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on the approximation of the laws of the Member States relating to active implantable medical devices
(90/385/EEC)
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[ © ] - [ Capital Goods Industries ] [Medical Devices] |
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 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
- This Directive shall apply to active implantable medical devices.
- 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.
(h) "placing on the market" means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished
(i) "manufacturer" means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient.
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 prevent the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE
marking
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
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).
5. Where the devices are subject to other Directives concerning other aspects and which also provide for the affixing of the
However, where one or more of these Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the
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 therefore. 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
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
(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) 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.
5 During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate stage of manufacture.
6. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative established in the Community, may apply to a body of his choice within the framework of the tasks for which the body has been notified.
7. The notified body may require, where duly justified, any information or data which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure.
8. Decisions taken by the notified bodies in accordance with Annexes II and III shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of five years.
9. By derogation from paragraphs 1 and 2 the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 and 2 have not been carried out and the use of which is in the interest of protection of health.
Article 9a
1. Where a Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. These measures shall be adopted in accordance with the procedure referred to in Article 7 (2) of Directive 93/42/EEC(9).
2. The Commission shall inform the Member States of the measures taken and, where appropriate, publish the relevant parts of these measures in the Official Journal of the European Communities.
Article 10
- 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.
- 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.
Member States may however authorize manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the Ethical Committee concerned has delivered a favourable opinion with respect to the investigation programme in question.
2a. The authorization referred to in the second subparagraph of paragraph 2 may be subject to approval by the competent authority.
3. The Member States shall, if necessary, take the appropriate steps to ensure public health and order.
Article 11
1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 9 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies and the identification numbers and the tasks for which they have been notified. The Commission 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
2. The
It must be followed by the identification number of the notified body responsible for implementation of the procedures set out in Annexes 2, 4 and 5.
3. The affixing of markings on the devices which are likely to deceive third parties as to the meaning and form of the
Article 13
Without prejudice to Article 7:
(a) where a Member State establishes that the
(b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.
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.
In the event of a decision as referred to in the previous paragraph, the manufacturer or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measures to be taken.
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.(10)(11)
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
Footnotes
(1)OJ No. C 14, 18.1.1989, p. 4
(2)OJ No. C 120, 16.5.1989, p. 75 and OJ No. C 149, 18.6.1990
(3)OJ No. C 159, 28.6.1989, 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
(9)OJ No. L 169, 12.7.1993, p. 1
(10)e transitional arrangements relating to the application of Directive 93/42/EEC ® see article 22 of that directive
(11)he transitional arrangements relating to the application of Directive 93/68/EEC ® see article 14 of that directive
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[ © ] - [ Capital Goods Industries ] [Medical Devices] |