1990, p. Notified bodies shall retain information on the geographical origin of the animals. 8. 1.1. 2. The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. All adverse incidents such as those specified in Article 10 must be fully recorded and notified to the competent authority. 1. - the name of the medical practitioner or other authorized person who made out the prescription and, where applicable, the name of the clinic concerned. 1976, p. 169. Any decision taken pursuant to this Directive: (a) to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations; or (b) to withdraw devices from the market, shall state the exact grounds on which it is based. - the results of the design calculations, risk analysis, investigations, technical tests, etc. In the event of a dispute between the manufacturer and the notified body concerned, resulting from the application of the classification rules, the matter shall be referred for decision to the competent authority to which the notified body is subject. Devices intended to be sterilized must be manufactured in appropriately controlled (e. g. environmental) conditions. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving a Class I, IIa, IIb or III device is recorded and evaluated centrally: (a) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; (b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer. 5. The Commission shall be assisted by the Committee set up by Article 6 (2) of Directive 90/385/EEC. Quality system 3.1. 3. EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative sample of the production covered fulfils the relevant provisions of this Directive. In addition, Class IIb devices must be reviewed by a notified body as required under the directive. In the case of devices falling within Class IIb, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either: (a) follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); in this case, point 4 of Annex II is not applicable; or. Because of the many types of devices covered by the MDD, the specific requirements depend on the classification and intended use of the device. - if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues. 6. Duration Transient Normally intended for continuous use for less than 60 minutes. 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. However, in most cases, the use of an EU Notified Body is required to assess compli… 3. Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). - satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections. Article 21 Repeal and amendment of Directives 1. 9. 1.5. Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which can be reused after appropriate procedures have been carried out. 13.5. Devices must be fitted with the means of preventing and/or indicating any inadequacies in the flow-rate which could pose a danger. 5. The certificate must contain the conclusions of the examination, the conditions of validity, the data needed for identification of the approved design, where appropriate, a description of the intended purpose of the product. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) … 7.2. 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). - if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb. 11.3. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonized standards shall be presumed to meet the relevant criteria. Article 23 This Directive is addressed to the Member States. All the appropriate features, including those involving the safety and performances of the device, and its effect on patients must be examined. Clinical investigations must be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims for the device; these investigations must include an adequate number of observations to guarantee the scientific validity of the conclusions. (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); (iii) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance). 12.3. 1.2. The Medical Devices Directive 93/42/EEC defines safety and performance requirements for medical equipment sold in the European Union. 12.2. 3.4. COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. 6.2. 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. The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action. 3. 1989, p. 19. Rule 8 All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended: - to be placed in the teeth, in which case they are in Class IIa, - to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III, - to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III, - or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III. 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. The manufacturer must ensure application of the quality system approved for the final inspection and testing of the product, as specified in Section 3 and must be subject to the surveillance referred to in Section 4. The Member States shall notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 11 and the specific tasks for which the bodies have been designated. Clinical investigations must be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims for the device; these investigations must include an adequate number of observations to guarantee the scientific validity of the conclusions. In deciding whether a product falls under that Directive or the present Directive, particular account shall be taken of the principal intended purpose of the product. 1.4. 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. 1. 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. 12.7.2. EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative sample of the production covered fulfils the relevant provisions of this Directive. They shall be accompanied by the information referred to in point 13 of Annex I which includes, where appropriate, the information supplied by the manufacturers of the devices which have been put together. 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. (12) OJ No L 109, 26. Medical Device Directives . International spricht man von der Richtlinie als Medical Device Directive (MDD), oder Directive 93/42/EEC. Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure. Since 1 December 2018 the references of harmonised standards are published in, and withdrawn from the Official Journal of the European Union by means of 'Commission implementing decisions'. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. 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. 4.4. 6. The Commission shall be assisted by the Committee set up by Article 5 of Directive 83/189/EEC. 2. 1992, p. 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. 7. The application allows you to: Compose in few minutes declaration of conformity compliant with applicable directives; Search for a standard … These measures shall be adopted in accordance with the procedure referred to in Article 7 (2) of Directive 93/42/EEC (*). (19) This Directive was notified to the Member States on 29 June 1993. 33. Such decisions shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the national law in force in the Member State in question and of the time limits to which such remedies are subject. 7. 1. (ii) any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) above leading to a systematic recall of devices of the same type by the manufacturer. The decision must be notified to the manufacturer after the final inspection and contain the conclusions of the inspection and a reasoned assessment. 1. Every product is examined individually and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out in order to verify, where appropriate, the conformity of the products with the EC type described in the type-examination certificate and with the requirements of the Directive which apply to them. Verification by examination and testing of every product. Rule 16 Non-active devices specifically intended for recording of X-ray diagnostic images are in Class IIa. To this end, an adequate sample of the final products, taken on site by the notified body, must be examined and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out. 4.4. 3.2. In the case of custom-made devices, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before placing each device on the market. Committee on Standards and Technical Regulations. It must notify the manufacturer of its decision. 1983, p. 8. 5. 3. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. 1992, p. EU-Directives. 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. Rule 14 All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb, unless they are implantable or long term invasive devices, in which case they are in Class III. Devices shall be divided into Classes I, IIa, IIb and III. 6.3. Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so as to provide optimal security. 1989, p. 28). Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 65/65/EEC, that device shall be governed by the present Directive, without prejudice to the provisions of Directive 65/65/EEC with regard to the medicinal product. 4.3. If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. By derogation from paragraphs 1 and 2 the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 and 2 have not been carried out and the use of which is in the interest of protection of health. 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. In addition, the notified body may pay unannounced visits to the manufacturer. GENERAL REQUIREMENTS 1. 8. 1. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. 9. 3.3. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION 7. 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. It must contain the conclusions of the inspection and a reasoned assessment. 8.2. ; (m) adequate information regarding the medicinal product or products which the device in question is designed to administer, including any limitations in the choice of substances to be delivered; (n) precautions to be taken against any special, unusual risks related to the disposal of the device; (o) medicinal substances incorporated into the device as an integral part in accordance with Section 7.4; (p) degree of accuracy claimed for devices with a measuring function. - 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. 5.3. - the name and address of the manufacturer and the name and address of the authorized representative if the application is lodged by the representative. Devices where the safety of the patients depends on an external power supply must include an alarm system to signal any power failure. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes. Devices with a measuring function 10.1. 8. 7.5. 7.3. 1.3. Directive as last amended by Directive 84/414/EEC (OJ No L 228, 25. 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. (10) OJ No L 265, 5. All the elements, requirements and provisions adopted by the manufacturer for his quality system must be documented in a systematic and orderly manner in the form of written policy statements and procedures. 1989, p. 3. 1993. (a) application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices; (b) a given device or family of devices should be classified, by way of derogation from the provisions of Annex IX, in another class; (c) the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 11, by applying solely one of the given procedures chosen from among those referred to in Article 11. it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. 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