guichett - 31993L0042 -

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=20 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;=20 whereas the internal market is an area without internal frontiers in = which the=20 free movement of goods, persons, services and capital is ensured;

Whereas the content and scope of the laws, regulations and = administrative=20 provisions in force in the Member States with regard to the safety, = health=20 protection and performance characteristics of medical devices are = different;=20 whereas the certification and inspection procedures for such devices = differ from=20 one Member State to another; whereas such disparities constitute = barriers to=20 trade within the Community;

Whereas the national provisions for the safety and health protection = of=20 patients, users and, where appropriate, other persons, with regard to = the use of=20 medical devices should be harmonized in order to guarantee the free = movement of=20 such devices within the internal market;

Whereas the harmonized provisions must be distinguished from the = measures=20 adopted by the Member States to manage the funding of public health and = sickness=20 insurance schemes relating directly or indirectly to such devices; = whereas,=20 therefore, the provisions do not affect the ability of the Member States = to=20 implement the abovementioned measures provided Community law is complied = with;=20

Whereas medical devices should provide patients, users and third = parties with=20 a high level of protection and attain the performance levels attributed = to them=20 by the manufacturer; whereas, therefore, the maintenance or improvement = of the=20 level of protection attained in the Member States is one of the = essential=20 objectives of this Directive;

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

Whereas the essential requirements and other requirements set out in = the=20 Annexes to this Directive, including any reference to 'minimizing' or = 'reducing'=20 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=20 economical considerations compatible with a high level of protection of = health=20 and safety;

Whereas, in accordance with the principles set out in the Council = resolution=20 of 7 May 1985 concerning a new approach to technical harmonization and=20 standardization (6), rules regarding the design and manufacture of = medical=20 devices must be confined to the provisions required to meet the = essential=20 requirements; whereas, because they are essential, such requirements = should=20 replace the corresponding national provisions; whereas the essential=20 requirements should be applied with discretion to take account of the=20 technological level existing at the time of design and of technical and = economic=20 considerations compatible with a high level of protection of health and = safety;=20

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

Whereas the electromagnetic compatibility aspects form an integral = part of=20 the safety of medical devices; whereas this Directive should contain = specific=20 rules on this subject with regard to Council Directive 89/336/EEC of 3 = May 1989=20 on the approximation of the laws of the Member States relating to=20 electromagnetic compatibility (8);

Whereas this Directive should include requirements regarding the = design and=20 manufacture of devices emitting ionizing radiation; whereas this = Directive does=20 not affect the authorization required by Council Directive = 80/836/Euratom of 15=20 July 1980 amending the Directives laying down the basic safety standards = for the=20 health protection of the general public and workers against the dangers = of=20 ionizing radiation (9), nor application of Council Directive = 84/466/Euratom of 3=20 September 1984 laying down basic measures for the radiation protection = of=20 persons undergoing medical examination or treatment (10); whereas = Council=20 Directive 89/391/EEC of 12 June 1989 on the introduction of measures to=20 encourage improvements in the safety and health of workers at work (11) = and the=20 specific directives on the same subject should continue to apply;

Whereas, in order to demonstrate conformity with the essential = requirements=20 and to enable conformity to be verified, it is desirable to have = harmonized=20 European standards to protect against the risks associated with the = design,=20 manufacture and packaging of medical devices; whereas such harmonized = European=20 standards are drawn up by private-law bodies and should retain their = status as=20 non-mandatory texts; whereas, to this end, the European Committee for=20 Standardization (CEN) and the European Committee for Electrotechnical=20 Standardization (Cenelec) are recognized as the competent bodies for the = adoption of harmonized standards in accordance with the general = guidelines on=20 cooperation between the Commission and these two bodies signed on 13 = November=20 1984;

Whereas, for the purpose of this Directive, a harmonized standard is = a=20 technical specification (European standard or harmonization document) = adopted,=20 on a mandate from the Commission, by either or both of these bodies in=20 accordance with Council Directive 83/189/EEC of 28 March 1983 laying = down a=20 procedure for the provision of information in the field of technical = standards=20 and regulations (12), and pursuant to the abovementioned general = guidelines;=20 whereas with regard to possible amendment of the harmonized standards, = the=20 Commission should be assisted by the Committee set up pursuant to = Directive=20 83/189/EEC; whereas the measures to be taken must be defined in line = with=20 procedure I, as laid down in Council Decision 87/373/EEC (13); whereas, = for=20 specific fields, what already exists in the form of European = Pharmacopoeia=20 monographs should be incorporated within the framework of this = Directive;=20 whereas, therefore, several European Pharmacopoeia monographs may be = considered=20 equal to the abovementioned harmonized standards;

Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the = modules=20 for the various phases of the conformity assessment procedures which are = intended to be used in the technical harmonization directives (14), the = Council=20 has laid down harmonized conformity assessment procedures; whereas the=20 application of these modules to medical devices enables the = responsibility of=20 manufacturers and notified bodies to be determined during conformity = assessment=20 procedures on the basis of the type of devices concerned; whereas the = details=20 added to these modules are justified by the nature of the verification = required=20 for medical devices;

Whereas it is necessary, essentially for the purpose of the = conformity=20 assessment procedures, to group the devices into four product classes; = whereas=20 the classification rules are based on the vulnerability of the human = body taking=20 account of the potential risks associated with the technical design and=20 manufacture of the devices; whereas the conformity assessment procedures = for=20 Class I devices can be carried out, as a general rule, under the sole=20 responsibility of the manufacturers in view of the low level of = vulnerability=20 associated with these products; whereas, for Class IIa devices, the = intervention=20 of a notified body should be compulsory at the production stage; = whereas, for=20 devices falling within Classes IIb and III which constitute a high risk=20 potential, inspection by a notified body is required with regard to the = design=20 and manufacture of the devices; whereas Class III is set aside for the = most=20 critical devices for which explicit prior authorization with regard to=20 conformity is required for them to be placed on the market;

Whereas in cases where the conformity of the devices can be assessed = under=20 the responsibility of the manufacturer the competent authorities must be = able,=20 particularly in emergencies, to contact a person responsible for placing = the=20 device on the market and established in the Community, whether the = manufacturer=20 or another person established in the Community and designated by the=20 manufacturer for the purpose;

Whereas medical devices should, as a general rule, bear the CE mark = to=20 indicate their conformity with the provisions of this Directive to = enable them=20 to move freely within the Community and to be put into service in = accordance=20 with their intended purpose;

Whereas, in the fight against AIDS and in the light of the = conclusions of the=20 Council adopted on 16 May 1989 regarding future activities on AIDS = prevention=20 and control at Community level (15), medical devices used for protection = against=20 the HIV virus must afford a high level of protection; whereas the design = and=20 manufacture of such products should be verified by a notified body;

Whereas the classification rules generally enable medical devices to = be=20 appropriately classified; whereas, in view of the diverse nature of the = devices=20 and technological progress in this field, steps must be taken to include = amongst=20 the implementing powers conferred on the Commission the decisions to be = taken=20 with regard to the proper classification or reclassification of the = devices or,=20 where appropriate, the adjustment of the classification rules = themselves;=20 whereas since these issues are closely connected with the protection of = health,=20 it is appropriate that these decisions should come under procedure IIIa, = as=20 provided for in Directive 87/373/EEC;

Whereas the confirmation of complicance with the essential = requirements may=20 mean that clinical investigations have to be carried out under the=20 responsibility of the manufacturer; whereas, for the purpose of carrying = out the=20 clinical investigations, appropriate means have to be specified for the=20 protection of public health and public order;

Whereas the protection of health and the associated controls may be = made more=20 effective by means of medical device vigilance systems which are = integrated at=20 Community level;

Whereas this Directive covers the medical devices referred to in = Council=20 Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of = the=20 Member States on clinical mercury-in-glass, maximum reading thermometers = (16);=20 whereas the abovementioned Directive must therefore be repealed; whereas = for the=20 same reasons Council Directive 84/539/EEC on 17 September 1984 on the=20 approximation of the laws of the Member States relating to = electro-medical=20 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=20 the purposes of this Directive, accessories shall be treated as medical = devices=20 in their own right. Both medical devices and accessories shall = hereinafter be=20 termed devices.

2. For the purposes of this Directive, the following definitions = shall apply:=20

(a) 'medical device' means any instrument, apparatus, appliance, = material or=20 other article, whether used alone or in combination, including the = software=20 necessary for its proper application intended by the manufacturer to be = used for=20 human beings for the purpose of:

- diagnosis, prevention, monitoring, treatment or alleviation of = disease,=20

- diagnosis, monitoring, treatment, alleviation of or compensation = for an=20 injury or handicap,

- investigation, replacement or modification of the anatomy or of a=20 physiological process,

- control of conception,

and which does not achieve its principal intended action in or on the = human=20 body by pharmacological, immunological or metabolic means, but which may = be=20 assisted in its function by such means;

(b) 'accessory' means an article which whilst not being a device is = intended=20 specifically by its manufacturer to be used together with a device to = enable it=20 to be used in accordance with the use of the device intended by the = manufacturer=20 of the device;

(c) 'device used for in vitro diagnosis' means any device which is a = reagent,=20 reagent product, kit, instrument, equipment or system, whether used = alone or in=20 combination, intended by the manufacturer to be used in vitro for the=20 examination of samples derived from the human body with a view to = providing=20 information on the physiological state, state of health or disease, or=20 congenital abnormality thereof;

(d) 'custom-made device' means any device specifically made in = accordance=20 with a duly qualified medical practitioner's written prescription which = gives,=20 under his responsibility, specific design characteristics and is = intended for=20 the sole use of a particular patient.

The abovementioned prescription may also be made out by any other = person=20 authorized by virtue of his professional qualifications to do so.

Mass-produced devices which need to be adapted to meet the specific=20 requirements of the medical practitioner or any other professional user = are not=20 considered to be custom-made devices;

(e) 'device intended for clinical investigation' means any device = intended=20 for use by a duly qualified medical practitioner when conducting = investigations=20 as referred to in Section 2.1 of Annex X in an adequate human clinical=20 environment.

For the purpose of conducting clinical investigation, any other = person who,=20 by virtue of his professional qualifications, is authorized to carry out = such=20 investigation shall be accepted as equivalent to a duly qualified = medical=20 practitioner;

(f) 'manufacturer' means the natural or legal person with = responsibility for=20 the design, manufacture, packaging and labelling of a device before it = is placed=20 on the market under his own name, regardless of whether these operations = are=20 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=20 the natural or legal person who assembles, packages, processes, fully=20 refurbishes and/or labels one or more ready-made products and/or assigns = to them=20 their intended purpose as a device with a view to their being placed on = the=20 market under his own name. This subparagraph does not apply to the = person who,=20 while not a manufacturer within the meaning of the first subparagraph, = assembles=20 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=20 instructions and/or in promotional materials;

(h) 'placing on the market' means the first making available in = return for=20 payment or free of charge of a device other than a device intended for = clinical=20 investigation, with a view to distribution and/or use on the Community = market,=20 regardless of whether it is new or fully refurbished;

(i) 'putting into service' means the stage at which a device is ready = for use=20 on the Community market for the first time for its intended purpose. =

3. Where a device is intended to administer a medicinal product = within the=20 meaning of Article 1 of Directive 65/65/EEC, that device shall be = governed by=20 the present Directive, without prejudice to the provisions of Directive=20 65/65/EEC with regard to the medicinal product.

If, however, such a device is placed on the market in such a way that = the=20 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,=20 that single product shall be governed by Directive 65/65/EEC. The = relevant=20 essential requirements of Annex I to the present Directive shall apply = as far as=20 safety and performance related device features are concerned.

4. Where a device incorporates, as an integral part, a substance = which, if=20 used separately, may be considered to be a medicinal product within the = meaning=20 of Article 1 of Directive 65/65/EEC and which is liable to act upon the = body=20 with action ancillary to that of the device, that device must be = assessed and=20 authorized in accordance with this Directive.

5. This Directive does not apply to:

(a) in vitro diagnostic devices;

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

(d) cosmetic products covered by Directive 76/768/EEC (18);

(e) human blood, human blood products, human plasma or blood cells of = human=20 origin or to devices which incorporate at the time of placing on the = market such=20 blood products, plasma or cells;

(f) transplants or tissues or cells of human origin nor to products=20 incorporating or derived from tissues or cells of human origin;

(g) transplants or tissues or cells of animal origin, unless a device = is=20 manufactured utilizing animal tissue which is rendered non-viable or = non-viable=20 products derived from animal tissue.

6. This Directive does not apply to personal protective equipment = covered by=20 Directive 89/686/EEC. In deciding whether a product falls under that = Directive=20 or the present Directive, particular account shall be taken of the = principal=20 intended purpose of the product.

7. This Directive is a specific Directive within the meaning of = Article 2 (2)=20 of Directive 89/336/EEC.

8. This Directive does not affect the application of Directive=20 80/836/Euratom, nor of Directive 84/466/Euratom.

Article 2

Placing on the market and putting into service

Member States shall take all necessary steps to ensure that devices = may be=20 placed on the market and put into service only if they do not compromise = the=20 safety and health of patients, users and, where applicable, other = persons when=20 properly installed, maintained and used in accordance with their = intended=20 purpose.

Article 3

Essential requirements

The devices must meet the essential requirements set out in Annex I = which=20 apply to them, taking account of the intended purpose of the devices = concerned.=20

Article 4

Free movement, devices intended for special purposes

1. Member States shall not create any obstacle to the placing on the = market=20 or the putting into service within their territory of devices bearing = the CE=20 marking provided for in Article 17 which indicate that they have been = the=20 subject of an assessment of their conformity in accordance with the = provisions=20 of Article 11.

2. Member States shall not create any obstacle to:

- devices intended for clinical investigation being made available to = medical=20 practitioners or authorized persons for that purpose if they meet the = conditions=20 laid down in Article 15 and in Annex VIII,

- custom-made devices being placed on the market and put into service = if they=20 meet the conditions laid down in Article 11 in combination with Annex = VIII;=20 Class IIa, IIb and III devices shall be accompanied by the statement = referred to=20 in Annex VIII.

These devices shall not bear the CE marking.

3. At trade fairs, exhibitions, demonstrations, etc. Member States = shall not=20 create any obstacle to the showing of devices which do not conform to = this=20 Directive, provided that a visible sign clearly indicates that such = devices=20 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=20 the user and the patient in accordance with Annex I, point 13, to be in = their=20 national language(s) or in another Community language, when a device = reaches the=20 final user, regardless of whether it is for professional or other use. =

5. Where the devices are subject to other Directives concerning other = aspects=20 and which also provide for the affixing of the CE marking, the latter = shall=20 indicate that the devices also fulfil the provisions of the other = Directives.=20

However, should one or more of these directives allow the = manufacturer,=20 during a transitional period, to choose which arrangements to apply, the = CE=20 marking shall indicate that the devices fulfil the provisions only of = those=20 directives applied by the manufacturer. In this case, the particulars of = these=20 directives, as published in the Official Journal of the European = Communities,=20 must be given in the documents, notices or instructions required by the=20 directives and accompanying such devices.

Article 5

Reference to standards

1. Member States shall presume compliance with the essential = requirements=20 referred to in Article 3 in respect of devices which are in conformity = with the=20 relevant national standards adopted pursuant to the harmonized standards = the=20 references of which have been publishes in the Official Journal of the = European=20 Communities; Member States shall publish the references of such national = standards.

2. For the purposes of this Directive, reference to harmonized = standards also=20 includes the monographs of the European Pharmacopoeia notably on = surgical=20 sutures and on interaction between medicinal products and materials used = in=20 devices containing such medicinal products, the references of which have = been=20 published in the Official Journal of the European Communities.

3. If a Member State or the Commission considers that the harmonized=20 standards do not entirely meet the essential requirements referred to in = Article=20 3, the measures to be taken by the Member States with regard to these = standards=20 and the publication referred to in paragraph 1 of this Article shall be = adopted=20 by the procedure defined in Article 6 (2).

Article 6

Committee on Standards and Technical Regulations

1. The Commission shall be assisted by the Committee set up by = Article 5 of=20 Directive 83/189/EEC.

The opinion shall be recorded in the minutes; in addition, each = Member State=20 shall have the right to ask to have its position recorded in the = minutes.

The Commission shall take the utmost account of the opinion delivered = by the=20 Committee. It shall inform the Committee of the manner in which its = opinion has=20 been taken into account.

Article 7

Committee on Medical Devices

1. The Commission shall be assisted by the Committee set up by = Article 6 (2)=20 of Directive 90/385/EEC.

2. The representative of the Commission shall submit to the Committee = a draft=20 of the measures to be taken. The Committee shall deliver its opinion on = the=20 draft within a time limit which the chairman may lay down according to = the=20 urgency of the matter. The opinion shall be delivered by the majority = laid down=20 in Article 148 (2) of the Treaty in the case of decisions which the = Council is=20 required to adopt on a proposal from the Commission. The votes of the=20 representatives of the Member States within the Committee shall be = weighted in=20 the manner set out in that Article. The chairman shall not vote.

The Commission shall adopt the measures envisaged if they are in = accordance=20 with the opinion of the Committee.

If the measures envisaged are not in accordance with the opinion of = the=20 Committee, or if no opinion is delivered, the Commission shall, without = delay,=20 submit to the Council a proposal relating to the measures to be taken. = The=20 Council shall act by a qualified majority.

If, on the expiry of a period of three months from the date of = referral to=20 the Council, the Council has not acted, the proposed measures shall be = adopted=20 by the Commission.

4. The Committee may examine any question connected with = implementation of=20 this Directive.

Article 8

Safeguard clause

1. Where a Member State ascertains that the devices referred to in = Article 4=20 (1) and (2) second indent, when correctly installed, maintained and used = for=20 their intended purpose, may compromise the health and/or safety of = patients,=20 users or, where applicable, other persons, it shall take all appropriate = interim=20 measures to withdraw such devices from the market or prohibit or = restrict their=20 being placed on the market or put into service. The Member State shall=20 immediately inform the Commission of any such measures, indicating the = reasons=20 for its decision and, in particular, whether non-compliance with this = Directive=20 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=20 far as it is claimed that the standards have been applied;

2. The Commission shall enter into consultation with the parties = concerned as=20 soon as possible. Where, after such consultation, the Commission finds = that:=20

- the measures are justified, it shall immediately so inform the = Member State=20 which took the initiative and the other Member States; where the = decision=20 referred to in paragraph 1 is attributed to shortcomings in the = standards, the=20 Commission shall, after consulting the parties concerned, bring the = matter=20 before the Committee referred to in Article 6 (1) within two months if = the=20 Member State which has taken the decision intends to maintain it and = shall=20 initiate the procedures referred to in Article 6,

- the measures are unjustified, it shall immediately so inform the = Member=20 State which took the initiative and the manufacturer or his authorized=20 representative established within the Community.

3. Where a non-complying device bears the CE marking, the competent = Member=20 State shall take appropriate action against whomsoever has affixed the = mark and=20 shall inform the Commission and the other Member States thereof.

4. The Commission shall ensure that the Member States are kept = informed of=20 the progress and outcome of this procedure.

Article 9

Classification

1. Devices shall be divided into Classes I, IIa, IIb and III. = Classification=20 shall be carried out in accordance with Annex IX.

2. In the event of a dispute between the manufacturer and the = notified body=20 concerned, resulting from the application of the classification rules, = the=20 matter shall be referred for decision to the competent authority to = which the=20 notified body is subject.

3. The classification rules set out in Annex IX may be adapted in = accordance=20 with the procedure referred to in Article 7 (2) in the light of = technical=20 progress and any information which becomes available under the = information=20 system provided for in

Article 10.

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=20 information brought to their knowledge, in accordance with the = provisions of=20 this Directive, regarding the incidents mentioned below involving a = Class I,=20 IIa, IIb or III device is recorded and evaluated centrally:

(a) any malfunction or deterioration in the characteristics and/or=20 performance of a device, as well as any inadequacy in the labelling or = the=20 instructions for use which might lead to or might have led to the death = of a=20 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=20 performance of a device for the reasons referred to in subparagraph (a), = leading=20 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=20 paragraph 1, it shall take the necessary steps to ensure that the = manufacturer=20 of the device concerned, or his authorized representative established in = the=20 Community, is also informed of the incident.

3. After carrying out an assessment, if possible together with the=20 manufacturer, Member States shall, without prejudice to Article 8, = immediately=20 inform the Commission and the other Member States of the incidents = referred to=20 in paragraph 1 for which relevant measures have been taken or are = contemplated.=20

Article 11

Conformity assessment procedures

1. In the case of devices falling within Class III, other than = devices which=20 are custom-made or intended for clinical investigations, the = manufacturer shall,=20 in order to affix the CE marking, either:

(a) follow the procedure relating to the EC declaration of conformity = set out=20 in Annex II (full quality assurance); or

(b) follow the procedure relating to the EC type-examination set out = in Annex=20 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=20 Annex V (production quality assurance).

2. In the case of devices falling within Class IIa, other than = devices which=20 are custom-made or intended for clinical investigations, the = manufacturer shall,=20 in order to affix the CE marking, follow the procedure relating to the = EC=20 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=20 Annex V (production quality assurance);

Instead of applying these procedures, the manufacturer may also = follow the=20 procedure referred to in paragraph 3 (a).

3. In the case of devices falling within Class IIb, other than = devices which=20 are custom-made or intended for clinical investigations, the = manufacturer shall,=20 in order to affix the CE marking, either:

(a) follow the procedure relating to the EC declaration of conformity = set out=20 in Annex II (full quality assurance); in this case, point 4 of Annex II = is not=20 applicable; or

(b) follow the procedure relating to the EC type-examination set out = in Annex=20 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=20 Annex V (production quality assurance);

(iii) the procedure relating to the EC declaration of conformity set = out in=20 Annex VI (product quality assurance).

4. The Commission shall, no later than five years from the date of=20 implementation of this Directive, submit a report to the Council on the=20 operation of the provisions referred to in Article 10 (1), Article 15 = (1), in=20 particular in respect of Class I and Class IIa devices, and on the = operation of=20 the provisions referred to in Annex II, Section 4.3 second and third=20 subparagraphs and in Annex III, Section 5 second and third subparagraphs = to this=20 Directive, accompanied, if necessary, by appropriate proposals.

5. In the case of devices falling within Class I, other than devices = which=20 are custom-made or intended for clinical investigations, the = manufacturer shall,=20 in order to affix the CE marking, follow the procedure referred to in = Annex VII=20 and draw up the EC declaration of conformity required before placing the = device=20 on the market.

6. In the case of custom-made devices, the manufacturer shall follow = the=20 procedure referred to in Annex VIII and draw up the statement set out in = that=20 Annex before placing each device on the market.

Member States may require that the manufacturer shall submit to the = competent=20 authority a list of such devices which have been put into service in = their=20 territory.

7. During the conformity assessment procedure for a device, the = manufacturer=20 and/or the notified body shall take account of the results of any = assessment and=20 verification operations which, where appropriate, have been carried out = in=20 accordance with this Directive at an intermediate stage of manufacture. =

8. The manufacturer may instruct his authorized representative = established in=20 the Community to initiate the procedures provided for in Annexes III, = IV, VII=20 and VIII.

9. Where the conformity assessment procedure involves the = intervention of a=20 notified body, the manufacturer, or his authorized representative = established in=20 the Community, may apply to a body of his choice within the framework of = the=20 tasks for which the body has been notified.

10. The notified body may require, where duly justified, any = information or=20 data, which is necessary for establishing and maintaining the = attestation of=20 conformity in view of the chosen procedure.

11. Decisions taken by the notified bodies in accordance with Annexes = II and=20 III shall be valid for a maximum of five years and may be extended on=20 application, made at a time agreed in the contract signed by both = parties, for=20 further periods of five years.

12. The records and correspondence relating to the procedures = referred to in=20 paragraphs 1 to 6 shall be in an official language of the Member State = in which=20 the procedures are carried out and/or in another Community language = acceptable=20 to the notified body.

13. By derogation from paragraphs 1 to 6, the competent authorities = may=20 authorize, on duly justified request, the placing on the market and = putting into=20 service, within the territory of the Member State concerned, of = individual=20 devices for which the procedures referred to in paragraphs 1 to 6 have = not been=20 carried out and the use of which is in the interest of protection of = health.=20

Article 12

Particular procedure for systems and procedure packs

1. By way of derogation from Article 11 this Article shall apply to = systems=20 and procedure packs.

2. Any natural or legal person who puts devices bearing the CE = marking=20 together within their intended purpose and within the limits of use = specified by=20 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=20 with the manufacturers' instructions and has carried out his operations = in=20 accordance with these instructions; and

(b) he has packaged the system or procedure pack and supplied = relevant=20 information to users incorporating relevant instructions from the = manufacturers;=20 and

Where the conditions above are not met, as in cases where the system = or=20 procedure pack incorporate devices which do not bear a CE marking or = where the=20 chosen combination of devices is not compatible in view of their = original=20 intended use, the system or procedure pack shall be treated as a device = in its=20 own right and as such be subjected to the relevant procedure pursuant to = Article=20 11.

3. Any natural or legal person who sterilized, for the purpose of = placing on=20 the market, systems or procedure packs referred to in paragraph 2 or = other=20 CE-marked medical devices designed by their manufacturers to be = sterilized=20 before use, shall, at his choice, follow one of the procedures referred = to in=20 Annex IV, V or VI. The application of the abovementioned Annexes and the = intervention of the notified body are limited to the aspects of the = procedure=20 relating to the obtaining of sterility. The person shall draw up a = declaration=20 stating that sterilization has been carried out in accordance with the=20 manufacturer's instructions.

4. The products referred to in paragraphs 2 and 3 themselves shall = not bear=20 an additional CE marking. They shall be accompanied by the information = referred=20 to in point 13 of Annex I which includes, where appropriate, the = information=20 supplied by the manufacturers of the devices which have been put = together. The=20 declaration referred to in paragraphs 2 and 3 above shall be kept at the = disposal of competent authorities for a period of five years.

Article 13

Decisions with regard to classification, derogation clause

1. Where a Member State considers that:

(a) application of the classification rules set out in Annex IX = requires a=20 decision with regard to the classification of a given device or category = of=20 devices;

(b) a given device or family of devices should be classified, by way = of=20 derogation from the provisions of Annex IX, in another class;

(c) the conformity of a device or family of devices should be = established, by=20 way of derogation from the provisions of Article 11, by applying solely = one of=20 the given procedures chosen from among those referred to in Article 11, =

it shall submit a duly substantiated request to the Commission and = ask it to=20 take the necessary measures. These measures shall be adopted in = accordance with=20 the procedure referred to in Article 7 (2).

2. The Commission shall inform the Member States of the measures = taken and,=20 where appropriate, publish the relevant parts of these measures in the = Official=20 Journal of the European Communities.

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=20 accordance with the procedures referred to in Article 11 (5) and (6) and = any=20 other natural or legal person engaged in the activities referred to in = Article=20 12 shall inform the competent authorities of the Member State in which = he has=20 his registered place of business of the address of the registered place = of=20 business and the description of the devices concerned.

2. Where a manufacturer who places devices referred to in paragraph 1 = on the=20 market under his own name does not have a registered place of business = in a=20 Member State, he shall designate the person(s) responsible for marketing = them=20 who is (are) established in the Community. These persons shall inform = the=20 competent authorities of the Member State in which they have their = registered=20 place of business of the address of the registered place of business and = the=20 category of devices concerned.

3. The Member States shall on request inform the other Member States = and the=20 Commission of the details referred to in paragraphs 1 and 2.

Article 15

Clinical investigation

1. In the case of devices intended for clinical investigations, the=20 manufacturer, or his authorized representative established in the = Community,=20 shall follow the procedure referred to in Annex VIII and notify the = competent=20 authorities of the Member States in which the investigations are to be=20 conducted.

2. In the case of devices falling within Class III and implantable = and=20 long-term invasive devices falling within Class IIa or IIb, the = manufacturer may=20 commence the relevant clinical investigation at the end of a period of = 60 days=20 after notification, unless the competent authorities have notified him = within=20 that period of a decision to the contrary based on considerations of = public=20 health or public policy.

Member States may however authorize manufacturers to commence the = relevant=20 clinical investigations before the expiry of the period of 60 days, in = so far as=20 the relevant ethics committee has issued a favourable opinion on the = programme=20 of investigation in question.

3. In the case of devices other than those referred to in the second=20 paragraph, Member States may authorize manufacturers to commence = clinical=20 investigations, immediately after the date of notification, provided = that the=20 ethics committee concerned has delivered a favourable opinion with = regard to the=20 investigational plan.

4. The authorization referred to in paragraph 2 second subparagraph = and=20 paragraph 3, may be made subject to authorization from the competent = authority.=20

5. The clinical investigations must be conducted in accordance with = the=20 provisions of Annex X. The provisions of Annex X may be adjusted in = accordance=20 with the procedure laid down in Article 7 (2).

6. The Member States shall, if necessary, take the appropriate steps = to=20 ensure public health and public policy.

7. The manufacturer or his authorized representative established in = the=20 Community shall keep the report referred to in point 2.3.7 of Annex X at = the=20 disposal of the competent authorities.

8. The provisions of paragraphs 1 and 2 do not apply where the = clinical=20 investigations are conducted using devices which are authorized in = accordance=20 with Article 11 to bear the CE marking unless the aim of these = investigations is=20 to use the devices for a purpose other than that referred to in the = relevant=20 conformity assessment procedure. The relevant provisions of Annex X = remain=20 applicable.

Article 16

Notified bodies

1. The Member States shall notify the Commission and other Member = States of=20 the bodies which they have designated for carrying out the tasks = pertaining to=20 the procedures referred to in Article 11 and the specific tasks for = which the=20 bodies have been designated. The Commission shall assign identification = numbers=20 to these bodies, hereinafter referred to as 'notified bodies'.

The Commission shall publish a list of the notified bodies, together = with the=20 identification numbers it has allocated to them and the tasks for which = they=20 have been notified, in the Official Journal of the European Communities. = It=20 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=20 standards which transpose the relevant harmonized standards shall be = presumed to=20 meet the relevant criteria.

3. A Member State that has notified a body shall withdraw that = notification=20 if it finds that the body no longer meets the criteria referred to in = paragraph=20 2. It shall immediately inform the other Member States and the = Commission=20 thereof.

4. The notified body and the manufacturer, or his authorized = representative=20 established in the Community, shall lay down, by common accord, the time = limits=20 for completion of the assessment and verification operations referred to = in=20 Annexes II to VI.

Article 17

CE marking

1. Devices, other than devices which are custom-made or intended for = clinical=20 investigations, considered to meet the essential requirements referred = to in=20 Article 3 must bear the CE marking of conformity when they are placed on = the=20 market.

2. The CE marking of conformity, as shown in Annex XII, must appear = in a=20 visible, legible and indelible form on the device or its sterile pack, = where=20 practicable and appropriate, and on the instructions for use. Where = applicable,=20 the CE marking must also appear on the sales packaging.

It shall be accompanied by the identification number of the notified = body=20 responsible for implementation of the procedures set out in Annexes II, = IV, V=20 and VI.

3. It is prohibited to affix marks or inscriptions which are likely = to=20 mislead third parties with regard to the meaning or the graphics of the = CE=20 marking. Any other mark may be affixed to the device, to the packaging = or to the=20 instruction leaflet accompanying the device provided that the visibility = and=20 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=20 unduly, the manufacturer or his authorized representative established = within the=20 Community shall be obliged to end the infringement under conditions = imposed by=20 the Member State;

(b) where non-compliance continues, the Member State must take all=20 appropriate measures to restrict or prohibit the placing on the market = of the=20 product in question or to ensure that it is withdrawn from the market, = in=20 accordance with the procedure in

Article 8.

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=20 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=20 notified without delay to the party concerned, who shall at the same = time be=20 informed of the remedies available to him under the national law in = force in the=20 Member State in question and of the time limits to which such remedies = are=20 subject.

2. In the event of a decision as referred to in paragraph 1, the=20 manufacturer, or his authorized representative established in the = Community,=20 shall have an opportunity to put forward his viewpoint in advance, = unless such=20 consultation is not possible because of the urgency of the measure to be = taken.=20

Article 20

Confidentiality

Without prejudice to the existing national provisions and practices = on=20 medical secrets, Member States shall ensure that all the parties = involved in the=20 application of this Directive are bound to observe confidentiality with = regard=20 to all information obtained in carrying out their tasks. This does not = affect=20 the obligation of Member States and notified bodies with regard to = mutual=20 information and the dissemination of warnings, nor the obligations of = the=20 persons concerned to provide information under criminal law.

Article 21

Repeal and amendment of Directives

1. Directive 76/764/EEC is hereby repealed with effect from 1 January = 1995.=20

2. In the title and Article 1 of Directive 84/539/EEC, 'human or' is = deleted.=20

In Article 2 of Directive 84/539/EEC, the following subparagraph is = added to=20 paragraph 1:

'If the appliance is at the same time a medical device within the = meaning of=20 Directive 93/42/EEC (*) and if it satisfies the essential requirements = laid down=20 therein for that device, the device shall be deemed to be in conformity = with the=20 requirements of this Directive.

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

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=20 payment or free of charge of a device other than a device intended for = clinical=20 investigation, with a view to distribution and/or use on the Community = market,=20 regardless of whether it is new or fully refurbished;

(i) "manufacturer " means the natural or legal person with = responsibility for=20 the design, manufacture, packaging and labelling of a device before it = is placed=20 on the market under his own name, regardless of whether these operations = are=20 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=20 and/or the notified body shall take account of the results of any = assessment and=20 verification operations which, where appropriate, have been carried out = in=20 accordance with this Directive at an intermediate stage of manufacture. =

6. Where the conformity assessment procedure involves the = intervention of a=20 notified body, the manufacturer, or his authorized representative = established in=20 the Community, may apply to a body of his choice within the framework of = the=20 tasks for which the body has been notified.

7. The notified body may require, where duly justified, any = information or=20 data which is necessary for establishing and maintaining the attestation = of=20 conformity in view of the chosen procedure.

8. Decisions taken by the notified bodies in accordance with Annexes = II and=20 III shall be valid for a maximum of five years and may be extended on=20 application, made at a time agreed in the contract signed by both = parties, for=20 further periods of five years.

9. By derogation from paragraphs 1 and 2 the competent authorities = may=20 authorize, on duly justified request, the placing on the market and = putting into=20 service, within the territory of the Member State concerned, of = individual=20 devices for which the procedures referred to in paragraphs 1 and 2 have = not been=20 carried out and the use of which is in the interest of protection of = health.';=20

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=20 of devices should be established, by way of derogation from the = provisions of=20 Article 9, by applying solely one of the given procedures chosen from = among=20 those referred to in

Article 9, it shall submit a duly substantiated request to the = Commission and=20 ask it to take the necessary measures. These measures shall be adopted = in=20 accordance with the procedure referred to in Article 7 (2) of Directive=20 93/42/EEC (*).

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

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=20 investigations in question before the expiry of the 60-day period, = provided that=20 the Ethical Committee concerned has delivered a favourable opinion with = respect=20 to the investigation programme in question.',

- the following paragraph shall be inserted:

'2a. The authorization referred to in the second subparagraph of = paragraph 2=20 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=20 manufacturer, or his authorized representative established in the = Community,=20 shall have an opportunity to put forward his viewpoint in advance, = unless such=20 consultation is not possible because of the urgency of the measures to = be=20 taken.'

Article 22

Implementation, transitional provisions

1. Member States shall adopt and publish the laws, regulations and=20 administrative provisions necessary to comply with this Directive not = later than=20 1 July 1994. They shall immediately inform the Commission thereof.

The Standing Committee referred to in Article 7 may assume its tasks = from the=20 date of notification (19) of this Directive. The Member States may take = the=20 measures referred to in Article 16 on notification of this Directive. =

When Member States adopt these provisions, these shall contain a = reference to=20 this Directive or shall be accompanied by such a reference at the time = of their=20 official publication. The procedure for such reference shall be adopted = by=20 Member States.

Member States shall apply these provisions with effect from 1 January = 1995.=20

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=20 bodies which are responsible pursuant to Article 11 (1) to (5) for = conformity=20 assessment take account of any relevant information regarding the=20 characteristics and performance of such devices, including in particular = the=20 results of any relevant tests and verification already carried out under = pre-existing national law, regulations or administrative provisions in = respect=20 of such devices.

4. Member States shall accept the placing on the market and putting = into=20 service of devices which conform to the rules in force in their = territory on 31=20 December 1994 during a period of five years following adoption of this=20 Directive.

In the case of devices which have been subjected to EEC pattern = approval in=20 accordance with Directive 76/764/EEC, Member States shall accept their = being=20 placed on the market and put into service during the period up to 30 = June 2004.=20

Article 23

This Directive is addressed to the Member States.

Done at Luxembourg, 14 June 1993.

For the Council

The President

J. TROEJBORG

(1) OJ No C 237, 12. 9. 1991 and OJ No C 251, 28. 9. 1992, p. 40.(2) = OJ No C=20 150, 31. 5. 1993 and OJ No C 176, 28. 6. 1993.(3) OJ No C 79, 30. 3. = 1992, p.=20 1.(4) OJ No 22, 9. 6. 1965, p. 369/65. Directive as last amended by = Directive=20 92/27/EEC (OJ No L 113, 30. 4. 1992, p. 8).(5) OJ No L 147, 9. 6. 1975, = p. 1.=20 Directive as last amended by Directive 91/507/EEC (OJ No L 270, 26. 9. = 1991, p.=20 32).(6) OJ No C 136, 4. 6. 1985, p. 1.(7) OJ No L 189, 20. 7. 1990, p. = 17.(8) OJ=20 No L 139, 23. 5. 1989, p. 19. Directive as last amended by Directive = 92/31/EEC=20 (OJ No L 126, 12. 5. 1992, p. 11).(9) OJ No L 246, 17. 9. 1980, p. 1. = Directive=20 as last amended by Directive 84/467/Euratom (OJ No L 265, 5. 10. 1984, = p.=20 4).(10) OJ No L 265, 5. 10. 1984, p. 1.(11) OJ No L 183, 29. 6. 1989, p. = 1.(12)=20 OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by Commission = Decision=20 92/400/EEC (OJ No L 221, 6. 8. 1992, p. 55).(13) OJ No L 197, 18. 7. = 1987, p.=20 33.(14) OJ No L 380, 31. 12. 1990, p. 13.(15) OJ No C 185, 22. 7. 1989, = p.=20 8.(16) OJ No L 262, 27. 9. 1976, p. 139. Directive as last amended by = Directive=20 84/414/EEC (OJ No L 228, 25. 8. 1984, p. 25).(17) OJ No L 300, 19. 11. = 1984, p.=20 179. Directive as amended by the Act of Accession of Spain and = Portugal.(18) OJ=20 No L 262, 27. 9. 1976, p. 169. Directive as last amended by Commission = Directive=20 92/86/EEC (OJ No L 325, 11. 11. 1992, p. 18).(19) This Directive was = notified to=20 the Member States on 29 June 1993.

ANNEX I

ESSENTIAL REQUIREMENTS I. GENERAL REQUIREMENTS 1. The devices must be = designed and manufactured in such a way that, when used under the = conditions and=20 for the purposes intended, they will not compromise the clinical = condition or=20 the safety of patients, or the safety and health of users or, where = applicable,=20 other persons, provided that any risks which may be associated with = their use=20 constitute acceptable risks when weighed against the benefits to the = patient and=20 are compatible with a high level of protection of health and safety. =

2. The solutions adopted by the manufacturer for the design and = construction=20 of the devices must conform to safety principles, taking account of the=20 generally acknowledged state of the art.

In selecting the most appropriate solutions, the manufacturer must = apply the=20 following principles in the following order:

- eliminate or reduce risks as far as possible (inherently safe = design and=20 construction),

- where appropriate take adequate protection measures including = alarms if=20 necessary, in relation to risks that cannot be eliminated,

- inform users of the residual risks due to any shortcomings of the=20 protection measures adopted.

3. The devices must achieve the performances intended by the = manufacturer and=20 be designed, manufactured and packaged in such a way that they are = suitable for=20 one or more of the functions referred to in Article 1 (2) (a), as = specified by=20 the manufacturer.

4. The characteristics and performances referred to in Sections 1, 2 = and 3=20 must not be adversely affected to such a degree that the clinical = conditions and=20 safety of the patients and, where applicable, of other persons are = compromised=20 during the lifetime of the device as indicated by the manufacturer, when = the=20 device is subjected to the stresses which can occur during normal = conditions of=20 use.

5. The devices must be designed, manufactured and packed in such a = way that=20 their characteristics and performances during their intended use will = not be=20 adversely affected during transport and storage taking account of the=20 instructions and information provided by the manufacturer.

6. Any undesirable side-effect must constitute an acceptable risk = when=20 weighed against the performances intended.

II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION 7. Chemical, = physical and=20 biological properties

7.1. The devices must be designed and manufactured in such a way as = to=20 guarantee the characteristics and performances referred to in Section I = on the=20 'General requirements'. Particular attention must be paid to:

- the choice of materials used, particularly as regards toxicity and, = where=20 appropriate, flammability,

- the compatibility between the materials used and biological = tissues, cells=20 and body fluids, taking account of the intended purpose of the device. =

7.2. The devices must be designed, manufactured and packed in such a = way as=20 to minimize the risk posed by contaminants and residues to the persons = involved=20 in the transport, storage and use of the devices and to the patients, = taking=20 account of the intended purpose of the product. Particular attention = must be=20 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=20 can be used safely with the materials, substances and gases with which = they=20 enter into contact during their normal use or during routine procedures; = if the=20 devices are intended to administer medicinal products they must be = designed and=20 manufactured in such a way as to be compatible with the medicinal = products=20 concerned according to the provisions and restrictions governing these = products=20 and that their performance is maintained in accordance with the intended = use.=20

7.4. Where a device incorporates, as an integral part, a substance = which, if=20 used separately, may be considered to be a medicinal product as defined = in=20 Article 1 of Directive 65/65/EEC and which is liable to act upon the = body with=20 action ancillary to that of the device, the safety, quality and = usefulness of=20 the substance must be verified, taking account of the intended purpose = of the=20 device, by analogy with the appropriate methods specified in Directive=20 75/318/EEC.

7.5. The devices must be designed and manufactured in such a way as = to reduce=20 to a minimum the risks posed by substances leaking from the device.

7.6. Devices must be designed and manufactured in such a way as to = reduce, as=20 much as possible, risks posed by the unintentional ingress of substances = into=20 the device taking into account the device and the nature of the = environment in=20 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=20 as to eliminate or reduce as far as possible the risk of infection to = the=20 patient, user and third parties. The design must allow easy handling = and, where=20 necessary, minimize contamination of the device by the patient or vice = versa=20 during use.

8.2. Tissues of animal origin must originate from animals that have = been=20 subjected to veterinary controls and surveillance adapted to the = intended use of=20 the tissues.

Notified bodies shall retain information on the geographical origin = of the=20 animals.

Processing, preservation, testing and handling of tissues, cells and=20 substances of animal origin must be carried out so as to provide optimal = security. In particular safety with regard to viruses and other = transferable=20 agents must be addressed by implementation of validated methods of = elimination=20 or viral inactivation in the course of the manufacturing process.

8.3. Devices delivered in a sterile state must be designed, = manufactured and=20 packed in a non-reusable pack and/or according to appropriate procedures = to=20 ensure that they are sterile when placed on the market and remain = sterile, under=20 the storage and transport conditions laid down, until the protective = packaging=20 is damaged or opened.

8.4. Devices delivered in a sterile state must have been manufactured = and=20 sterilized by an appropriate, validated method.

8.5. Devices intended to be sterilized must be manufactured in = appropriately=20 controlled (e. g. environmental) conditions.

8.6. Packaging systems for non-sterile devices must keep the product = without=20 deterioration at the level of cleanliness stipulated and, if the devices = are to=20 be sterilized prior to use, minimize the risk of microbial = contamination; the=20 packaging system must be suitable taking account of the method of = sterilization=20 indicated by the manufacturer.

8.7. The packaging and/or label of the device must distinguish = between=20 identical or similar products sold in both sterile and non-sterile = condition.=20

9. Construction and environmental properties

9.1. If the device is intended for use in combination with other = devices or=20 equipment, the whole combination, including the connection system must = be safe=20 and must not impair the specified performances of the devices. Any = restrictions=20 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=20 minimize as far as is possible:

- the risk of injury, in connection with their physical features, = including=20 the volume/pressure ratio, dimensional and where appropriate ergonomic = features,=20

- risks connected with reasonably foreseeable environmental = conditions, such=20 as magnetic fields, external electrical influences, electrostatic = discharge,=20 pressure, temperature or variations in pressure and acceleration,

- the risks of reciprocal interference with other devices normally = used in=20 the investigations or for the treatment given,

- risks arising where maintenance or calibration are not possible (as = with=20 implants), from ageing of materials used or loss of accuracy of any = measuring or=20 control mechanism.

9.3. Devices must be designed and manufactured in such a way as to = minimize=20 the risks of fire or explosion during normal use and in single fault = condition.=20 Particular attention must be paid to devices whose intended use includes = exposure to flammable substances or to substances which could cause = combustion.=20

10. Devices with a measuring function

10.1. Devices with a measuring function must be designed and = manufactured in=20 such a way as to provide sufficient accuracy and stability within = appropriate=20 limits of accuracy and taking account of the intended purpose of the = device. The=20 limits of accuracy must be indicated by the manufacturer.

10.2. The measurement, monitoring and display scale must be designed = in line=20 with ergonomic principles, taking account of the intended purpose of the = device.=20

10.3. The measurements made by devices with a measuring function must = be=20 expressed in legal units conforming to the provisions of Council = Directive=20 80/181/EEC (1).

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=20 far as possible compatible with the intended purpose, whilst not = restricting the=20 application of appropriate specified levels for therapeutic and = diagnostic=20 purposes.

11.2. Intended radiation

11.2.1. Where devices are designed to emit hazardous levels of = radiation=20 necessary for a specific medical purpose the benefit of which is = considered to=20 outweigh the risks inherent in the emission, it must be possible for the = user to=20 control the emissions. Such devices shall be designed and manufactured = to ensure=20 reproducibility and tolerance of relevant variable parameters.

11.2.2. Where devices are intended to emit potentially hazardous, = visible=20 and/or invisible radiation, they must be fitted, where practicable, with = visual=20 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,=20 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=20 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=20 eliminating the risks inherent in installation.

11.5. Ionizing radiation

11.5.1. Devices intended to emit ionizing radiation must be designed = and=20 manufactured in such a way as to ensure that, where practicable, the = quantity,=20 geometry and quality of radiation emitted can be varied and controlled = taking=20 into account the intended use.

11.5.2. Devices emitting ionizing radiation intended for diagnostic = radiology=20 shall be designed and manufactured in such a way as to achieve = appropriate image=20 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=20 monitoring and control of the delivered dose, the beam type and energy = and where=20 appropriate the quality of radiation.

12. Requirements for medical devices connected to or equipped with an = energy=20 source

12.1. Devices incorporating electronic programmable systems must be = designed=20 to ensure the repeatability, reliability and performance of these = systems=20 according to the intended use. In the event of a single fault condition = (in the=20 system) appropriate means should be adopted to eliminate or reduce as = far as=20 possible consequent risks.

12.2. Devices where the safety of the patients depends on an internal = power=20 supply must be equipped with a means of determining the state of the = power=20 supply.

12.3. Devices where the safety of the patients depends on an external = power=20 supply must include an alarm system to signal any power failure.

12.4. Devices intended to monitor one or more clinical parameters of = a=20 patient must be equipped with appropriate alarm systems to alert the = user of=20 situations which could lead to death or severe deterioration of the = patient's=20 state of health.

12.5. Devices must be designed and manufactured in such a way as to = minimize=20 the risks of creating electromagnetic fields which could impair the = operation of=20 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=20 as possible, the risk of accidental electric shocks during normal use = and in=20 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=20 the patient and user against mechanical risks connected with, for = example,=20 resistance, stability and moving parts.

12.7.2. Devices must be designed and manufactured in such a way as to = reduce=20 to the lowest possible level the risks arising from vibration generated = by the=20 devices, taking account of technical progress and of the means available = for=20 limiting vibrations, particularly at source, unless the vibrations are = part of=20 the specified performance.

12.7.3. Devices must be designed and manufactured in such a way as to = reduce=20 to the lowest possible level the risks arising from the noise emitted, = taking=20 account of technical progress and of the means available to reduce = noise,=20 particularly at source, unless the noise emitted is part of the = specified=20 performance.

12.7.4. Terminals and connectors to the electricity, gas or hydraulic = and=20 pneumatic energy supplies which the user has to handle must be designed = and=20 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=20 not attain potentially dangerous temperatures under normal use.

12.8. Protection against the risks posed to the patient by energy = supplies or=20 substances

12.8.1. Devices for supplying the patient with energy or substances = must be=20 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=20 user.

12.8.2. Devices must be fitted with the means of preventing and/or = indicating=20 any inadequacies in the flow-rate which could pose a danger.

Devices must incorporate suitable means to prevent, as far as = possible, the=20 accidental release of dangerous levels of energy from an energy and/or = substance=20 source.

12.9. The function of the controls and indicators must be clearly = specified=20 on the devices.

Where a device bears instructions required for its operation or = indicates=20 operating or adjustment parameters by means of a visual system, such = information=20 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=20 safely and to identify the manufacturer, taking account of the training = and=20 knowledge of the potential users.

This information comprises the details on the label and the data in = the=20 instructions for use.

As far as practicable and appropriate, the information needed to use = the=20 device safely must be set out on the device itself and/or on the = packaging for=20 each unit or, where appropriate, on the sales packaging. If individual = packaging=20 of each unit is not practicable, the information must be set out in the = leaflet=20 supplied with one or more devices.

Instructions for use must be included in the packaging for every = device. By=20 way of exception, no such instructions for use are needed for devices in = Class I=20 or IIa if they can be used safely without any such instructions.

13.2. Where appropriate, this information should take the form of = symbols.=20 Any symbol or identification colour used must conform to the harmonized=20 standards. In areas for which no standards exist, the symbols and = colours must=20 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=20 imported into the Community, in view of their distribution in the = Community, the=20 label, or the outer packaging, or instructions for use, shall contain in = addition the name and address of either the person responsible referred = to in=20 Article 14 (2) or of the authorized representative of the manufacturer=20 established within the Community or of the importer established within = the=20 Community, as appropriate;

(b) the details strictly necessary for the user to identify the = device and=20 the contents of the packaging;

(d) where appropriate, the batch code, preceded by the word 'LOT', or = the=20 serial number;

(e) where appropriate, an indication of the date by which the device = should=20 be used, in safety, expressed as the year and month;

(f) where appropriate, an indication that the device is for single = use;

(g) if the device is costum-made, the words 'custom-made device'; =

(h) if the device is intended for clinical investigations, the words=20 '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).=20 This indication may be included in the batch or serial number;

(m) where applicable, method of sterilization.

13.4. If the intended purpose of the device is not obvious to the = user, the=20 manufacturer must clearly state it on the label and in the instructions = for use.=20

13.5. Wherever reasonable and practicable, the devices and detachable = components must be identified, where appropriate in terms of batches, to = allow=20 all appropriate action to detect any potential risk posed by the devices = and=20 detachable components.

13.6. Where appropriate, the instructions for use must contain the = following=20 particulars:

(a) the details referred to in Section 13.3, with the exception of = (d) and=20 (e);

(b) the performances referred to in Section 3 and any undesirable=20 side-effects;

(c) if the device must be installed with or connected to other = medical=20 devices or equipment in order to operate as required for its intended = purpose,=20 sufficient details of its characteristics to identify the correct = devices or=20 equipment to use in order to obtain a safe combination;

(d) all the information needed to verify whether the device is = properly=20 installed and can operate correctly and safely, plus details of the = nature and=20 frequency of the maintenance and calibration needed to ensure that the = devices=20 operate properly and safely at all times;

(e) where appropriate, information to avoid certain risks in = connection with=20 implantation of the device;

(f) information regarding the risks of reciprocal interference posed = by the=20 presence of the device during specific investigations or treatment;

(g) the necessary instructions in the event of damage to the sterile=20 packaging and, where appropriate, details of appropriate methods of=20 resterilization;

(h) if the device is reusable, information on the appropriate = processes to=20 allow reuse, including cleaning, disinfection, packaging and, where = appropriate,=20 the method of sterilization of the device to be resterilized, and any=20 restriction on the number of reuses.

Where devices are supplied with the intention that they be sterilized = before=20 use, the instructions for cleaning and sterilization must be such that, = if=20 correctly followed, the device will still comply with the requirements = in=20 Section I;

(i) details of any further treatment or handling needed before the = device can=20 be used (for example, sterilization, final assembly, etc.);

(j) in the case of devices emitting radiation for medical purposes, = details=20 of the nature, type, intensity and distribution of this radiation.

The instructions for use must also include details allowing the = medical staff=20 to brief the patient on any contra-indications and any precautions to be = taken.=20 These details should cover in particular:

(k) precautions to be taken in the event of changes in the = performance of the=20 device;

(l) precautions to be taken as regards exposure, in reasonably = foreseeable=20 environmental conditions, to magnetic fields, external electrical = influences,=20 electrostatic discharge, pressure or variations in pressure, = acceleration,=20 thermal ignition sources, etc.;

(m) adequate information regarding the medicinal product or products = which=20 the device in question is designed to administer, including any = limitations in=20 the choice of substances to be delivered;

(n) precautions to be taken against any special, unusual risks = related to the=20 disposal of the device;

(o) medicinal substances incorporated into the device as an integral = part in=20 accordance with Section 7.4;

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

14. Where conformity with the essential requirements must be based on = clinical data, as in Section I (6), such data must be established in = accordance=20 with Annex X.

(1) OJ No L 39, 15. 2. 1980, p. 40. Directive as last amended by = Directive=20 89/617/EEC (OJ No L 357, 7. 12. 1989, p. 28).

ANNEX II

EC DECLARATION OF CONFORMITY (Full quality assurance system) 1. The=20 manufacturer must ensure application of the quality system approved for = the=20 design, manufacture and final inspection of the products concerned, as = specified=20 in Section 3 and is subject to audit as laid down in Sections 3.3 and 4 = and to=20 Community surveillance as specified in Section 5.

2. The declaration of conformity is the procedure whereby the = manufacturer=20 who fulfils the obligations imposed by Section 1 ensures and declares = that the=20 products concerned meet the provisions of this Directive which apply to = them.=20

The manufacturer must affix the CE marking in accordance with Article = 17 and=20 draw up a written declaration of conformity. This declaration must cover = a given=20 number of the products manufactured and be kept by the manufacturer. =

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his = quality=20 system with a notified body.

The application must include:

- the name and address of the manufacturer and any additional = manufacturing=20 site covered by the quality system,

- all the relevant information on the product or product category = covered by=20 the procedure,

- a written declaration that no application has been lodged with any = other=20 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=20 quality system approved,

- an undertaking by the manufacturer to keep the approved quality = system=20 adequate and efficacious,

- an undertaking by the manufacturer to institute and keep up to date = a=20 systematic procedure to review experience gained from devices in the=20 post-production phase and to implement appropriate means to apply any = necessary=20 corrective action. This undertaking must include an obligation for the=20 manufacturer to notify the competent authorities of the following = incidents=20 immediately on learning of them:

(i) any malfunction or deterioration in the characteristics and/or=20 performance of a device, as well as any inadequacy in the instructions = for use=20 which might lead to or might have led to the death of a patient or user = or to a=20 serious deterioration in his state of health;

(ii) any technical or medical reason connected with the = characteristics or=20 performance of a device leading for the reasons referred to in = subparagraph (i)=20 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=20 to the provisions of this Directive which apply to them at every stage, = from=20 design to final inspection. All the elements, requirements and = provisions=20 adopted by the manufacturer for his quality system must be documented in = a=20 systematic and orderly manner in the form of written policies and = procedures=20 such as quality programmes, quality plans, quality manuals and quality = records.=20

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=20 and their organizational authority where quality of design and = manufacture of=20 the products is concerned,

- the methods of monitoring the efficient operation of the quality = system and=20 in particular its ability to achieve the desired quality of design and = of=20 product, including control of products which fail to conform;

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

- the design specifications, including the standards which will be = applied=20 and the results of the risk analysis, and also a description of the = solutions=20 adopted to fulfil the essential requirements which apply to the products = if the=20 standards referred to in Article 5 are not applied in full,

- the techniques used to control and verify the design and the = processes and=20 systematic measures which will be used when the products are being = designed,=20

- if the device is to be connected to other device(s) in order to = operate as=20 intended, proof must be provided that it conforms to the essential = requirements=20 when connected to any such device(s) having the characteristics = specified by the=20 manufacturer,

- a statement indicating whether or not the device incorporates, as = an=20 integral part, a substance as referred to in Section 7.4 of Annex I and = data on=20 the tests conducted in this connection,

- the clinical data referred to in Annex X,

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

(d) the inspection and quality assurance techniques at the = manufacturing=20 stage and in particular:

- the processes and procedures which will be used, particularly as = regards=20 sterilization, purchasing and the relevant documents,

- the product identification procedures drawn up and kept up to date = from=20 drawings, specifications or other relevant documents at every stage of=20 manufacture;

(e) the appropriate tests and trials which will be carried out = before, during=20 and after manufacture, the frequency with which they will take place, = and the=20 test equipment used; it must be possible to trace back the calibration = of the=20 test equipment adequately.

3.3. The notified body must audit the quality system to determine = whether it=20 meets the requirements referred to in Section 3.2. It must presume that = quality=20 systems which implement the relevant harmonized standards conform to = these=20 requirements.

The assessment team must include at least one number with past = experience of=20 assessments of the technology concerned. The assessment procedure must = include=20 an inspection on the manufacturer's premises and, in duly substantiated = cases,=20 on the premises of the manufacturer's suppliers and/or subcontractors to = inspect=20 the manufacturing processes.

The decision is notified to the manufacturer. It must contain the = conclusions=20 of the inspection and a reasoned assessment.

3.4. The manufacturer must inform the notified body which approved = the=20 quality system of any plan for substantial changes to the quality system = or the=20 product-range covered. The notified body must assess the changes = proposed and=20 verify whether after these changes the quality system still meets the=20 requirements referred to in Section 3.2. It must notify the manufacturer = of its=20 decision. This decision must contain the conclusions of the inspection = and a=20 reasoned assessment.

4. Examination of the design of the product

4.1. In addition to the obligations imposed by Section 3, the = manufacturer=20 must lodge with the notified body an application for examination of the = design=20 dossier relating to the product which he plans to manufacture and which = falls=20 into the category referred to in Section 3.1.

4.2. The application must describe the design, manufacture and = performances=20 of the product in question. It must include the documents needed to = assess=20 whether the product conforms to the requirements of this Directive, as = referred=20 to in Section 3.2 (c).

4.3. The notified body must examine the application and, if the = product=20 conforms to the relevant provisions of this Directive, issue the = application=20 with an EC design-examination certificate. The notified body may require = the=20 application to be completed by further tests or proof to allow = assessment of=20 conformity with the requirements of the Directive. The certificate must = contain=20 the conclusions of the examination, the conditions of validity, the data = needed=20 for identification of the approved design, where appropriate, a = description of=20 the intended purpose of the product.

In the case of devices referred to in Annex I, paragraph 7.4, the = notified=20 body shall, in view of the aspects addressed in that paragraph, consult = one of=20 the competent bodies established by the Member States in accordance with = Directive 65/65/EEC before taking a decision.

The notified body will give due consideration to the views expressed = in this=20 consultation when making its decision. It will convey its final decision = to the=20 competent body concerned.

4.4. Changes to the approved design must receive further approval = from the=20 notified body which issued the EC design-examination certificate = wherever the=20 changes could affect conformity with the essential requirements of the = Directive=20 or with the conditions prescribed for use of the product. The applicant = shall=20 inform the notified body which issued the EC design-examination = certificate of=20 any such changes made to the approved design. This additional approval = must take=20 the form of a supplement to the EC design-examination certificate.

5. Surveillance

5.1. The aim of surveillance is to ensure that the manufacturer duly = fulfils=20 the obligations imposed by the approved quality system.

5.2. The manufacturer must authorize the notified body to carry out = all the=20 necessary inspections and supply it with all relevant information, in=20 particular:

- the documentation on the quality system,

- the data stipulated in the part of the quality system relating to = design,=20 such as the results of analyses, calculation tests, etc.,

- the data stipulated in the part of the quality system relating to=20 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=20 and assessments to make sure that the manufacturer applies the approved = quality=20 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=20 necessary, carry out or ask for tests in order to check that the quality = system=20 is working properly. It must provide the manufacturer with an inspection = report=20 and, if a test has been carried out, with a test report.

6. Administrative provisions

6.1. The manufacturer must, for a period ending at least five years = after the=20 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, =

- 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=20 3.3, 4.3, 4.4, 5.3 and 5.4.

6.2. The notified body must make available to the other notified = bodies and=20 the competent authority, on request, all relevant information concerning = quality=20 system approvals issued, refused or withdrawn.

6.3. In respect of devices subject to the procedure in Section 4, = when=20 neither the manufacturer nor his authorized representative is = established in the=20 Community, the obligation to keep available the technical documentation = shall=20 fall to the person responsible for placing the device on the Community = market or=20 the importer referred to in Annex I, Section 13.3 (a).

7. Application to devices in Classes IIa and IIb

In line with Article 11 (2) and (3), this Annex may apply to products = in=20 Classes IIa and IIb. Section 4, however, does not apply.

ANNEX III

EC TYPE-EXAMINATION 1. EC type-examination is the procedure whereby a = notified body ascertains and certifies that a representative sample of = the=20 production covered fulfils the relevant provisions of this Directive. =

2. The application includes:

- the name and address of the manufacturer and the name and address = of the=20 authorized representative if the application is lodged by the = representative,=20

- the documentation described in Section 3 needed to assess the = conformity of=20 the representative sample of the production in question, hereinafter = referred to=20 as the 'type', with the requirements of this Directive. The applicant = must make=20 a 'type' available to the notified body. The notified body may request = other=20 samples as necessary,

- a written declaration that no application has been lodged with any = other=20 notified body for the same type.

3. The documentation must allow an understanding of the design, the=20 manufacture and the performances of the product and must contain the = following=20 items in particular:

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

- design drawings, methods of manufacture envisaged, in particular as = regards=20 sterilization, and diagrams of components, sub-assemblies, circuits, = etc.,

- the descriptions and explanations necessary to understand the=20 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=20 part, and descriptions of the solutions adopted to meet the essential=20 requirements if the standards referred to in Article 5 have not been = applied in=20 full,

- the results of the design calculations, risk analysis, = investigations,=20 technical tests, etc. carried out,

- the clinical data referred to in Annex X,

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

4. The notified body must:

4.1. examine and assess the documentation and verify that the type = has been=20 manufactured in conformity with that documentation; it must also record = the=20 items designed in conformity with the applicable provisions of the = standards=20 referred to in Article 5, as well as the items not designed on the basis = of the=20 relevant provisions of the abovementioned standards;

4.2. carry out or arrange for the appropriate inspections and the = tests=20 necessary to verify whether the solutions adopted by the manufacturer = meet the=20 essential requirements of this Directive if the standards referred to in = Article=20 5 have not been applied; if the device is to be connected to other = device(s) in=20 order to operate as intended, proof must be provided that it conforms to = the=20 essential requirements when connected to any such device(s) having the=20 characteristics specified by the manufacturer;

4.3. carry out or arrange for the appropriate inspections and the = tests=20 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=20 and tests will be caried out.

5. If the type conforms to the provisions of this Directive, the = notified=20 body issues the applicant with an EC type-examination certificate. The=20 certificate must contain the name and address of the manufacturer, the=20 conclusions of the inspection, the conditions of validity and the data = needed=20 for identification of the type approved. The relevant parts of the = documentation=20 must be annexed to the certificate and a copy kept by the notified body. =

The notified body will give due consideration to the views expressed = in this=20 consultation when making its decision. It will convey its final decision = to the=20 competent body concerned.

6. The applicant must inform the notified body which issued the EC=20 type-examination certificate of any significant change made to the = approved=20 product.

Changes to the approved product must receive further approval from = the=20 notified body which issued the EC type-examination certificate wherever = the=20 changes may affect conformity with the essential requirements or with = the=20 conditions prescribed for use of the product. This new approval must, = where=20 appropriate, take the form of a supplement to the initial EC = type-examination=20 certificate.

7. Administrative provisions

7.1. The notified body must make available to the other notified = bodies on=20 request, all relevant information on EC type-examination certificates = and=20 supplements issued, refused or withdrawn.

7.2. Other notified bodies may obtain a copy of the EC = type-examination=20 certificates and/or the supplements thereto. The Annexes to the = certificates=20 must be made available to other notified bodies on reasoned application, = after=20 the manufacturer has been informed.

7.3. The manufacturer or his authorized representative must keep with = the=20 technical documentation copies of EC type-examination certificates and = their=20 additions for a period ending at least five years after the last device = has been=20 manufactured.

7.4. When neither the manufacturer nor his authorized representative = is=20 established in the Community, the obligation to keep available the = technical=20 documentation shall fall to the person responsible for placing the = device on the=20 Community market or the importer referred to in Annex I, Section 13.3 = (a).

ANNEX IV

EC VERIFICATION 1. EC verification is the procedure whereby the = manufacturer=20 or his authorized representative established in the Community ensures = and=20 declares that the products which have been subject to the procedure set = out in=20 Section 4 conform to the type described in the EC type-examination = certificate=20 and meet the requirements of this Directive which apply to them.

2. The manufacturer must take all the measures necessary to ensure = that the=20 manufacturing process produces products which conform to the type = described in=20 the EC type-examination certificate and to the requirements of the = Directive=20 which apply to them. Before the start of manufacture, the manufacturer = must=20 prepare documents defining the manufacturing process, in particular as = regards=20 sterilization where necessary, together with all the routine, = pre-established=20 provisions to be implemented to ensure homogeneous production and, where = appropriate, conformity of the products with the type described in the = EC=20 type-examination certificate and with the requirements of this Directive = which=20 apply to them. The manufacturer must affix the CE marking in accordance = with=20 Article 17 and draw up a declaration of conformity.

In addition, for products placed on the market in sterile condition, = and only=20 for those aspects of the manufacturing process designed to secure and = maintain=20 sterility, the manufacturer must apply the provisions of Annex V, = Sections 3 and=20 4.

3. The manufacturer must undertake to institute and keep up to date a = systematic procedure to review experience gained from devices in the=20 post-production phase and to implement appropriate means to apply any = necessary=20 corrective action. This undertaking must include an obligation for the=20 manufacturer to notify the competent authorities of the following = incidents=20 immediately on learning of them:

(i) any malfunction or deterioration in the characteristics and/or=20 performance of a device, as well as any inadequacy in the labelling or = the=20 instructions for use which might lead to or might have led to the death = of a=20 patient or user or to a serious deterioration in his state of health; =

(ii) any technical or medical reason connected with the = characteristics or=20 performance of a device for the reasons referred to in subparagraph (i) = leading=20 to systematic recall of devices of the same type by the manufacturer. =

4. The notified body must carry out the appropriate examinations and = tests in=20 order to verify the conformity of the product with the requirements of = the=20 Directive either by examining and testing every product as specified in = Section=20 5 or by examining and testing products on a statistical basis as = specified in=20 Section 6, as the manufacturer decides.

The aforementioned checks do not apply to those aspects of the = manufacturing=20 process designed to secure sterility.

5. Verification by examination and testing of every product

5.1. Every product is examined individually and the appropriate tests = defined=20 in the relevant standard(s) referred to in Article 5 or equivalent tests = must be=20 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=20 the requirements of the Directive which apply to them.

5.2. The notified body must affix, or have affixed its identification = number=20 to each approved product and must draw up a written certificate of = conformity=20 relating to the tests carried out.

6. Statistical verification

6.1. The manufacturer must present the manufactured products in the = form of=20 homogeneous batches.

6.2. A random sample is taken from each batch. The products which = make up the=20 sample are examined individually and the appropriate tests defined in = the=20 relevant standard(s) referred to in Article 5 or equivalent tests must = be=20 carried out to verify, where appropriate, the conformity of the products = with=20 the type described in the EC type-examination certificate and with the=20 requirements of the Directive which apply to them in order to determine = whether=20 to accept or reject the batch.

6.3. Statistical control of products will be based on attributes, = entailing a=20 sampling system ensuring a limit quality corresponding to a probability = of=20 acceptance of 5 %, with a non-conformity percentage of between 3 and 7 = %. The=20 sampling method will be established by the harmonized standards referred = to in=20 Article 5, taking account of the specific nature of the product = categories in=20 question.

6.4. If the batch is accepted, the notified body affixes or has = affixed its=20 identification number to each product and draws up a written certificate = of=20 conformity relating to the tests carried out. All products in the batch = may be=20 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=20 measures to prevent the batch from being placed on the market. In the = event of=20 frequent rejection of batches, the notified body may suspend the = statistical=20 verification.

The manufacturer may, on the responsibility of the notified body, = affix the=20 notified body's identification number during the manufacturing process. =

7. Administrative provisions

The manufacturer or his authorized representative must, for a period = ending=20 at least five years after the last product has been manufactured, make = available=20 to the national authorities:

- 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=20 III.

8. Application to devices in Class IIa

In line with Article 11 (2), this Annex may apply to products in = Class IIa,=20 subject to the following exemptions:

8.1. in derogation from Sections 1 and 2, by virtue of the = declaration of=20 conformity the manufacturer ensures and declares that the products in = Class IIa=20 are manufactured in conformity with the technical documentation referred = to in=20 Section 3 of Annex VII and meet the requirements of this Directive which = apply=20 to them;

8.2. in derogation from Sections 1, 2, 5 and 6, the verifications = conducted=20 by the notified body are intended to confirm the conformity of the = products in=20 Class IIa with the technical documentation referred to in Section 3 of = Annex=20 VII.

ANNEX V

EC DECLARATION OF CONFORMITY (Production quality assurance) 1. The=20 manufacturer must ensure application of the quality system approved for = the=20 manufacture of the products concerned and carry out the final = inspection, as=20 specified in Section 3, and is subject to the Community surveillance = referred to=20 in Section 4.

2. The declaration of conformity is the part of the procedure whereby = the=20 manufacturer who fulfils the obligations imposed by Section 1 ensures = and=20 declares that the products concerned conform to the type described in = the EC=20 type-examination certificate and meets the provisions of this Directive = which=20 apply to them.

The manufacturer must affix the CE marking in accordance with Article = 17 and=20 draw up a written declaration of conformity. This declaration must cover = a given=20 number of identified specimens of the products manufactured and must be = kept by=20 the manufacturer.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his = quality=20 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=20 the procedure,

- a written declaration that no application has been lodged with any = other=20 notified body for the same products,

- the documentation on the quality system,

- an undertaking to fulfil the obligations imposed by the quality = system is=20 approved,

- an undertaking to maintain the practicability and effectiveness of = the=20 approved quality system,

- where appropriate, the technical documentation on the types = approved and a=20 copy of the EC type-examination certificates,

(ii) any technical or medical reason connected with the = characteristics or=20 performance of a device for the reasons referred to in subparagraph (i) = above=20 leading to a systematic recall of devices of the same type by the = manufacturer.=20

3.2. Application of the quality system must ensure that the products = conform=20 to the type described in the EC type-examination certificate.

All the elements, requirements and provisions adopted by the = manufacturer for=20 his quality system must be documented in a systematic and orderly manner = in the=20 form of written policy statements and procedures. This quality system=20 documentation must permit uniform interpretation of the quality policy = and=20 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=20 and their organizational authority where manufacture of the products is=20 concerned,

- the methods of monitoring the efficient operation of the quality = system and=20 in particular its ability to achieve the desired quality of product, = including=20 control of products which fail to conform;

- the processes and procedures which will be used, particularly as = regards=20 sterilization, purchasing and the relevant documents,

- the product identification procedures drawn up and kept up to date = from=20 drawings, specifications or other relevant documents at every stage of=20 manufacture;

(d) the appropriate tests and trials to be carried out before, during = and=20 after manufacture, the frequency with which they will take place, and = the test=20 equipment used; it must be possible adequately to trace back the = calibration of=20 the test equipment.

The assessment team must include at least one member with past = experience of=20 assessments of the technology concerned. The assessment procedure must = include=20 an inspection on the manufacturer's premises and, in duly substantiated = cases,=20 on the premises of the manufacturer's suppliers to inspect the = manufacturing=20 processes.

The decision must be notified to the manufacturer after the final = inspection=20 and contain the conclusions of the inspection and a reasoned assessment. =

3.4. The manufacturer must inform the notified body which approved = the=20 quality system of any plan for substantial changes to the quality = system.

The notified body must assess the changes proposed and verify whether = after=20 these changes the quality system still meets the requirements referred = to in=20 Section 3.2.

After the abovementioned information has been received the decision = is=20 notified to the manufacturer. It must contain the conclusions of the = inspection=20 and a reasoned assessment.

4. Surveillance

4.1. The aim of surveillance is to ensure that the manufacturer duly = fulfils=20 the obligations imposed by the approved quality system.

4.2. The manufacturer authorizes the notified body to carry out all = the=20 necessary inspections and must supply it with all relevant information, = in=20 particular:

- the documentation on the quality system,

4.3. The notified body must periodically carry out appropriate = inspections=20 and assessments to make sure that the manufacturer applies the approved = quality=20 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=20 necessary, carry out or ask for tests in order to check that the quality = system=20 is working properly. It must provide the manufacturer with an inspection = report=20 and, if a test has been carried out, with a test report.

5. Administrative provisions

5.1. The manufacturer must, for a period ending at least five years = after the=20 last product has been manufactured, make available to the national = authorities:=20

- 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=20 4.3 and 4.4,

- where appropriate, the type-examination certificate referred to in = Annex=20 III.

5.2. The notified body must make available to the other notified = bodies, on=20 request, all relevant information concerning the quality system = approvals=20 issued, refused or withdrawn.

6. Application to devices in Class IIa

In line with Article 11 (2), this Annex may apply to products in = Class IIa,=20 subject to the following exemption:

6.1. in derogation from Sections 2, 3.1 and 3.2, by virtue of the = declaration=20 of conformity the manufacturer ensures and declares that the products in = Class=20 IIa are manufactured in conformity with the technical documentation = referred to=20 in Section 3 of Annex VII and meet the requirements of this Directive = which=20 apply to them.

ANNEX VI

EC DECLARATION OF CONFORMITY (Product quality assurance) 1. The = manufacturer=20 must ensure application of the quality system approved for the final = inspection=20 and testing of the product, as specified in Section 3 and must be = subject to the=20 surveillance referred to in Section 4.

2. The declaration of conformity is the part of the procedure whereby = the=20 manufacturer who fulfils the obligations imposed by Section 1 ensures = and=20 declares that the products concerned conform to the type described in = the EC=20 type-examination certificate and meet the provisions of this Directive = which=20 apply to them.

The manufacturer affixes the CE marking in accordance with Article 17 = and=20 draws up a written declaration of conformity. This declaration must = cover a=20 given number of identified specimens of the products manufactured and be = kept by=20 the manufacturer. The CE marking must be accompanied by the = identification=20 number of the notified body which performs the tasks referred to in this = Annex.=20

3. Quality system

3.1. The manufacturer lodges an application for assessment of his = quality=20 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=20 the procedure,

- a written declaration specifying that no application has been = lodged with=20 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=20 quality system approved,

- an undertaking by the manufacturer to keep the approved quality = system=20 adequate and efficacious,

- where appropriate, the technical documentation on the types = approved and a=20 copy of the EC type-examination certificates,

(ii) any technical or medical reason connected with the = characteristics or=20 the performance of a device for the reasons referred to in subparagraph = (i)=20 leading to a systematic recall of devices of the same type by the = manufacturer.=20

3.2. Under the quality system, each product or a representative = sample of=20 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=20 ensure that the products conform to the type described in the EC=20 type-examination certificate and fulfil the provisions of this Directive = which=20 apply to them. All the elements, requirements and provisions adopted by = the=20 manufacturer must be documented in a systematic and orderly manner in = the form=20 of written measures, procedures and instructions. This quality system=20 documentation must permit uniform interpretation of the quality = programmes,=20 quality plans, quality manuals and quality records.

It must include in particular an adequate description of:

- the quality objectives and the organizational structure, = responsibilities=20 and powers of the managerial staff with regard to product quality,

- the examinations and tests that will be carried out after = manufacture; it=20 must be possible to trace back the calibration of the test equipment = adequately,=20

- 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.

The aforementioned checks do not apply to those aspects of the = manufacturing=20 process designed to secure sterility.

3.3. The notified body audits the quality system to determine whether = it=20 meets the requirements referred to in section 3.2. It must presume that = quality=20 systems which implement the relevant harmonized standards conform to = these=20 requirements.

The decision must be notified to the manufacturer. It must contain = the=20 conclusions of the inspection and a reasoned assessment.

3.4. The manufacturer must inform the notified body which approved = the=20 quality system of any plan for substantial changes to the quality = system.

The notified body must assess the changes proposed and verify whether = after=20 these changes the quality system will still meet the requirements = referred to in=20 Section 3.2.

After receiving the abovementioned information it must notify the=20 manufacturer of its decision. This decision must contain the conclusions = of the=20 inspection and a reasoned assessment.

4. Surveillance

4.1. The aim of surveillance is to ensure that the manufacturer duly = fulfils=20 the obligations imposed by the approved quality system.

4.2. The manufacturer must allow the notified body access for = inspection=20 purposes to the inspection, testing and storage locations and supply it = with all=20 relevant information, in particular:

- the documentation on the quality system,

- the technical documentation,

- the quality records, such as inspection reports, test data, = calibration=20 data, qualification reports of the staff concerned, etc.

4.3. The notified body must periodically carry out appropriate = inspections=20 and assessments to make sure that the manufacturer applies the quality = system=20 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=20 necessary, carry out or ask for tests in order to check that the quality = system=20 is working properly and that the production conforms to the requirements = of the=20 Directive which apply to it. To this end, an adequate sample of the = final=20 products, taken on site by the notified body, must be examined and the=20 appropriate tests defined in the relevant standard(s) referred to in = Article 5=20 or equivalent tests must be carried out. Where one or more of the = samples fails=20 to conform, the notified body must take the appropriate measures.

It must provide the manufacturer with an inspection report and, if a = test has=20 been carried out, with a test report.

5. Administrative provisions

5.1. The manufacturer must, for a period ending at least five years = after the=20 last product has been manufactured, make available to the national = authorities:=20

- 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=20 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.=20

5.2. The notified body must make available to the other notified = bodies, on=20 request, all relevant information concerning the quality system = approvals=20 issued, refused or withdrawn.

6. Application to devices in Class IIa

In line with Article 11 (2), this Annex may apply to products in = Class IIa,=20 subject to this derogation:

6.1. by derogation from Sections 2, 3.1 and 3.2 by virtue of the = declaration=20 of conformity the manufacturer ensures and declares that the products in = Class=20 IIa are manufactured in conformity with the technical documentation = referred to=20 in Section 3 of Annex VII and meet the requirements of this Directive = which=20 apply to them.

ANNEX VII

EC DECLARATION OF CONFORMITY 1. The EC declaration of conformity is = the=20 procedure whereby the manufacturer or his authorized representative = established=20 in the Community who fulfils the obligations imposed by Section 2 and, = in the=20 case of products placed on the market in a sterile condition and devices = with a=20 measuring function, the obligations imposed by Section 5 ensures and = declares=20 that the products concerned meet the provisions of this Directive which = apply to=20 them.

2. The manufacturer must prepare the technical documentation = described in=20 Section 3. The manufacturer or his authorized representative established = in the=20 Community must make this documentation, including the declaration of = conformity,=20 available to the national authorities for inspection purposes for a = period=20 ending at least five years after the last product has been manufactured. =

Where neither the manufacturer nor his authorized representative are=20 established in the Community, this obligation to keep the technical=20 documentation available must fall to the person(s) who place(s) the = product on=20 the Community market.

3. The technical documentation must allow assessment of the = conformity of the=20 product with the requirements of the Directive. It must include in = particular:=20

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

- design drawings, methods of manufacture envisaged and diagrams of=20 components, sub-assemblies, circuits, etc.,

- the descriptions and explanations necessary to understand the=20 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=20 Article 5, applied in full or in part, and descriptions of the solutions = adopted=20 to meet the essential requirements of the Directive if the standards = referred to=20 in Article 5 have not been applied in full,

- in the case of products placed on the market in a sterile = condition,=20 description of the methods used,

- the results of the design calculations and of the inspections = carried out,=20 etc.; if the device is to be connected to other device(s) in order to = operate as=20 intended, proof must be provided that it conforms to the essential = requirements=20 when connected to any such device(s) having the characteristics = specified by the=20 manufacturer,

- the test reports and, where appropriate, clinical data in = accordance with=20 Annex X,

- the label and instructions for use.

4. The manufacturer shall institute and keep up to date a systematic=20 procedure to review experience gained from devices in the = post-production phase=20 and to implement appropriate means to apply any necessary corrective = actions,=20 taking account of the nature and risks in relation to the product. He = shall=20 notify the competent authorities of the following incidents immediately = on=20 learning of them:

(ii) any technical or medical reason connected with the = characteristics on=20 the performance of a device for the reasons referred to in subparagraph = (i)=20 leading to systematic recall of devices of the same type by the = manufacturer.=20

5. With products placed on the market in sterile condition and Class = I=20 devices with a measuring function, the manufacturer must observe not = only the=20 provisions laid down in this Annex but also one of the procedures = referred to in=20 Annex IV, V or VI. Application of the abovementioned Annexes and the=20 intervention by the notified body is limited to:

- in the case of products placed on the market in sterile condition, = only the=20 aspects of manufacture concerned with securing and maintaining sterile=20 conditions,

- in the case of devices with a measuring function, only the aspects = of=20 manufacture concerned with the conformity of the products with the = metrological=20 requirements.

Section 6.1. of this Annex is applicable.

6. Application to devices in Class IIa

In line with Article 11 (2), this Annex may apply to products in = Class IIa,=20 subject to the following derogation:

6.1. where this Annex is applied in conjunction with the procedure = referred=20 to in Annex IV, V or VI, the declaration of conformity referred to in = the=20 abovementioned Annexes forms a single declaration. As regards the = declaration=20 based on this Annex, the manufacturer must ensure and declare that the = product=20 design meets the provisions of this Directive which apply to it.

ANNEX VIII

STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES 1. For custom-made = devices=20 or for devices intended for clinical investigations the manufacturer or = his=20 authorized representative established in the Community must draw up the=20 statement containing the information stipulated in Section 2.

2. The statement must contain the following information:

2.1. for custom-made devices:

- data allowing identification of the device in question,

- a statement that the device is intended for exclusive use by a = particular=20 patient, together with the name of the patient,

- the name of the medical practitioner or other authorized person who = made=20 out the prescription and, where applicable, the name of the clinic = concerned,=20

- the particular features of the device as specified in the relevant = medical=20 prescription,

- a statement that the device in question conforms to the essential=20 requirements set out in Annex I and, where applicable, indicating which=20 essential requirements have not been fully met, together with the = grounds;

2.2. for devices intended for the clinical investigations covered by = Annex X:=20

- data allowing identification of the device in question,

- an investigation plan stating in particular the purpose, = scientific,=20 technical or medical grounds, scope and number of devices concerned, =

- the opinion of the ethics committee concerned and details of the = aspects=20 covered by its opinion,

- the name of the medical practitioner or other authorized person and = of the=20 institution responsible for the investigations,

- the place, starting date and scheduled duration for the = investigations,=20

- a statement that the device in question conforms to the essential=20 requirements apart from the aspects covered by the investigations and = that, with=20 regard to these aspects, every precaution has been taken to protect the = health=20 and safety of the patient.

3. The manufacturer must also undertake to keep available for the = competent=20 national authorities:

3.1. for custom-made devices, documentation allowing an understanding = of the=20 design, manufacture and performances of the product, including the = expected=20 performances, so as to allow assessment of conformity with the = requirements of=20 this Directive.

The manufacturer must take all the measures necessary to ensure that = the=20 manufacturing process produces products which are manufactured in = accordance=20 with the documentation mentioned in the first paragraph;

3.2. for devices intended for clinical investigations, the = documentation must=20 contain:

- a general description of the product,

- design drawings, methods of manufacture envisaged, in particular as = regards=20 sterilization, and diagrams of components, sub-assemblies, circuits, = etc.,

- the descriptions and explanations necessary to understand the=20 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=20 Article 5, applied in full or in part, and descriptions of the solutions = adopted=20 to meet the essential requirements of this Directive if the standards = referred=20 to in Article 5 have not been applied,

- the results of the design calculations, and of the inspections and=20 technical tests carried out, etc.

The manufacturer must authorize the assessment, or audit where = necessary, of=20 the effectiveness of these measures.

4. The information contained in the declarations concerned by this = Annex=20 should be kept for a period of time of at least five years.

ANNEX IX

CLASSIFICATION CRITERIA I. DEFINITIONS 1. Definitions for the = classification=20 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=20 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=20 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=20 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=20 the previous subparagraph and which produce penetration other than = through an=20 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=20 procedure.

Any device intended to be partially introduced into the human body = through=20 surgical intervention and intended to remain in place after the = procedure for at=20 least 30 days is also considered an implantable device.

1.3. Reusable surgical instrument

Instrument intended for surgical use by cutting, drilling, sawing,=20 scratching, scraping, clamping, retracting, clipping or similar = procedures,=20 without connection to any active medical device and which can be reused = after=20 appropriate procedures have been carried out.

1.4. Active medical device

Any medical device operation of which depends on a source of = electrical=20 energy or any source of power other than that directly generated by the = human=20 body or gravity and which acts by converting this energy. Medical = devices=20 intended to transmit energy, substances or other elements between an = active=20 medical device and the patient, without any significant change, are not=20 considered to be active medical devices.

1.5. Active therapeutical device

Any active medical device, whether used alone or in combination with = other=20 medical devices, to support, modify, replace or restore biological = functions or=20 structures with a view to treatment or alleviation of an illness, injury = or=20 handicap.

1.6. Active device for diagnosis

Any active medical device, whether used alone or in combination with = other=20 medical devices, to supply information for detecting, diagnosing, = monitoring or=20 treating physiological conditions, states of health, illnesses or = congenital=20 deformities.

1.7. Central circulatory system

For the purposes of this Directive, 'central circulatory system' = means the=20 following vessels:

arteriae pulmonales, aorta ascendens, arteriae coronariae, arteria = carotis=20 communis, arteria carotis externa, arteria carotis interna, arteriae = cerebrales,=20 truncus brachicephalicus, venae cordis, venae pulmonales, vena cava = superior,=20 vena cava inferior.

1.8. Central nervous system

For the purposes of this Directive, 'central nervous system' means = brain,=20 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,=20 the classification rules shall apply separately to each of the devices.=20 Accessories are classified in their own right separately from the device = with=20 which they are used.

2.3. Software, which drives a device or influences the use of a = device, falls=20 automatically in the same class.

2.4. If the device is not intended to be used solely or principally = in a=20 specific part of the body, it must be considered and classified on the = basis of=20 the most critical specified use.

2.5. If several rules apply to the same device, based on the = performance=20 specified for the device by the manufacturer, the strictest rules = resulting in=20 the higher classification shall apply.

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=20 hereinafter applies.

1.2. Rule 2

All non-invasive devices intended for channelling or storing blood, = body=20 liquids or tissues, liquids or gases for the purpose of eventual = infusion,=20 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=20 higher class,

- if they are intended for use for storing or channelling blood or = other body=20 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=20 composition of blood, other body liquids or other liquids intended for = infusion=20 into the body are in Class IIb, unless the treatment consists of = filtration,=20 centrifugation or exchanges of gas, heat, in which case they are in = Class IIa.=20

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=20 compression or for absorption of exudates,

- are in Class IIb if they are intended to be used principally with = wounds=20 which have breached the dermis and can only heal by secondary intent, =

- are in Class IIa in all other cases, including devices principally = intended=20 to manage the micro-environment of a wound.

2. Invasive devices

2.1. Rule 5

All invasive devices with respect to body orifices, other than = surgically=20 invasive devices and which are not intended for connection to an active = medical=20 device:

- 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=20 are used in the oral cavity as far as the pharynx, in an ear canal up to = the ear=20 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=20 used in the oral cavity as far as the pharynx, in an ear canal up to the = ear=20 drum or in a nasal cavity and are not liable to be absorbed by the = mucous=20 membrane, in which case they are in Class IIa.

All invasive devices with respect to body orifices, other than = surgically=20 invasive devices, intended for connection to an active medical device in = Class=20 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=20 unless they are:

- intended specifically to diagnose, monitor or correct a defect of = the heart=20 or of the central circulatory system through direct contact with these = parts of=20 the body, in which case they are in Class III,

- reusable surgical instruments, in which case they are in Class I, =

- intended to supply energy in the form of ionizing radiation in = which case=20 they are in Class IIb,

- intended to have a biological effect or to be wholly or mainly = absorbed in=20 which case they are in Class IIb,

- intended to administer medicines by means of a delivery system, if = this is=20 done in a manner that is potentially hazardous taking account of the = mode of=20 application, in which they are in Class IIb.

2.3. Rule 7

All surgically invasive devices intended for short-term use are in = Class IIa=20 unless they are intended:

- either specifically to diagnose, monitor or correct a defect of the = heart=20 or of the central circulatory system through direct contact with these = parts of=20 the body, in which case they are in Class III,

- or specifically for use in direct contact with the central nervous = system,=20 in which case they are in Class III,

- or to supply energy in the form of ionizing radiation in which case = they=20 are in Class IIb,

- or to have a biological effect or to be wholly or mainly absorbed = in which=20 case they are in Class III,

- or to undergo chemical change in the body, except if the devices = are placed=20 in the teeth, or to administer medicines, in which case they are in = Class IIb.=20

2.4. Rule 8

All implantable devices and long-term surgically invasive devices are = in=20 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=20 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=20 case they are in Class III,

- or to undergo chemical change in the body, except if the devices = are placed=20 in the teeth, or to administer medicines, in which case they are in = Class III.=20

3. Additional rules applicable to active devices

3.1. Rule 9

All active therapeutic devices intended to administer or exchange = energy are=20 in Class IIa unless their characteristics are such that they may = administer or=20 exchange energy to or from the human body in a potentially hazardous = way, taking=20 account of the nature, the density and site of application of the = energy, in=20 which case they are in Class IIb.

All active devices intended to control or monitor the performance of = active=20 therapeutic devices in Class IIb, or intended directly to influence the=20 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=20 body, except for devices used to illuminate the patient's body, in the = visible=20 spectrum,

- if they are intended to image in vivo distribution of = radiopharmaceuticals,=20

- if they are intended to allow direct diagnosis or monitoring of = vital=20 physiological processes, unless they are specifically intended for = monitoring of=20 vital physiological parameters, where the nature of variations is such = that it=20 could result in immediate danger to the patient, for instance variations = in=20 cardiac performance, respiration, activity of CNS in which case they are = in=20 Class IIb.

Active devices intended to emit ionizing radiation and intended for=20 diagnostic and therapeutic interventional radiology including devices = which=20 control or monitor such devices, or which directly influence their = performance,=20 are in Class IIb.

Rule 11

All active devices intended to administer and/or remove medicines, = body=20 liquids or other substances to or from the body are in Class IIa, unless = this is=20 done in a manner:

- that is potentially hazardous, taking account of the nature of the=20 substances involved, of the part of the body concerned and of the mode = of=20 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=20 separately, can be considered to be a medicinal product, as defined in = Article 1=20 of Directive 65/65/EEC, and which is liable to act on the human body = with action=20 ancillary to that of the devices, are in Class III.

4.2. Rule 14

All devices used for contraception or the prevention of the = transmission of=20 sexually transmitted diseases are in Class IIb, unless they are = implantable or=20 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,=20 rinsing or, when appropriate, hydrating contact lenses are in Class IIb. =

All devices intended specifically to be used for disinfecting medical = devices=20 are in Class IIa.

This rule does not apply to products that are intended to clean = medical=20 devices other than contact lenses by means of physical action.

4.4. Rule 16

Non-active devices specifically intended for recording of X-ray = diagnostic=20 images are in Class IIa.

4.5. Rule 17

All devices manufactured utilizing animal tissues or derivatives = rendered=20 non-viable are Class III except where such devices are intended to come = into=20 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=20 concerning the characteristics and performances referred to in Sections = 1 and 3=20 of Annex I under the normal conditions of use of the device and the = evaluation=20 of the undesirable side-effects must be based on clinical data in = particular in=20 the case of implantable devices and devices in Class III. Taking account = of any=20 relevant harmonized standards, where appropriate, the adequacy of the = clinical=20 data must be based on:

1.1.1. either a compilation of the relevant scientific literature = currently=20 available on the intended purpose of the device and the techniques = employed as=20 well as, if appropriate, a written report containing a critical = evaluation of=20 this compilation;

1.1.2. or the results of all the clinical investigations made, = including=20 those carried out in conformity with Section 2.

1.2. All the data must remain confidential, in accordance with the = provisions=20 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=20 devices conform to those referred to in Section 3 of Annex I, and

- to determine any undesirable side-effects, under normal conditions = of use,=20 and assess whether they constitute risks when weighed against the = intended=20 performance of the device.

2.2. Ethical considerations

Clinical investigations must be carried out in accordance with the = Helsinki=20 Declaration adopted by the 18th World Medical Assembly in Helsinki, = Finland, in=20 1964, as last amended by the 41st World Medical Assembly in Hong Kong in = 1989.=20 It is mandatory that all measures relating to the protection of human = subjects=20 are carried out in the spirit of the Helsinki Declaration. This includes = every=20 step in the clinical investigation from first consideration of the need = and=20 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=20 appropriate plan of investigation reflecting the latest scientific and = technical=20 knowledge and defined in such a way as to confirm or refute the = manufacturer's=20 claims for the device; these investigations must include an adequate = number of=20 observations to guarantee the scientific validity of the conclusions. =

2.3.2. The procedures used to perform the investigations must be = appropriate=20 to the device under examination.

2.3.3. Clinical investigations must be performed in circumstances = similar to=20 the normal conditions of use of the device.

2.3.4. All the appropriate features, including those involving the = safety and=20 performances of the device, and its effect on patients must be examined. =

2.3.5. All adverse incidents such as those specified in Article 10 = must be=20 fully recorded and notified to the competent authority.

2.3.6. The investigations must be performed under the responsibility = of a=20 medical practitioner or another authorized qualified person in an = appropriate=20 environment.

The medical practitioner or other authorized person must have access = to the=20 technical and clinical data regarding the device.

2.3.7. The written report, signed by the medical practitioner or = other=20 authorized person responsible, must contain a critical evaluation of all = the=20 data collected during the clinical investigation.

ANNEX XI

CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES 1. The = notified=20 body, its Director and the assessment and verification staff shall not = be the=20 designer, manufacturer, supplier, installer or user of the devices which = they=20 inspect, nor the authorized representative of any of these persons. They = may not=20 be directly involved in the design, construction, marketing or = maintenance of=20 the devices, nor represent the parties engaged in these activities. This = in no=20 way precludes the possibility of exchanges of technical information = between the=20 manufacturer and the body.

2. The notified body and its staff must carry out the assessment and=20 verification operations with the highest degree of professional = integrity and=20 the requisite competence in the field of medical devices and must be = free from=20 all pressures and inducements, particularly financial, which might = influence=20 their judgment or the results of the inspection, especially from persons = or=20 groups of persons with an interest in the results of the verifications. =

Should the notified body subcontract specific tasks connected with = the=20 establishment and verification of the facts, it must first ensure that = the=20 subcontractor meets the provisions of the Directive and, in particular, = of this=20 Annex. The notified body shall keep at the disposal of the national = authorities=20 the relevant documents assessing the subcontractor's qualifications and = the work=20 carried out by the subcontractor under this Directive.

3. The notified body must be able to carry out all the tasks assigned = to such=20 bodies by one of Annexes II to VI and for which it has been notified, = whether=20 these tasks are carried out by the body itself or on its responsibility. = In=20 particular, it must have the necessary staff and possess the facilities = needed=20 to perform properly the technical and administrative tasks entailed in=20 assessment and verification. It must also have access to the equipment = necessary=20 for the verifications required.

4. The notified body must have:

- sound vocational training covering all the assessment and = verification=20 operations for which the body has been designated,

- satisfactory knowledge of the rules on the inspections which they = carry out=20 and adequate experience of such inspections,

- the ability required to draw up the certificates, records and = reports to=20 demonstrate that the inspections have been carried out.

5. The impartiality of the notified body must be guaranteed. Their=20 remuneration must not depend on the number of inspections carried out, = nor on=20 the results of the inspections.

6. The body must take out civil liability insurance, unless liability = is=20 assumed by the State under domestic legislation or the Member State = itself=20 carries out the inspections directly.

7. The staff of the notified body are bound to observe professional = secrecy=20 with regard to all information gained in the course of their duties = (except=20 vis-=C3=A0-vis the competent administrative authorities of the State in = which their=20 activities are carried out) pursuant to this Directive or any provision = of=20 national law putting it into effect.

ANNEX XII

CE MARKING OF CONFORMITY The CE conformity marking shall consist of = the=20 initials 'CE' taking the following form:

- If the marking is reduced or enlarged the proportions given in the = above=20 graduated drawing must be respected.

- The various components of the CE marking must have substantially = the same=20 vertical dimension, which may not be less than 5 mm.

This minimum dimension may be waived for small-scale devices.