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Specimen receptacles are considered to be in vitro diagnostic medical devices. The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of a higher order. For devices for performance evaluation the manufacturer or his authorised representative shall draw up the statement containing the information stipulated in section 2 and ensure that the relevant provisions of this Directive are met. 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. 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. This Directive shall not apply to devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity. 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 devices cannot be marketed or put into service until they have been made to comply. In particular, it must have the necessary staff and possess the facilities needed to perform properly the technical and administrative tasks entailed in assessment and verification. (2) OJ C 102, 4.4.1996, p. 1. withdrawn, and on the vigilance procedure; whereas a system of adverse incident reporting (vigilance procedure) constitutes a useful tool for surveillance of the market, including the performance of new devices; whereas information obtained from the vigilance procedure as well as from external quality assessment schemes is useful for decision-making on classification of devices; Whereas it is essential that manufacturers notify the competent authorities of the placing on the market of ‘new products´ with regard both to the technology used and the substances to be analysed or other parameters; whereas this is true in particular of high-density DNA probe devices (known as micro-chips) used in genetic screening; Whereas, when a Member State considers that, as regards a given product or group of products, it is necessary, in order to protect health and safety and/or ensure compliance with the imperatives of public health, in accordance with Article 36 of the Treaty, to prohibit or restrict their availability or to subject it to special conditions, it may take any transitional measures that are necessary and justified; whereas, in such cases, the Commission consults the interested parties and the Member States and, if the national measures are justified, adopts the necessary Community measures, in accordance with procedure III(a) as laid down in Decision 87/373/EEC; Whereas this Directive covers in vitro diagnostic medical devices manufactured from tissues, cells or substances of human origin; whereas it does not refer to the other medical devices manufactured using substances of human origin; whereas, therefore, work will have to continue in this connection in order to produce Community legislation as soon as possible; Whereas, in view of the need to protect the integrity of the human person during the sampling, collection and use of substances derived from the human body, it is appropriate to apply 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; whereas, furthermore, national regulations relating to ethics continue to apply; Whereas, in the interests of overall consistency between directives on medical devices, some of the provisions of this Directive should be incorporated into Directive 93/42/EEC, which needs to be amended accordingly; Whereas it is necessary to draw up as quickly as possible the legislation which is lacking on medical devices manufactured using substances of human origin. (21) Directive 98/79/EC allows the Commission to adopt common technical specifications for specif ic categor ies of in vitro diagnostic medical devices. The other references of standards published in the Commission communication 2017/C 389/04 ... 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). 4. Risk-rule based classification system ... Annex II to Directive 98/79/EC … The notified body must carry out the appropriate examinations and tests taking account of section 2.2 in order to verify the conformity of the product with the requirements of the Directive either by examining and testing every product as specified in section 5 or by examining and testing products on a statistical basis as specified in section 6, as the manufacturer decides. Article 20 ANNEX II - LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3) Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive. Fabio Faraulo. Devices must be designed and manufactured in such a way as to protect the user against mechanical risks. The manufacturer shall also undertake to keep available for the competent national authorities the documentation allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive. It shall also make available, on request, all additional relevant information. Article 1 - Scope, definitions The annexes to the certificates must be available to the other notified bodies on reasoned application, after the manufacturer has been informed. The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed time-frame, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates. Introduction Cont’d The In Vitro Diagnostics Directive is a substantial document with significant detail. 4.2. Devices which meet these standards are given a CE marking and can be used throughout the EU. LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3) Any restrictions on use must be indicated on the label and/or in the instructions for use. - an evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of the evaluation and number of devices concerned. Article 17 - Wrongly affixed CE marking The methods of making such a reference shall be laid down by the Member States. Member States shall take all necessary measures to ensure that the notifications referred to in paragraphs 1 and 3 are registered immediately in the databank described in Article 12. (PRODUCTION QUALITY ASSURANCE). Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. 2. Summarily, amongst other rules, the IVDD prescribes essential requirements of safety, quality and performance for all IVDs in the EU market. He shall notify the competent authorities of the following incidents immediately on learning of them: (i) any malfunction, failure 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, directly or indirectly, might lead to, or might have led to, the death of a patient or user or other persons or to a serious deterioration in his or their state of health; (ii) any technical or medical reason connected with the characteristics or the performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer. The applicant shall inform the notified body which issued the EC design-examination certificate of any significant change made to the approved design. To the extent that for certain aspects the final testing according to section 6.3 is not appropriate, adequate process testing, monitoring and control methods shall be established by the manufacturer with the approval of the notified body. 6.4.3. Article 13 - Particular health monitoring measures Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis. Learn from our experts through live events. The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. Article 16 - CE marking The assessment procedure must include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes. standards in accordance with the general guidelines on cooperation between the Commission and those two bodies signed on 13 November 1984; Whereas, for the purpose of this Directive, a harmonised standard is a technical specification (European standard of harmonisation document) adopted, on a mandate from the Commission, by CEN or Cenelec or by both of those bodies in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (1), and pursuant to the above mentioned general guidelines; Whereas, by way of exception to the general principles, the drawing up of common technical specifications takes account of a current practice in some Member States whereby for selected devices mainly used for the evaluation of the safety of blood supply and of organ donation, such specifications are adopted by the public authorities; whereas it is appropriate that these particular specifications should be replaced by common technical specifications; whereas these common technical specifications can be used for performance evaluation and reevaluation; Whereas scientific experts from various interested parties could be involved in the drafting of common technical specifications and in the examination of other specific or general questions; Whereas manufacturing, as covered by this Directive, also includes the packaging of the medical device, insofar as such packaging is related to the safety and performance aspects of this device; Whereas certain devices have a limited life owing to the decline in their performance over time, which is related, for example, to the deterioriation in their physical or chemical properties, including the sterility or integrity of the packaging; whereas the manufacturer should determine and indicate the period during which the device will perform as intended; whereas the labelling should indicate the(1) OJ L 204, 21.7.1998, p. 37. 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