Directive as last amended by Directive 92/31/EEC (OJ No L 126, 12. 8. Every product is examined individually and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out in order to verify, where appropriate, the conformity of the products with the EC type described in the type-examination certificate and with the requirements of the Directive which apply to them. Medical Device Directives . In addition, for products placed on the market in sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer must apply the provisions of Annex V, Sections 3 and 4. Requirements for medical devices connected to or equipped with an energy source 12.1. 2. 13.6. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The application must describe the design, manufacture and performances of the product in question. The manufacturer must allow the notified body access for inspection purposes to the inspection, testing and storage locations and supply it with all relevant information, in particular: - the documentation on the quality system, - the technical documentation, - the quality records, such as inspection reports, test data, calibration data, qualification reports of the staff concerned, etc. 2.2. 4. It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. (6) OJ No C 136, 4. 12.8. - where appropriate, the technical documentation on the types approved and a copy of the EC type-examination certificates. After receiving the abovementioned information it must notify the manufacturer of its decision. The manufacturer must, for a period ending at least five years after the last product has been manufactured, make available to the national authorities: - the declaration of conformity, - the documentation referred to in the seventh indent of Section 3.1, - the changes referred to in Section 3.4, - the decisions and reports from the notified body as referred to in the final indent of Section 3.4 and in Sections 4.3 and 4.4, - where appropriate, the certificate of conformity referred to in Annex III. 2.3.7. 1. 3. (19) This Directive was notified to the Member States on 29 June 1993. This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results. The applicant shall inform the notified body which issued the EC design-examination certificate of any such changes made to the approved design. Because of the many types of devices covered by the MDD, the specific requirements depend on the classification and intended use of the device. Construction and environmental properties 9.1. The manufacturer must prepare the technical documentation described in Section 3. 4. 4. 1976, p. 139. 4.3. This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results. As regards the declaration based on this Annex, the manufacturer must ensure and declare that the product design meets the provisions of this Directive which apply to it. In the event of frequent rejection of batches, the notified body may suspend the statistical verification. It must presume that quality systems which implement the relevant harmonized standards conform to these requirements. 4.2. Such devices shall be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters. Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class IIb. 13.5. Normally intended for continuous use for less than 60 minutes. (1) OJ No L 39, 15. 2. Article 21 Repeal and amendment of Directives 1. 4. The Commission shall enter into consultation with the parties concerned as soon as possible. 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. A random sample is taken from each batch. Clinical investigations 2.1. Instructions 11.4.1. 6. 7. Where a Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. - the test reports and, where appropriate, clinical data in accordance with Annex X. 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. (14) OJ No L 380, 31. 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. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them: (i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; (ii) any technical or medical reason connected with the characteristics or performance of a device leading for the reasons referred to in subparagraph (i) to systematic recall of devices of the same type by the manufacturer. 6. '; 'In the event of a decision as referred to in the previous paragraph the manufacturer, or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measures to be taken.'. The notified body must affix, or have affixed its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out. It shall include in particular an adequate description of: (a) the manufacturer's quality objectives; (b) the organization of the business and in particular: - the organizational structures, the responsibilities of the managerial staff and their organizational authority where quality of design and manufacture of the products is concerned, - the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of design and of product, including control of products which fail to conform; (c) the procedures for monitoring and verifying the design of the products and in particular: - a general description of the product, including any variants planned, - the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full, - the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed, - if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer, - a statement indicating whether or not the device incorporates, as an integral part, a substance as referred to in Section 7.4 of Annex I and data on the tests conducted in this connection, - the clinical data referred to in Annex X, - the draft label and, where appropriate, instructions for use; (d) the inspection and quality assurance techniques at the manufacturing stage and in particular: - the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents, - the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture; (e) the appropriate tests and trials which will be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible to trace back the calibration of the test equipment adequately. ANNEX I. 18). They cover: Active implantable medical devices; In vitro diagnostic products ‘General’ medical devices (the great majority of products) This legislation is implemented and enforced in each EU member state by a Competent Authority. In Article 2 of Directive 84/539/EEC, the following subparagraph is added to paragraph 1: 'If the appliance is at the same time a medical device within the meaning of Directive 93/42/EEC (*) and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this Directive. (11) OJ No L 183, 29. 12.9. 1989, p. 12.4. Die Richtlinie 93/42/EWG des Rates vom 14. 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. An invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation. Verification by examination and testing of every product. Rule 3 All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa. MEDICAL DEVICES DIRECTIVE (93/42/EEC) Try it for free on: https://ce-marking.help. These persons shall inform the competent authorities of the Member State in which they have their registered place of business of the address of the registered place of business and the category of devices concerned. 8. Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. It must presume that quality systems which implement the relevant harmonized standards conform to these requirements. 1984, p. 179. 8.5. 5. L169, July 12, 1993. 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. 1.3. 6. Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to substances which could cause combustion. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation. 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. - in the case of products placed on the market in a sterile condition, description of the methods used. All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III except where such devices are intended to come into contact with intact skin only. 6.1. The notified body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. The manufacturer or his authorized representative established in the Community shall keep the report referred to in point 2.3.7 of Annex X at the disposal of the competent authorities. - the particular features of the device as specified in the relevant medical prescription. 6. 7.6. 9. The notified body must make available to the other notified bodies, on request, all relevant information concerning the quality system approvals issued, refused or withdrawn. It must notify the manufacturer of its decision. This minimum dimension may be waived for small-scale devices. The manufacturer must affix the CE marking in accordance with Article 17 and draw up a declaration of conformity. The applicant shall inform the notified body which issued the EC design-examination certificate of any such changes made to the approved design. 6.2. By derogation from other rules, blood bags are in Class IIb. All surgically invasive devices intended for transient use are in Class IIa unless they are: - intended specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III. Statistical control of products will be based on attributes, entailing a sampling system ensuring a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity percentage of between 3 and 7 %. This declaration must cover a given number of the products manufactured and be kept by the manufacturer. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. This does not affect the obligation of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote. For a manufacturer to legally place a medical device on the European market the requirements of the Directive have to be met and a CE mark applied. 5. 3. 2.3.5. 11.3. - 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. This Directive shall apply to medical devices and their accessories. 9. 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. 5. Commission communication 2017/C 389/03 repealed by Commission Implementing Decision (EU) 2020/437 of 24 March 2020: Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices - OJ C 389 of 17 November 2017, Internal Market, Industry, Entrepreneurship and SMEs, Electrical and Electronic Engineering Industries, Raw materials, metals, minerals and forest-based industries, Textiles, Fashion and Creative Industries, Accreditation of conformity assessment bodies, Simplification of 8 legal metrology directives, Free movement in harmonised and non-harmonised sectors, Enforcement of Single Market for Goods rules, International aspects of the single market, European single procurement document and eCertis, Emerging technologies in public procurement, Public procurement of innovative products and services, Enlargement and European Neighborhood Policy, Bilateral relations with non-EU countries, Recognition of professional qualifications in practice, Recognition based on professional experience, Professions falling under specific legislation, Transparency and mutual evaluation of regulated professions, CP-DS: Legislation on substances in construction products, EDEN - European Destinations of Excellence, European Sustainable Chemicals Support - Self Assessment Tool, Noise emissions for outdoor equipment - Database, Public procurement - ex-ante assessment of large infrastructure projects, Small Business Act - database of good practices, Guidelines related to medical devices directives. Accessories are classified in their own right separately from the device with which they are used. Definitions for the classification rules 1.1. 1. Where one or more of the samples fails to conform, the notified body must take the appropriate measures. - the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established within the Community. Where devices are supplied with the intention that they be sterilized before use, the instructions for cleaning and sterilization must be such that, if correctly followed, the device will still comply with the requirements in Section I; (i) details of any further treatment or handling needed before the device can be used (for example, sterilization, final assembly, etc. 4. - to replace an epithelial surface or the surface of the eye. The notified body must make available to the other notified bodies, on request, all relevant information concerning the quality system approvals issued, refused or withdrawn. Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices; (e) 'device intended for clinical investigation' means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment. 9. Invasive devices Invasive device A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. 9.3. Rule 12 All other active devices are in Class I. All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in Class IIb. 5. 6. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION 7. When neither the manufacturer nor his authorized representative is established in the Community, the obligation to keep available the technical documentation shall fall to the person responsible for placing the device on the Community market or the importer referred to in Annex I, Section 13.3 (a). 1983, p. 8. It must contain the conclusions of the inspection and a reasoned assessment. All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class IIa, unless this is done in a manner: - that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb. All the data must remain confidential, in accordance with the provisions of Article 20. - a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full. 5. 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. 12.8. Should the notified body subcontract specific tasks connected with the establishment and verification of the facts, it must first ensure that the subcontractor meets the provisions of the Directive and, in particular, of this Annex. 2.3. 1. Insert free text, CELEX number or descriptors. Statistical control of products will be based on attributes, entailing a sampling system ensuring a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity percentage of between 3 and 7 %. ); (j) in the case of devices emitting radiation for medical purposes, details of the nature, type, intensity and distribution of this radiation. COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devicesTHE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas measures should be adopted in the context of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics of medical devices are different; whereas the certification and inspection procedures for such devices differ from one Member State to another; whereas such disparities constitute barriers to trade within the Community; Whereas the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized in order to guarantee the free movement of such devices within the internal market; Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to implement the abovementioned measures provided Community law is complied with; Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive; Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (4); whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; whereas if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (5); Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to 'minimizing' or 'reducing' risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety; Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization (6), rules regarding the design and manufacture of medical devices must be confined to the provisions required to meet the essential requirements; whereas, because they are essential, such requirements should replace the corresponding national provisions; whereas the essential requirements should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety; Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (7) is the first case of application of the new approach to the field of medical devices; whereas in the interest of uniform Community rules applicable to all medical devices, this Directive is based largely on the provisions of Directive 90/385/EEC; whereas for the same reasons Directive 90/385/EEC must be amended to insert the general provisions laid down in this Directive; Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas this Directive should contain specific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (8); Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the authorization required by Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation (9), nor application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment (10); whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (11) and the specific directives on the same subject should continue to apply; Whereas, in order to demonstrate conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; whereas such harmonized European standards are drawn up by private-law bodies and should retain their status as non-mandatory texts; whereas, to this end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984; Whereas, for the purpose of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (12), and pursuant to the abovementioned general guidelines; whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the measures to be taken must be defined in line with procedure I, as laid down in Council Decision 87/373/EEC (13); whereas, for specific fields, what already exists in the form of European Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovementioned harmonized standards; Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives (14), the Council has laid down harmonized conformity assessment procedures; whereas the application of these modules to medical devices enables the responsibility of manufacturers and notified bodies to be determined during conformity assessment procedures on the basis of the type of devices concerned; whereas the details added to these modules are justified by the nature of the verification required for medical devices; Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market; Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose; Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose; Whereas, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16 May 1989 regarding future activities on AIDS prevention and control at Community level (15), medical devices used for protection against the HIV virus must afford a high level of protection; whereas the design and manufacture of such products should be verified by a notified body; Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of the diverse nature of the devices and technological progress in this field, steps must be taken to include amongst the implementing powers conferred on the Commission the decisions to be taken with regard to the proper classification or reclassification of the devices or, where appropriate, the adjustment of the classification rules themselves; whereas since these issues are closely connected with the protection of health, it is appropriate that these decisions should come under procedure IIIa, as provided for in Directive 87/373/EEC; Whereas the confirmation of complicance with the essential requirements may mean that clinical investigations have to be carried out under the responsibility of the manufacturer; whereas, for the purpose of carrying out the clinical investigations, appropriate means have to be specified for the protection of public health and public order; Whereas the protection of health and the associated controls may be made more effective by means of medical device vigilance systems which are integrated at Community level; Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometers (16); whereas the abovementioned Directive must therefore be repealed; whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine (17) must be amended, HAS ADOPTED THIS DIRECTIVE: Article 1 Definitions, scope 1. 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