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 =