7. 9. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced. 8. United Kingdom Accreditation Service (UKAS) accreditation and close links with European Commission and Competent Authorities make us a natural partner to meeting your CE certification requirements. Information supplied by the manufacturer 13.1. Article 14 Registration of persons responsible for placing devices on the market 1. The notified body must make available to the other notified bodies and the competent authority, on request, all relevant information concerning quality system approvals issued, refused or withdrawn. Non-active devices specifically intended for recording of X-ray diagnostic images are in Class IIa. Software, which drives a device or influences the use of a device, falls automatically in the same class. Member States shall not create any obstacle to: - devices intended for clinical investigation being made available to medical practitioners or authorized persons for that purpose if they meet the conditions laid down in Article 15 and in Annex VIII. The Medical Device Directive 93/42/EEC regulates the area of medical devices for human use and includes non-active medical devices, non-active implants, devices for wound care, non-active dental devices, medical devices relying on a source of electrical energy/active medical devices, medical devices for diagnostic imaging and medical therapy, monitoring devices, medical devices for radio/thermotherapy, sterile medical devices etc. When neither the manufacturer nor his authorized representative is established in the Community, the obligation to keep available the technical documentation shall fall to the person responsible for placing the device on the Community market or the importer referred to in Annex I, Section 13.3 (a). In the title and Article 1 of Directive 84/539/EEC, 'human or' is deleted. - the results of the design calculations, risk analysis, investigations, technical tests, etc. If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 65/65/EEC. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity. The applicant shall inform the notified body which issued the EC design-examination certificate of any such changes made to the approved design. The provisions of paragraphs 1 and 2 do not apply where the clinical investigations are conducted using devices which are authorized in accordance with Article 11 to bear the CE marking unless the aim of these investigations is to use the devices for a purpose other than that referred to in the relevant conformity assessment procedure. Active device for diagnosis Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. 12. 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 relevant measures have been taken or are contemplated. This declaration must cover a given number of the products manufactured and be kept by the manufacturer. - the particular features of the device as specified in the relevant medical prescription. - 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 products which fail to conform; (c) the inspection and quality assurance techniques at the manufacturing stage and in particular: (d) 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 adequately to trace back the calibration of the test equipment. Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 (date of application) to meet the requirements of the MDR. CLINICAL EVALUATION 1. Article 19 Decision in respect of refusal or restriction 1. 6. 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. Consumer and Industrial Goods The Standing Committee referred to in Article 7 may assume its tasks from the date of notification (19) of this Directive. Reusable surgical instrument Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which can be reused after appropriate procedures have been carried out. Any natural or legal person who puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack, shall draw up a declaration by which he states that: (a) he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and has carried out his operations in accordance with these instructions; and, (b) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and. - an undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved. Marking of Medical Devices. 5.3. 13. Article 7 Committee on Medical Devices 1. The declaration referred to in paragraphs 2 and 3 above shall be kept at the disposal of competent authorities for a period of five years. 12. 1.2. All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb, unless they are implantable or long term invasive devices, in which case they are in Class III. Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible. For the purposes of this Directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices. Classification shall be carried out in accordance with Annex IX. The manufacturer may, on the responsibility of the notified body, affix the notified body's identification number during the manufacturing process. It must include in particular an adequate description of: - the organizational structures, the responsibilities of the managerial staff and their organizational authority where manufacture of the products is concerned. All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III except where such devices are intended to come into contact with intact skin only. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them: (i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; (ii) any technical or medical reason connected with the characteristics or performance of a device leading for the reasons referred to in subparagraph (i) to systematic recall of devices of the same type by the manufacturer. All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb. This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity. - a written declaration that no application has been lodged with any other notified body for the same type. These persons shall inform the competent authorities of the Member State in which they have their registered place of business of the address of the registered place of business and the category of devices concerned. The notified body may require the application to be completed by further tests or proof to allow assessment of conformity with the requirements of the Directive. Today, due to the stricter rules of the new Regulation system, the class of many devices changed. Committee on Standards and Technical Regulations. 1991 and OJ No C 251, 28. 11. 1. Article 18 Wrongly affixed CE marking Without prejudice to Article 8: (a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorized representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State; (b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8. The applicant must make a 'type' available to the notified body. In line with Article 11(2) and (3), this Annex may... 7.2. Rule 8 All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended: - to be placed in the teeth, in which case they are in Class IIa, - to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III, - to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III, - or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III. 1992, p. 4) Guidance documents for Medical Device Directive 93/42/EEC Harmonized European Standards, available for a fee. 5.4. Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. (18) OJ No L 262, 27. They shall be accompanied by the information referred to in point 13 of Annex I which includes, where appropriate, the information supplied by the manufacturers of the devices which have been put together. The notified body must affix, or have affixed its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out. For the purposes of this Directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices. Published on: 08/10/2007. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 11 (1) to (5) 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 tests and verification already carried out under pre-existing national law, regulations or administrative provisions in respect of such devices. 2. The manufacturer must prepare the technical documentation described in Section 3. The manufacturer must allow the notified body access for inspection purposes to the inspection, testing and storage locations and supply it with all relevant information, in particular: - the documentation on the quality system, - the technical documentation, - the quality records, such as inspection reports, test data, calibration data, qualification reports of the staff concerned, etc. Medical Devices Directive 93/42/EEC . 3. In the event of a decision as referred to in paragraph 1, the manufacturer, or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measure to be taken. - in the case of products placed on the market in a sterile condition, description of the methods used. 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 authorized representative of any of these persons. 7. The MDD is the Medical Device Directive or 93/42/EEC. This Directive shall apply to medical devices and their accessories. The chairman shall not vote. 4. The applicant must inform the notified body which issued the EC type-examination certificate of any significant change made to the approved product. 4.4. After IP completion day (31 December 2020 11pm) no further amendments will be applied to this version. - sound vocational training covering all the assessment and verification operations for which the body has been designated. Free movement, devices intended for special purposes. 1984, p. It will consolidate two existing legal provisions and replace both the current Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC). All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class IIa, unless this is done in a manner: - that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb. Slide 1 of 37 Robert Packard, Consultant www.MedicalDeviceAcademy.com rob@13485cert.com Medical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC Medical Devices Directive. - intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which they are in Class IIb. 10.3. In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy. (13) OJ No L 197, 18. In line with Article 11 (2), this Annex may apply to products in Class IIa, subject to the following derogation: 6.1. where this Annex is applied in conjunction with the procedure referred to in Annex IV, V or VI, the declaration of conformity referred to in the abovementioned Annexes forms a single declaration. The notified body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. Medical Device Directive 93/42/EEC Annex VII, Risk Class I compilation of the CE Mark Technical File Systematic consulting delivery starts with an experienced regulatory affairs consultant explaining the detailed compliance project plan based on the Annex VII of the medical device directive to be implemented with their guidance by phone and emails. The notified body must make available to the other notified bodies, on request, all relevant information concerning the quality system approvals issued, refused or withdrawn. Where appropriate, this information should take the form of symbols. For the purposes of this Directive, accessories are treated as medical devices in their own right. 3. - an undertaking to fulfil the obligations imposed by the quality system is approved. To this end, an adequate sample of the final products, taken on site by the notified body, must be examined and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out. 2. in Article 9 the following paragraphs are added: '5. Rule 3 All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa. Accessible parts of the devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use. 5. The Commission shall take the utmost account of the opinion delivered by the Committee. EC verification is the procedure whereby the manufacturer or his authorized representative established in the Community ensures and declares that the products which have been subject to the procedure set out in Section 4 conform to the type described in the EC type-examination certificate and meet the requirements of this Directive which apply to them. 8. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, that device must be assessed and authorized in accordance with this Directive. 6.2. - to be totally introduced into the human body or. Texte de la directive dispositifs médicaux 93/42/CE Author: Communauté européenne Subject: directive Keywords: directive, réglement, réglementation, europe, marquage ce, dispositifs médicaux Created Date: 3/8/2002 4:56:19 PM EC TYPE-EXAMINATION 1. 3.2. Ionizing radiation 11.5.1. Base: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993. Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended. Directive as last amended by Directive 84/467/Euratom (OJ No L 265, 5. At trade fairs, exhibitions, demonstrations, etc. 6. 7.4. 10. 5. 8. - an undertaking to maintain the practicability and effectiveness of the approved quality system. Decisions taken by the notified bodies in accordance with Annexes II and III shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of five years. 2.3.2. Article 11 Conformity assessment procedures 1. The assessment team must include at least one number with past experience of assessments of the technology concerned. Directive as last amended by Directive 92/31/EEC (OJ No L 126, 12. Medical Device Directive (MDD) 93/42/EEC as amended by 2007/42/EC Pavan Kumar Malwade 01 April 2016 1 2. 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. 2.3.7. In Article 2 of Directive 84/539/EEC, the following subparagraph is added to paragraph 1: 'If the appliance is at the same time a medical device within the meaning of Directive 93/42/EEC (*) and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this Directive. In the event of a single fault condition (in the system) appropriate means should be adopted to eliminate or reduce as far as possible consequent risks. (ii) any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) above leading to a systematic recall of devices of the same type by the manufacturer. Article 16 Notified bodies 1. All products in the batch may be put on the market except any in the sample which failed to conform. 2. All non-invasive devices which come into contact with injured skin: - are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates. International spricht man von der Richtlinie als Medical Device Directive (MDD), oder Directive 93/42/EEC. Where devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must be fitted, where practicable, with visual displays and/or audible warnings of such emissions. Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance. 4.2. For the purposes of this Directive, reference to harmonized standards also includes the monographs of the European Pharmacopoeia notably on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in the Official Journal of the European Communities. 5. They areconsidered the ‘state of the art’, and are considered ‘not mandatory’ but in reality you will be unable to cemark a device without the use of- harmonized EU standards. The manufacturer must authorize the notified body to carry out all the necessary inspections and supply it with all relevant information, in particular: - the documentation on the quality system, - 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. 1990, p. The information contained in the declarations concerned by this Annex should be kept for a period of time of at least five years. 252 of 1994 European Communities (Medical Devices) Regulations, 1994 which transposed Directive 93/42/EEC into Irish law and became mandatory on 14 June 1998. 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