Council Directive 93/42/EEC Concerning Medical Devices PDF

12. 7. 93 Official Journal of the European Communities No L 169/1 II (Acts whose publication is not obligatory)...

12. 7. 93 Official Journal of the European Communities No L 169/1 II (Acts whose publication is not obligatory) COUNCIL COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, States to manage the funding of public health and sickness insurance schemes relating directly or indirectly Having regard to the Treaty establishing the European to such devices; whereas, therefore, the provisions do not Economic Community, and in particular Article 100a affect the ability of the Member States to implement the thereof, abovementioned measures provided Community law is complied with; Having regard to the proposal from the Commission (*), Whereas medical devices should provide patients, users In cooperation with the European Parliament (2), and third parties with a high level of protection and attain the performance levels attributed to them by the Having regard to the opinion of the Economic and Social manufacturer; whereas, therefore, the maintenance or Committee (3 ), improvement of the level of protection attained in the Member States is one of the essential objectives of this Whereas measures should be adopted in the context of Directive; the internal market; whereas the internal market is an area without internal frontiers in which the free Whereas certain medical devices are intended to movement of goods, persons, services and capital is administer medicinal products within the meaning of ensured; Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, Whereas the content and scope of the laws, regulations regulation or administrative action relating to proprietary and administrative provisions in force in the Member medicinal products (4); whereas, in such cases, the placing States with regard to the safety, health protection and on the market of the medical device as a general rule is performance characteristics of medical devices , are governed by the present Directive and the placing on the different; whereas the certification and inspection market of the medicinal product is governed by Directive procedures for such devices differ from one Member 65/65/EEC; whereas if, however, such a device is placed State to another; whereas such disparities constitute on the market in such a way that the device and the barriers to trade within the Community; medicinal product form a single integral unit which is intended exclusively for use in the given combination and Whereas the national provisions for the safety and health which is not reusable, that single-unit product shall be protection of patients, users and, where appropriate, governed by Directive 65/65/EEC; whereas a distinction other persons, with regard to the use of medical devices must be drawn between the abovementioned devices and should be harmonized in order to guarantee the free medical devices incorporating, inter alia, substances movement of such devices within the internal market; which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such cases, if the substances Whereas the harmonized provisions must be distinguished from the measures adopted by the Member incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this H OJ No C 237, 12. 9. 1991 and OJ No C 251 , 28. 9. 1992, Directive; whereas, in this context, the safety, quality and p. 40. (2) OJ No C 150, 31. 5. 1993 and OJ No C 176, 28. 6. 1993. (4) OJ No 22, 9. 6. 1965, p. 369/65. Directive as last amended (3) OJ No C 79, 30. 3. 1992, p. 1. by Directive 92/27/EEC (OJ No L 113, 30. 4. 1992, p. 8 ). No L 169/2 Official Journal of the European Communities 12. 7. 93 usefulness of the substances must be verified by analogy 80/836/Euratom of 15 July 1980 amending the Directives with the appropriate methods specified in Council laying down the basic safety standards for the health Directive 75/318/EEC of 20 May 1975 on the protection of the general public and workers against the approximation of the laws of the Member States relating dangers of ionizing radiation (5 ), nor application of to analytical, pharmaco-toxicological and clinical Council Directive 84/466/Euratom of 3 September 1984 standards and protocols in respect of the testing of laying down basic measures for the radiation protection proprietary medicinal products ( J ); of persons undergoing medical examination or treatment (6); whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to Whereas the essential requirements and other encourage improvements in the safety and health of requirements set out in the Annexes to this Directive, workers at work (7) and the specific directives on the including any reference to 'minimizing' or 'reducing' risk same subject should continue to apply; must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations Whereas, in order to demonstrate conformity with the compatible with a high level of protection of health and essential requirements and to enable conformity to be safety; verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; Whereas, in accordance with the principles set out in whereas such harmonized European standards are drawn the Council resolution of 7 May 1985 concerning a up by private-law bodies and should retain their status as new approach to technical harmonization and non-mandatory texts; whereas, to this end, the European standardization (2), rules regarding the design and Committee for Standardization (CEN) and the European manufacture of medical devices must be confined to the Committee for Electrotechnical Standardization (Cenelec) provisions required to meet the essential requirements; are recognized as the competent bodies for the adoption whereas, because they are essential, such requirements of harmonized standards in accordance with the general should replace the corresponding national provisions; guidelines on cooperation between the Commission and whereas the essential requirements should be applied with these two bodies signed on 13 November 1984; discretion to take account of the technological level existing at the time of design and of technical and Whereas, for the purpose of this Directive, a harmonized economic considerations compatible with a high level of standard is a technical specification (European standard protection of health and safety; or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in accordance with Council Directive 83/189/EEC of Whereas Council Directive 90/385/EEC of 20 June 1990 28 March 1983 laying down a procedure for the on the approximation of the laws of the Member States provision of information in the field of technical relating to active implantable medical devices (3 ) is the standards and regulations ( 8 ), and pursuant to the first case of application of the new approach to the field abovementioned general guidelines; whereas with regard of medical devices; whereas in the interest of uniform to possible amendment of the harmonized standards, the Community rules applicable to all medical devices, this Commission should be assisted by the Committee set up Directive is based largely on the provisions of Directive pursuant to Directive 83/189/EEC; whereas the measures 90/385/EEC; whereas for the same reasons Directive to be taken must be defined in line with procedure I, as 90/385/EEC must be amended to insert the general laid down in Council Decision 87/373/EEC (9); whereas, provisions laid down in this Directive; for specific fields, what already exists in the form of European Pharmacopoeia monographs should be incorporated within the framework of this Directive; Whereas the electromagnetic compatibility aspects form whereas, therefore, several European Pharmacopoeia an integral part of the safety of medical devices; whereas monographs may be considered equal to the this Directive should contain specific rules on this subject abovementioned harmonized standards; with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (4); Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to Whereas this Directive should include requirements be used in the technical harmonization directives (*), the regarding the design and manufacture of devices emitting Council has laid down harmonized conformity ionizing radiation; whereas this Directive does not affect the authorization required by Council Directive (5) OJ No L 246, 17. 9. 1980, p. 1. Directive as last amended by Directive 84/467/Euratom ( OJ No L 265, 5. 10. 1984, p. 4 ). ( ) OJ No L 147, 9. 6. 1975, p. 1. Directive as last amended by (6) OJ No L 265, 5. 10; 1984, p. 1. Directive 91/507/EEC ( OJ No L 270, 26. 9. 1991 , p. 32 ). (7) OJ No L 183, 29. 6. 1989, p. 1. (2) OJ No C 136, 4. 6. 1985, p. 1. (8) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by (3) OJ No L 189, 20. 7. 1990, p. 17. Commission Decision 92/400/EEC (OJ No L 221 , 6. 8. (4) OJ No L 139, 23. 5. 1989, p. 19. Directive as last amended 1992, p. 55 ). by Directive 92/31/EEC (OJ No L 126, 12. 5. 1992, p. 11 ). (») OJ No L 197, 18. 7. 1987, p. 33. 12. 7. 93 Official Journal of the European Communities No L 169/3 assessment procedures; whereas the application of these Commission the decisions to be taken with regard to the modules to medical devices enables the responsibility of proper classification or reclassification of the devices or, manufacturers and notified bodies to be determined where appropriate, the adjustment of the classification during conformity assessment procedures on the basis of rules themselves; whereas since these issues are closely the type of devices concerned; whereas the details added connected with the protection of health, it is appropriate to these modules are justified by the nature of the that these decisions should come under procedure Ilia, as verification required for medical devices; provided for in Directive 87/373/EEC; Whereas the confirmation of complicance with the Whereas it is necessary, essentially for the purpose of the essential requirements may mean that clinical conformity assessment procedures, to group the devices investigations have to be carried out under the into four product classes; whereas the classification rules responsibility of the manufacturer; whereas, for the are based on the vulnerability of the human body taking purpose of carrying out the clinical investigations, account of the potential risks associated with the appropriate means have to be specified for the protection technical design and manufacture of the devices; whereas of public health and public order; the conformity assessment procedures for Class I devices can be, carried out, as a general rule, under the sole Whereas the protection of health and the associated responsibility of the manufacturers in view of the low controls may be made more effective by means of medical level of vulnerability associated with these products; device vigilance systems which are integrated at whereas, for Class Ila devices, the intervention of a Community level; notified body should be compulsory at the production stage; whereas, for devices falling within Classes lib and Whereas this Directive covers the medical devices referred III which constitute a high risk potential, inspection by a to in Council Directive 76/764/EEC of 27 July 1976 on notified body is required with regard to the design and the approximation of the laws of the Member States on manufacture of the devices; whereas Class III is set aside clinical mercury-in-glass, maximum reading for the most critical devices for which explicit prior thermometers (3 ); whereas the abovementioned Directive authorization with regard to conformity is required for must therefore be repealed; whereas for the same reasons them to be placed on the market; Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or Whereas in cases where the conformity of the devices can veterinary medicine (4) must be amended, be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the HAS ADOPTED THIS DIRECTIVE: Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose; Article 1 Definitions, scope Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely 1. This Directive shall apply to medical devices and within the Community and to be put into service in their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their accordance with their intended purpose; own right. Both medical devices and accessories shall hereinafter be termed devices. Whereas, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16 May 1989 2. For the purposes of this Directive, the following regarding future activities on AIDS prevention and definitions shall apply: control at Community level (2), medical devices used for protection against the HIV virus must afford a high level (a ) 'medical device' means any instrument, apparatus, of protection; whereas the design and manufacture of appliance, material or other article, whether used such products should be verified by a notified body; alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of — diagnosis, prevention, monitoring, treatment or the diverse nature of the devices and technological alleviation of disease, progress in this field, steps must be taken to include amongst the implementing powers conferred on the (3 ) OJ No L 262, 27. 9. 1976, p. 139. Directive as last amended by Directive 84/414/EEC (OJ No L 228, 25. 8. 1984, p. 25 ). O OJ No L 380, 31. 12. 1990, p. 13. (4) OJ No L 300, 19. 11. 1984, p. 179. Directive as amended by (2) OJ No C 185, 22. 7. 1989, p. 8. the Act of Accession of Spain and Portugal. No L 169/4 Official Journal of the European Communities 12. 7. 93 — diagnosis, monitoring, treatment, alleviation of or products and/or assigns to them their intended compensation for an injury or handicap, purpose as a device with a view to their being placed on the market under his own name. This — investigation, replacement or modification of the subparagraph does not apply to the person who, anatomy or of a physiological process, while not a manufacturer within the meaning of the — control of. conception, first subparagraph, assembles or adapts devices already on the market to their intended purpose for and which does not achieve its principal intended an individual patient; action in or on the human body by pharmacological, immunological or metabolic means, but which may (g) 'intended purpose' means the use for which the be assisted in its function by such means; device is intended according to the data supplied by the manufacturer on the labelling, in the instructions (b) 'accessory' means an article which whilst not being a and/or in promotional materials; device is intended specifically by its manufacturer to (h) 'placing on the market' means the first making be used together with a device to enable it to be used available in return for payment or free of charge of a in accordance with the use of the device intended by device other than a device intended for clinical the manufacturer of the device; investigation, with a view to distribution and/or use on the Community market, regardless of whether it (c) 'device used for in vitro diagnosis' means any device is new or fully refurbished; which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in (i) 'putting into service' means the stage at which a combination, intended by the manufacturer to be device is ready for use on the Community market for used in vitro for the examination of samples derived the first time for its intended purpose. from the human body with a view to providing information on the physiological state, state of health 3. Where a device is intended to administer a or disease, or congenital abnormality thereof; medicinal product within the meaning of Article 1 of Directive 65/65/EEC, that device shall be governed by the (d) 'custom-made device' means any device specifically present Directive, without prejudice to the provisions of made in accordance with a duly qualified medical Directive 65/65/EEC with regard to the medicinal practitioner's written prescription which gives, under product. his responsibility, specific design characteristics and is intended for the sole use of a particular patient. If, however, such a device is placed on the market in such a way that the device and the medicinal product form a The abovementioned prescription may also be made out by any other person authorized by virtue of his single integral product which is intended exclusively for use in the given combination and which is not reusable, professional qualifications to do so. that single product shall be governed by Directive Mass-produced devices which need to be adapted to 65/65/EEC. The relevant essential requirements of meet the specific requirements of the medical Annex I to the present Directive shall apply as far as practitioner or any other professional user are not safety and performance related device features are considered to be custom-made devices; concerned. (e) 'device intended for clinical investigation' means any 4. Where a device incorporates, as an integral part, a device intended for use by a duly qualified medical substance which, if used separately, may be considered to practitioner when conducting investigations as be a medicinal product within the meaning of Article 1 of referred to in Section 2.1 of Annex X in an adequate Directive 65/65/EEC and which is liable to act upon the human clinical environment. body with action ancillary to that of the device, that device must be assessed and authorized in accordance For the purpose of conducting clinical investigation, with this Directive. any other person who, by virtue of his professional qualifications, is authorized to carry out such 5. This Directive does not apply to: investigation shall be accepted as equivalent to a duly qualified medical practitioner; (a ) in vitro diagnostic devices; (f) 'manufacturer' means the natural or legal person (b ) active implantable devices covered by Directive with responsibility for the design, manufacture, 90/385/EEC; packaging and labelling of a device before it is placed on the market under his own name, regardless of (c ) medicinal products covered by Directive 65/65/EEC; whether these operations are carried out by that person himself or on his behalf by a third party. (d ) cosmetic products covered by Directive 76/76 8/EEC ( M; The obligations of this Directive to be met by manufacturers also apply to the natural or legal (') OJ No L 262, 27. 9. 1976, p. 169. Directive as last amended person who assembles, packages, processes, fully by Commission Directive 92/86/EEC (OJ No L 325, 11. 11. refurbishes and/or labels one or more ready-made 1992, p. 18 ). 12. 7. 93 Official Journal of the European Communities No L 169/5 (e ) human blood, human blood products, human plasma 2. Member States shall not create any obstacle to: or blood cells of human origin or to devices which incorporate at the time of placing on the market — devices intended for clinical investigation being made such blood products, plasma or cells; available to medical practitioners or authorized persons for that purpose if they meet the conditions ( f) transplants or tissues or cells of human origin nor to laid down in Article 15 and in Annex VIII, products incorporating or derived from tissues or cells of human origin; — custom-made devices being placed on the market and put into service if they meet the conditions laid down (g) transplants or tissues or cells of animal origin, unless in Article 11 in combination with Annex VIII; a device is manufactured utilizing animal tissue Class Ha, lib and III devices shall be accompanied by which is rendered non-viable or non-viable products the statement referred to in Annex VIII. derived from animal tissue. 6. This Directive does not apply to personal protective These devices shall not bear the CE marking. equipment covered by Directive 89/686/EEC. In deciding whether a product falls under that Directive or the 3. At trade fairs, exhibitions, demonstrations, etc. present Directive, particular account shall be taken of the principal intended purpose of the product. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates 7. This Directive is a specific Directive within the that such devices cannot be marketed or put into service meaning of Article 2 (2) of Directive 89/336/EEC. until they have been made to comply. 8. This Directive does not affect the application of 4. Member States may require the information, which Directive 80/836/Euratom, nor of Directive 84/466/Euratom. must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of Article 2 whether it is for professional or other use. Placing on the market and putting into service 5. Where the devices are subject to other Directives concerning other aspects and which also provide for the Member States shall take all necessary steps to ensure affixing of the CE marking, the latter shall indicate that that devices may be placed on the market and put into the devices also fulfil the provisions of the other Directives. service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in However, should one or more of these directives allow accordance with their intended purpose. the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those Article 3 directives applied by the manufacturer. In this case, the particulars of these directives, as published in the Official Journal of the European Communities, must be given in Essential requirements the documents, notices or instructions required by the directives and accompanying such devices. The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned. Article 5 Article 4 Reference to standards Free movement, devices intended for special purposes 1. Member States shall presume compliance with the essential requirements referred to in Article 3 in respect 1. Member States shall not create any obstacle to the of devices which are in conformity with the relevant placing on the market or the putting into service within national standards adopted pursuant to the harmonized their territory of devices bearing the CE marking standards the references of which have been publishes in provided for in Article 17 which indicate that they have the Official Journal of the European , Communities; been the subject of an assessment of their conformity in Member States shall publish the references of such accordance with the provisions of Article 11. national standards. No L 169/6 Official Journal of the European Communities 12. 7. 93 2. For the purposes of this Directive, reference to The Commission shall adopt the measures envisaged if harmonized standards also includes the monographs of they are in accordance with the opinion of the the European Pharmacopoeia notably on surgical sutures Committee. and on interaction between medicinal products and materials used in devices containing such medicinal If the measures envisaged are not in accordance with the products, the references of which have been published in opinion of the Committee, or if no opinion is delivered, the Official Journal of the European Communities. the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. 3. If a Member State or the Commission considers The Council shall act by a qualified majority. that the harmonized standards do not entirely meet the essential requirements referred to in Article 3, the If, on the expiry of a period of three months from the measures to be taken by the Member States with regard date of referral to the Council, the Council has not acted, to these standards and the publication referred to in the proposed measures shall be adopted by the paragraph 1 of this Article shall be adopted by the Commission. procedure defined in Article 6 (2). 4. The Committee may examine any question connected with implementation of this Directive. Article 6 Article 8 Committee on Standards and Technical Regulations Safeguard clause 1. The Commission shall be assisted by the Committee set up by Article 5 of Directive 83/189/EEC. 1. Where a Member State ascertains that the devices referred to in Article 4 ( 1 ) and (2) second indent, when 2. The representative of the Commission shall submit correctly installed, maintained and used for their intended to the Committee a draft of the measures to be taken. purpose, may compromise the health and/or safety of The Committee shall deliver its opinion on the draft patients, users or, where applicable, other persons, it within a time limit which the chairman may lay down shall take all appropriate interim measures to withdraw according to the urgency of the matter, if necessary by such devices from the market or prohibit or restrict their taking a vote. being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its The opinion shall be recorded in the minutes; in addition, decision and, in particular, whether non-compliance with each Member State shall have the right to ask to have its this Directive is due to: position recorded in the minutes. (a ) failure to meet the essential requirements referred to The Commission shall take the utmost account of the in Article 3; opinion delivered by the Committee. It shall inform the ( b ) incorrect application of the standards referred to in Committee of the manner in which its opinion has been Article 5, in so far as it is claimed that the standards taken into account. have been applied; (c) shortcomings in the standards themselves. Article 7 2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after Committee on Medical Devices such consultation, the Commission finds that: 1. The Commission shall be assisted by the Committee — the measures are justified, it shall immediately so inform the Member State which took the initiative set up by Article 6 (2) of Directive 90/385/EEC. and the other Member States; where the decision referred to in paragraph 1 is attributed to 2. The representative of the Commission shall submit shortcomings in the standards, the Commission shall, to the Committee a draft of the measures to be taken. after consulting the parties concerned, bring the The Committee shall deliver its opinion on the draft matter before the Committee referred to in Article 6 within a time limit which the chairman may lay down ( 1 ) within two months if the Member State which has according to the urgency of the matter. The opinion shall taken the decision intends to maintain it and shall be delivered by the majority laid down in Article 148 (2 ) initiate the procedures referred to in Article 6, of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. — the measures are unjustified, it shall immediately so The votes of the representatives of the Member States inform the Member State which took the initiative within the Committee shall be weighted in the manner set and the manufacturer or his authorized representative out in that Article. The chairman shall not vote. established within the Community. 12. 7. 93 Official Journal of the European Communities No L 169/7 3. Where a non-complying device bears the CE 3. After carrying out an assessment, if possible marking, the competent Member State shall take together with the manufacturer, Member States shall, appropriate action against whomsoever has affixed the without prejudice to Article 8, immediately inform the mark and shall inform the Commission and the other Commission and the other Member States of the Member States thereof. incidents referred to in paragraph 1 for which relevant measures have been taken or are contemplated. 4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure. Article 11 Conformity assessment procedures Article 9 1. In the case of devices falling within Class III, other Classification than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to 1. Devices shall be divided into Classes I, Ila, lib and affix the CE marking, either: III. Classification shall be carried out in accordance with (a ) follow the procedure relating to the EC declaration Annex IX. of conformity set out in Annex II ( full quality assurance); or 2. In the event of a dispute between the manufacturer and the notified body concerned, resulting from the ( b ) follow the procedure relating to the EC application of the classification rules, the matter shall be type-examination set out in Annex III, coupled referred for decision to the competent authority to which with: the notified body is subject. (i) the procedure relating to the EC verification set out in Annex IV; 3. The classification rules set out in Annex IX may be adapted in accordance with the procedure referred to in or Article 7 (2) in the light of technical progress and any ( ii) the procedure relating to the EC declaration of information which becomes available under the conformity set out in Annex V (production information system provided for in Article 10. quality assurance). 2. In the case of devices falling within Class Ila, other Article 10 than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to Information on incidents occuring following placing of affix the CE marking, follow the procedure relating to devices on the market the EC declaration of conformity set out in Annex VII, coupled with either: 1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, ( a) the procedure relating to the EC verification set out in accordance with the provisions of this Directive, in Annex IV; regarding the incidents mentioned below involving a or Class I, Ila, lib or III device is recorded and evaluated centrally: ( b ) the procedure relating to the EC declaration of conformity set out in Annex V (production quality (a ) any malfunction or deterioration in the assurance); characteristics and/or performance of a device, as or well as any inadequacy in the labelling or the instructions for use which might lead to or might (c ) the procedure relating to the EC declaration of have led to the death of a patient or user or to a conformity set out in Annex VI (product quality serious deterioration in his state of health; assurance). (b) any technical or medical reason in relation to the Instead of applying these procedures, the manufacturer characteristics or performance of a device for the may also follow the procedure referred to in reasons referred to in subparagraph (a ), leading to paragraph 3 (a). systematic recall of devices of the same type by the manufacturer. 3. In the case of devices falling within Class lib, other than devices which are custom-made or intended for 2. Where a Member State requires medical clinical investigations, the manufacturer shall, in order to practitioners or the medical institutions to inform the affix the CE marking, either: competent authorities of any incidents referred to in paragraph 1 , it shall take the necessary steps to ensure (a ) follow the procedure relating to the EC declaration that the manufacturer of the device concerned, or his of conformity set out in Annex II (full quality authorized representative established in the Community, assurance); in this case, point 4 of Annex II is not is also informed of the incident. applicable; or No L 169/8 Official Journal of the European Communities 12. 7. 93 ( b) follow the procedure relating to the EC 11. Decisions taken by the notified bodies in type-examination set out in Annex III, coupled accordance with Annexes II and III shall be valid for a with: maximum of five years and may be extended on (i ) the procedure relating to the EC verification set application, made at a time agreed in the contract signed out in Annex IV; by both parties, for further periods of five years. or 12. The records and correspondence relating to the (ii ) the procedure relating to the EC declaration of procedures referred to in paragraphs 1 to 6 shall be in an conformity set out in Annex V (production official language of the Member State in ^vhich the quality assurance); procedures are carried out and/or in another Community or language acceptable to the notified body. (iii) the procedure relating to the EC declaration of conformity set out in Annex VI (product 13. By derogation from paragraphs 1 to 6, the quality assurance). competent authorities may authorize, on duly justified request, the placing on the market and putting into 4. The Commission shall, no later than five years from service, within the territory of the Member State the date of implementation of this Directive, submit a concerned, of individual devices for which the procedures report to the Council on the operation of the provisions referred to in paragraphs 1 to 6 have not been carried referred to in Article 10 ( 1 ), Article 15 ( 1 ), in particular out and the use of which is in the interest of protection of health. in respect of Class I and Class Ila devices, and on the operation of the provisions referred to in Annex II, Section 4.3 second and third subparagraphs and in Annex III, Section 5 second and third subparagraphs to Article 12 this Directive, accompanied, if necessary, by appropriate proposals. Particular procedure for systems and procedure packs 5. In the case of devices falling within Class I, other than devices which are custom-made or intended for 1. By way of derogation from Article 11 this Article clinical investigations, the manufacturer shall, in order to shall apply to systems and procedure packs. affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity 2. Any natural or legal person who puts devices required before placing the device on the market. bearing the CE marking together within their intended 6. In the case of custom-made devices, the purpose and within the limits of use specified by their manufacturer shall follow the procedure referred to in manufacturers, in order to place them on the market as a Annex VIII and draw up the statement set out in that system or procedure pack, shall draw up a declaration by which he states that: Annex before placing each device on the market. Member States may require that the manufacturer shall (a) he has verified the , mutual compatibility of the submit to the competent authority a list of such devices devices in accordance with the manufacturers ' which have been put into service in their territory. instructions and has carried out his operations in accordance with these instructions; and 7. During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall (b ) he has packaged the system or procedure pack and take account of the results of any assessment and supplied relevant information to users incorporating verification operations which, where appropriate, have relevant instructions from the manufacturers; and been carried out in accordance with this Directive at an intermediate stage of manufacture. (c) the whole activity^ is subjected to appropriate methods of internal control and inspection. 8. The manufacturer may instruct his authorized representative established in the Community to initiate Where the conditions above are not met, as in cases the procedures provided for in Annexes III, IV, VII and where the system or procedure pack incorporate devices VIII. which do not bear a CE marking or where the chosen 9. Where the conformity assessment procedure combination of devices is not compatible in view of their involves the intervention of a notified body, the original intended use, the system or procedure pack shall manufacturer, or his authorized representative established be treated as a device in its own right and as such be in the Community, may apply to a body of his choice subjected to the. relevant procedure pursuant to Article 11. within the framework of the tasks for which the body has been notified. 3. Any natural or legal person who sterilized, for the 10. The notified body may require, where duly purpose of placing on the market, systems or procedure justified, any information or data, which is necessary for packs referred to in paragraph 2 or other CE-marked establishing and maintaining the attestation of conformity medical devices designed by their manufacturers to be in view of the chosen procedure. sterilized before use, shall, at his choice, follow one of the 12. 7. 93 Official Journal of the European Communities No L 169/9 procedures referred to in Annex IV, V or VI. The does not have a registered place of business in a Member application of the abovementioned Annexes and the State, he shall designate the person(s ) responsible for intervention of the notified body are limited to the marketing them who is (are) established in the aspects of the procedure relating to the obtaining of Community. These persons shall inform the competent sterility. The person shall draw up a declaration stating authorities of the Member State in which they have their that sterilization has been carried out in accordance with registered place of business of the address of the the manufacturer's instructions. registered place of business and the category of devices concerned. 4. The products referred to in paragraphs 2 and 3 themselves shall not bear an additional CE marking. They 3. The Member States shall on request inform the shall be accompanied by the information referred to in other Member States and the Commission of the details point 13 of Annex I which includes, where appropriate, referred to in paragraphs 1 and 2. the information supplied by the manufacturers of the devices which have been put together. The declaration Article IS referred to in paragraphs 2 and 3 above shall be kept at the disposal of competent authorities for a period of five Clinical investigation years. 1. In the case of devices intended for clinical Article 13 investigations, the manufacturer, or his authorized representative established in the Community, shall follow Decisions with regard to classification, derogation clause the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the 1. Where a Member State considers that: investigations are to be conducted. (a ) application of the classification rules set out in 2. In the case of devices falling within Class III and Annex IX requires a decision with regard to the implantable and long-term invasive devices falling within classification of a given device or category of Class Ila or lib, the manufacturer may commence the devices; relevant clinical investigation at the end of a period of 60 or days after notification, unless the competent authorities ( b ) a given device or family of devices should be have notified him within that period of a decision to the contrary based on considerations of public health or classified, by way of derogation from the provisions of Annex IX, in another class; public policy. or Member States may however authorize manufacturers to (c) the conformity of a device or family of devices commence the relevant clinical investigations before the should be established, by way of derogation from the expiry of the period of 60 days, in so far as the relevant provisions of Article 11 , by applying solely one of ethics committee has issued a favourable opinion on the the given procedures chosen from among those programme of investigation in question. referred to in Article 11 , 3. In the case of devices other than those referred to in it shall submit a duly substantiated request to the the second paragraph, Member States may authorize Commission and ask it to take the necessary measures. manufacturers to commence clinical investigations, These measures shall be adopted in accordance with the immediately after the date of notification, provided that procedure referred to in Article 7 (2). the ethics committee concerned has delivered a favourable opinion with regard to the investigational 2. The Commission shall inform the Member States of plan. the measures taken and, where appropriate, publish the relevant parts of these measures in the Official Journal of 4. The authorization referred to in paragraph 2 second the European Communities. subparagraph and paragraph 3, may be made subject to authorization from the competent authority. Article 14 5. The clinical investigations must be conducted in accordance with the provisions of Annex X. The Registration of persons responsible for placing devices on provisions of Annex X may be adjusted in accordance the market with the procedure laid down in Article 7 (2 ). 1. Any manufacturer who, under his own name, places 6. The Member States shall, if necessary, take the devices on the market in accordance with the procedures appropriate steps to ensure public health and public referred to in Article 11 (5 ) and (6 ) and any other natural policy. or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the 7. The manufacturer or his authorized representative Member State in which he has his registered place of established in the Community shall keep the report business of the address of the registered place of business referred to in point 2.3.7 of Annex X at the disposal of and the description of the devices concerned. the competent authorities. 2. Where a manufacturer who places devices referred 8. The provisions of paragraphs 1 and 2 do not apply to in paragraph 1 on the market under his own name where the clinical investigations are conducted using No L 169/10 Official Journal of the European Communities 12. 7. 93 devices which are authorized in accordance with applicable, the CE marking must also appear on the sales Article 1 1 to bear the CE marking unless the aim of these packaging. investigations is to use the devices for a purpose other than that referred to in the relevant conformity It shall be accompanied by the identification number of assessment procedure. The relevant provisions of the notified body responsible for implementation of the Annex X remain applicable. procedures set out in Annexes II, IV, V and VI. 3. It is prohibited to affix marks or inscriptions which Article 16 are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other \ mark may be affixed to the device, to the packaging or to Notified bodies the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not 1. The Member States shall notify the Commission thereby reduced. and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 11 and the specific tasks Article 18 for which the bodies have been designated. The Commission shall assign identification numbers to these Wrongly affixed CE marking bodies, hereinafter referred to as 'notified bodies'. Without prejudice to Article 8 : The Commission shall publish a list of the notified bodies, together with the identification numbers it has (a ) where a Member State establishes that the CE allocated to them and the tasks for which they have been marking has been affixed unduly, the manufacturer notified, in the Official Journal of the European or his authorized representative established within Communities. It shall ensure that the list is kept up to the Community shall be obliged to end the date. infringement under conditions imposed by the Member State; 2. Member States shall apply the criteria set out in Annex XI for the designation of bodies. Bodies that meet (b ) where non-compliance continues, the Member State the criteria laid down in the national standards which must take all appropriate measures to restrict or transpose the relevant harmonized standards shall be prohibit the placing on the market of the product in presumed to meet the relevant criteria. question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8. 3. A Member State that has notified a body shall withdraw that notification if it finds that the body no longer meets the criteria referred to in paragraph 2. It Article 19 shall immediately inform the other Member States and the Commission thereof. Decision in respect of refusal or restriction 4. The notified body and the manufacturer, or his authorized representative established in the Community, 1. Any decision taken pursuant to this Directive: shall lay down, by common accord, the time limits for (a ) to refuse or restrict the placing on the market or the completion of the assessment and verification operations putting into service of a device or the carrying out of referred to in Annexes II to VI. clinical investigations; or Article 17 ( b ) to withdraw devices from the market, CE marking shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the party concerned, who shall at the same time be informed of the 1. Devices, other than devices which are custom-made remedies available to him under the national law in force or intended for clinical investigations, considered to meet in the Member State in question and of the time limits to the essential requirements referred to in Article 3 must which such remedies are subject. bear the CE marking of conformity when they are placed on the market. 2. In the event of a decision as referred to in paragraph 1 , the manufacturer, or his authorized 2. The CE marking of conformity, as shown in representative established in the Community, shall have Annex XII, must appear in a visible, legible and indelible an opportunity to put forward his viewpoint in advance, form on the device or its sterile pack, where practicable unless such consultation is not possible because of the and appropriate, and on the instructions for use. Where urgency of the measure to be taken. 12. 7. 93 Official Journal of the European Communities No L 169/11 Article 20 while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices Confidentiality already on the market to their intended purpose for an individual patient;' Without prejudice to the existing national provisions and practices on medical secrets, Member States shall ensure that all the parties involved in the application of this 2. in Article 9 the following paragraphs are added: Directive are bound to observe confidentiality with regard to all information obtained in carrying out their '5. During the conformity assessment procedure tasks. This does not affect the obligation of Member for a device, the manufacturer and/or the notified States and notified bodies with regard to mutual body shall take account of the results of any information and the dissemination of warnings, nor the assessment and verification operations which, where obligations of the persons concerned to provide appropriate, have been carried out in accordance with information under criminal law. this Directive at an intermediate stage of manufacture. Article 21 6. Where the conformity assessment procedure involves the intervention of a notified body, the Repeal and amendment of Directives manufacturer, or his authorized representative established in the Community, may apply to a body 1. Directive 76/764/EEC is hereby repealed with effect of his choice within the framework of the tasks for from 1 January 1995. which the body has been notified. 2. In the title and Article 1 of Directive 84/539/EEC, 'human or' is deleted. 7. The notified body may require, where duly justified, any information or data which is necessary In Article 2 of Directive 84/539/EEC, the following for establishing and maintaining the attestation of subparagraph is added to paragraph 1 : conformity in view of the chosen procedure. 'If the appliance is at the same time a medical device 8. Decisions taken by the notified bodies in within the meaning of Directive 93/42/EEC (*) and if accordance with Annexes II and III shall be valid for it satisfies the essential requirements laid down therein a maximum of five years and may be extended on for that device, the device shall be deemed to be in application, made at a time agreed in the contract conformity with the requirements of this Directive. signed by both parties, for further periods of five years. (*) OJ No L 169, 12. 7. 1993 , p. 1.' 3. Directive 90/385/EEC is hereby amended as 9. By derogation from paragraphs 1 and 2 the follows: competent authorities may authorize, on duly justified request, the placing on the market and putting into 1. in Article 1 (2 ) the following two subparagraphs are service, within the territory of the Member State added : concerned, of individual devices for which the procedures referred to in paragraphs 1 and 2 have '(h) "placing on the market" means the first making not been carried out and the use of which is in the available in return for payment or free of charge of interest of protection of health.'; a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it 3. the following Article 9a is inserted after Article 9 : is new or fully refurbished; (i ) " manufacturer " means the natural or legal person 'Article 9a with responsibility for the design, manufacture, packaging and labelling of a device before it is 1. Where a Member State considers that the placed on the market under his own name, conformity of a device or family of devices should be regardless of whether these operations are carried established, by way of derogation from the provisions x out by that person himself or on his behalf by a of Article 9, by applying solely one of the given third party. procedures chosen from among those referred to in The obligations of this Directive to be met by Article 9, it shall submit a duly substantiated request manufacturers also apply to the natural or legal to the Commission and ask it to take the necessary person who assembles, packages, processes, fully measures. These measures shall be adopted in refurbishes and/or labels one or more ready-made accordance with the procedure referred to in Article 7 products and/or assigns to them their intended (2 ) of Directive 93/42/EEC (*). purpose as a device with a view to their being placed on the market under his own name. This 2. The- Commission shall inform the Member subparagraph does not apply to the person who, States of the measures taken and, where appropriate, No L 169/12 Official Journal of the European Communities 12. 7. 93 publish the relevant parts of these measures in the When Member States adopt these provisions, these shall Official Journal of the European Communities. contain a reference to this Directive or shall be accompanied by such a reference at the time of their (*) OJ No L 169, 12. 7. 1993 , p. 1.' official publication. The procedure for such reference shall be adopted by Member States. 4. Article 10 shall be amended as follows : Member States shall apply these provisions with effect — the following subparagraph shall be added to from 1 January 1995. paragraph 2 : 2. Member States shall communicate to the 'Member States may however authorize Commission the texts of the provisions of national law manufacturers to start the clinical investigations in which they adopt in the field covered by this Directive. question before the expiry of the 60-day period, provided that the Ethical Committee concerned 3. Member States shall take the necessary action to has delivered a favourable opinion with respect to ensure that the notified bodies which are responsible the investigation programme in question.', pursuant to Article 11 ( 1 ) to ( 5 ) for conformity assessment take account of any relevant information — the following paragraph shall be inserted: regarding the characteristics and performance of such '2a. The authorization referred to in the second devices, including in particular the results of any relevant subparagraph of paragraph 2 may be subject to tests and verification already carried out under approval by the competent authority.'; pre-existing national law, regulations or administrative provisions in respect of such devices. 5. the following is added to Article 14: 4. Member States shall accept the placing on the 'In the event of a decision as referred to in the market and putting into service of devices which conform previous paragraph the manufacturer, or his to the rules in force in their territory on 31 December authorized representative established in the 1994 during a period of five years following adoption of this Directive. Community, shall have an opportunity to put forward his viewpoint in advance, unless such In the case of devices which have been subjected to EEC consultation is not possible because of the urgency of pattern approval in accordance with Directive the measures to be taken.' 76/764/EEC, Member States shall accept their being placed on the market and put into service during the period up to 30 June 2004. Article 22 Article 23 Implementation, transitional provisions This Directive is addressed to the Member States. 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1994. They shall immediately inform the Commission thereof. Done at Luxembourg, 14 June 1993. The Standing Committee referred to in Article 7 may assume its tasks from the date of notification (*) of this For the Council Directive. The Member States may take the measures referred to in Article 16 on notification of this The President Directive. J. TR0JBORG (l ) This Directive was notified to the Member States on 29 June 1993. 12. 7. 93 Official Journal of the European Communities No L 169/13 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 for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. 2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: — eliminate or reduce risks as far as possible (inherently safe design and construction), — where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, — inform users of the residual risks due to any shortcomings of the protection measures adopted. 3. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer. 4. The characteristics and performances referred to in Sections 1 , 2 and 3 must not be adversely affected to such a degree that the clinical conditions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use. 5. The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer. 6. Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended. II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION 7. Chemical, physical and biological properties 7.1. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the 'General requirements'. Particular attention must be paid to : — the choice of materials used, particularly as regards toxicity and, where appropriate, flammability, — the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device. 7.2. The devices must be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure. 7.3. The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during their normal use or during routine procedures; if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing these products and that their performance is maintained in accordance with the intended use. No L 169/14 Official Journal of the European Communities 12. 7. 93 7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in Directive 75/318/EEC. 7.5. The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. 7.6. Devices must be designed and manufactured in such a way as to reduce, as much as possible, risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used. 8. Infection and microbial contamination 8.1. The devices and manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties. The design must allow easy handling and, where necessary, minimize contamination of the device by the patient or vice versa during use. 8.2. Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues. Notified bodies shall retain information on the geographical origin of the animals. Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so as to provide optimal security. In particular safety with regard to viruses and other transferable agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process. 8.3. Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate procedures to ensure that they are sterile when placed on the market and remain sterile, under the storage and transport conditions laid down, until the protective packaging is damaged or opened. 8.4. Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method. 8.5. Devices intended to be sterilized must be manufactured in appropriately controlled (e. g. environmental) conditions. 8.6. Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilized prior to use, minimize the risk of microbial contamination; the packaging system must be suitable taking account of the method of sterilization indicated by the manufacturer. 8.7. The packaging and/or label of the device must distinguish between identical 1 or similar products sold in both sterile and non-sterile condition. 9. Construction and environmental properties 9.1. If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must be safe and must not impair the specified performances of the devices. Any restrictions on use must be indicated on the label or in the instructions for use. 9.2. Devices must be designed and manufactured in such a way as to remove or minimize as far as is possible: — the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features, — risks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure and acceleration, — the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given, — risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism. 12. 7. 93 Official Journal of the European Communities No L 169/15 9.3. Devices must be designed and manufactured in such a way as to minimize the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to substances which could cause combustion. 10. Devices with a measuring function 10.1. Devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer. 10.2. The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device. 10.3. The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC ( 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 far as possible compatible with the intended purpose, whilst not restricting the application.of appropriate specified levels for therapeutic and diagnostic purposes. 11.2. Intended radiation 11.2.1. Where devices are designed to emit hazardous, levels of radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it must be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters. 11.2.2. Where devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must be fitted, where practicable, with visual displays and/or audible warnings of such emissions. 11.3. Unintended radiation 11.3.1. Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible. 11.4. Instructions 11.4.1. The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation, means of protecting the patient and the user and on ways of avoiding misuse and of eliminating the risks inherent in installation. 11.5. Ionizing radiation 11.5.1. Devices intended to emit ionizing radiation must be designed and manufactured in such a way as to ensure that, where practicable, the quantity, geometry and quality of radiation emitted can be varied and controlled taking into account the intended use. 11.5.2. Devices emitting ionizing radiation intended for diagnostic radiology shall be designed and manufactured in such a way as to achieve appropriate image and/or output quality for the intended medical purpose whilst minimizing radiation exposure of the patient and user. 11.5.3. Devices emitting ionizing radiation, intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type and energy and where appropriate the quality of radiation. (l) OJ No L 39, 15. 2. 1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJ No L 357, 7. 12. 1989, p. 28). No L 169/16 Official Journal of the European Communities 12. 7. 93 12. Requirements for medical devices connected to or equipped with an energy source 12.1. Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use. In the event of a single fault condition (in the system) appropriate means should be adopted to eliminate or reduce as far as possible consequent risks. 12.2. Devices where the safety of the patients depends on an internal power supply must be equipped with a means of determining the state of the power supply. 12.3. Devices where the safety of the patients depends on an external power supply must include an alarm system to signal any power failure. 12.4. Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health. 12.5. Devices must be designed and manufactured in such a way as to minimize the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment. 12.6. Protection against electrical risks Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during normal use and in single fault condition, provided the devices are installed correctly. 12.7. Protection against mechanical and thermal risks 12.7.1. Devices must be designed and manufactured in such a way as to protect the patient and user against mechanical risks connected with, for example, resistance, stability and moving parts. 12.7.2. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance. 12.7.3. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance. 12.7.4. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user has to handle must be designed and constructed in such a way as to minimize all possible risks. 12.7.5. Accessible parts of the devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use. 12.8. Protection against the risks posed to the patient by energy supplies or substances 12.8.1. Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the flow-rate can be set and maintained accurately enough to guarantee the safety of the patient and of the user. 12.8.2. Devices must be fitted with the means of preventing and/or indicating any inadequacies in the flow-rate which could pose a danger. Devices must incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy from an energy and/or substance source. 12.9. The function of the controls and indicators must be clearly specified on the devices. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information must be understandable to the user and, as appropriate, the patient. 12. 7. 93 Official Journal of the European Communities No L 169/17 13. Information supplied by the manufacturer 13.1. Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential users. This information comprises the details on the label and the data in the instructions for use. As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices. Instructions for use must be included in the packaging for every device. By way of exception, no such instructions for use are needed for devices in Class I or Ha if they can be used safely without any such instructions. 13.2. Where appropriate, this information should take the form of symbols. Any symbol or identification colour used must conform to the harmonized standards. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device. 13.3. The label must bear the following particulars: (a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of either the person responsible referred to in Article 14 (2 ) or of the authorized representative of the manufacturer established within the Community or of the importer established within the Community, as appropriate; (b) the details strictly necessary for the user to identify the device and the contents of the packaging; (c) where appropriate, the word 'STERILE'; (d) where appropriate, the batch code, preceded by the word 'LOT', or the serial number; (e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month; (f) where appropriate, an indication that the device is for single use; (g) if the device is costum-made, the words 'custom-made device'; (h) if the device is intended for clinical investigations, the words 'exclusively for clinical investigations'; (i) any special storage and/or handling conditions; (j ) any special operating instructions; (k) any warnings and/or precautions to take; (1) year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial number; (m) where applicable, method of sterilization. 13.4.