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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 - OJ L189 of 20 July 1990) This consolidated text has been prepared by Commission services on the basis of the above Directives amending Directive 90/385/EEC. The amendments introduced by Directive 93/42/EEC are indicated in bold, the amendments following Directive 93/68/EEC are in italic. The consolidation has no official status. In case of doubt, the original text of the relevant Directive should be consulted. January 1994 Amended byCouncil Directive 93/42/EEC of 14 June 1993 (OJ L 169 of 12 July 1993)
and
COUNCIL DIRECTIVE of 20 June 1990 (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, 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
(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:
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 provided for in Article 12 which indicate that they have been the subject of an evaluation of their conformity in accordance with Article 9. 2. Member States shall not create any obstacles to:
These devices shall not bear the CE marking. 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 CE marking, the latter shall indicate that the devices are also presumed to conform to the provisions of the other Directives. However, where one or more of these Directives allow the manufacturer,
during a transitional period, to choose which arrangements to apply, the
CE marking shall indicate conformity to the provisions only of those Directives
applied by the manufacturer. In this case, particulars of the Directives
applied, as published in the Official Journal of the European Communities,
must be given in the documents, notices or instructions required by the
Directives and accompanying such devices; these documents, notices or instructions
shall be accessible without it being necessary to destroy the packaging
which keeps the device sterile.
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:
3. Where a device which does not comply bears the CE marking, 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 marking, 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) 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
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 CE marking of conformity. 2. The CE marking 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 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 CE marking shall be prohibited.
Any other marking may be affixed to the packaging or to the instruction
leaflet accompanying the device provided that the visibility and legibility
of the CE marking is not hereby reduced.
Article 13 Without prejudice to Article 7: (a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorized representative established within the Community shall be obliged to end the infringement under the conditions imposed by the Member State; (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. For the Council
Footnotes (1) OJ No. C 14, 18.1.1989, p. 4
ANNEX 1 Essential Requirements I. General Requirements
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: 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: 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(15), as last amended by Directive 89/341/EEC(16). 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: 14.2.On the sales packaging: 15. When placed on the market, each device must be accompanied by instructions for use giving the following particulars: 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: 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. Footnotes
(12)OJ No L 246, 17. 9. 1980, p. 1. ANNEX 2
EC Declaration of Conformity
2. The declaration of conformity is the procedure by means of which the manufacturer who satisfies the obligations of section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them. The manufacturer or his authorized representative established within the Community shall affix the CE marking in accordance with Article 12 and shall draw up a written declaration of conformity. This declaration shall cover one or more identified examples of the product and shall be kept by the manufacturer or his authorized representative established within the Community. The CE marking shall be accompanied by the identification number of the notified body responsible. 3. Quality system 3.1. The manufacturer shall make an application for evaluation of his quality system to a notified body. The application shall include: (i) any deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or a deterioration in his state of health; (ii) any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer. 3.2. The application of the quality system must ensure that the products conform to the provisions of this Directive which apply to them at every stage, from design to final controls. All the elements, requirements and provisions adopted by the manufacturer for his quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records. It shall include in particular an adequate description of: (a) the manufacturer's quality objectives; (b) the organization of the business and in particular: (c) the procedures for monitoring and verifying the design of the products and in particular: (d) the techniques of control and of quality assurance at the manufacturing stage and in particular: (e) the appropriate tests and trials which will be effected before, during and after production, the frequency with which they will take place, and the test equipment used. 3.3 Without prejudice to Article 13 of this Directive, the notified body shall effect an audit of the quality system to determine whether it meets the requirements referred to in 3.2. It shall presume conformity with these requirements for the quality systems which use the corresponding harmonized standards. The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned. The evaluation procedure shall include an inspection on the manufacturer's premises. The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluation. 3.4. The manufacturer shall inform the notified body which has approved the quality system of any plan to alter the quality system. The notified body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the control and a reasoned evaluation. 4. Examination of the design of the product 4.1. In addition to the obligations incumbent on him under section 3, the manufacturer shall make an application for examination of the design dossier relating to the product which he plans to manufacture and which falls into the category referred to in 3.1. 4.2. The application shall describe the design, manufacture, and performances of the product in question and shall include the necessary particulars which make it possible to evaluate whether it complies with the requirements of this Directive. It shall include inter alia: 4.3. The notified body shall examine the application and, where the product complies with the relevant provisions of this Directive, shall issue the applicant with an EC design examination certificate. The notified body may require the application to be supplemented by further tests or proof so that compliance with the requirements of the Directive may be evaluated. The certificate shall contain the conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product. 4.4. The applicant shall inform the notified body which issued the EC design examination certificate of any modification made to the approved design. Modifications made to the approved design must obtain supplementary approval from the notified body which issued the EC design examination certificate where such modifications may affect conformity with the essential requirements of this Directive or the conditions prescribed for the use of the product. This supplementary approval shall be given in the form of an addendum to the EC design examination certificate. 5. Surveillance 5.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality system. 5.2. The manufacturer shall authorize the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular: 5.3. The notified body shall periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report. 5.4. In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report. 6. Administrative provisions 6.1. For at least five years from last date of manufacture of the product, the manufacturer shall keep available for the national authorities: - the declaration of conformity, - the documentation referred to in the second indent of section 3.1, - the amendments referred to in section 3.4, - the documentation referred to in section 4.2, - the decisions and reports of the notified body referred to in sections 3.4, 4.3, 5.3 and 5.4. 6.2 On request, the notified body shall make available to the other notified bodies and the competent authority all relevant information on approvals of quality systems issued, refused or withdrawn. 6.3 Where neither the manufacturer nor his authorized representative
are established in the Community, the task of keeping available for the
authorities the technical documentation referred to in Article 4 (2) shall
fall to the person responsible for placing the appliance on the Community
market.
ANNEX 3 EC Type-Examination
1. EC type-examination is the procedure whereby a notified
body observes and certifies that a representative sample of the production
envisaged satisfies the relevant provisions of this Directive.
2. The application for EC type-examination shall be made by the manufacturer, or by his authorized representative established in the Community, to a notified body. The application shall include:
The applicant shall make a "type" available to the notified body. The notified
body may request other samples as necessary.
3. The documentation must make it possible to understand the design, the manufacture and the performances of the product. The documentation shall contain the following items in particular:
4.1 examine and evaluate the documentation, verify that the type has been manufactured in accordance with that documentation; it shall also record the items which have been designed in accordance with the applicable provisions of the standards referred to in Article 5, as well as the items for which the design is not based on the relevant provisions of the said standards; 4.2 carry out or have carried out the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements of this Directive where the standards referred to in Article 5 have not been applied; 4.3 carry out or have carried out the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied; 4.4 agree with the applicant on the place where the necessary inspections
and tests will be carried out.
5. Where the type meets the provisions of this Directive, the notified body shall issue an EC type-examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, the conclusions of the control, the conditions under which the certificate is valid and the information necessary for identification of the type approved. The significant parts of the documentation shall be attached to the
certificate and a copy shall be kept by the notified body.
6. The applicant shall inform the notified body which issued the EC type-examination certificate of any modification made to the approved product. Modifications to the approved product must receive further approval
from the notified body which issued the EC type-examination certificate
where such modifications may affect conformity with the essential requirements
or with the conditions of use specified for the product. This new approval
shall be issued, where appropriate, in the form of a supplement to the
initial EC type-examination certificate.
7. Administrative provisions 7.1 On request, each notified body shall make available to the other notified bodies and the competent authority, all relevant information on EC type-examination certificates and addenda issued, refused or withdrawn. 7.2 Other notified bodies may obtain a copy of the EC type-examination certificates and/or the addenda to them. The annexes to the certificates shall be made available to the other notified bodies when a reasoned application is made and after the manufacturer has been informed. 7.3 The manufacturer or his authorized representative shall keep with the technical documentation a copy of the EC type-examination certificates and the supplements to them for a period of at least five years from the manufacture of the last appliance. 7.4 Where neither the manufacturer nor his authorized representative
are established in the Community, the task of keeping the technical documentation
available for the authorities shall fall to the person responsible for
placing the appliance concerned on the Community market.
ANNEX IV EC Verification 1. EC verification is the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the products subject to the provisions of section 3 are in conformity with the type as described in the EC type-examination certification and satisfy the requirements of this Directive that apply to them. 2. The manufacturer or his authorized representative established within the Community shall take all measures necessary in order that the manufacturing process ensures conformity of the products to the type as described in the EC type-examination certification and to the requirements of this Directive that apply to them. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and draw up a written declaration of conformity. 3. The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular as regards sterilization, together with all the routine, pre-established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the EC type-examination certificate as well as with the relevant requirements of this Directive. 4. The manufacturer shall undertake to institute and keep updated a post-marketing surveillance system. This undertaking shall include the obligation on the part of the manufacturer to notify the competent authorities of the following events immediately on learning of them: (i) any change in the characteristics or performances and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or deterioration in his state of health; (ii) any technical or medical reason resulting in the withdrawal of a device from the market by a manufacturer. 5. The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this Directive by examination and testing of products on a statistical basis, as specified in section 6. The manufacturer must authorize the notified body to evaluate the efficiency of the measures taken pursuant to section 3, by audit where appropriate. 6. Statistical verification 6.1. Manufacturers shall present the products manufactured in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced. 6.2. A random sample shall be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standard(s) referred to in Article 5, or equivalent tests shall be carried out to verify their conformity to the type as described in the EC type-examination certificate and thereby determine whether a batch is to be accepted or rejected. 6.3. Statistical control of products shall be based on attributes, entailing a sampling system with the following characteristics: - a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of between 0,29 and 1 %, - a limit quality corresponding to a probability of acceptance of 5 %, with a percentage of non-conformity of between 3 and 7 %. 6.4. Where batches are accepted, the notified body shall affix, or cause to be affixed, its identification number to each product and draw up a written certificate of conformity relating to the tests carried out. All products in the batch may be placed on the market except for those products from the sample which were found not to be in conformity. Where a batch is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches the notified body may suspend the statistical verification. The manufacturer may, under the responsibility of the notified body, affix the latter's identification number during the manufacturing process. 6.5. The manufacturer or his authorized representative shall ensure
that he is able to supply the notified body's certificates of conformity
on request.
ANNEX 5 EC Declaration of Conformity to Type
(Assurance of production quality) The manufacturer or his authorized representative established within the Community shall affix the CE marking in accordance with Article 12 and shall draw up a written declaration of conformity. This declaration shall cover one or more identified specimens of the product and shall be kept by the manufacturer. The CE marking shall be accompanied by the identification number of the notified body responsible. 3. Quality system 3.1 The manufacturer shall make an application for evaluation of his quality system to a notified body. The application shall include: (i) any deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or a deterioration in his state of health; (ii) any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer. 3.2. Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate. All the elements, requirements and provisions adopted by the manufacturer for his quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records. It shall include in particular an adequate description of: (a) the manufacturer's quality objectives; (b) the organization of the business and in particular: (c) the techniques of control and of quality assurance at the manufacturing stage and in particular: (d) the appropriate tests and trials which will be effected before, during and after production, the frequency with which they will take place, and the test equipment used. 3.3 Without prejudice to Article 13, the notified body shall effect an audit of the quality system to determine whether it meets the requirements referred to in 3.2. It shall presume conformity with these requirements for the quality systems which use the corresponding harmonized standards. The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned. The evaluation procedure shall include an inspection on the manufacturer's premises. The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluation. 3.4 The manufacturer shall inform the notified body which has approved the quality system of any plan to alter that system. The notified body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the control and a reasoned evaluation. 4. Surveillance 4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations which arise from the approved quality system. 4.2 The manufacturer shall authorize the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular: 4.3. The notified body shall periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report. 4.4. In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report. 5. The notified body shall communicate to the other notified bodies
all relevant information concerning approvals of quality systems issued,
refused or withdrawn.
ANNEX 6 Statement Concerning Devices Intended for Special Purposes
2.1. For custom-made devices: 2.2. For devices intended for clinical investigations covered in Annex 7: 3. The manufacturer shall undertake to keep available for the competent national authorities: 3.1. For custom-made devices, documentation enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirement of this Directive to be assessed. The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured conform to the documentation referred to in the first paragraph. 3.2. For devices intended for clinical investigations, the documentation shall also contain: The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured conform to the documentation referred to in 3.1 and in in the first paragraph of this section. The manufacturer may authorize the evaluation, by audit where necessary,
of the effectiveness of these measures.
ANNEX 7 Clinical Evaluation
1. General provisions 1.1. Adequacy of the clinical data presented, as referred to in section 4.2 of Annex 2, and in section 3 of Annex 3, shall be based, account being taken as appropriate of the relevant harmonized standards, on either: 1.1.1 a collation of currently available relevant scientific literature covering the intended use of the device and the techniques therefore, as well as, if appropriate, a written report making a critical assessment of this collation; or 1.1.2. the results of all clinical investigations made, including those carried out in accordance with section 2. 2.1. Purpose The purpose of clinical investigation is to: 2.2. Ethical consideration Clinical investigations shall be made in accordance with the Declaration of Helsinki approved by the 18th World Medical Assembly in Helsinki, Finland, in 1964, and amended by the 29th World Medical Assembly in Tokyo, Japan, in 1975 and the 35th World Medical Assembly in Venice, Italy, in 1983. It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Declaration of Helsinki. This includes every step in the clinical investigation from first consideration of need and justification of the study to publication of results. 2.3. Methods 2.3.1 Clinical investigations shall be performed according to an appropriate state of the art plan of investigation defined in such a way as to confirm or refute the manufacturer's claims for the device; the investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions. 2.3.2. The procedures utilized to perform the investigations shall be appropriate to the device under examination. 2.3.3. Clinical investigations shall be performed in circumstances equivalent to those which would be found in normal conditions of use of the device. 2.3.4. All appropriate features, including those involving the safety and performances of the device, and its effects on the patients, shall be examined. 2.3.5. All adverse events shall be fully recorded. 2.3.6. The investigations shall be performed under the responsibility of an appropriately qualified medical specialist, in an appropriate environment. The medical specialist shall have access to the technical data regarding the device. 2.3.7. The written report, signed by the responsible medical specialist,
shall comprise a critical evaluation of all the data collected during the
clinical investigation.
ANNEX 8 Minimum Criteria to be Met When Designating Inspection Bodies to be Notified
5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of controls carried out, nor on the results of such controls. 6. The body must take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for controls. 7. The staff of the body are bound to observe professional secrecy with
regard to all information gained in carrying out their tasks (except vis-à-vis
the competent administrative authorities of the State in which their activities
are carried out) under this Directive or any provision of national law
giving effect to it.
ANNEX IX CE Conformity Marking - The CE conformity marking shall consist of the initials" CE" taking the following form:
- If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected. |
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