Proposal for a European Parliament and Council Directive on in vitro diagnostic medical devices (95/C 172/02) COM(95) 130 final - 95/0013(COD)

(Submitted by the Commission on 19 April 1995)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee,

Acting in accordance with the procedure referred to in Article 189b of the Treaty establishing the European Community,

Whereas measures should be adopted for the progressive establishment of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;

Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics and authorization procedures for in vitro diagnostic medical devices are different; whereas the existence of such disparities constitutes barriers to trade and the need to establish harmonized rules was confirmed by a comparative survey of national legislations carried out on behalf of the Commission;

Whereas the harmonization of national legislations is the only means of removing these barriers to free trade and preventing new barriers; whereas this objective cannot be achieved in a satisfactory manner at another level by the individual Member States; whereas this Directive only lays down necessary and sufficient requirements for the free circulation of the in vitro diagnostic medical devices to which it is applicable;

Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to implement the abovementioned measures provided Community law is complied with;

Whereas in vitro diagnostic medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive;

Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization (1), rules regarding the design and manufacture of relevant products must be confined to the provisions required to meet the essential requirements; whereas, because they are essential, such requirements should replace the corresponding national provisions; whereas the essential requirements, including requirements to minimize and reduce risks, should be applied with discretion, taking into account the technology and practice at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety;

Whereas the major part of medical devices are covered by Council Directive 90/385/EEC relating to active implantable medical devices (2) and Council Directive 93/42/EEC relating to all other medical devices (3) with the exclusion of in vitro diagnostic medical devices, the present Directive shall extend the harmonization to in vitro diagnostic medical devices; whereas, in the interest of uniform Community rules, this Directive is based largely on the provisions of Directives 90/385/EEC and 93/42/EEC;

Whereas certified international reference materials and materials used for external quality assessment schemes are not covered by this Directive, calibrators and control materials needed by the user to establish or verify performances of devices are in vitro diagnostic medical devices;

Whereas reagents produced within user laboratories and which are not subject to commercial transactions, taking account of the principle of subsidiarity, are not included in this Directive;

Whereas the electromagnetic compatibility aspects form an integral part of the essential requirements of this Directive, Council Directive 89/336/EEC of 3 May 1989 relating to electromagnetic compatibility (4) shall not apply;

Whereas, in order to ease the task of proving conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonized standards in respect of the prevention of risks associated with the design, manufacture and packaging of medical devices; whereas such harmonized standards are drawn up by private-law bodies and should retain their status as non-mandatory texts; whereas, to this end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984;

Whereas, for the purpose of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in accordance with 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 (5), and pursuant to the abovementioned general guidelines;

Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives (6), the Council has laid down harmonized conformity assessment procedures; whereas the details added to these modules are justified by the nature of the verification required for in vitro diagnostic medical devices and by the need for consistency with the previous directives on medical devices;

Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group in vitro diagnostic medical devices into two product classes; whereas, since the large majority of such devices do not constitute a direct risk to patients and are used by competently trained professionals, and the results obtained can often be confirmed by other means, the conformity assessment procedures can be carried out, as a general rule, under the sole responsibility of the manufacturer; whereas, taking account of existing national regulations and of notifications received following the procedure of Directive 83/189/EEC, the intervention of notified bodies is needed only for defined devices, the correct performance of which is essential to medical practice and the failure of which can cause a serious risk to health;

Whereas the list of in vitro diagnostic medical devices to be subjected to third-party conformity assessment needs updating, taking account of technological progress and of evolution in the domain of protection of health; whereas such updating measures must be taken in line with the procedure IIIa as laid down in Council Decision 87/373/EEC (7); whereas a system of adverse incident reporting (vigilance) constitutes a useful tool for the surveillance of the market, including the performance of new devices; whereas information obtained from vigilance as well as from external quality assessment schemes becomes useful for decision-making on classification of devices;

Whereas medical devices should, as a general rule, bear the CE marking to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose;

Whereas manufacturers shall have the possibility, when the intervention of a notified body is required, to choose amongst those bodies published by the Commission; whereas the Member States do not have an obligation to designate such notified bodies, they must ensure however that bodies designated as notified bodies comply with the assessment criteria laid down in this Directive;

Whereas the competent authorities in charge of market surveillance must be able, particularly in emergencies, to contact the manufacturer or his authorized representative established in the Community; whereas cooperation and exchange of information between Member States are necessary in view of uniform application of this Directive, in particular for the purpose of market surveillance;

Whereas this Directive includes in vitro diagnostic medical devices incorporating substances derived from the human body, it does not affect national regulations relating to the ethics of use of such substances; whereas for the purpose of overall consistency between medical-devices directives, Directive 93/42/EEC needs to be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Scope, Definitions

1. This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices.

2. For the purpose 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, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

- diagnosis, prevention, monitoring, treatment or alleviation of disease,

- diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,

- investigation, replacement or modification of the anatomy or of a physiological process,

- control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

(b) 'in vitro diagnostic medical device' means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients. For the purpose of this Directive, a specimen receptacle, whether evacuated or not, specifically intended by its manufacturer to contain a specimen for the purpose of in vitro diagnostic examination is considered to be a device.

Products for general laboratory use are not devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

(c) 'accessory' means an article which, whilst not being a device in the meaning of paragraph 2 (b), is intended specifically by its manufacturer to be used together with a device to enable this device to be used in accordance with its intended purpose;

(d) 'device for self-testing' means any device intended by the manufacturer to be used in the home environment;

(e) 'device for performance evaluation' means any device intended by the manufacturer to be subject to one or more performance evaluation studies in clinical laboratories or in other appropriate environments outside his own premises;

(f) '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 devices with a view to their being placed on the market under his own name;

(g) 'authorized representative' means the natural or legal person established within the Community who, being explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community in substitution for the manufacturer with regard to the latter's obligations in accordance with this Directive.

(h) 'intended purpose' means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials;

(i) 'placing on the market' means the first making available in return for payment or free of charge of a device with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;

(j) 'putting into service' means the stage at which a device is ready for use on the Community market for the first time for its intended purpose;

(k) 'calibrator', 'control material' mean any substance, material or article intended by its manufacturer to establish and/or verify performance characteristics of a device in conjunction with the use of that device.

3. Where a device incorporates tissues or substances of human origin, this Directive shall not affect national regulations relating to the ethics of the collection of tissues or substances of human origin as well as any regulations relating to the ethics governing distribution of given types of devices of such origin.

4. This Directive shall not apply to devices manufactured and used only within the same institution and on the premises of their manufacture. This does not affect the right of Member States to subject such activities to appropriate protection requirements.

5. This Directive is a specific directive within the meaning of Article 2 (2) of Directive 89/336/EEC (8).

Article 2

Placing on the market and putting into service

Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they comply with the requirements laid down in this Directive when properly installed, maintained and used in accordance with their intended purpose.

Article 3

Essential requirements

Devices must meet the essential requirements set out in Annex 1 which apply to them, taking account of the intended purpose of the devices concerned.

Article 4

Free movement

1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 14 or labelled as devices for performance evaluation if these devices have been the subject of an assessment of their conformity in accordance with the provisions of Article 9.

2. At trade fairs, exhibitions, demonstrations, Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply.

3. Member States may require, when a device reaches the final user, information, as referred to in Annex 1, point 13 to be in their national language(s) or in other Community language(s) to the extent that it is needed for safe and correct use of the device. In the application of this provision Member States shall take into account the principle of proportionality and in particular whether information can be provided by recognized symbols or codes and whether the device is intended for use by trained professionals.

4. 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 also fulfil the provisions of the other directives.

However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer. In this case, the particulars of these directives, 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.

Article 5

Reference to standards

1. 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 which transpose the harmonized standards the reference of which have been published in the Official Journal of the European Communities; Member States shall publish the references of such national standards.

2. If the Member State or the Commission considers that the harmonized standards do not entirely meet the essential requirements referred to in Article 3, the measures to be taken with regard to these standards and the publication referred to in paragraph 1 of this Article shall be adopted by the procedure defined in Article 6 (2).

Article 6

Committee on Standards and Technical Regulations

1. The Commission shall be assisted by the Committee set up by Article 5 of Directive 83/189/EEC.

2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down 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

Committee on Medical Devices

1. The Commission shall be assisted by the Committee set up by Article 6 (2) of Directive 90/385/EEC.

2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.

If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

If, on the expiry of a period of three months from the date of referal to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

3. The Committee referred to in paragraph 1 may examine any question connected with the implementation of this Directive.

Article 8

Safeguard clause

1. Where a Member State ascertains that the devices referred to in Article 4 (1), when correctly installed, maintained and used for their intended purpose may compromise the health and/or safety of patients, users or, where applicable, other persons, and the safety of property, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, 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;

(b) incorrect application of the standards referred to in Article 5, in so far as it is claimed that the standards have been applied;

(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,

- 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 non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking 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 9

Conformity assessment procedures

1. For all devices other than those covered by Annex 2 and devices for performance evaluation, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex 3 and draw up the EC declaration of conformity required before placing the devices on the market.

For all devices for self-testing the manufacturer shall, prior to the drawing up of the aforementioned declaration of conformity, fulfil the supplementary requirements set out in Annex 3 point 6. Instead of applying this procedure, the manufacturer may also follow the procedure referred to in paragraph 2.

2. For all devices covered by Annex 2 other than those intended for performance evaluation, the manufacturer shall, in order to affix the CE marking, either:

(a) follow the procedure relating to the EC declaration of conformity set out in Annex 4 (full quality assurance); or

(b) follow the procedure relating to EC type examination set out in Annex 5 coupled with:

(i) the procedure relating to EC verification set out in Annex 6; or

(ii) the procedure relating to the EC declaration of conformity set out in Annex 7 (production quality assurance).

3. In the case of devices for performance evaluation, the manufacturer shall follow the procedure referred to in Annex 8 and draw up the statement set out in that Annex before placing such devices on the market.

4. During the conformity assessment procedure for a device, the manufacturer and, if involved, 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.

5. The manufacturer may instruct his authorized representative established in the Community to initiate the procedures provided for in Annexes 3, 5, 6 and 8.

6. The manufacturer must keep the declaration of conformity, the technical documentation referred to in Annexes 3 to 8, as well as the decisions, reports and certificates established by notified bodies, and make it available to the national authorities for inspection purposes for a period ending five years after the last product has been manufactured. Where the manufacturer is not established in the Community, the obligation to make the aforementioned documentation available on request applies to his authorized representative established within the Community.

7. 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.

8. 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.

9. Decisions taken by the notified bodies in accordance with Annexes 3, 4 and 5 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.

10. The records and correspondence relating to the procedures referred to in paragraphs 1 to 3 shall be in one of the official languages of the European Community and in the case of involvement of a notified body in a Community language acceptable to the notified body.

11. By derogation from paragraphs 1 to 3, 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 to 3 have not been carried out and the use of which is in the interest of protection of health.

Article 10

Registration of manufacturers

1. Any manufacturer, who places devices on the market under his own name, shall notify the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business, the categories of devices as defined in terms of common characteristics of technology and/or analytes and of any significant change thereto. The abovementioned notification shall also include any new device as referred to in Article 11 (4).

2. Where a manufacturer, who places devices on the market under his own name, does not have a registered place of business in a Member State, he shall designate an authorized representative established in the Community. The authorized representative shall inform the competent authorities of the Member State, in which he has his registered place of business, of all particulars as referred to in paragraph 1.

3. The Member States shall on request inform the other Member States and the Commission of the details referred to in paragraphs 1 and 2. The procedures implementing the present Article shall be adopted in accordance with the procedure referred to in Article 7 (2).

Article 11

Vigilance

1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving devices bearing the CE marking is recorded and evaluated centrally:

(a) any malfunction, failure or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer.

2. Where a Member State requires medical practitioners, the medical institutions or the organizers of external quality assessment schemes to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorized representative established in the Community, is also informed of the incident.

3. After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which relevant measures have been taken or are contemplated.

4. Where, in the context of notification referred to in Article 10, a device notified, bearing a CE marking, is a 'new' product, the manufacturer shall indicate this fact on his notification. The competent authority so notified may at any time within the following two years and on justified grounds, require the manufacturer to submit a report relating to the experience with the device subsequent to its being placed on the market. For this purpose, a device is 'new' if:

(a) such a device, for the relevant analyte or other parameter, has not been continuously available on the Community market during the previous three years;

(b) the procedure involves analytical technology not used in connection with a given analyte or other parameter on the Community market continuously during the previous three years.

5. The Member States shall on request inform the other Member States of the details referred to in paragraphs 1 and 4. The procedures implementing the present Article shall be adopted in accordance with the procedure referred to in Article 7 (2).

Article 12

Modification of Annex 2, derogation clause

1. Where a Member State considers that:

(a) the list of devices covered by Annex 2 should be modified or extended; or

(b) the conformity of a device or a category of devices should be established by way of derogation from the provisions of Article 9, by applying one or several alternative procedures taken from amongst those referred to in Article 9,

it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. The measures shall be adopted in accordance with Article 7 (2).

2. When a measure is to be taken in accordance with paragraph 1, due consideration shall be given:

(a) to any relevant information available from the vigilance procedures and from external quality assessment schemes as referred to in Article 11;

(b) to the following criteria:

(i) whether total reliance has to be put on the result obtained with a given device, having a direct impact on the subsequent medical action; and

(ii) whether an action taken on the basis of an incorrect result obtained using a given device could prove to be hazardous to the patient or third party as a consequence of false positive or false negative results; and

(iii) whether the involvement of a notified body is appropriate and justified.

3. The Commission shall inform the Member States of the measures taken and, where appropriate, publish these measures in the Official Journal of the European Communities.

Article 13

Notified bodies

1. Member States shall notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 9 and the specific tasks for which the bodies have been designated. The Commission shall assign identification numbers to these bodies, hereinafter referred to as 'notified bodies'.

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

2. Member States shall apply the criteria set out in Annex 9 for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonized standards shall be presumed to meet the relevant 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 of any withdrawal of notification for the aforementioned or any other reason.

4. The notified body and the manufacturer, or its authorized representative established in the Community, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes 3 to 7.

5. The notified body must make available to the other notified bodies and the competent authority, on request, all relevant information concerning approvals and certificates issued, refused or withdrawn.

Article 14

CE marking

1. Devices, other than devices for performance evaluation, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.

2. The CE marking of conformity, as shown in Annex 10, must appear in a visible, legible and indelible form on the device, where practicable and appropriate, and on the instructions for use. Where applicable the CE marking of conformity must also appear on the sales packaging. The CE marking shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes 4, 6 and 7.

3. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced.

Article 15

Unduly affixed CE marking

Without prejudice to Article 8:

(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 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 product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8.

Article 16

Decisions in respect of refusal or restriction

1. Any decision taken pursuant to this Directive:

(a) to refuse or restrict the placing on the market or the putting into service of a device; or

(b) to withdraw devices from the market,

shall state the exact grounds on which it is based. Such decisions 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 national law in force in the Member State in question and of the time limits to which such remedies are subject.

2. In the event of a decision as referred to in paragraph 1, 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 measure to be taken.

Article 17

Confidentiality

Without prejudice to the existing national provisions and practices on medical secrets, Member States shall ensure that all the parties involved in the application of this Directive are bound to observe confidentiality with regard to 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, nor the obligations of the persons concerned to provide information under criminal law.

Article 18

Cooperation between Member States

Member States shall take appropriate measures to ensure that competent authorities charged with the implementation of the present Directive cooperate with each other and convey to each other the information necessary to ensure compliance with the provisions of this Directive.

Article 19

Amendment of Directives

1. Directive 93/42/EEC is hereby amended as follows:

(a) Article 1 (2) (c) shall read as follows:

'(c) in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients.'

(b) Article 1 (5) (f) shall read as follows:

'(f) transplants or tissues or cells of human origin, unless a device is manufactured utilizing tissues or substances derived from such tissues which are non viable or rendered non viable. In this case, the Directive shall not affect national regulations relating to the ethics of the collection of tissues or substances of human origin, as well as any regulations relating to the ethics governing distribution of given types of devices of such origin.';

(c) Annex I, paragraph 8.2 shall read as follows:

'8.2. Where a device is manufactured utilizing human tissues or substances derived from human tissues, the use of such tissues or substances must be subject to the relevant validated selection and screening procedures, including traceability as appropriate in relation to the inherent risk.

Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues.

Processing, preservation, testing and handling of tissues, cells and substances of human or animal origin must be carried out so as to provide optimal security. In particular safety with regard to viruses and other transmissible agents must be addressed as appropriate by implementation of validated methods of elimination or inactivation of such viruses or other transmissible agents in the course of the

manufacturing process, taking into account the sourcing and control methods applied.';

(d) Annex I, paragraph 13.3 shall be completed by the following subparagraph:

'(n) in the case of devices incorporating tissues of human origin or substances derived from such tissues, a statement indicating that the device incorporates tissue or substances derived from tissue of human origin as appropriate';

(e) in Annex II, paragraph 3.2 (c) and Annex III, paragraph 3 the following indent shall be included as third-last indent:

'in the case of devices incorporating tissues of human or animal origin, information on the selection and origin';

(f) Annex IX, Section III, paragraph 4.5: the following subparagraph shall be added:

'All devices manufactured utilizing human tissues or substances derived from such tissues are in class III.'

2. In Directive 89/392/EEC, the text of Article 1 (3), second indent, 'machinery for medical use, used in direct contact with patients', is replaced by the following text:

'- medical devices'.

Article 20

Implementation, transitional provisions

1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 April 1998. They shall immediately inform the Commission thereof.

The Standing Committee referred to in Article 7 may assume its tasks from the date of notification of this Directive. The Member States may take the measures referred to in Article 13 on notification of this Directive.

When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedures for such reference shall be adopted by Member States.

Member States shall apply these provisions with effect from1 July 1998.

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 take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 9 for conformity assessment take account of any relevant information regarding the characteristics and performance of such devices, including in particular the results of any relevant test and verification already carried out under pre-existing national law, regulations or administrative provisions in respect of such devices.

4. Member States shall accept during a period of four years following adoption of the present Directive the placing on the market and putting into service of devices which conform to the rules in force in their territory on the date of adoption of this Directive.

Article 21

This Directive shall enter into force on the 20th day after its publication.

Article 22

This Directive is addressed to the Member States.

(1) OJ No C 136, 4. 6. 1985, p. 1.

(2) OJ No L 189, 20. 7. 1990, p. 17.

(3) OJ No L 169, 12. 7. 1993, p. 1.

(4) OJ No L 139, 23. 5. 1989, p. 19. Directive as last amended by Directive 93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).

(5) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by Directive 94/10/EC of the European Parliament and the Council (OJ No L 100, 19. 4. 1994, p. 30).

(6) OJ No L 380, 31. 12. 1990, p. 13. Decision as last amended by Decision 93/465/EEC (OJ No L 220, 30. 8. 1993, p. 23).

(7) OJ No L 197, 18. 7. 1987, p. 23.

(8) Council Directive 89/336/EEC relating to electromagnetic compatibility (OJ No L 139, 23. 5. 1989, p. 19), as last amended by Directive 93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).

ANNEX 1

ESSENTIAL REQUIREMENTS

I. GENERAL REQUIREMENTS

1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety and health of users and, where applicable, other persons, and the safety of property. Any risks which may be associated with their use must be acceptable when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety.

2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.

In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:

- eliminate or reduce risks as far as possible (inherently safe design and construction),

- where appropriate, take adequate protection measures in relation to risks that cannot be eliminated,

- inform users of the residual risks due to any shortcomings of the protection measures.

3. The devices must be designed and manufactured in such a way that they are suitable for the purposes referred to in Article 1 (2) (b), as specified by the manufacturer, taking account of the generally acknowledged state of the art. They must achieve the performances in particular in terms of analytical sensitivity, specificity, accuracy, repeatability, reproducibility and limits of detection stated by the manufacturer.

The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of higher order.

4. The characteristics and performances referred to in Sections 1 and 3 must not be adversely affected to such a degree that the health or the safety of the patient or the user and, where applicable, of other persons, are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subject to the stresses which can occur during normal conditions of use. When no lifetime is stated, the same applies for the lifetime reasonably to be expected of a device of that kind, having regard to the intended purpose and the anticipated use of the device.

5. The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected in the storage and transport conditions (temperature, humidity, etc.), taking account of the instruction and information provided by the manufacturer.

II. REQUIREMENTS REGARDING DESIGN AND MANUFACTURING

6. Chemical and physical properties

6.1. The devices must be designed and manufactured in such a way as to achieve the characteristics and performances referred to in Section I, 'General Requirements'. Attention must be paid to the possibility of impairment of analytical performance due to incompatibility between the materials used and the samples (such as biological tissues, cells, body fluids and micro-organisms) intended to be used with the device, taking account of its intended purpose.

6.2. The devices must be designed, manufactured and packed in such a way as to reduce as far as possible the risk posed by leakage products, contaminants and residues to the persons involved in the transport, storage and use of the devices, taking account of the intended purpose of the products.

7. Infection and microbial contamination

7.1. The devices must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or other persons. The design must allow easy handling and, where necessary, reduce as far as possible contamination of and leakage from the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. The manufacturing processes must be appropriate for these purpopses.

7.2. Where a device incorporates biological substances, the risks of infection must be reduced as far as possible by selecting appropriate donors, appropriate substances and using appropriate inactivation, conservation, test and control procedures.

7.3. Devices labelled either as 'STERILE' or as having a special microbiological state must be designed, manufactured and packed in an appropriate pack, according to procedures suitable to ensure that they remain in the microbiological state indicated on the label when placed on the market, under the storage and transport conditions as laid down by the manufacturer, until the protective packaging is damaged or opened.

7.4. Devices labelled either as 'STERILE' or as having a special microbiological state must have been processed by an appropriate, validated method.

7.5. Packaging systems for devices other than those referred to in section 7.3 must keep the product without deterioration at the level of cleanliness, if any, as indicated by the manufacturer and, if the devices are to be sterilized prior to use, reduce as far as possible the risk of microbial contamination.

Steps shall be taken to reduce microbial contamination during selection and handling of raw materials, manufacture, storage and distribution where the performance of the device can be adversely affected by such contamination.

8. Construction and environmental properties

8.1. If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must be safe and must not impair the specified performances of the devices. Any restrictions on use must be indicated on the label and/or in the instructions for use.

8.2. Devices must be designed and manufactured in such a way as to remove or reduce as far as possible:

- the risk of injury, in connection with their physical features, including aspects of volume × pressure, dimensional and where appropriate ergonomic features,

- risks connected with reasonably foreseeable external influences, such as magnetic fields, external electrical effects, electrostatic discharge, pressure, temperature or variations in pressure or acceleration.

Devices must be designed and manufactured in such a way as to provide an adequate level of intrinsic immunity from electromagnetic disturbance to enable them to operate in accordance with their intended purpose.

8.3. Devices must be designed and manufactured in such a way as to reduce as far as possible the risks of fire or explosion during normal use. Particular attention must be paid to devices whose intended use includes exposure to or use in association with flammable substances or substances which could cause combustion.

8.4. Devices must be designed and manufactured in such a way as to facilitate the management of safe waste disposal.

8.5. The measuring, monitoring or display scale (including colour change and other visual indicators) must be designed and manufactured in line with ergonomic principles, taking account of the intended purpose of the device.

9. Devices which are instruments or apparatus with a measuring function

9.1. Devices which are instruments or apparatus having a primary analytical measuring function must be designed and manufactured in such a way as to provide adequate stability and accuracy of measurement within appropriate accuracy limits, taking into account the intended purpose of the device and of available and appropriate reference measurement procedures and materials. The accuracy limits have to be specified by the manufacturer.

9.2. When values are expressed numerically, they must be given in legal units conforming to the provisions of Council Directive 80/181/EEC (1).

10. Protection against radiation

10.1. Devices shall be designed and manufactured in such a way that exposure of users and other persons to the emitted radiation is reduced as far as possible.

10.2. When devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must be:

- designed and manufactured in such a way as to ensure that the quality and quantity of radiation emitted can be adjusted and controlled,

- fitted, where practicable, with visual displays and/or audible warnings of such emissions.

10.3. The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation, means of protecting the user, and on ways of avoiding misuse and of eliminating the risks inherent in installation.

11. Requirements for medical devices connected to or equipped with an energy source

11.1. Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use.

11.2. Devices must be designed and manufactured in such a way as to minimize the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment.

11.3. Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during normal use and in single fault condition, provided the devices are installed and maintained correctly.

11.4. Protection against mechanical and thermal risks

11.4.1. Devices must be designed and manufactured in such a way as to protect the user against mechanical risks connected with, for example, resistance, stability and moving parts. Annex 1, Sections 1.3 and 1.4 of Directive 89/392/EEC (2) shall apply, where appropriate.

11.4.2. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.

11.4.3. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance.

11.4.4. Terminals and connectors to electricity, gas or hydraulic and pneumatic energy supplies which the user has to handle must be designed and manufactured in such a way as to minimize all possible risks.

11.4.5. Accessible parts of the devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use.

12. Requirements for devices for self-testing

Devices for self-testing must be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in users' technique and environment. The information and instructions provided by the manufacturer should be easily understood and applied by the user.

12.1. Devices for self-testing must be designed and manufactured in such a way as to reduce as far as practicable the risk of user's error in handling and in interpretation of the result.

12.2. Devices for self-testing must, where reasonably possible, include a method of user control, i.e. a procedure by which the user can reasonably verify that, at the time of use, the product will perform as intended.

13. Information supplied by the manufacturer

13.1. Each device must be accompanied by the information needed to use it properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.

This information comprises the data on the label and in the instructions for use.

As far as practicable and appropriate, the information needed to use the device properly must be set out on the device itself and/or on the packaging or, where appropriate, on the sales packaging. If individual full labelling of each unit is not practicable, the information must be set out on the packaging and/or in the instructions for use supplied with one or more devices.

Instructions for use must accompany or be included in the packaging of one or more devices.

By way of exception, no such instructions for use are needed for a device if it can be used properly and safely without them.

13.2. Where appropriate, this information to be supplied should take the form of symbols. Any symbol and identification colour used must conform to the harmonized standards. In areas for which no standards exist, the symbols and colours as used must be described in the documentation supplied with the device.

13.3. In the case of a device containing a substance or being a preparation which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant danger symbols and labelling requirements of Directive 67/548/EEC and Directive 88/379/EEC shall apply. Where there is insufficient space to put all information on the device itself or on its label, the relevant danger symbols shall be put on the label and the other information required by those Directives shall be given in the instructions for use.

The provisions of the abovementioned Directives on the safety data sheet shall apply, unless all relevant information as appropriate is already made available by the instructions for use.

13.4. The label must bear the following particulars which may take the form of symbols as appropriate:

(a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorized representative of the manufacturer established within the Community;

(b) the details strictly necessary for the user to identify the device and the contents of the packaging;

(c) where appropriate, the word 'STERILE' or a statement indicating any special microbiological state or state of cleanliness;

(d) where appropriate, the batch code, preceded by the word 'LOT', or the serial number;

(e) where appropriate, an indication of the date by which the device or part of it should be used, expressed as the year, the month and, where relevant, the day;

(f) in cases of devices for performance evaluation, the words 'for performance evaluation only';

(g) where appropriate, a statement indicating the in vitro nature of the device;

(h) any special storage and/or handling conditions;

(i) where applicable, any special operating instructions;

(j) appropriate warnings and/or precautions to take;

(k) in the case of a device intended for self-testing, this fact should be clearly stated;

(l) in the case of devices incorporating tissues of human origin or substances derived from such tissues, a statement indicating that the device incorporates tissues or substances derived from tissue of human origin.

13.5. If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state the intended purpose in the instructions for use and, if appropriate, on the label.

13.6. Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components.

13.7. Where appropriate, the instructions for use must contain the following particulars:

(a) the details referred to in Section 13.4, with exception of points (d) and (e);

(b) composition of the reagent product by nature and amount or concentration of the active ingredient(s) of the reagent(s) or kit as well as a statement that the device contains other ingredients influencing the measurement;

(c) the storage conditions and shelf life following the first opening of the immediate container, together with the storage conditions and stability of working reagents;

(d) the performances referred to in Section 3;

(e) a statement of any special materials required including information necessary to enable those special materials to be identified for proper use;

(f) the type of specimen to be used, any special conditions of collection, pre-treatment and, if necessary, storage conditions;

(g) a detailed description of the procedure to be followed in using the device;

(h) the measurement procedure to be followed with the device, including as appropriate:

- the principle of the method,

- the specific analytical performance characteristics (e.g. analytical sensitivity, specificity, accuracy, repeatability, reproducibility and limits of detection), limitations of the method and information about the use of available reference measurement procedures and materials by the user,

- the details of any further procedure or handling needed before the device can be used (for example, reconstitution, incubation, dilution, instrument checks, etc.),

- the indication whether any particular training is required;

(i) the mathematical approach upon which the calculation of the analytical result is made;

(j) measures to be taken in the event of changes in the analytical performance of the device;

(k) information appropriate to users on:

- internal quality control, including specific validation procedures,

- the traceability of the calibration of the devices;

(l) the reference intervals for the quantities being determined;

(m) if the device must be used in combination with or installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose, sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe and proper combination;

(n) all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the device operates properly and safely; information about safe waste disposal;

(o) the necessary instructions in the event of damage to the sterile protective packaging and details of appropriate methods of resterilization or decontamination;

(p) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and resterilization or decontamination, and any restriction on the number of reuses;

(q) precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources, etc.;

(r) precautions to be taken against any special, unusual risks related to the use or disposal of the device including special protective measures; where the device includes substances of human or animal origin, attention shall be drawn to their potential infectious nature;

(s) specifications for devices for self-testing:

- the results need to be expressed and presented in a way that is readily understood by a non-professional person; information needs to be provided with advice to the user on action to be taken (in case of positive, negative or indeterminate result) and on the possibility of false positive or false negative result,

- specific particulars may be omitted provided that the other information supplied by the manufacturer is sufficient to enable the user to know how to use the device and to understand the result(s) produced by the device,

- the information provided must include a statement clearly directing that the user should not take any decision of medical relevance without first consulting his or her medical practitioner;

(t) the date of issue or last revision of the instructions for use.

(1) OJ No L 39, 15. 2. 1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJ No L 357, 7. 12. 1989, p. 28).

(2) Council Directive 89/392/EEC (OJ No L 183, 29. 6. 1989), as last amended by Council Directive 93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).

ANNEX 2

LIST OF DEVICES REFERRED TO IN ARTICLE 9 (2)

1. Reagents and reagent products for blood grouping (A, B, 0 and Rho/D)

2. Reagents and reagent products for the detection in human specimens of markers of HIV infection and hepatitis B and C.

ANNEX 3

EC DECLARATION OF CONFORMITY

1. The EC declaration of conformity is the procedure whereby the manufacturer or his authorized representative established in the Community who fulfils the obligations imposed by Sections 2 to 5 and additionally, in the case of devices for self-testing, the obligations imposed by Section 6, ensures and declares that the products concerned meet the provisions of this Directive which apply to them. The manufacturer must affix the CE marking in accordance with Article 14.

2. The manufacturer must prepare the technical documentation described in Section 3 and ensure that the manufacturing process follows the principles of quality assurance as set out in Section 4.

3. The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. It must include in particular:

- a general description of the product, including any variants planned,

- the documentation of the quality system,

- design information, including performance characteristics and limitation, methods of manufacture and, in the case of instruments, design drawings, diagrams of components, sub-assemblies, circuits, etc.,

- the descriptions and explanations necessary to understand the abovementioned characteristics, drawings and diagrams and the operation of the product,

- the results of the risk analysis, where appropriate, and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in Article 5 have not been applied in full,

- in the case of sterile products or products with a special microbiological state or state of cleanliness, a description of the procedures used,

- the results of the design calculations and of the inspections carried out, etc.,

- if the device is to be combined with other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when combined with any such device(s) having the characteristics specified by the manufacturer,

- the test reports,

- adequate performance evaluation data, supported by a reference measurement system (when available), originated from studies in a clinical or other appropriate environment or resulting from available literature; this applies in particular to biological materials, culture media and devices using a new technology,

- the labels and instructions for use.

4. The manufacturer shall take necessary measures to ensure that the manufacturing process follows the principles of quality assurance as appropriate for the products manufactured.

The system shall address:

- the organizational structure and responsibilities,

- the manufacturing processes and systematic quality control of production,

- the means to monitor the performance of the quality system.

5. The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:

(i) any malfunction, failure or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(ii) any technical or medical reason connected with the characteristics or the performance of a device for the reasons referred to in subparagraph (i) above leading to systematic recall of devices of the same type by the manufacturer.

6. For devices for self-testing the manufacturer shall lodge an application for examination of the design with a notified body.

6.1. The application shall enable the design of the device to be understood and shall enable conformity with the design-related requirements of the Directive to be assessed.

It shall include:

- test reports including, where appropriate, results of studies carried out with lay persons,

- data showing the handling suitability of the device in view of its intended purpose for self-testing,

- the information to be provided with the device on its label and its instructions for use.

6.2. The notified body shall examine the application and, if the design conforms to 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 completed by further tests or proof to allow assessment of conformity with the design-related requirements of the Directive. The certificate shall contain the conclusions of the examination, the conditions of validity, the data needed for identification of the approved design and, where appropriate, a description of the intended purpose of the product.

6.3. The applicant shall inform the notified body which issued the EC design-examination certificate of any significant change made to the approved design. Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product. This additional approval shall take the form of a supplement to the EC design-examination certificate.

ANNEX 4

EC DECLARATION OF CONFORMITY (FULL QUALITY ASSURANCE SYSTEM)

1. The manufacturer must ensure application of the quality system approved for the design, manufacture and final inspection of the products concerned, as specified in Section 3, and is subject to audit as laid down in Section 3.3 and to the EC surveillance as specified in Section 4.

2. The declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.

The manufacturer shall affix the CE marking in accordance with Article 14 and shall draw up a declaration of conformity covering the products concerned.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body.

The application must include:

- the name and address of the manufacturer and any additional manufacturing site covered by the quality system,

- adequate information on the product or product category covered by the procedure,

- a written declaration that no such application has been lodged with any other notified body for the same product-related quality system,

- the documentation on the quality system,

- an undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved,

- an undertaking by the manufacturer to keep the approved quality system adequate and efficacious,

- an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action and notification as referred to in Annex 3, Section 5.

3.2. 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 inspection. All the elements, requirements and provisions adopted by the manufacturer for his quality system must be documented in a systematic and orderly manner in the form of written 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:

- the organizational structures, the responsibilities of the managerial staff and their organizational authority where quality of design and manufacture of the products is concerned,

- the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of design and of product, including control of products which fail to conform;

(c) the procedures for monitoring and verifying the design of the products and in particular:

- a general description of the product, including any variants planned,

- all documentation referred to in Annex 3, Section 3, indents 3 to 11,

- in the case of devices for self-testing, the information referred to in Annex 3, Section 6.1,

- the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed;

(d) the inspection and quality assurance techniques at the manufacturing stage and in particular:

- the processes and procedures which will be used, particularly as regards sterilization and purchasing,

- the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;

(e) the appropriate tests and trials which will be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible to trace back the calibration of the test equipment adequately.

3.3. The notified body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant harmonized standards conform to these requirements.

The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.

The decision shall be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.

3.4. The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product range covered.

The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.

4. Surveillance

4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system.

4.2. The manufacturer must authorize the notified body to carry out all the necessary inspections and supply it with all relevant information, in particular:

- the documentation on the quality system,

- the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculation, tests, etc.,

- the data stipulated in the part of the quality system relating to manufacture, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the approved quality system and must supply the manufacturer with an assessment report.

4.4. In addition, the notified body may pay unannounced visits to the manufacturer. At the time of such visits, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly. It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report.

ANNEX 5

EC TYPE-EXAMINATION

1. EC type-examination is the part of the procedure whereby a notified body ascertains and certifies that a representative sample of the production envisaged fulfils the relevant provisions of this Directive.

2. The application for EC type-examination shall be lodged by the manufacturer or by his authorized representative established in the Community with a notified body.

The application shall include:

- the name and address of the manufacturer and the name and address of the authorized representative if the application is lodged by the representative,

- the documentation described in Section 3 needed to assess the conformity of the representative sample of the production in question, hereinafter referred to as the 'type', with the requirements of this Directive. The applicant shall make a 'type' available to the notified body. The notified body may request other samples as necessary,

- a written declaration that no application has been lodged with any other notified body for the same type.

3. The documentation must allow an understanding of the design, the manufacture and the performances of the product. The documentation shall contain the following items in particular:

- a general description of the type, including any variants planned,

- all documentation referred to in Annex 3, Section 3, indents 3 to 5, 7, 10 and 11.

4. The notified body shall:

4.1. examine and assess the documentation and verify that the type has been manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable provisions of the standards referred to in Article 5, as well as the items not designed on the basis of the relevant provisions of the abovementioned standards;

4.2. perform or have performed appropriate examinations and the tests necessary to verify whether the solutions adopted by the manufacturer meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied; if the device is to be combined with other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when combined with any such device(s) having the characteristics specified by the manufacturer;

4.3. carry out or ask for the appropriate examinations and the tests necessary to verify whether, if 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 examinations and tests will be carried out.

5. If the type conforms to the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions of validity and the data needed for identification of the type approved. The relevant parts of the documentation shall be annexed 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 significant change made to the approved product.

Changes to the approved product must receive further approval from the notified body which issued the EC type-examination certificate wherever the changes may affect conformity with the essential requirements or with the conditions prescribed for use of the product. This new approval shall, where appropriate, take the form of a supplement to the initial EC type-examination certificate.

7. Administrative provisions

Other notified bodies may obtain a copy of the EC type-examination certificates and/or the supplements thereto. The annexes to the certificates must be made available to the other notified bodies on reasoned application, after the manufacturer has been informed.

ANNEX 6

EC VERIFICATION

1. EC verification is the procedure whereby the manufacturer or his authorized representative established in the Community ensures and declares that the products which have been subject to the procedure set out in Section 4 conform to the type described in the EC type-examination certificate and meet the requirements of this Directive which apply to them.

2.1. The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which conform to the type described in the EC type-examination certificate and to the requirements of the Directive which apply to them. Before the start of manufacture, the manufacturer must prepare documents defining the manufacturing process, in particular as regards sterilization and the suitability of starting materials, where necessary, and define the necessary testing procedures according to the state of the art. All the routine, pre-established provisions must be implemented to ensure homogeneous production and conformity of the products with the type described in the EC type-examination certificate and with the requirements of this Directive which apply to them. The manufacturer must affix the CE marking in accordance with Article 14 and draw up a declaration of conformity covering the products concerned.

2.2. To the extent that for certain aspects the final testing according to Section 6.3 is not appropriate, adequate in-process testing, monitoring and control methods shall be established by the manufacturer with the approval of the notified body. The provisions of Annex 4, Section 4 shall apply accordingly in relation to the abovementioned approved procedures.

3. The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective and notification action as referred to in Annex 3, Section 5.

4. The notified body must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of the Directive either by examining and testing every product as specified in Section 5 or by examining and testing products on a statistical basis as specified in Section 6, as the manufacturer decides.

In as far as the conduct of examinations and tests on a statistical basis is not appropriate, examinations and tests may be carried out on a random basis provided that such procedure in conjunction with the measures taken in accordance with Section 2.2 ensures an equivalent level of conformity.

5. Verification by examination and testing of every product

5.1. Every product is examined individually and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out in order to verify the conformity of the products with the EC type described in the type-examination certificate and with the requirements of the Directive which apply to them.

5.2. The notified body must affix, or have affixed, its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out.

6. Statistical verification

6.1. The manufacturer must present the manufactured products in the form of homogeneous batches.

6.2. A random sample is taken from each batch. The products which make up the sample are examined individually and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the EC type-examination certificate and with the requirements of the Directive which apply to them in order to determine whether to accept or reject the batch.

6.3. Statistical control of products will be based on attributes, entailing a sampling system ensuring a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity percentage of between 3 and 7 %. The sampling method will be established by the harmonized standards referred to in Article 5, taking account of the specific nature of the product categories in question.

6.4. If the batch is accepted, the notified body affixes, or has affixed its identification number to each product and draws up a written certificate of conformity relating to the tests carried out. All products in the batch may be put on the market except any in the sample which failed to conform.

If a batch is rejected the competent notified body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the notified body may suspend the statistical verification.

The manufacturer may, on the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.

ANNEX 7

EC DECLARATION OF CONFORMITY (PRODUCTION QUALITY ASSURANCE)

1. The manufacturer must ensure application of the quality system approved for the manufacture of the products concerned and carry out the final inspection, as specified in Section 3, and is subject to the EC surveillance referred to in Section 4.

2. The declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.

The manufacturer must affix the CE marking in accordance with Article 14 and draw up a declaration of conformity.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body.

The application must include:

- all documentation and undertakings referred to in Annex 4, Section 3.1, and

- the technical documentation on the types approved and a copy of the EC type-examination certificates.

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 must be documented in a systematic and orderly manner in the form of written policy statements and procedures. This quality system documentation must permit uniform interpretation of the quality policy and procedures such as quality programmes, plans, manuals and records.

It must include in particular an adequate description of:

(a) the manufacturer's quality objectives;

(b) the organization of the business and in particular:

- the organizational structures, the responsibilities of the managerial staff and their organizational authority where manufacture of the products is concerned,

- the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of product, including control of products which fail to conform;

(c) the inspection and quality assurance techniques at the manufacturing stage and in particular:

- the processes and procedures which will be used, particularly as regards sterilization and purchasing,

- the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;

(d) the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible adequately to trace back the calibration of the test equipment.

3.3. The notified body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant harmonized standards conform to these requirements.

The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an inspection of the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.

The decision must be notified to the manufacturer after the final inspection and contain the conclusions of the inspection and a reasoned assessment.

3.4. The manufacturer shall inform the notified body which approved the quality system of any plan for substantial changes to the quality system.

The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2.

It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.

4. Surveillance

The provision of Annex 4, Section 4, shall apply.

ANNEX 8

STATEMENT AND PROCEDURES CONCERNING DEVICES FOR PERFORMANCE EVALUATION

1. For devices for performance evaluation the manufacturer or his authorized representative established in the Community shall draw up the statement containing the information stipulated in Section 2 of this Annex and ensure that the relevant provisions of this Directive are met.

2. The statement shall contain the following information:

- the list of laboratories or other institutions taking part in the performance evaluation study,

- in the case of devices for self-testing, the place, starting date and scheduled duration for the investigations and the number of lay-persons involved,

- a statement that the device in question conforms to the requirements of the Directive, apart from the aspects covered by the investigation and apart from those specifically itemized in the statement, and that every precaution has been taken to protect the health and safety of the patient, user and third parties.

3. The manufacturer shall also undertake to keep available for the competent national authorities the documentation allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive. This documentation must be kept for a period ending at least five years after the end of the performance evaluation.

The manufacturer shall take all the measures necessary for the manufacturing process to ensure that the products manufactured conform to the documentation mentioned in the first paragraph.

ANNEX 9

CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES

1. The notified body, its director and the assessment and verification staff shall not be the designer, manufacturer, supplier, installer or user of the devices which they inspect, nor the authorized representative of any of these persons. They may not be directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body.

2. The notified body and its staff must carry out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of the verifications.

Should the notified body subcontract specific tasks connected with the establishment and verification of the facts, it must first ensure that the subcontractor meets the provisions of the Directive. The notified body shall keep at the disposal of the national authorities the relevant documents assessing the subcontractor's qualifications and the work carried out by the subcontractor under this Directive.

3. The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes 3 to 7 and for which it has been notified, whether these tasks are carried out by the body itself or on its responsibility. In particular, it must have the necessary staff and possess the facilities needed to perform properly the technical and administrative tasks entailed in assessment and verification. It must also have access to the equipment necessary for the verifications required.

4. The notified body must have:

- sound vocational training covering all the assessment and verification operations for which the body has been designated,

- satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections,

- the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.

5. The impartiality of the inspection staff must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of the inspections.

6. The body must take out civil liability insurance, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly.

7. The staff of the inspection body are bound to observe professional secrecy with regard to all information gained in the course of their duties (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 putting it into effect.

ANNEX 10

CE MARKING OF CONFORMITY

The CE conformity marking shall consist of the initials 'CE' taking the following form:

>REFERENCE TO A FILM>

- If the marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

- The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.