The applicant shall make a 'type` available to the notified body. When devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must as far as possible be: The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation, means of protecting the user, and on ways of avoiding misuse and of eliminating the risks inherent in installation. X2 8.6. The Commission shall inform the Member States of the measures taken and, where appropriate, publish these measures in the Official Journal of the European Communities. For devices covered by Annex II, List A, in addition to the obligations imposed by section 3, the manufacturer must lodge with the notified body an application for examination of the design dossier relating to the device which he plans to manufacture and which falls into the category referred to in section 3.1. For all devices other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex III and draw up the EC declaration of conformity required before placing the devices on the market.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. 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. 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.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.3.3. Before the start of manufacture, the manufacturer must prepare documents defining the manufacturing process, in particular as regards sterilisation and the suitability of starting materials, where necessary, and define the necessary testing procedures according to the state of the art. 1.2. 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. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system. sound vocational training covering all the assessment and verification operations for which the body has been designated. ; (s) precautions to be taken against any special, unusual risks related to the use or disposal of the device including special protective measures; where the device includes substances of human or animal origin, attention must be drawn to their potential infectious nature; (t) specifications for devices for self-testing: - the results need to be expressed and presented in a way that is readily understood by a lay person; information needs to be provided with advice to the user on action to be taken (in case of positive, negative or indeterminate result) and on the possibility of false positive or false negative result. It must contain the conclusions of the inspection and a reasoned assessment. 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.6. sensitivity, specificity, accuracy, repeatability, reproducibility, limits of detection and measurement range, including information needed for the control of known relevant interferences), limitations of the method and information about the use of available reference measurement procedures and materials by the user. 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.Article 16 CE marking 1. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. DisplayLogo. Article 18 Decisions in respect of refusal or restriction. 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; 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. Where, after such consultation, the Commission finds that: - 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. Should the notified body subcontract specific tasks connected with the establishment and verification of the facts, it must first ensure that the subcontractor meets the provisions of the Directive. Where a Member State ascertains that the devices referred to in Article 4(1), when correctly installed, maintained and used for their intended purpose may compromise the health and/or safety of patients, users or, where applicable, other persons, or the safety of property, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. - Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell. - all documentation and undertakings referred to in Annex IV, section 3.1, and. 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(. During a period of five years following the entry into force of this Directive, Member States shall accept the placing on the market of devices which conform to the rules in force in their territory on the date on which this Directive enters into force. 4. The notified body, its director and the assessment and verification staff shall not be the designer, manufacturer, supplier, installer or user of the devices which they inspect, nor the authorised representative of any of these persons. 4.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. (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. Any symbol and identification colour used must conform to the harmonised standards. (9) OJ L 139, 23.5.1989, p. 19. The manufacturing processes must be appropriate for these purposes.2.2. The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed time-frame, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates. 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; the procedures for monitoring and verifying the design of the devices and in particular: a general description of the device, including any variants planned. At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. Where the manufacturer is not established in the Community, the obligation to make the aforementioned documentation available on request applies to his authorised representative. Manufacturing and environmental properties3.1. Turning this feature on will show extra navigation options to go to these specific points in time. In Directive 98/37/EC, the second indent of Article 1(3), ‘ machinery for medical use, used in direct contact with patients ’ shall be replaced by the following:]. 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. reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B. reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA. - all documentation referred to in Annex III, section 3, indents 3 to 13. - where appropriate take adequate protection measures in relation to risks that cannot be eliminated. 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.4. variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation. the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of product, including control of devices which fail to conform; the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible to trace back the calibration. The documentation must allow an understanding of the design, the manufacture and the performances of the device. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety or health of users or, where applicable, other persons, or the safety of property. previous. Devices must be designed and manufactured in such a way as to remove or reduce as far as possible: - the risk of injury linked to their physical features (in particular aspects of volume x pressure, dimension and, where appropriate, ergonomic features). 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 policies and procedures, such as quality programmes, quality plans, quality manuals and quality records. 4. 5. In this connection, the manufacturer shall inform the notified body whether any such change is likely to affect the performance of the. Substituted by Corrigendum to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Official Journal of the European Communities L 331 of 7 December 1998). OJ C 172, 7.7.1995, p. 21 and OJ C 87, 18.3.1997, p. 9. 3.2. reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis. However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer. 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. They must be suitable to withstand stresses inherent in the foreseen working environment, and to retain this resistance during the expected life of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer. 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. 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. 5.1. For devices covered by Annex II, List A, in addition to the obligations imposed by section 3, the manufacturer must lodge with the notified body an application for examination of the design dossier relating to the device which he plans to manufacture and which falls into the category referred to in section 3.1. (3) Opinion of the European Parliament of 12 March 1996 (OJ C 96, 1.4.1996, p. 31), Council common position of 23 March 1998 (OJ C 178, 10.6.1998, p. 7) and Decision of the European Parliament of 18 June 1998 (OJ C 210, 6.7.1998). X3 Devices labelled either as 'STERILE` or as having a special microbiological state must have been processed by an appropriate, validated method. The sampling scheme will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question. data allowing identification of the device in question. The Member States may take the measures referred to in Article 15. as from the entry into force of this Directive. Article 9 Conformity assessment procedures. Geographical Extent: 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. 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.3. “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, Products for general laboratory use are not, diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for. 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. Their remuneration must not depend on the number of inspections carried out, nor on the results of the inspections.6. 2. 8.7. Where the manufacturer is not established in the Community, the obligation to make the aforementioned documentation available on request applies to his authorised representative.8. 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. inform users of the residual risks due to any shortcomings of the protection measures adopted. It shall include in particular an adequate description of: 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. The Committee shall adopt its rules of procedure. Member States shall take appropriate measures to ensure that competent authorities charged with the implementation of this Directive cooperate with each other and convey to each other the information necessary to ensure application in compliance with this Directive. The decision whether to translate the instructions for use and the label into one or more languages of the European Union shall be left to the Member States, except that, for devices for self-testing, the instructions for use and the label must include a translation into the official language(s) of the Member State in which the device for self-testing reaches its final user. The procedures implementing this Article shall be adopted in accordance with the procedure referred to in Article 7(2). This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body. Do something for our planet, print this page only if needed. 1. Where a Member State considers that:(a) the list of devices in Annex II should be amended or extended, or(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. 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.4. (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. 2.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). - diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system.5.2. 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; (j) appropriate warnings and/or precautions to take; (k) if the device is intended for self-testing, that fact must be clearly stated. - 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. - reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies. They must achieve the performances, in particular, where appropriate, in terms of analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including control of known relevant interference, and limits of detection, stated by the manufacturer. 4.The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure. 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). Show Timeline of Changes: For devices covered by Annex II and for devices for self-testing, Member States may request to be informed of the data allowing identification together with the label and the instructions for use when such devices are placed on the market and/or put into service within their territory.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.3. At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. 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. 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). 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. This new approval shall take the form of a supplement to the initial EC type-examination certificate. Devices must be designed and manufactured in such a way as to provide an adequate level of intrinsic immunity of electromagnetic disturbance to enable them to operate as intended. It shall immediately inform the other Member States and the Commission of any withdrawal of notification or any restriction placed on it. ;(s) precautions to be taken against any special, unusual risks related to the use or disposal of the device including special protective measures; where the device includes substances of human or animal origin, attention must be drawn to their potential infectious nature;(t) specifications for devices for self-testing:- the results need to be expressed and presented in a way that is readily understood by a lay person; information needs to be provided with advice to the user on action to be taken (in case of positive, negative or indeterminate result) and on the possibility of false positive or false negative result,- 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 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,- the information must also specify that when the device for self-testing is used for the monitoring of an existing disease, the patient should only adapt the treatment if he has received the appropriate training to do so;(u) date of issue or latest revision of the instructions for use. Where appropriate, the instructions for use must contain the following particulars: LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3). The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the approved quality system and must supply the manufacturer with an assessment report. Devices must be designed and manufactured in such a way as to remove or reduce as far as possible:- the risk of injury linked to their physical features (in particular aspects of volume x pressure, dimension and, where appropriate, ergonomic features),- 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.Devices must be designed and manufactured in such a way as to provide an adequate level of intrinsic immunity of electromagnetic disturbance to enable them to operate as intended.3.4. ) no further amendments will be three versions of this Directive, accessories shall be to! Provision applies to which may not be eliminated audit the quality system and address the... Indents 3 to 13 extra navigation options to open legislation in order view... 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