform and cannot be put into service until they have been made to comply by the manufacturer or his authorized representative established within the Community.

4. When a device is put into service, Member States may require the information described in sections 13, 14 and 15 of Annex 1 to be in their national language(s).

Article 5
Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the references of which have been published in the Official Journal of the European Communities; Member States shall publish the references of such national standards.

Article 6
1. Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 do not entirely meet the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up under Directive 83/189/EEC, giving the reasons therefor. The Committee shall deliver an opinion without delay.

In the light of the opinion of the Committee, the Commission shall inform Member States of the measures to be taken with regard to the standards and the publication referred to in Article 5.

2. A Standing Committee, hereinafter referred to as the 'Committee', shall be set up, composed of the representatives of the Member States and chaired by the representative of the Commission.

The Committee shall draw up its rules of procedure.

Any matter relating to the implementation and practical application of this Directive may be brought before the Committee, in accordance with the procedure set out below.

The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion according to the urgency of the matter, if necessary by taking a vote.

The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.

The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account.

Article 7
1. Where a Member State finds that the devices referred to in Article 1 (2) (c) and (d), correctly put into service and used in accordance with their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or their being put into service.

The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:

(a) failure to meet the essential requirements referred to in Article 3, where the device does not meet in full or in part the standards referred to in Article 5;

(b)incorrect application of those standards;

(c)shortcomings in the standards themselves.

2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that:

- the measures are justified, it shall immediately so inform the Member State which took the initiative and the

other Member States; where the decision referred to

in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 6 (1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6 (1),

- the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established within the Community.

3. Where a device which does not comply bears the CE mark, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.

4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
 
Article 8

1. Member States shall take the necessary steps to ensure that information brought to their knowledge regarding the incidents mentioned below involving a device is recorded and evaluated in a centralized manner:

(a) any deterioration in the characteristics and performances of a device, as well as any inaccuracies in the instruction leaflet which might lead to or might have led to the death of a patient or to a deterioration in his state of health;

(b) any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer.

2. Member States shall, without prejudice to Article 7, forthwith inform the Commission and the other Member States of the incidents referred to in paragraph 1 and of the relevant measures taken or contemplated.

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

1. In the case of devices intended for clinical investigations, the manufacturer or his authorized representative established in the Community shall, at least 60 days before the commencement of the investigations, submit the statement referred to in Annex 6 to the competent authorities of the Member State in which the investigations are to be conducted.

2. The manufacturer may commence the relevant clinical investigations at the end of a period of 60 days after notification, unless the competent authorities have notified

him within that period of a decision to the contrary, based on considerations of public health or public order.

3. The Member States shall, if necessary, take the appropriate steps to ensure public health and order.

Article 11
1. Each Member State shall notify the other Member States and the Commission of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Articles 9 and 13, the specific tasks for which each body has been designated and the identifying logo of these bodies, hereinafter referred to as 'notified bodies'.

The Commission shall publish a list of these notified bodies, together with the tasks for which they have been notified, in the Official Journal of the European Communities and shall ensure that the list is kept up to date.

2. Member States shall apply the minimum criteria, set out in Annex 8, for the designation of bodies. Bodies that satisfy the criteria fixed by the relevant harmonized standards shall be presumed to satisfy the relevant minimum criteria.

3. A Member State that has notified a body shall withdraw that notification if it finds that the body no longer meets the criteria referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof.

4. The notified body and the manufacturer or his agent established in the Community shall fix, by common accord, the time limits for completion of the evaluation and verification operations referred to in Annexes 2 to 5.
 
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
Any decision taken pursuant to this Directive and resulting in the refusal of or restrictions on the placing on the market and/or putting into service of a device shall state the exact grounds on which it is based. Such decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.
 
Article 15
Member States shall ensure that all the parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in

carrying out their tasks. This does not affect the obligations of Member States and notified bodies with regard to mutual information and the dissemination of warnings.
 
Article 16
1. Before 1 July 1992, Member States shall adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive. They shall forthwith inform the Commission thereof.

They shall apply such provisions from 1 January 1993.

2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.

3. Member States shall, for the period up to 31 December 1994, permit the placing on the market and putting into service of devices complying with national rules in force in their territory on 31 December 1992.

Article 17
This Directive is addressed to the Member States.

Done at Luxembourg, 20 June 1990.

For the Council

The President

D. J. O'MALLEY

(1) OJ No C 14, 18. 1. 1989, p. 4.

(2) OJ No C 120, 16. 5. 1989, p. 75, and(3) OJ No C 159, 26. 6. 1989, p. 47.(4) OJ No L 109, 26. 4. 1983, p. 8.

(5) OJ No L 81, 26. 3. 1988, p. 75.(6) OJ No 22, 9. 2. 1965, p. 369/65.

(7) OJ No L 15, 17. 1. 1987, p. 36.(8) OJ No L 139, 23. 5. 1989, p. 19.


ANNEX 1 ESSENTIAL REQUIREMENTS I. GENERAL REQUIREMENTS

1.The devices must be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients. They must not present any risk to the persons implanting them or, where applicable, to other persons.

2.The devices must achieve the performances intended by the manufacturer, viz. be designed and manufactured in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a) as specified by him.

3.The characteristics and performances referred to in sections 1 and 2 must not be adversely affected to such a degree that the clinical condition and safety of the patients or, as appropriate, of other persons are compromised during the lifetime of the device anticipated by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use.

4.The devices must be designed, manufactured and packed in such a way that their characteristics and performances are not adversely affected in the storage and transport conditions laid down by the manufacturer (temperature, humidity, etc.).

5.

Any side effects or undesirable conditions must constitute acceptable risks when weighed against the performances intended.

II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

6.The solutions adopted by the manufacturer for the design and construction of the devices must comply with safety principles taking account of the generally acknowledged state of the art.

7.Implantable devices must be designed, manufactured and packed in a non-reusable pack according to appropriate procedures to ensure they are sterile when placed on the market and, in the storage and transport conditions stipulated by the manufacturer, remain so until the packaging is removed and they are implanted.

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.