101: Implementing Acts. Verification of manufactured products covered by Annex II, List A. Devices shall be designed, manufactured and packaged in such a way that exposure of users and other persons to the emitted radiation is minimised. - sound vocational training covering all the assessment and verification operations for which the body has been designated. It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. REGULATORY CHALLENGE FOR IVD MANUFACTURERS 2 III. The measuring, monitoring or display scale (including colour change and other visual indicators) must be designed and manufactured in line with ergonomic principles, taking account of the intended purpose of the device. Oktober 1998 über In-vitro-Diagnostika ist eine EG-Richtlinie und wird in Deutschland und Österreich kurz als IVD-Richtlinie bezeichnet. (21) Directive 98/79/EC allows the Commission to adopt common technical specifications for specif ic categor ies of in vitro diagnostic medical devices. 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. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. If individual full labelling of each unit is not practicable, the information must be set out on the packaging and/or in the instructions for use supplied with one or more devices. They may not be directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. 7. 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. - in the case of devices for self-testing, the information referred to in Annex III, section 6.1. 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. 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. Devices lawfully placed on the market in accordance with IVDD (directive 98/79/EC) prior to the date of application by virtue of a valid certificate may continue to be made available on the market or put into service until 27 th May 2025 (Article 110 of the IVDR). 1. 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. A subgroup of medical products, their market access, use, and market surveillance is regulated. 3. 6.1. 3. Learn from our experts through live events. 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. 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. STATEMENT AND PROCEDURES CONCERNING DEVICES FOR PERFORMANCE EVALUATION. Directive 98/79/EC for in vitro diagnostic medical devices is a legal requirement for all manufacturers placing their products on the market in the EU, European Free Trade Area (EFTA), Switzerland, Turkey and some countries wishing to join the EU. (FULL QUALITY ASSURANCE SYSTEM). 2.7. The manufacturing processes must be appropriate for these purposes. 3. 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. This Directive shall apply to in vitro diagnostic medical devices and their accessories. 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. It shall immediately inform the other Member States and the Commission of any withdrawal of notification or any restriction placed on it. 3.1. 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. Implementation, transitional provisions. 4.4. Placing on the market and putting into service. Article 13 - Particular health monitoring measures 15). 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. Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices Article 14 - Amendments to Annex II, and derogation clause 2. 1. 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. Devices must be designed and manufactured in such a way as to facilitate the management of safe waste disposal. Member States shall not create any obstacle to devices intended for performance evaluation being made available for that purpose to the laboratories or other institutions listed in the statement referred to in Annex VIII if they meet the conditions laid down in Article 9(4) and Annex VIII. 5.1. It must include in particular: - a general description of the product, including any variants planned. 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. Be confident of medical device market approval. The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. The IVDR looks at software in more detail (compared to the IVD Directive 98/79/EC). The IVDD is implemented in the national laws of the member states. The notified body and the manufacturer, or his authorised representative established in the Community, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII. This is a critical area and European Commission guidance for manufacturers is available 1, which was last updated in 2009. 1 I. This documentation must be kept for a period ending at least five years after the end of the performance evaluation. Devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned. The provisions of Article 10(1), (3) and (5) shall apply to devices intended for performance evaluation. 4. The CE marking of conformity must also appear on the sales packaging. 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.” 6.3. 1.2. 6.4.4. Particular attention must be paid to the possibility of impairment of analytical performance due to incompatibility between the materials used and the specimens (such as biological tissues, cells, body fluids and micro-organisms) intended to be used with the device, taking account of its intended purpose. ‘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. Article 23 - Publication The Member States shall on request inform the other Member States of the details referred to in paragraphs 1 to 4. 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 Commission shall be assisted by the committee set up by Article 5 of Directive 98/34/EC. The Directive was develo… 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. The annexes to the certificates must be available to the other notified bodies on reasoned application, after the manufacturer has been informed. Cooperation between Member States. In the case of devices for performance evaluation, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before such devices are made available. 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. of information relating to the reagents, reagent products and calibration and control materials in terms of common technological characteristics and/or analytes and of any significant change thereto including discontinuation of placing on the market; for other devices, the appropriate indications. 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 manufacturer must undertake to 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 and notification action as referred to in Annex III, section 5. Data shall be forwarded in a standardised format. 5.2. EC DECLARATION OF CONFORMITY 1. Where a device incorporates biological substances, the risks of infection must be reduced as far as possible by selecting appropriate donors and appropriate substances and by using appropriate, validated inactivation, conservation, test and control procedures. In addition to these general requirements, there are other requirements that apply above all to the design and manufacture of the devices and refer to: The IVDD distinguishes four different groups - based on the risk associated with the use of the respective products. 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 notified body may request other samples as necessary. Article 19 - Confidentiality The assessment team must have past experience of assessments of the technology concerned. 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. 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; (b) the details strictly necessary for the user to uniquely identify the device and the contents of the packaging; (c) where appropriate, the word ‘STERILE´ or a statement indicating any special microbiological state or state of cleanliness; (d) the batch code, preceded by the word ‘LOT´, or the serial number; (e) 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; (f) in case of devices for performance evaluation, the words ‘for performance evaluation only´; (g) where appropriate, a statement indicating the in vitro use of the device; (h) any particular storage and/or handling conditions; (i) where applicable, any particular operating instructions; (k) if the device is intended for self-testing, that fact must be clearly stated. This IVD directive is also a contractual requirement in some other regions of the world. The manufacturer shall inform the notified body which approved the quality system of any plan for substantial changes to the quality system. IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. Article 17 - Wrongly affixed CE marking 3. Devices which are instruments or apparatus with a measuring function 26 5. 6.1. The provisions of Annex IV, section 5, shall apply accordingly in relation to the abovementioned approved procedures. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 7 December 1999. - data showing the handling suitability of the device in view of its intended purpose for self-testing. 4.1. No. The manufacturer must lodge an application for assessment of his quality system with a notified body. Devices incorporating electronic programmable systems, including software, must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use. 6.2. - an undertaking by the manufacturer to keep the approved quality system adequate and efficacious. 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. 1. The Member States may take the measures referred to in Article 15 as from the entry force of this Directive. 5. Every product is examined individually and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out in order to verify the conformity of the products with the EC type described in the type-examination certificate and with the requirements of the Directive which apply to them. 1. 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. 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. 2. They shall immediately inform the Commission thereof. Title: CL1998L0079EN0030010.0001.3bi_cp 1..1 Author: Publications Office Created Date: 1/23/2012 11:04:05 PM 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. (5) OJ L 159, 29.6.1996, p. 33. The European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD), became operational in June 2000. It shall inform the committee of the manner in which its opinion has been taken into account. 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. 3.3. 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. 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 must affix the CE marking in accordance with Article 16 and draw up a declaration of conformity covering the devices concerned. (h) Annex II, section 6.2, Annex III, section 7.1, Annex V, section 5.2 and Annex VI, section 5.2 shall be deleted; (i) in Annex XI, section 3 the following sentence shall be inserted after the second sentence: ‘This presupposes the availability of sufficient scientific staff within the organisation who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Directive and, in particular, those set out in Annex I.´, Article 22 (6) OJ L 139, 23.5.1989, p. 19. Devices for self-testing require the participation of a Notified Body in the conformity assessment procedure. It shall then inform the Commission and all the other Member States giving the reasons for its decision. In the event of frequent rejection of batches, the notified body may suspend the statistical verification. When no lifetime is stated, the same applies for the lifetime reasonably to be expected of a device of that kind, having regard to the intended purpose and the anticipated use of the device. 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 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. 5.3. 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. 3.6. Annex III (EC Declaration of Conformity) of the IVDD (98/79/EC) delineates the steps that a device manufacturer (or the device manufacturer’s European Authorized Representative) must perform in the pursuit of making application to their notified body. 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. - 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. Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. (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. The principle of integrated safety applies, i.e. 10: 15. (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.´. 3.1. 4.3. The certificate must contain the conclusions of the examination, the conditions of validity, the data needed for the identification of the approved design and, where appropriate, a description of the intended purpose of the device. The information and instructions provided by the manufacturer should be easily understood and applied by the user. The assessment team must have experience of assessments of the technology concerned. Revision of Europe’s IVD Directive 98/79/EC Lessons and results from the Public Consultation document. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. 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. The IVDD defines tasks performed by Notified Bodies (NBs) which are assigned by individual Member States. Article 18 Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever affixed the marking and shall inform the Commission and the other Member States thereof. The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks for which they have been notified, in the Official Journal of the European Communities. It must presume that quality systems which implement the relevant harmonised standards conform to these requirements. The manufacturer shall affix the CE marking in accordance with Article 16 and shall draw up a declaration of conformity covering the devices concerned. UK Approved Bodies 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 manufacturer may, on the responsibility of the notified body, affix the notified body's identification number during the manufacturing process. 11. Health and Consumers Health and Consumers Revision of the IVD Directive: IVD specific issues 3. - test reports including, where appropriate, results of studies carried out with lay persons. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. 3. Whereas measures should be adopted for the smooth operation of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance, characteristics and authorisation procedures for in vitro diagnostic medical devices are different; whereas the existence of such disparities creates barriers to(1) OJ C 172, 7.7.1995, p. 21 and OJ C 87, 18.3.1997, p. (f) the following paragraph shall be added to Article 18: ‘Those provisions 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.´. These measures cannot constitute a precondition for the placing on the market and/or putting into service of devices which are in conformity with this Directive. Article 1 - Scope, definitions Article 9 - Conformity assessment procedures 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. This minimum dimension may be waived for small-scale devices. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards shall be presumed to meet the relevant criteria. EU Medical Device Regulations: 2: May 28, 2013: P: Proposed Changes to the Medical Device Directive (and IVDD) EU Medical Device Regulations: 0: Apr 11, 2013: M: IVDD ER 8.3 Vs. Where, in this Directive, reference is made to harmonised standards, this is also meant to refer to the common technical specifications. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Devices for self-testing must be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in users' technique and environment. Having regard to the proposal from the Commission (1), In addition, the notified body may pay unannounced visits to the manufacturer. 2. 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 manufacturer must prepare the technical documentation described in section 3 and ensure that the manufacturing process follows the principles of quality assurance as set out in section 4. - an evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of the evaluation and number of devices concerned. ); (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. - adequate performance evaluation data showing the performances claimed by the manufacturer and supported by a reference measurement system (when available), with information on the reference methods, the reference materials, the known reference values, the accuracy and measurement units used; such data should originate from studies in a clinical or other appropriate environment or result from relevant biographical references. 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 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. 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. Article 10 5. 1. Manufacturers of finished IVD products outside the EU must have a representative within the EU. 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