The Member States may take the measures referred to in Article 15 as from the entry force of this Directive. - a written declaration that no such application has been lodged with any other notified body for the same device-related quality system. 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. 2. Article 3 - Essential requirements Committee on Standards and Technical Regulations. Article 20 - Cooperation between Member States Article 23 - Publication In this connection, the manufacturer shall inform the notified body whether any such change is likely to affect the performance of the in vitro diagnostic medical device concerned. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The manufacturing processes must be appropriate for these purposes. Article 22 - Implementation, transitional provisions 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. - where appropriate take adequate protection measures in relation to risks that cannot be eliminated. ANNEX IV 6.3. Cooperation between Member States. Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system must be suitable taking account of the method of sterilisation indicated by the manufacturer. 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. Devices which meet these standards are given a CE marking and can be used throughout the EU. 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. Any restrictions on use must be indicated on the label and/or in the instructions for use. Choose another country to see content specific to your location. The body must take out civil liability insurance, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly. 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. Article 10 ANNEX VII - 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. LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3) For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. 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. - the following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar. 1. - reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21. 5. The Directive: IVDD 98/79/EC. Art.1(2)d [98/79/EC]: ‘device for self-testing´ means any device intended by the manufacturer to be able to be used by lay persons in a home environment; IVD devices for performance evaluation: Art.1(2)e [98/79/EC]: ‘device for performance evaluation´ means any device intended by the manufacturer to be subject to one or Revision of Europe’s IVD Directive 98/79/EC Lessons and results from the Public Consultation document. The In Vitro Diagnostics Directive (IVDD) 98/79/EC is a set of regulatory requirements that medical device manufacturers must comply with in order to place a CE marking to their product for the European market. One or more random samples, as necessary, are taken from each batch. Devices intended to be sterilised must be manufactured in appropriately controlled (e.g. Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the device. 3. 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. 3. 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. Directive as last amended by Directive 89/617/EEC (OJ L 357, 7.12.1989, p. 28).6.2. 2.1. 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. 2.2. 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. 6.2. Directive (98/79/EC) The In Vitro Diagnostic Directive (IVDD) 98/79/EC was introduced in the later part of 1998 and compliance became mandatory on December 7, 2003. This is a critical area and European Commission guidance for manufacturers is available 1, which was last updated in 2009. The chairman shall not vote. 2. 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. 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. - risks linked to reasonably foreseeable external influences, such as magnetic fields, external electrical effects, electrostatic discharge, pressure, humidity, temperature or variations in pressure or acceleration or accidental penetration of substances into the device. Once adopted, the new regulation will replace the EU’s Directive on in vitro diagnostic medical devices (98/79/EC). The applicant shall inform the notified body which issued the EC type-examination certificate of any such change made to the approved device.    A. Where, in this Directive, reference is made to harmonised standards, this is also meant to refer to the common technical specifications. Where the manufacturer is not established in the Community, the obligation to make the aforementioned documentation available on request applies to his authorised representative. ESSENTIAL REQUIREMENTS Recital 8 of the IVD Directive 98/79/EC states: “Whereas instruments, apparatus, appliances, materials or other articles, including software, which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation.” 7. 6.1. 4.3. In addition, where, in the context of such notification, a device notified, bearing the CE marking, is a ‘new product´, the manufacturer shall indicate this fact on his notification. This does not affect the right of Member State to subject such activities to appropriate protection requirements. When values are expressed numerically, they must be given in legal units conforming to the provisions of Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement (1). (e) the following paragraphs shall be added to Article 16: ‘5. 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.    List B 1. No. 7. > IVDR requirements highlighted in green are either identical, or very similar, to a corresponding IVDD requirement. The Directive sets out device classification rules, requirements for both devices and manufactures … If the batch is rejected the competent notified body must take appropriate measures to prevent the batch from being placed on the market. 6.1. 2. 3. The provisions of this Article shall apply accordingly to any natural or legal person who manufacturers devices covered by this Directive and, without placing them on the market, puts them into service and uses them in the context of his professional activity. (b) the conformity of a device or category of devices should be established, by way of derogation from the provisions of Article 9, by applying one or more given procedures taken from amongst those referred to in Article 9. it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. 3. The In Vitro-Diagnostic Medical Devices Directive 98/79/EC (IVDD) offers multiple routes to compliance – depending on the specifications and intended purpose of use of your product. Article 5 - Reference to standards 6.4.4. 2. 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. ANNEX IX - CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES of the address of the registered place of business. ANNEX I. 2. Does the product meet the definition of an in vitro diagnostic medical device? EC DECLARATION OF CONFORMITY 5000 words: Based on Internal document QARAD. 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. - the technical documentation on the types approved and a copy of the EC type-examination certificates. The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by section 2 to 5 and additionally, in the case of devices for self-testing, the obligations imposed by section 6, ensures and declares that the products concerned meet the provisions of this Directive which apply to them. 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. 4.2. Data shall be forwarded in a standardised format. 4. 2. Devices must be designed and manufactured in such a way as to minimise the risks of creating electromagnetic perturbation which could impair the operation of other devices or equipment in the usual environment. 2. 5.1. mdi Europa guides you through the entire process and assists to optimize your compliance program to meet your product specifications and business needs. 5. In vitro diagnostic medical devices (IVDs) are subject to the European Directive 98/79/EC (IVDD). 8.7. 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. (c) the following paragraph shall be added to Article 14(1): ‘For all medical devices of classes IIb and III, Member States may request to be informed of all data allowing for identification of such devices together with the label and the instructions for use when such devices are put into service within their territory.´. 2. The declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them. Devices must be designed and manufactured in such a way as to reduce as far as possible the risks linked to their use in conjunction with materials, substances and gases with which they may come into contact during normal conditions of use. The additional approval must take the form of a supplement to the EC design-examination certificate. taking account of the instructions and information provided by the manufacturer. 8.2. Where a Member State requires medical practitioners, the medical institutions or the organisers of external quality assessment schemes to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident. - data showing the handling suitability of the device in view of its intended purpose for self-testing. - the name and the address of the manufacturer and the name and address of the authorised representative if the application is lodged by the representative. 5.2. 6. 2. (ii) the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance). If a Member State or the Commission considers that the harmonised standards do not entirely meet the essential requirements referred to in Article 3, the measures to be taken by the Member States with regard to these standards and the publication referred to in paragraph 1 of this Article shall be adopted by the procedure defined in Article 6(2). 5. 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. (iii) whether the involvement of a notified body would be conducive to establishing the conformity of the device. A subgroup of medical products, their market access, use, and market surveillance is regulated. 1. 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 196, 16.8.1967, p. 1). THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, - the details of any further procedure or handling needed before the device can be used (for example, reconstitution, incubation, dilution, instrument checks, etc.). In the case of devices covered by Annex II, List A, the manufacturer shall forward to the notified body without delay after the conclusion of the controls and tests the relevant reports on the tests carried out on the manufactured devices or each batch of devices. 4. - all documentation and undertakings referred to in Annex IV, section 3.1, and. 6.3. ); (p) the necessary instructions in the event of damage to the protective packaging and details of appropriate methods of resterilisation or decontamination; (q) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and resterilisation or decontamination, and any restriction on the number of reuses; (r) precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources, etc. Overcoming hazards in connected healthcare, Transforming the way we track, manage and improve our health, In Vitro Diagnostic Devices Directive 98/79/EC, Medical Device Market Approval & Certification, Directive for Active Implantable Medical Devices 90/385/EEC (AIMD), Directive on Medical Devices 93/42/EEC (MDD), EU In Vitro Diagnostic Medical Device Regulation, Quality Management and Quality Control for Medical Devices, Questionnaires and Application Forms for Medical Devices, See all Healthcare and Medical Devices services, Blood sugar monitoring systems for diabetics, Receptacles manufactured specifically for medical specimens, Chemical and physical characteristics (compatibility with the material to be tested), Protection against infection and microbial contamination (processing, packaging), Suitability for use under the respective environmental conditions (risk minimisation), Combination with other products, disposal, Measurement function (precision, display), Protection against radiation (intentional or unintentional radiation, ionising radiation), Protection against electric shocks, electromagnetic compatibility, Protection against mechanical or thermal risks, Use by laypersons: easy to use, low risk of incorrect interpretation of results (products for self-testing only), Provision of information by the manufacturer (labeling, instructions), blood groups (ABO system, rhesus, anti-Kell), HIV-1/-2 infections, HTLV-I/-II infections, and hepatitis B, C, and D. for the determination of blood groups (anti-Duffy and anti-Kidd); for determination of irregular anti-erythrocytic antibodies; for the detection of rubella and toxoplasmosis; for the detection of infections with cytomegalovirus or chlamydia; for the detection of the tumor marker PSA; for the determination of HLA tissue types DR, A, B; for the evaluation of the risk of trisomy 21, including software; products for self-diagnosis of blood sugar levels, including instruments. Reference of the standard . For the purposes of this Directive, the following definitions shall apply: (a) ‘medical device´ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; (b) ‘in vitro diagnostic medical device´ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: Specimen receptacles are considered to be in vitro diagnostic medical devices. Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 187, 16.7.1988, p. 14). So the idea is not completely new. 7. 6.2. 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. 3. (21) Directive 98/79/EC allows the Commission to adopt common technical specifications for specif ic categor ies of in vitro diagnostic medical devices. (b) the procedure relating to EC type-examination set out in Annex V couplet with: (i) the procedure relating to EC verification set out in Annex VI, or. The provisions of Article 10(1), (3) and (5) shall apply to devices intended for performance evaluation. 5. The applicant shall inform the notified body which issued the EC design-examination certificate of any such changes made to the approved design. - the procedures in relation to purchasing. 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. The manufacturer must keep the declaration of conformity, the technical documentation referred to in Annexes III to VIII, as well as the decisions, reports and certificates, established by notified bodies, and make it available to the national authorities for inspection purposes for a period ending five years after the last product has been manufactured. It shall immediately inform the other Member States and the Commission of any withdrawal of notification or any restriction placed on it. 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 IX requirements. Note: Products for determining blood sugar levels are exempted from this device group (see List B). - reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia. The provisions of Annex IV, section 5, shall apply accordingly in relation to the abovementioned approved procedures. 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. - the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of design and of product, including control of devices which fail to conform; (c) the procedures for monitoring and verifying the design of the devices and in particular: - a general description of the device, including any variants planned. 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. Verification of manufactured products covered by Annex II, List A. In Directive 89/392/EEC, the second indent of Article 1(3), ‘machinery for medical use, used in direct contact with patients´ shall be replaced by the following: 2. (a) data relating to registration of manufacturers and devices in accordance with Article 14; (b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures, as laid down in Annexes II to VII; (c) data obtained in accordance with the vigilance procedure as defined in Article 10; 3. 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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