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Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 9 for conformity assessment take account of any relevant information regarding the characteristics and performance of such devices, including in particular the results of any relevant test and verification already carried out under pre-existing national law, regulations or administrative provisions in respect of such devices. The authorised representative shall notify the competent authorities of the Member State in which he has his registered place of business of all particulars as referred to in paragraph 1. The notified body and its staff must carry out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of the verifications. Article 9 The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. A subgroup of medical products, their market access, use, and market surveillance is regulated. 2. The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the Page 4/10 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. International spricht man von der Richtlinie als In-vitro Diagnostic Directive (IVDD) oder Directive 98/79/EC. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. Title: CL1998L0079EN0030010.0001.3bi_cp 1..1 Author: Publications Office Created Date: 1/23/2012 11:04:05 PM 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. 2. (d) the following Articles shall be inserted: 1. ANNEX VI - EC VERIFICATION 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. Any risks which may be associated with their use must be acceptable when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety. 8.5. The references published under Directive 98/79/EC on in vitro diagnostic medical devices are found in Commission Implementing Decision (EU) 2020/439 of 24 March 2020 (OJ L 90I , 25 March 2020) listed below. The manufacturer must ensure application of the quality system approved for the design, manufacture and final inspection of the devices concerned, as specified in section 3, and is subject to audit as laid down in section 3.3 and to the surveillance as specified in section 5. 6. 7. The manufacturer must authorise the notified body to carry out all the necessary inspections and supply it with all relevant information, in particular: - the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculation, tests, etc.. - the data stipulated in the part of the quality system relating to manufacture, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc. ANNEX IX 1.2. The market access, use, and market surveillance of in vitro diagnostic medical devices are subject and regulated by the European Directive 98/79/EC (IVDD). The provision of Annex IV, section 5, shall apply. Once adopted, the new regulation will replace the EU’s Directive on in vitro diagnostic medical devices (98/79/EC). Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;´. 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). diagnosis, prevention, monitoring, treatment or alleviation of disease. The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which conform to the type described in the EC type-examination certificate and the requirements of the Directive which apply to them. - specific particulars may be omitted provided that the other information supplied by the manufacturer is sufficient to enable the user to use the device and to understand the result(s) produced by the device. - the documentation of the quality system. 8.1. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. taking account of the instructions and information provided by the manufacturer. As an IVD Notified Body our product experts can help you with the regulatory process. 5. The representative of the Commission shall submit to the committee a draft of the measures to be taken. 4. If the batch is rejected the competent notified body must take appropriate measures to prevent the batch from being placed on the market. The devices must be designed and manufactured in such a way that they are suitable for the purposes referred to in Article 1(2)(b), as specified by the manufacturer, taking account of the generally acknowledged state of the art. 3. Where possible, such devices must include a user control which allows verification of correct performance at the time of use. Article 23 - Publication 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. For an additional period of two years, the said devices may be put into service. 3.2. Verification of manufactured products covered by Annex II, List A. Where, in this Directive, reference is made to harmonised standards, this is also meant to refer to the common technical specifications. 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. 2. The Commission shall take the utmost account of the opinion delivered by the committee. - the documentation on the quality system. If the type conforms to the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer. The European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD), ... schemes and other measures intended to improve the reliability of the test results, but would be more difficult to implement in many point-of-care settings. In testing the devices covered by Annex II, List A, the manufacturer shall take into account the most recent available information, in particular as regards the biological complexity and variability of the specimens to be tested with the in vitro device concerned. Application of the quality system must ensure that the devices conform to the type described in the EC type-examination certificate. 2. - an evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of the evaluation and number of devices concerned. ANNEX VII This Directive shall apply to in vitro diagnostic medical devices and their accessories. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions of validity and the data needed for identification of the type approved. ANNEX X - CE MARKING OF CONFORMITY, [[{"type":"media","fid":"328","view_mode":"media_large","instance_fields":"override"}]] Back to top. Ab jetzt bestellbar. 3. 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. It shall inform the committee of the manner in which its opinion has been taken into account. Placing on the market and putting into service. mdi Europa guides you through the entire process and assists to optimize your compliance program to meet your product specifications and business needs. 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. 3. In vitro diagnostic medical devices (IVDs) are subject to the European Directive 98/79/EC (IVDD). The annexes to the certificates must be available to the other notified bodies on reasoned application, after the manufacturer has been informed. 2. A. - the information to be provided with the device on its label and its instructions for use. The European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD), became operational in June 2000. 2.4. 1. During the conformity assessment procedure for a device, the manufacturer and, if involved, the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate state of manufacture. 4.1. 5. Having regard to the opinion of the Economic and Social Committee (2), 1. The chairman shall not vote. Accessible parts of the devices (excluding the parts of areas intended to supply heat or reach given temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use. Devices labelled either as ‘STERILE´ or as having a special microbiological state must be designed, manufactured and packed in an appropriate pack, according to procedures suitable for ensuring that they remain in the appropriate microbiological state indicated on the label when placed on the market, under the storage and transport conditions specified by the manufacturer, until the protective packaging is damaged or opened. 6.1. - the indication whether any particular training is required; (i) the mathematical approach upon which the calculation of the analytical result is made; (j) measures to be taken in the event of changes in the analytical performance of the device; - internal quality control including specific validation procedures. We herewith declare that the above mentioned - all documentation and undertakings referred to in Annex IV, section 3.1, and. (PRODUCTION QUALITY ASSURANCE). 1. Such decision must be taken in consultation with the manufacturer. The Commission shall be assisted by the committee set up by Article 5 of Directive 98/34/EC. Verification by examination and testing of every product. By: Dirk Stynen, PhD The European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD), became operational in June 2000.1 It provides Europe with one single regulation for in vitro diagnostics (IVD). 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).'. 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. 8. The CE marking shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes III, IV, VI and VII. It is separate from the Medical Device Directive with its own dedicated set of requirements for manufacturers wishing to place medical devices in the European Economic Area. Obtain Regulatory Approvals for EU Market Access for IVDD 98/79/EC. Health and Consumers Health and Consumers Revision of the IVD Directive: IVD specific issues 3. (b) Article 2 shall be replaced by the following: Placing on the market and putting into service, 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.´. 1. The Member States may take the measures referred to in Article 15 as from the entry force of this Directive. In addition, the manufacturer must follow, for devices covered by Annex II, List A, the procedures laid down in sections 4 and 6. (ii) the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance). It is separate from the Medical Device Directive with its own dedicated set of requirements for manufacturers wishing to place in vitro diagnostic medical devices in the European Economic Area. It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. Article 9 - Conformity assessment procedures Instead of applying this procedure, the manufacturer may follow the procedure referred to in paragraphs 2 or 3. The information and instructions provided by the manufacturer should be easily understood and applied by the user. 6.    A. Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. All products in the batch may be put on the market except any in the sample which failed to conform . shall state the exact grounds on which it is based. Use this tool to ensure your in vitro diagnostic medical devices satisfy all the applicable general safety and performance requirements to demonstrate conformity with the IVDR. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. All supporting documentations 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. Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user. According to the IVDD, in vitro diagnostic medical devices include: reagents, reagent products, calibration materials, control materials, kits, instruments, apparatus, equipment, and systems that are intended for use in the examination of specimens taken from the human body (tissue, blood, urine, etc.) Requirements for medical devices connected to or equipped with an energy source 27 7. Where, after such consultation, the Commission finds that: 3. 10: 74. 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. 1. (b) follow the procedure relating to EC type-examination set out in Annex V coupled with the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance). Introduction Cont’d The In Vitro Diagnostics Directive is a substantial document with significant detail. Choose another country to see content specific to your location. Article 18 4. In the case of devices containing or a preparation which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant danger symbols and labelling requirements of Directive 67/548/EEC (1) and Directive 88/379/EEC (2) shall apply. - reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D. - Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd. The records and correspondence relating to the procedures referred to in paragraphs 1 to 4 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. 1. 2. IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. 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. The manufacturer must affix the CE marking in accordance with Article 16. ANNEX IV Devices intended to be sterilised must be manufactured in appropriately controlled (e.g. ANNEX VIII - STATEMENT AND PROCEDURES CONCERNING DEVICES FOR PERFORMANCE EVALUATION Registration of manufacturers and devices. 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. The IVDR provides much more guidance on how to comply with the requirements of the IVDD including incorporating Meddev Guidance Medical Device Manufacturers have a 5-year transition period from the 25th May 2017 to the 26th May 2022 . 6.4.2. EC DECLARATION OF CONFORMITY 6.3. device (98/79/EC article 11). Thus, the suppliers will also be affected by a part of these regulations. The manufacturer shall carry out the required controls and tests according to the latest state of the art. List of devices referred to in this Directive shall not affect national laws the! 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