2.2. (2) OJ C 18, 22.1.1996, p. - the name and address of the manufacturer and any additional manufacturing site covered by the quality system. 1. 1. - reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA. - 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. Where possible, such devices must include a user control which allows verification of correct performance at the time of use. 2. Devices which meet these standards are given a CE marking and can be used throughout the EU. When a measure is to be taken in accordance with paragraph 1, due consideration shall be given to: (a) any relevant information available from the vigilance procedures and from external quality assessment schemes as referred to in Article 11; (i) whether total reliance has to be placed on the result obtained with a given device, this result having a direct impact on subsequent medical action, and, (ii) whether action taken on the basis of an incorrect result obtained using a given device could prove to be hazardous to the patient, to a third party or to the public, in particular as a consequence of false positive or false negative results, and. That’s because under IVDD 98/79/EC, about 80-90% of finished devices are not subject to Notified Body oversight. 15). The declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by section 1 ensures and declares that the devices concerned meet the provisions of this Directive which apply to them. In duly justified and exceptional cases no such instructions for use are needed for a device if it can be used properly and safely without them. A platform of digital products to improve, simplify and automate RA/QA activities, The latest industry news and insights from our global team. 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. in the case of devices covered by Annex II and of devices for self-testing, of all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Annex I, part A. section 3, the outcome of performance evaluation pursuant to Annex VIII, certificates and any significant change thereto, including discontinuation of placing on the market. The IVDD is implemented in the national laws of the member states. The Directive: IVDD 98/79/EC. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. investigation, replacement or modification of the anatomy or of a physiological process, concerning a physiological or pathological state, or, to determine the safety and compatibility with potential recipients, or. For all devices for self-testing other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, prior to the drawing up of the aforementioned declaration of conformity, fulfil the supplementary requirements set out in Annex III, point 6. ANNEX IX The committee referred to in paragraph 1 may examine any question connected with the implementation of this Directive. Devices must be designed and manufactured in such a way as to reduce as far as possible the risks of fire or explosion during normal use and in single fault condition. taking account of the instructions and information provided by the manufacturer. Where the conformity assessment procedure involves intervention of a notified body, the manufacturer, or authorised representative, may apply to a body of his choice within the framework of tasks for which the body has been notified. International spricht man von der Richtlinie als In-vitro Diagnostic Directive (IVDD) oder Directive 98/79/EC. ANNEX X - CE MARKING OF CONFORMITY, [[{"type":"media","fid":"328","view_mode":"media_large","instance_fields":"override"}]] Back to top. to diagnose diseases, to monitor a person’s state of health, or to monitor therapeutic procedures. The IVDD is implemented in the national laws of the member states. Article 18 - Decisions in respect of refusal or restriction 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. 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. The notified body shall, on request, supply all relevant information and documents including budgetary documents, required to enable the Member State to verify compliance with Annex XI requirements.´. 4. 7. 5.2. 1. 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. If the batch is accepted, the notified body affixes, or has affixed its identification number to each product and draws up a written certificate of conformity relating to the tests carried out. Article 19 - Confidentiality - adequate information on the device or device category covered by the procedure. Particular attention must be paid to devices whose intended use includes exposure to or use in association with flammable substances or substances which could cause combustion. In the application of this provision, Member States shall take into account the principle of proportionality and, in particular: (a) whether the information can be supplied by harmonised symbols or recognised codes or other measures; (b) the type of user anticipated for the device. 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. 2. A subgroup of medical products, their market access, use, and market surveillance is regulated. The risk of errors in use or in the interpretation of results must be kept as low as possible. 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. The notified body shall examine the application and, if the design conforms to the relevant provisions of this Directive shall issue the applicant with an EC design-examination certificate. 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. 1.    A. 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. Terminals and connectors to electricity, gas or hydraulic and pneumatic energy supplies which the user has to handle must be designed and manufactured in such a way as to minimise all possible risks. EC DIRECTIVE 98/79/EC ON IVDS – COMPARISON WITH OTHER … They include reagents, calibrators, and controls for the determination of: List B of Annex II contains high-risk products (reagents, calibrators, and controls unless otherwise stated): These devices are subject to special requirements which are described in Annex I, Section 7 of the IVDD. It shall include in particular an adequate description of: (a) the manufacturer's quality objectives; (b) the organisation of the business and in particular: - the organisational structures, the responsibilities of the managerial staff and their organisational authority where quality of design and manufacture of the devices is concerned. Transitionally, pending the establishment of a European databank accessible to the competent authorities of the Member States and containing the data relating to all devices available on the territory of the Community, the manufacturer shall give such notification to the competent authorities of each Member State concerned by the placing on the market. Reference of the standard . The statement shall contain the following information: - data allowing identification of the device in question. 5.3. 6. 2. The application must describe the design, manufacture and performances of the device in question. Article 14 - the list of laboratories or other institutions taking part in the evaluation study. For all devices referred to in List A in Annex II other than those intended for performance evaluation, 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 IV (full quality assurance), or. Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards transposing the harmonised standards the reference numbers of which have been published in the Official Journal of the European Communities; Member States shall publish the reference numbers of such national standards. 6.1. (5) OJ L 159, 29.6.1996, p. 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 ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out. 6. The manufacturer shall carry out the required controls and tests according to the latest state of the art. Article 13 - Particular health monitoring measures This Directive shall not affect national laws which provide for the supply of devices by a medical prescription. 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. 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). The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system. Devices which are instruments or apparatus having a primary analytical measuring function must be designed and manufactured in such a way as to provide adequate stability and accuracy of measurement within appropriate accuracy limits, taking into account the intended purpose of the device and of available and appropriate reference measurement procedures and materials. In areas for which no standards exist, the symbols and colour used must be described in the documentation supplied with the device. Where, in the context of notification referred to in Article 10, a device notified, bearing the CE marking, is a ‘new´ product, the manufacturer shall indicate this fact on his notification. - 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. Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorised representative. They shall immediately inform the Commission thereof. 1. The Council shall act by a qualified majority. «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. This definition needs to be read in conjunction with the definition of a medical device in the UK MDR 2002 (Regulation 2): ‘Medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, Instructions for use must accompany or be included in the packaging of one or more devices. Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis. Committee on Standards and Technical Regulations. The common technical specifications shall be adopted in accordance with the procedure mentioned in Article 7(2) and be published in the Official Journal of the European Communities. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. So the idea is not completely new. The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the Page 4/10 - the organisational structure and responsibilities. 4. 5. The CE marking of conformity must also appear on the sales packaging. 3. Devices shall be designed, manufactured and packaged in such a way that exposure of users and other persons to the emitted radiation is minimised. This decision must contain the conclusions of the inspection and a reasoned assessment. - design information, including the determination of the characteristics of the basic materials, characteristics and limitation of the performance of the devices, methods of manufacture and, in the case of instruments, design drawings, diagrams of components, sub-assemblies, circuits, etc.. - in the case of devices containing tissues of human origin or substances derived from such tissue, information on the origin of such material and on the conditions in which it was collected. The IVDD will be valid until May 26th, 2022. Implementation, transitional provisions. 1 It provides Europe with one single regulation for in vitro diagnostics (IVD). 2. The relevant parts of the documentation shall be annexed to the certificate and a copy shall be kept by the notified body. Classification: Other Device of IVDD 98/79/EC Conformity Assessment Route: IVDD 98/79/EC Annex III EDMA Code: 15 70 90 90 00 We herewith declare that the above mentioned products meet the transposition into national law, the provisions of the following EC Council Directives and Standards. 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; (c) ‘accessory´ means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose. The additional approval must take the form of a supplement to the EC design-examination certificate. Devices for self-testing require the participation of a Notified Body in the conformity assessment procedure. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. 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. (g) in Article 22(4), the first subparagraph shall be replaced by the following: - devices which conform to the rules in force in their territory on 31 December 1994 being placed on the market during a period of five years following the adoption of this Directive, and, - the aforementioned devices being put into service until 30 June 2001 at the latest.´. 113: Annexes. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. Article 20 - Cooperation between Member States ANNEX VII The documentation shall contain the following items in particular: - a general description of the type, including any variants planned. The staff of the inspection body are bound to observe professional secrecy with regard to all information gained in the course of their duties (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) under this Directive or any provision of national law putting it into effect. Devices must be designed and manufactured in such a way as to protect the user against mechanical risks. 1. Article 4 - Free movement Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. 1. 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