Article 2

COUNCIL DIRECTIVE 93/42/EEC

of 14 June 1993

concerning medical devices

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

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

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

In cooperation with the European Parliament ( 2 ),

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

Whereas measures should be adopted in the context 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 of medical devices are different; whereas the certification and inspection procedures for such devices differ from one Member State to another; whereas such disparities constitute barriers to trade within the Community;

Whereas the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized in order to guarantee the free movement of such devices within the internal market;

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 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 certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products ( 4 ); whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; whereas if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products ( 5 );

Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety;

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 ( 6 ), rules regarding the design and manufacture of medical devices 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 should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety;

Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( 7 ) is the first case of application of the new approach to the field of medical devices; whereas in the interest of uniform Community rules applicable to all medical devices, this Directive is based largely on the provisions of Directive 90/385/EEC; whereas for the same reasons Directive 90/385/EEC must be amended to insert the general provisions laid down in this Directive;

Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas this Directive should contain specific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility ( 8 );

Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the authorization required by Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation ( 9 ), nor application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment ( 10 ); whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work ( 11 ) and the specific directives on the same subject should continue to apply;

Whereas, in order to demonstrate conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; whereas such harmonized European 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 ( 12 ), and pursuant to the abovementioned general guidelines; whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the measures to be taken must be defined in line with procedure I, as laid down in Council Decision 87/373/EEC ( 13 ); whereas, for specific fields, what already exists in the form of European Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovementioned harmonized standards;

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 ( 14 ), the Council has laid down harmonized conformity assessment procedures; whereas the application of these modules to medical devices enables the responsibility of manufacturers and notified bodies to be determined during conformity assessment procedures on the basis of the type of devices concerned; whereas the details added to these modules are justified by the nature of the verification required for medical devices;

Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market;

Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose;

Whereas medical devices should, as a general rule, bear the CE mark 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, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16 May 1989 regarding future activities on AIDS prevention and control at Community level ( 15 ), medical devices used for protection against the HIV virus must afford a high level of protection; whereas the design and manufacture of such products should be verified by a notified body;

Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of the diverse nature of the devices and technological progress in this field, steps must be taken to include amongst the implementing powers conferred on the Commission the decisions to be taken with regard to the proper classification or reclassification of the devices or, where appropriate, the adjustment of the classification rules themselves; whereas since these issues are closely connected with the protection of health, it is appropriate that these decisions should come under procedure IIIa, as provided for in Directive 87/373/EEC;

Whereas the confirmation of complicance with the essential requirements may mean that clinical investigations have to be carried out under the responsibility of the manufacturer; whereas, for the purpose of carrying out the clinical investigations, appropriate means have to be specified for the protection of public health and public order;

Whereas the protection of health and the associated controls may be made more effective by means of medical device vigilance systems which are integrated at Community level;

Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometers ( 16 ); whereas the abovementioned Directive must therefore be repealed; whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine ( 17 ) must be amended,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Definitions, scope

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

2.For the purposes of this Directive, the following definitions shall apply:

(a) ►M5 ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and 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 of 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)‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;

(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 or pathological state, or

—concerning a congenital abnormality, or

—to determine the safety and compatibility with potential recipients, or

—to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

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

(d)‘custom-made device’ means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.

The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.

Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user ►M5 shall not be ◄ considered to be custom-made devices;

(e)‘device intended for clinical investigation’ means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment.

For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorized to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;

(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 a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;

(g)‘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 and/or in promotional materials;

(h)‘placing on the market’ means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;

(i)‘putting into service’ means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose;

(j) ‘authorised representative’ means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;

(k)‘clinical data’ means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

—clinical investigation(s) of the device concerned; or

—clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or

—published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

(l)‘device subcategory’ means a set of devices having common areas of intended use or common technology;

(m) ‘generic device group’ means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

(n)‘single use device’ means a device intended to be used once only for a single patient.

3.Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC ( 18 ), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.

If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.

4.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive ►M5 2001/83/EC ◄ and which is liable to act upon the body with action ancillary to that of the device, ►M5 that device shall ◄ be assessed and authorized in accordance with this Directive.

4 a.Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive ►M5 2001/83/EC ◄ and which is liable to act upon the human body with action ancillary to that of the device, hereinafter referred to as a ‘human blood derivative’, ►M5 that device shall ◄ be assessed and authorised in accordance with this Directive.

5. ►M5 This Directive shall not apply to: ◄

(a) in vitro diagnostic devices;

(b)active implantable devices covered by Directive 90/385/EEC;

(c)medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;

(d)cosmetic products covered by Directive 76/768/EEC ( 19 );

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(e)human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells, with the exception of devices referred to in paragraph 4a;

(f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;

(g)transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

6.Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC ( 20 ) and this Directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.

7.This Directive is a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC of the European Parliament and of the Council ( 21 ).

8.This Directive shall not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation ( 22 ), nor of Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure ( 23 ).

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/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose.

Article 3

Essential requirements

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

Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery ( 24 ) shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive.

Article 4

Free movement, devices intended for special purposes

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 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11.

2.Member States shall not create any obstacle to:

—devices intended for clinical investigation being made available to medical practitioners or authorized persons for that purpose if they meet the conditions laid down in Article 15 and in Annex VIII,

—custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.

These devices shall not bear the CE marking.

3.At trade fairs, exhibitions, demonstrations, etc. 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.

4.Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.

5.Where the devices are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the devices 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 adopted pursuant to the harmonized standards the references of which have been publishes in the Official Journal of the European Communities; Member States shall publish the references of such national standards.

2.For the purposes of this Directive, reference to harmonized standards also includes the monographs of the European Pharmacopoeia notably on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in the Official Journal of the European Communities.

3.If a 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 by the Member States 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).

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Article 6

Committee on Standards and Technical Regulations

1.The Commission shall be assisted by the Committee set up by Article 5 of Directive ►M5 98/34/EC ( 25 ) ◄ , hereinafter referred to as ‘the Committee’.

2.Where reference is made to this Article, Articles 3 and 7 of Decision 1999/468/EC ( 26 ) shall apply, having regard to the provisions of Article 8 thereof.

3.The Committee shall adopt its rules of procedure.

Article 7

1.The Commission shall be assisted by the Committee set up by Article 6(2) of Directive 90/385/EEC, hereinafter referred to as ‘the Committee’.

2.Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4.Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 8

Safeguard clause

1.Where a Member State ascertains that the devices referred to in Article 4 (1) and (2) second indent, 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, 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:

(a)the measures are justified:

(i)it shall immediately so inform the Member State which took the measures 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 advisory procedure referred to in Article 6(2);

(ii) when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);

(b)the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.

3.Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.

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

Article 9

Classification

1.Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX.

2.In the event of a dispute between the manufacturer and the notified body concerned, resulting from the application of the classification rules, the matter shall be referred for decision to the competent authority to which the notified body is subject.

3.Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures for adaptation of classification rules. The measures designed to amend non-essential elements of this Directive relating to adaptation of classification rules shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).

Article 10

Information on incidents occuring following placing of devices on the market

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 a Class I, IIa, IIb or III device is recorded and evaluated centrally:

(a)any malfunction 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 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 or the medical institutions 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 ►M5 ————— ◄ , is also informed of the incident.

3.After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.

4.Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).

Article 11

Conformity assessment procedures

1.In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, 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 II (full quality assurance); or

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

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

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

2.In the case of devices falling within Class IIa, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure relating to the EC declaration of conformity set out in Annex VII, coupled with either:

(a)the procedure relating to the EC verification set out in Annex IV;

(b)the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance);

(c)the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).

Instead of applying these procedures, the manufacturer may also follow the procedure referred to in paragraph 3 (a).

3.In the case of devices falling within Class IIb, other than devices which are custom-made or intended for clinical investigations, 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 II (full quality assurance); in this case, point 4 of Annex II is not applicable; or

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

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

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

(iii) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).

4.The Commission shall, no later than five years from the date of implementation of this Directive, submit a report to the Council on the operation of the provisions referred to in Article 10 (1), Article 15 (1), in particular in respect of Class I and Class IIa devices, and on the operation of the provisions referred to in Annex II, Section 4.3 second and third subparagraphs and in Annex III, Section 5 second and third subparagraphs to this Directive, accompanied, if necessary, by appropriate proposals.

5.In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market.

6.In the case of custom-made devices, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before placing each device on the market.

Member States may require that the manufacturer shall submit to the competent authority a list of such devices which have been put into service in their territory.

7.During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate stage of manufacture.

8.The manufacturer may instruct his authorized representative ►M5 ————— ◄ to initiate the procedures provided for in Annexes III, IV, VII and VIII.

9.Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative ►M5 ————— ◄ , may apply to a body of his choice within the framework of the tasks for which the body has been notified.

10.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.

11.Decisions taken by the notified bodies in accordance with ►M5 Annexes II, III, V and VI ◄ 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, ►M5 for further periods of a maximum length of five years ◄ .

12.The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body.

13.By derogation from paragraphs 1 to 6, 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 6 have not been carried out and the use of which is in the interest of protection of health.

14.The measures designed to amend non-essential elements of this Directive, by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).

Article 12

►M5 Particular procedure for systems and procedure packs and procedure for sterilisation ◄

1.By way of derogation from Article 11 this Article shall apply to systems and procedure packs.

2.Any natural or legal person who puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack, shall draw up a declaration by which he states that:

(a)he has verified the, mutual compatibility of the devices in accordance with the manufacturers' instructions and has carried out his operations in accordance with these instructions; and

(b)he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and

(c)the whole activity is subjected to appropriate methods of internal control and inspection.

Where the conditions above are not met, as in cases where the system or procedure pack incorporate devices which do not bear a CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack shall be treated as a device in its own right and as such be subjected to the relevant procedure pursuant to Article 11.

3.Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.

4.The products referred to in paragraphs 2 and 3 themselves shall not bear an additional CE marking. They shall be accompanied by the information referred to in point 13 of Annex I which includes, where appropriate, the information supplied by the manufacturers of the devices which have been put together. ►M5 The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years. ◄

Article 12a

Reprocessing of medical devices

The Commission shall, no later than 5 September 2010, submit a report to the European Parliament and to the Council on the issue of the reprocessing of medical devices in the Community.

In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate in order to ensure a high level of health protection.

Article 13

Decisions with regard to classification and derogation clause

1.A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:

(a)that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;

(b)that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;

(c)that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;

(d)that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).

The measures referred to in the first subparagraph of this paragraph shall, as appropriate, be adopted in accordance with the procedure referred to in Article 7(2).

2.The Commission shall inform the Member States of the measures taken.

Article 14

Registration of persons responsible for placing devices on the market

1.Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform 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 and the description of the devices concerned.

For all medical devices of ►M5 classes IIa, IIb and III ◄ , Member States may request to be informed of all data allowing for identification of such devices together with the label and the instructions for use when such devices are put into service within their territory.

2.Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details 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 the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.

Article 14a

European databank

1.Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.

The databank shall contain the following:

(a)data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;

(b)data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures, as laid down in Annexes II to VII;

(c)data obtained in accordance with the vigilance procedure as defined in Article 10;

(d)data relating to clinical investigations referred to in Article 15.

2.Data shall be forwarded in a standardised format.

3.The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).

4.The provisions of this Article shall be implemented no later than 5 September 2012. The Commission shall, no later than 11 October 2012, evaluate the operational functioning and the added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council or present draft measures in accordance with paragraph 3.

Article 14b

Particular health monitoring measures

Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.

The Member State shall then inform the Commission and all other Member States, giving the reasons for its decision.

The Commission shall, whenever possible, consult the interested Parties and the Member States.

The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties thereof.

When appropriate, the necessary measures designed to amend non-essential elements of this Directive, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4).

Article 15

Clinical investigation

1.In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.

2.In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.

Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.

3.In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.

4.The authorization referred to in paragraph 2 second subparagraph and paragraph 3, may be made subject to authorization from the competent authority.

5.The clinical investigations must be conducted in accordance with the provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).

6.The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission. Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.

7.The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.

8.The provisions of paragraphs 1 and 2 do not apply where the clinical investigations are conducted using devices which are authorized in accordance with Article 11 to bear the CE marking unless the aim of these investigations is to use the devices for a purpose other than that referred to in the relevant conformity assessment procedure. The relevant provisions of Annex X remain applicable.

Article 16

Notified bodies

1.The 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 11 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 XI 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.

When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).

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

4.The notified body and the manufacturer, or his authorized representative ►M5 ————— ◄ , shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes II to VI.

5.The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information.

6.Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The Member State shall inform the other Member States and the Commission.

7.The notified body shall, on request, supply all relevant information and documents including budgetary documents, required to enable the Member State to verify compliance with Annex XI requirements.

Article 17

CE marking

1.Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.

2.The CE marking of conformity, as shown in Annex XII, must appear in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. Where applicable, the CE marking must also appear on the sales packaging.

It shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes II, IV, V and VI.

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 18

Wrongly affixed CE marking

Without prejudice to Article 8:

(a)where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative 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.

Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.

Article 19

Decision 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 the carrying out of clinical investigations;

(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 ►M5 ————— ◄ , 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 20

Confidentiality

1.Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.

This does not affect the obligation 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.

2.The following information shall not be treated as confidential:

(a)information on the registration of persons responsible for placing devices on the market in accordance with Article 14;

(b)information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure according to Article 10(3);

(c)information contained in certificates issued, modified, supplemented, suspended or withdrawn.

3.The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to determination of the conditions under which other information may be made publicly available, and in particular for Class IIb and Class III devices to any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).

Article 20a

Cooperation

Member States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.

The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.

Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.

Article 21

Repeal and amendment of Directives

1.Directive 76/764/EEC is hereby repealed with effect from 1 January 1995.

2.In the title and Article 1 of Directive 84/539/EEC, ‘human or’ is deleted.

In Article 2 of Directive 84/539/EEC, the following subparagraph is added to paragraph 1:

‘If the appliance is at the same time a medical device within the meaning of Directive 93/42/EEC ( 27 ) and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this Directive.

3.Directive 90/385/EEC is hereby amended as follows:

1. in Article 1 (2) the following two subparagraphs are added:

‘(h)“placing on the market” means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;

(i)“manufacturer” means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

2. in Article 9 the following paragraphs are added:

‘5.During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate stage of manufacture.

6.Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative established in the Community, may apply to a body of his choice within the framework of the tasks for which the body has been notified.

7.The notified body may require, where duly justified, any information or data which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure.

8.Decisions taken by the notified bodies in accordance with Annexes II and III shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of five years.

9.By derogation from paragraphs 1 and 2 the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 and 2 have not been carried out and the use of which is in the interest of protection of health.’;

3. the following Article 9a is inserted after Article 9:

‘Article 9a

1.Where a Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. These measures shall be adopted in accordance with the procedure referred to in Article 7 (2) of Directive 93/42/EEC ( 28 ).

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

4. Article 10 shall be amended as follows:

—the following subparagraph shall be added to paragraph 2:

—

‘Member States may however authorize manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the Ethical Committee concerned has delivered a favourable opinion with respect to the investigation programme in question.’,

—the following paragraph shall be inserted:

—

‘2a.The authorization referred to in the second subparagraph of paragraph 2 may be subject to approval by the competent authority.’;

5. the following is added to Article 14:

‘In the event of a decision as referred to in the previous paragraph the manufacturer, or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measures to be taken.’

Article 22

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 July 1994. They shall immediately inform the Commission thereof.

The Standing Committee referred to in Article 7 may assume its tasks from the date of notification ( 29 ) of this Directive. The Member States may take the measures referred to in Article 16 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 procedure for such reference shall be adopted by Member States.

Member States shall apply these provisions with effect from 1 January 1995.

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 11 (1) to (5) 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 tests and verification already carried out under pre-existing national law, regulations or administrative provisions in respect of such devices.

4.Member States shall accept:

—devices which conform to the rules in force in their territory on 31 December 1994 being placed on the market during a period of five years following the adoption of this Directive, and

—the aforementioned devices being put into service until 30 June 2001 at the latest.

In the case of devices which have been subjected to EEC pattern approval in accordance with Directive 76/764/EEC, Member States shall accept their being placed on the market and put into service during the period up to 30 June 2004.

Article 23

This Directive is addressed to the Member States.

ANNEX I

ESSENTIAL REQUIREMENTS

I. GENERAL REQUIREMENTS

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 the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.

This shall include:

—reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and

—consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).

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 including alarms if necessary, in relation to risks that cannot be eliminated,

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

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

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

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 during transport and storage taking account of the instructions and information provided by the manufacturer.

Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended.

6a.

Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.

II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

7. Chemical, physical and biological properties

7.1.

The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the ‘General requirements’. Particular attention must be paid to:

—the choice of materials used, particularly as regards toxicity and, where appropriate, flammability,

—the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device,

—where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.

7.2.

The devices must be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure.

7.3.

The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during their normal use or during routine procedures; if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing these products and that their performance is maintained in accordance with the intended use.

7.4.

Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.

For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004 ( 30 ) on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.

Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.

Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.

When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

7.5.

The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances ( 31 ).

If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.

If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.

7.6.

Devices must be designed and manufactured in such a way as to reduce, as much as possible, risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used.

8. Infection and microbial contamination

8.1.

The devices and manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties. The design must allow easy handling and, where necessary, minimize contamination of the device by the patient or vice versa during use.

8.2.

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.

Notified bodies shall retain information on the geographical origin of the animals.

Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so as to provide optimal security. In particular safety with regard to viruses and other ►M5 transmissible ◄ agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process.

8.3.

Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate procedures to ensure that they are sterile when placed on the market and remain sterile, under the storage and transport conditions laid down, until the protective packaging is damaged or opened.

8.4.

Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method.

8.5.

Devices intended to be sterilized must be manufactured in appropriately controlled (e. g. environmental) conditions.

8.6.

Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilized prior to use, minimize the risk of microbial contamination; the packaging system must be suitable taking account of the method of sterilization indicated by the manufacturer.

8.7.

The packaging and/or label of the device must distinguish between identical or similar products sold in both sterile and non-sterile condition.

9. Construction and environmental properties

9.1.

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 or in the instructions for use.

9.2.

Devices must be designed and manufactured in such a way as to remove or minimize as far as is possible:

—the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features,

—risks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure and acceleration,

—the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given,

—risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism.

9.3.

Devices must be designed and manufactured in such a way as to minimize the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to substances which could cause combustion.

10. Devices with a measuring function

10.1.

Devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer.

10.2.

The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device.

10.3.

The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC ( 32 ).

11. Protection against radiation

11.1. General

11.1.1.

Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to radiation shall be reduced as far as possible compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.

11.2. Intended radiation

11.2.1.

Where devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it must be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters.

11.2.2.

Where devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must be fitted, where practicable, with visual displays and/or audible warnings of such emissions.

11.3. Unintended radiation

11.3.1.

Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible.

11.4. Instructions

11.4.1.

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

11.5. Ionizing radiation

11.5.1.

Devices intended to emit ionizing radiation must be designed and manufactured in such a way as to ensure that, where practicable, the quantity, geometry and quality of radiation emitted can be varied and controlled taking into account the intended use.

11.5.2.

Devices emitting ionizing radiation intended for diagnostic radiology shall be designed and manufactured in such a way as to achieve appropriate image and/or output quality for the intended medical purpose whilst minimizing radiation exposure of the patient and user.

11.5.3.

Devices emitting ionizing radiation, intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type and energy and where appropriate the quality of radiation.

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

12.1.

Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use. In the event of a single fault condition (in the system) appropriate means should be adopted to eliminate or reduce as far as possible consequent risks.

12.1a

For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.

12.2.

Devices where the safety of the patients depends on an internal power supply must be equipped with a means of determining the state of the power supply.

12.3.

Devices where the safety of the patients depends on an external power supply must include an alarm system to signal any power failure.

12.4.

Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health.

12.5.

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.

12.6.

Protection against electrical risks

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 correctly.

12.7.

Protection against mechanical and thermal risks

12.7.1.

Devices must be designed and manufactured in such a way as to protect the patient and user against mechanical risks connected with, for example, resistance, stability and moving parts.

12.7.2.

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.

12.7.3.

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.

12.7.4.

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

12.7.5.

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.

12.8.

Protection against the risks posed to the patient by energy supplies or substances

12.8.1.

Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the flow-rate can be set and maintained accurately enough to guarantee the safety of the patient and of the user.

12.8.2.

Devices must be fitted with the means of preventing and/or indicating any inadequacies in the flow-rate which could pose a danger.

Devices must incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy from an energy and/or substance source.

12.9.

The function of the controls and indicators must be clearly specified on the devices.

Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information must be understandable to the user and, as appropriate, the patient.

13. Information supplied by the manufacturer

13.1.

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

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

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

Instructions for use must be included in the packaging for every device. By way of exception, no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions.

13.2.

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

13.3.

The label must bear the following particulars:

(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 authorised representative where the manufacturer does not have a registered place of business in the Community;

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

(c)where appropriate, the word ‘STERILE’;

(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 should be used, in safety, expressed as the year and month;

(f) where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;

(g)if the device is costum-made, the words ‘custom-made device’;

(h)if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’;

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

(j) any special operating instructions;

(k)any warnings and/or precautions to take;

(l)year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial number;

(m) where applicable, method of sterilization;

(n)in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.

13.4.

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

13.5.

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.

13.6.

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

(a)the details referred to in Section 13.3, with the exception of (d) and (e);

(b)the performances referred to in Section 3 and any undesirable side-effects;

(c)if the device must be 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 combination;

(d)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 devices operate properly and safely at all times;

(e)where appropriate, information to avoid certain risks in connection with implantation of the device;

(f) information regarding the risks of reciprocal interference posed by the presence of the device during specific investigations or treatment;

(g)the necessary instructions in the event of damage to the sterile packaging and, where appropriate, details of appropriate methods of resterilization;

(h)if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device to be resterilized, and any restriction on the number of reuses.

Where devices are supplied with the intention that they be sterilized before use, the instructions for cleaning and sterilization must be such that, if correctly followed, the device will still comply with the requirements in Section I.

If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;

(i)details of any further treatment or handling needed before the device can be used (for example, sterilization, final assembly, etc.);

(j) in the case of devices emitting radiation for medical purposes, details of the nature, type, intensity and distribution of this radiation.

The instructions for use must also include details allowing the medical staff to brief the patient on any contra-indications and any precautions to be taken. These details should cover in particular:

(k)precautions to be taken in the event of changes in the performance of the device;

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

(m) adequate information regarding the medicinal product or products which the device in question is designed to administer, including any limitations in the choice of substances to be delivered;

(n)precautions to be taken against any special, unusual risks related to the disposal of the device;

(o)medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;

(p)degree of accuracy claimed for devices with a measuring function;

(q)date of issue or the latest revision of the instructions for use.

▼M5 —————

ANNEX II

EC DECLARATION OF CONFORMITY

(Full quality assurance system)

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 Sections 3.3 and 4 and to Community surveillance as specified in Section 5.

The EC 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 must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.

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,

—all the relevant information on the product or product category covered by the procedure,

—a written declaration that no 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,

— ►M5 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, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them: ◄

—

(i)any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which 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 performance of a device leading for the reasons referred to in subparagraph (i) to systematic recall of devices of the same type by the manufacturer.

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 the corresponding documentation, data and records arising from the procedures referred to in point (c).

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,

—where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;

(c)the procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:

—a general description of the product, including any variants planned, and its intended use(s),

—the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,

—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,

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

—a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC ( 33 ),

—the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—the pre-clinical evaluation,

—the clinical evaluation referred to in Annex X,

—the draft label and, where appropriate, instructions for use;

(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, purchasing and the relevant documents,

—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 assessment, on a representative basis, of the documentation of the design of the product(s) concerned, 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 is 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.

Examination of the design of the product

4.1.

In addition to the obligations imposed by Section 3, the manufacturer must lodge with the notified body an application for examination of the design dossier relating to the product which he plans to manufacture and which falls into the category referred to in Section 3.1.

4.2.

The application must describe the design, manufacture and performances of the product in question. It must include the documents needed to assess whether the product conforms to the requirements of this Directive, as referred to in Section 3.2 (c).

4.3.

The notified body must examine the application and, if the product conforms to the relevant provisions of this Directive, issue the application 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 requirements of the Directive. The certificate must contain the conclusions of the examination, the conditions of validity, the data needed for identification of the approved design, where appropriate, a description of the intended purpose of the product.

In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.

In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable. It will convey its final decision to the EMEA.

In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.

4.4.

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. The applicant shall inform the notified body which issued the EC design-examination certificate of any such changes made to the approved design. This additional approval must take the form of a supplement to the EC design-examination certificate.

Surveillance

5.1.

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

5.2.

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, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, 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.

5.3.

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.

5.4.

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.

Administrative provisions

6.1.

►M5 The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities: ◄

—the declaration of conformity,

—the documentation referred to in the fourth indent of Section 3.1 ►M5 and in particular the documentation, data and records referred to in the second paragraph of Section 3.2 ◄ ,

—the changes referred to in Section 3.4,

—the documentation referred to in Section 4.2, and

—the decisions and reports from the notified body as referred to in Sections 3.3, 4.3, 4.4, 5.3 and 5.4.

▼M1 —————

▼M5 —————

Application to devices in Classes IIa and IIb.

7.1.

In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply.

7.2.

For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

7.3.

For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.

7.4.

In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Directive. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.

7.5.

Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.

Application to the devices referred to Article 1(4a)

Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with ►M5 Article 114(2) of Directive 2001/83/EC ◄ .

ANNEX III

EC TYPE-EXAMINATION

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

The application includes:

—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 must 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.

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

—a general description of the type, including any variants planned, and its intended use(s),

—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

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

—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 if the standards referred to in Article 5 have not been applied in full,

—the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,

—a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,

—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,

—the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—the pre-clinical evaluation,

—the clinical evaluation referred to in Annex X,

—the draft label and, where appropriate, instructions for use.

The notified body must:

4.1.

examine and assess the documentation and verify that the type has been manufactured in conformity with that documentation; it must 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.

carry out or arrange for the appropriate inspections 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 connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer;

4.3.

carry out or arrange for the appropriate inspections 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 inspections and tests will be caried out.

If the type conforms to the provisions of this Directive, the notified body issues the applicant with an EC type-examination certificate. The certificate must contain the name and address of the manufacturer, the conclusions of the inspection, the conditions of validity and the data needed for identification of the type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the notified body.

In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.

In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the notified body must follow the procedures referred to in that Directive.

The applicant must 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 must, where appropriate, take the form of a supplement to the initial EC type-examination certificate.

Administrative provisions

▼M1 —————

7.2.

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 other notified bodies on reasoned application, after the manufacturer has been informed.

7.3.

The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least five years after the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.

▼M5 —————

ANNEX IV

EC VERIFICATION

EC verification is the procedure whereby the manufacturer or his authorized representative ►M5 ————— ◄ 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.

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 where necessary, together with all the routine, pre-established provisions to be implemented to ensure homogeneous production and, where appropriate, 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 17 and draw up a declaration of conformity.

In addition, for products placed on the market in sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer must apply the provisions of Annex V, Sections 3 and 4.

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, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:

(i)any malfunction 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 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 performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.

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.

The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility.

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, where appropriate, 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.

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 and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised 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.

Administrative provisions

—the declaration of conformity,

—the documentation referred to in Section 2,

—the certificates referred to in Sections 5.2 and 6.4,

—where appropriate, the type-examination certificate referred to in Annex III.

Application to devices in Class IIa

In line with Article 11 (2), this Annex may apply to products in Class IIa, subject to the following ►M5 ————— ◄ :

8.1.

in derogation from Sections 1 and 2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them;

8.2.

in derogation from Sections 1, 2, 5 and 6, the verifications conducted by the notified body are intended to confirm the conformity of the products in Class IIa with the technical documentation referred to in Section 3 of Annex VII.

Application to devices referred to in Article 1(4a)

In the case of section 5, upon completing the manufacture of each batch of devices referred to in Article 1(4a), and in the case of verification under section 6, the manufacturer shall inform the notified body of the release of this batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with ►M5 Article 114(2) of Directive 2001/83/EC ◄ .

ANNEX V

EC DECLARATION OF CONFORMITY

(Production quality assurance)

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 Community surveillance referred to in Section 4.

The EC 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.

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,

—all the relevant information on the product or product category covered by the procedure,

—a written declaration that no application has been lodged with any other notified body for the same products,

—the documentation on the quality system,

—an undertaking to fulfil the obligations imposed by the quality system is approved,

—an undertaking to maintain the practicability and effectiveness of the approved quality system,

—where appropriate, the technical documentation on the types approved and a copy of the EC type-examination certificates,

—

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

3.2.

Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate.

All the elements, requirements and provisions adopted by the manufacturer for his quality system 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,

—where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;

(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, purchasing and the relevant documents,

—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 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 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 must 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.

After the abovementioned information has been received the decision is notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.

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 authorizes the notified body to carry out all the necessary inspections and must supply it with all relevant information, in particular:

—the documentation on the quality system,

—the technical documentation,

—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 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.

Administrative provisions

5.1.

—the declaration of conformity,

—the documentation referred to in the fourth indent of Section 3.1,

—the changes referred to in Section 3.4,

—the documentation referred to in the seventh indent of Section 3.1,

—the decisions and reports from the notified body as referred to in Sections 4.3 and 4.4,

—where appropriate, the type-examination certificate referred to in Annex III.

▼M1 —————

Application to devices in Class IIa

In line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:

6.1.

By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.

6.2.

For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.

6.3.

6.4.

Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.

Application to devices referred to in Article 1(4a)

Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with ►M5 Article 114(2) of Directive 2001/83/EC ◄ .

ANNEX VI

EC DECLARATION OF CONFORMITY

(Product quality assurance)

The manufacturer must ensure application of the quality system approved for the final inspection and testing of the product, as specified in Section 3 and must be subject to the surveillance referred to in Section 4.

The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer. The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.

Quality system

3.1.

The manufacturer lodges an application for assessment of his quality system with a notified body.

The application must include:

—the name and address of the manufacturer,

—all the relevant information on the product or product category covered by the procedure,

—a written declaration specifying that no application has been lodged with any other notified body for the same products,

—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,

—where appropriate, the technical documentation on the types approved and a copy of the EC type-examination certificates,

—

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

3.2.

Under the quality system, each product or a representative sample of each batch is examined and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests are carried out to ensure that the products conform to the type described in the EC type-examination certificate and fulfil the provisions of this Directive which apply to them. All the elements, requirements and provisionsadopted by the manufacturer must be documented in a systematic and orderly manner in the form of written measures, procedures and instructions. This quality system documentation must permit uniform interpretation of the quality programmes, quality plans, quality manuals and quality records.

It must include in particular an adequate description of:

—the quality objectives and the organizational structure, responsibilities and powers of the managerial staff with regard to product quality,

—the examinations and tests that will be carried out after manufacture; it must be possible to trace back the calibration of the test equipment adequately,

—the methods of monitoring the efficient operation of the quality system,

—the quality records, such as reports concerning inspections, tests, calibration and the qualifications of the staff concerned, etc.,

—where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.

The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility.

3.3.

The notified body audits 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 decision must 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.

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

After receiving the abovementioned information it must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.

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 allow the notified body access for inspection purposes to the inspection, testing and storage locations and supply it with all relevant information, in particular:

—the documentation on the quality system,

—the technical documentation,

—the quality records, such as inspection reports, test data, calibration data, qualification reports of the staff concerned, etc.

4.3.

The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the 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 and that the production conforms to the requirements of the Directive which apply to it. To this end, an adequate sample of the final products, taken on site by the notified body, must be examined and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out. Where one or more of the samples fails to conform, the notified body must take the appropriate measures.

It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report.

Administrative provisions

5.1.

—the declaration of conformity,

—the documentation referred to in the seventh indent of Section 3.1,

—the changes referred to in Section 3.4,

—the decisions and reports from the notified body as referred to in the final indent of Section 3.4 and in Sections 4.3 and 4.4,

—where appropriate, the certificate of conformity referred to in Annex III.

▼M1 —————

Application to devices in Class IIa

In line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:

6.1.

6.2.

6.3.

6.4.

Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.

ANNEX VII

EC DECLARATION OF CONFORMITY

The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.

The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.

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 and its intended use(s),

—design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc.,

—the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operations of the product,

—the results of the risk analysis 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 products placed on the market in a sterile condition, description of the methods used and the validation report,

—the results of the design calculations and of the inspections carried out, etc.; if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,

—the solutions adopted as referred to in Annex I, Chapter I, Section 2,

—the pre-clinical evaluation,

—the clinical evaluation in accordance with Annex X,

—the label and instructions for use.

The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, 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:

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

With products placed on the market in sterile condition and Class I devices with a measuring function, the manufacturer must observe not only the provisions laid down in this Annex but also one of the procedures referred to in ►M5 Annex II, IV, V or VI ◄ . Application of the abovementioned Annexes and the intervention by the notified body is limited to:

—in the case of products placed on the market in sterile condition, only the aspects of manufacture concerned with securing and maintaining sterile conditions,

—in the case of devices with a measuring function, only the aspects of manufacture concerned with the conformity of the products with the metrological requirements.

Section 6.1. of this Annex is applicable.

Application to devices in Class IIa

In line with Article 11 (2), this Annex may apply to products in Class IIa, subject to the following derogation:

6.1.

where this Annex is applied in conjunction with the procedure referred to in Annex IV, V or VI, the declaration of conformity referred to in the abovementioned Annexes forms a single declaration. As regards the declaration based on this Annex, the manufacturer must ensure and declare that the product design meets the provisions of this Directive which apply to it.

ANNEX VIII

STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES

For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representative ►M5 ————— ◄ must draw up the statement containing the information stipulated in Section 2.

The statement must contain the following information:

2.1.

for custom-made devices:

—the name and address of the manufacturer,

—data allowing identification of the device in question,

—a statement that the device is intended for exclusive use by a particular patient, together with the name of the patient,

—the name of the medical practitioner or other authorized person who made out the prescription and, where applicable, the name of the clinic concerned,

—the specific characteristics of the product as indicated by the prescription,

—a statement that the device in question conforms to the essential requirements set out in Annex I and, where applicable, indicating which essential requirements have not been fully met, together with the grounds;

2.2.

for devices intended for the clinical investigations covered by Annex X:

—data allowing identification of the device in question,

—the clinical investigation plan,

—the investigator's brochure,

—the confirmation of insurance of subjects,

—the documents used to obtain informed consent,

—a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,

—a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,

—the opinion of the ethics committee concerned and details of the aspects covered by its opinion,

—the name of the medical practitioner or other authorized person and of the institution responsible for the investigations,

—the place, starting date and scheduled duration for the investigations,

—a statement that the device in question conforms to the essential requirements apart from the aspects covered by the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.

The manufacturer must also undertake to keep available for the competent national authorities:

3.1.

For custom-made devices, documentation, indicating manufacturing site(s) and 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.

The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation mentioned in the first paragraph;

3.2.

For devices intended for clinical investigations, the documentation must contain:

—a general description of the product and its intended use,

—design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,

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

—the results of the risk analysis 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 this Directive if the standards referred to in Article 5 have not been applied,

—if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

—if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,

—the results of the design calculations, and of the inspections and technical tests carried out, etc.

The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.

The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.

The information contained in the declarations concerned by this Annex shall be kept for a period of time of at least five years. In the case of implantable devices the period shall be at least 15 years.

For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:

ANNEX IX

CLASSIFICATION CRITERIA

I. DEFINITIONS

1. Definitions for the classification rules

1.1. Duration

Transient

Normally intended for continuous use for less than 60 minutes.

Short term

Normally intended for continuous use for not more than 30 days.

Long term

Normally intended for continuous use for more than 30 days.

1.2. Invasive devices

Invasive device

A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

Body orifice

Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

Surgically invasive device

An invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation.

For the purposes of this Directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices.

Implantable device

Any device which is intended:

—to be totally introduced into the human body or,

—to replace an epithelial surface or the surface of the eye,

by surgical intervention which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.

1.3. Reusable surgical instrument

Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which can be reused after appropriate procedures have been carried out.

1.4. Active medical device

Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. ►M5 Stand alone software is considered to be an active medical device. ◄

1.5. Active therapeutical device

Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap.

1.6. Active device for diagnosis

Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.

1.7. Central circulatory system

For the purposes of this Directive, ‘central circulatory system’ means the following vessels:

arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.

1.8. Central nervous system

For the purposes of this Directive, ‘central nervous system’ means brain, meninges and spinal cord.

II. IMPLEMENTING RULES

2. Implementing rules

2.1.

Application of the classification rules shall be governed by the intended purpose of the devices.

2.2.

If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used.

2.3.

Software, which drives a device or influences the use of a device, falls automatically in the same class.

2.4.

If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use.

2.5.

If several rules apply to the same device, based on the performance specified for the device by the manufacturer, the strictest rules resulting in the higher classification shall apply.

2.6.

In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means ‘an uninterrupted actual use of the device for the intended purpose’. However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device.

III. CLASSIFICATION

1. Non-invasive devices

1.1. Rule 1

All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies.

1.2. Rule 2

All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa:

—if they may be connected to an active medical device in Class IIa or a higher class,

—if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues,

in all other cases they are in Class I.

1.3. Rule 3

All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa.

1.4. Rule 4

All non-invasive devices which come into contact with injured skin:

—are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates,

—are in Class IIb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent,

—are in Class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound.

2. Invasive devices

2.1. Rule 5

►M5 All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I: ◄

—are in Class I if they are intended for transient use,

—are in Class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class I,

—are in Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa.

All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa.

2.2. Rule 6

All surgically invasive devices intended for transient use are in Class IIa unless they are:

—intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,

—reusable surgical instruments, in which case they are in Class I,

—intended specifically for use in direct contact with the central nervous system, in which case they are in Class III,

—intended to supply energy in the form of ionising radiation in which case they are in Class IIb,

—intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb,

—intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb.

2.3. Rule 7

All surgically invasive devices intended for short-term use are in Class IIa unless they are intended:

—either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,

—or specifically for use in direct contact with the central nervous system, in which case they are in Class III,

—or to supply energy in the form of ionizing radiation in which case they are in Class IIb,

—or to have a biological effect or to be wholly or mainly absorbed in which case they are in Class III,

—or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class IIb.

2.4. Rule 8

All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended:

—to be placed in the teeth, in which case they are in Class IIa,

—to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III,

—to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III,

—or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III.

3. Additional rules applicable to active devices

3.1. Rule 9

All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in Class IIb.

All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb.

3.2. Rule 10

Active devices intended for diagnosis are in Class IIa:

—if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient's body, in the visible spectrum,

—if they are intended to image in vivo distribution of radiopharmaceuticals,

—if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb.

Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class IIb.

Rule 11

All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class IIa, unless this is done in a manner:

—that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb.

3.3. Rule 12

All other active devices are in Class I.

4. Special Rules

4.1. Rule 13

All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive ►M5 2001/83/EC ◄ , and which is liable to act on the human body with action ancillary to that of the devices, are in Class III.

All devices incorporating, as an integral part, a human blood derivative are in Class III.

4.2. Rule 14

All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb, unless they are implantable or long term invasive devices, in which case they are in Class III.

4.3. Rule 15

All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb.

All devices intended specifically to be used for disinfecting medical devices are in Class IIa. ►M5 Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb. ◄

This rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action.

4.4. Rule 16

►M5 Devices ◄ specifically intended for recording of X-ray diagnostic images are in Class IIa.

4.5. Rule 17

All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III except where such devices are intended to come into contact with intact skin only.

5. Rule 18

By derogation from other rules, blood bags are in Class IIb.

ANNEX X

CLINICAL EVALUATION

1. General provisions

1.1.

As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as ‘clinical evaluation’, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:

1.1.1.

Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:

—there is demonstration of equivalence of the device to the device to which the data relates, and

—the data adequately demonstrate compliance with the relevant essential requirements.

1.1.2.

Or a critical evaluation of the results of all clinical investigations made.

1.1.3.

Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.

1.1a

In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.

1.1b

The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.

1.1c

The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.

1.1d

Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device/body interaction, the clinical performances intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly substantiated.

1.2.

All the data must remain confidential, in accordance with the provisions of Article 20.

2. Clinical investigations

2.1. Objectives

The objectives of clinical investigation are:

—to verify that, under normal conditions of use, the performance of the devices conform to those referred to in Section 3 of Annex I, and

—to determine any undesirable side-effects, under normal conditions of use, and assess whether they constitute risks when weighed against the intended performance of the device.

2.2. Ethical considerations

►M5 Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly. ◄ It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Helsinki Declaration. This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results.

2.3. Methods

2.3.1.

Clinical investigations must be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims for the device; these investigations must include an adequate number of observations to guarantee the scientific validity of the conclusions.

2.3.2.

The procedures used to perform the investigations must be appropriate to the device under examination.

2.3.3.

Clinical investigations must be performed in circumstances similar to the normal conditions of use of the device.

2.3.4.

All the appropriate features, including those involving the safety and performances of the device, and its effect on patients must be examined.

2.3.5.

All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.