6.3. The notified body must audit the quality system to determine whether it meets the requirements referred to in section 3.2. At the time of such visits, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly. Article 13 Particular health monitoring measures. Committee on Standards and Technical Regulations, The Commission shall be assisted by the Committee set up by Article 5 of Directive 98/34/EC (hereinafter referred to as, Where reference is made to this Article, Articles 3 and 7 of Decision 1999/468/EC. Where, after such consultation, the Commission finds that:- the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6; where the measure referred to in paragraph 1 is attributed to problems related to the contents or to the application of the common technical specifications, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 7(1) within two months,- the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative.3. After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which appropriate measures, including possible withdrawal, have been taken or are contemplated.4. The Commission shall assign identification numbers to these bodies, hereinafter referred to as ‘notified bodies’. Devices must be designed and manufactured in such a way as to facilitate the management of safe waste disposal.3.6. The applicant shall make a 'type` available to the notified body. - the manufacturing processes and systematic quality control of production. The Commission shall enter into consultation with the parties concerned as soon as possible. The provision of Annex IV, section 5, shall apply. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devicescannot be marketed or put into service until they have been made to comply. Use this menu to access essential accompanying documents and information for this legislation item. - the documentation on the quality system. - the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative. The procedures for implementing this Article and in particular those referring to the notification and the concept of significant change shall be adopted in accordance with the procedure referred to in Article 7. Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption . For devices imported into the Community with a view to their distribution in the Community, the label, the outer packaging, or the instructions for use shall contain in addition the name and address of the authorised representative of the manufacturer; the details strictly necessary for the user to uniquely identify the device and the contents of the packaging; where appropriate, the word ‘STERILE’ or a statement indicating any special microbiological state or state of cleanliness; the batch code, preceded by the word ‘LOT’, or the serial number; if necessary, an indication of the date by which the device or part of it should be used, in safety, without degradation of performance, expressed as the year, the month and, where relevant, the day, in that order; in case of devices for performance evaluation, the words ‘for performance evaluation only’; where appropriate, a statement indicating the in vitro use of the device; any particular storage and/or handling conditions; where applicable, any particular operating instructions; appropriate warnings and/or precautions to take; if the device is intended for self-testing, that fact must be clearly stated. adequate information on the device or device category covered by the procedure. It must presume that quality systems which implement the relevant harmonised standards conform to the requirements. When carrying out statistical verification according to section 6, the notified body has to decide when statistical procedures for lot-by-lot inspection or isolated lot inspection have to be applied. Other notified bodies may obtain a copy of the EC type-examination certificates and/or the supplements thereto. In vitro diagnostic medical devices (IVDs) are subject to the European Directive 98/79/EC (IVDD). Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced.Article 17 Wrongly affixed CE marking 1. 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 and maintained correctly.6.4. 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.2. the documentation described in section 3 needed to assess the conformity of the representative sample of the production in question, hereinafter referred to as the ‘type’, with the requirements of this Directive. Where, in this Directive, reference is made to harmonised standards, this is also meant to refer to the common technical specifications. Devices shall be designed, manufactured and packaged in such a way that exposure of users and other persons to the emitted radiation is minimised. It must include in particular: The manufacturer shall take necessary measures to ensure that the manufacturing process follows the principles of quality assurance as appropriate for the products manufactured. - reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies. [F1Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission ( OJ L 184, 17.7.1999, p. 23 ).]. In the event of frequent rejection of batches, the notified body may suspend the statistical verification. 2.Data shall be forwarded in a standardised format. Where those measures concern matters referred to in point (b), they shall be adopted in accordance with the regulatory procedure referred to in Article 7(2). 2.1. 6.The manufacturer may instruct his authorised representative to initiate the procedures provided for in Annexes III, V, VI and VIII. If the batch is rejected the competent notified body must take appropriate measures to prevent the batch from being placed on the market. 4. Decisions taken by the notified bodies in accordance with Annexes III, IV, and V shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of up to five years. EC verification is the procedure whereby the manufacturer or his authorised representative ensures and declares that the products which have been subject to the procedure set out in section 4 conform to the type described in the EC type-examination certificate and meet the requirements of this Directive which apply to them. - the various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. 2. 1. The annexes to the certificates must be available to the other notified bodies on reasoned application, after the manufacturer has been informed. On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 7(4).]. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devicescannot be marketed or put into service until they have been made to comply. It shall also make available, on request, all additional relevant information.6. After a stepwise introductory period offive years it will come into full power for placing on the marketby December 7, 2003 with all its rules and amendments. The manufacturer shall inform the notified body without delay if it has obtained information about changes to the pathogen and markers of infections to be tested, in particular as a consequence of biological complexity and variability. The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes III to VII and for which it has been notified, whether these tasks are carried out by the body itself or on its responsibility. “Specimen receptacles” are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. In as far as the conduct of examinations and tests on a statistical basis is not appropriate, examinations and tests may be carried out on a random basis provided that such procedure in conjunction with the measures taken in accordance with section 2.2 ensures an equivalent level of conformity. The design must allow easy handling and, where necessary, reduce as far as possible contamination of, and leakage from, the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to: (a)failure to meet the essential requirements referred to in Article 3; (b)incorrect application of the standards referred to in Article 5, insofar as it is claimed that the standards have been applied; (c)shortcomings in the standards themselves. - the details of any further procedure or handling needed before the device can be used (for example, reconstitution, incubation, dilution, instrument checks, etc.). 5. Such decision must be taken in consultation with the manufacturer. CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). When devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must as far as possible be: - designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation emitted can be controlled and/or adjusted. Results from selected external quality assessment (EQA) schemes between 1993 and 2008. reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B. reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA. After exit day there will be three versions of this legislation to consult for different purposes. F1 Where, after such consultation, the Commission finds that: - the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6; where the measure referred to in paragraph 1 is attributed to problems related to the contents or to the application of the common technical specifications, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 7(1) within two months. The manufacturer shall carry out the required controls and tests according to the latest state of the art. the information provided must include a statement clearly directing that the user should not take any decision of medical relevance without first consulting his or her medical practitioner. 1. This includes the availability of sufficient scientific staff within the organisation who possess adequate experience and knowledge necessary to assess the biological and medical functionality and performance of devices for which it has been notified, in relation to the requirements of this Directive and, in particular, with Annex I requirements. - a statement that the device in question conforms to the requirements of the Directive, apart from the aspects covered by the evaluation and apart from those specifically itemised in the statement, and that every precaution has been taken to protect the health and safety of the patient, user and other persons. After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which appropriate measures, including possible withdrawal, have been taken or are contemplated. The notified body must also have access to the equipment necessary for the verifications required. 5.3. 2.The provisions stated in paragraph 1 shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive. 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. The notified body shall inform the other notified bodies and the competent authority about all certificates suspended or withdrawn and, on request, about certificates issued or refused. satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections. The provisions of Annex IV, section 5, shall apply accordingly in relation to the abovementioned approved procedures. The Member State shall inform the other Member States and the Commission.7. Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1). 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.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.The Commission shall take the utmost account of the opinion delivered by the committee. - the name and address of the manufacturer and any additional manufacturing site covered by the quality system. Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication, on the labelling of certain foodstuffsproduced from genetically modified organisms, of particulars other than thoseprovided for in Directive 79/112/EEC. Acting in accordance with the procedure laid down in Article 189b of the Treaty(3). The Commission shall, whenever possible, consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures in accordance with the procedure referred to in Article 7(2).`. Inserted by Corrigendum to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Official Journal of the European Communities L 331 of 7 December 1998). 6. Once adopted, the new regulation will replace the EU’s Directive on in … 1. Decisions taken by the notified bodies in accordance with Annexes III, IV, and V shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of up to five years.11. the organisational structure and responsibilities. 3.6. This provision does not affect national regulations relating to the ethical aspects of carrying out performance evaluation studies using tissues or substances of human origin. Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. 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 symbol and identification colour used must conform to the harmonised standards. Official Journal L 331 , 07/12/1998 P. 0001 - 0037. The manufacturer shall 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 actions, taking account of the nature and risks in relation to the product. the details of any further procedure or handling needed before the device can be used (for example, reconstitution, incubation, dilution, instrument checks, etc.). In this case, the particulars of these directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such devices. It shall immediately inform the other Member States and the Commission of any withdrawal of notification or any restriction placed on it.4. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The controls and tests shall cover the manufacturing process including the characterisation of the raw material and the individual devices or each batch of devices manufactured. Without prejudice to national law and practice on medical secrecy, Member States shall ensure that all the parties involved in the application of this Directive are bound to observe confidentiality with regard to information obtained in carrying out their tasks. In this connection, the manufacturer shall inform the notified body whether any such change is likely to affect the performance of the in vitro device concerned.6.1. For all devices referred to in List B in Annex II other than those intended for performance evaluation, the manufacturer shall for the purposes of affixing the CE marking, follow either: the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance) or. The certificate shall contain the conclusions of the examination, the conditions of validity, the data needed for identification of the approved design and, where appropriate, a description of the intended purpose of the product. For the purposes of this Directive, calibration and control materials refer to any substance, material or article intended by their manufacturer either to establish measurement relationships or to verify the performance characteristics of a device in conjunction with the intended use of that device.4. They must be suitable to withstand stresses inherent in the foreseen working environment, and to retain this resistance during the expected life of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer.Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means must be incorporated.Any guards or other means included with the device to provide protection, in particular against moving parts, must be secure and must not interfere with access for the normal operation of the device, or restrict routine maintenance of the device as intended by the manufacturer.6.4.2. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. - all documentation and undertakings referred to in Annex IV, section 3.1, and. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices This document comes with our free Notification Service, good for … EC Directive 98/79/EC (hereafter abbreviated as 98/79/EC) represents a robust and workable regulatory framework based on ISO 13485 for quality system compliance. For the purposes of this Article, a device is ‘new’ if: (a)there has been no such device continuously available on the Community market during the previous three years for the relevant analyte or other parameter; (b)the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Community market during the previous three years. Turning this feature on will show extra navigation options to go to these specific points in time. 74–79) For the purposes of this Directive, the removal, collection and use of tissues, cells and substances of human origin shall be governed, in relation to ethics, by the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine and by any Member States regulations on this matter. If the type conforms to the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. The devices must be designed, manufactured and packed in such a way as to reduce as far as possible the risk posed by product leakage, contaminants and residues to the persons involved in the transport, storage and use of the devices, taking account of the intended purpose of the products.2. Requirements for devices for self-testing. This does not affect the right of Member State to subject such activities to appropriate protection requirements. 7.This Directive is a specific directive within the meaning of Article 2(2) of Directive 89/336/EEC, which shall cease to apply to devices which have complied with this Directive. an evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of the evaluation and number of devices concerned. the details referred to in section 8.4 with the exception of points (d) and (e); composition of the reagent product by nature and amount or concentration of the active ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the device contains other ingredients which might influence the measurement; the storage conditions and shelf life following the first opening of the primary container, together with the storage conditions and stability of working reagents; the performances referred to in section 3 of part A; an indication of any special equipment required including information necessary for the identification of that special equipment for proper use; the type of specimen to be used, any special conditions of collection, pre-treatment and, if necessary, storage conditions and instructions for the preparation of the patient; a detailed description of the procedure to be followed in using the device; the measurement procedure to be followed with the device including as appropriate: the specific analytical performance characteristics (e.g. At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. It must include the documents needed to assess whether the device conforms to the requirements of this Directive, as referred to in section 3.2(c). It must contain the conclusions of the inspection and a reasoned assessment. It shall also make available, on request, all additional relevant information. By way of derogation from paragraphs 1 to 4, the competent authorities may authorise, 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 to 4 have not been carried out and the use of which is in the interest of protection of health.13. It shall immediately inform the other Member States and the Commission of any withdrawal of notification or any restriction placed on it. Member States shall apply continual surveillance of notified bodies to ensure ongoing compliance with the criteria set out in Annex IX. the starting date and scheduled duration for the evaluations and, in the case of devices for self-testing, the location and number of lay persons involved. 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