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Decree No. 2015 - 1084 Of 27 August 2015 Relative To The Electromagnetic Compatibility Of Electrical And Electronic Equipment

Original Language Title: Décret n° 2015-1084 du 27 août 2015 relatif à la compatibilité électromagnétique des équipements électriques et électroniques

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Keywords

ECONOMY , COMPATIBILITY , COMPATIBILITY ELECTROMAGNETIC , ELECTRICAL EQUIPMENT , ELECTROMAGNETIC , ELECTROMAGNETIC PERTURBATION , ELECTRONIC EQUIPMENT


JORF n°0199 of 29 August 2015 page 15348
text No. 44



Decree No. 2015-1084 of 27 August 2015 on electromagnetic compatibility of electrical and electronic equipment

NOR: EINI1426176D ELI: https://www.legifrance.gouv.fr/eli/decret/2015/8/27/EINI1426176D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2015/8/27/2015-1084/jo/texte


Publics concerned: companies, consumers and control bodies interested in electromagnetic compatibility of electrical and electronic equipment.
Purpose: electromagnetic compatibility of electrical and electronic equipment; harmonization of legislation.
Entry into force: the text comes into force on 20 April 2016.
Notice: the decree transposes in French law the Directive 2014/30/EU of 26 February 2014 on the harmonization of the laws of the Member States concerning electromagnetic compatibility, which aims to ensure that the electrical and electronic equipment available on the market meet requirements for an adequate level of electromagnetic compatibility, while allowing the proper functioning of the internal market. He substitutes for Decree No. 2006-1278 of 18 October 2006 concerning electromagnetic compatibility of electrical and electronic equipment.
References: The decree is available on the website Légifrance (http://www.legifrance.gouv.fr).
The Prime Minister,
On the report of the Minister of Economy, Industry and Digital Affairs,
Considering Regulation (EC) No 216/2008 of the European Parliament and Council of 20 February 2008 concerning common rules in the field of civil aviation and establishing a European Aviation Safety Agency;
Having regard to Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 establishing the requirements for certification and market surveillance for the marketing of products and repealing Council Regulation (EC) No. 339/93;
Having regard to Regulation (EU) No. 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European Standardization, amending Council Directives 89/686/EEC and 93/15/EEC and Council Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2009/23/EC and 2009/105/EC of the European Parliament and the Council decision
Considering the Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States concerning electromagnetic compatibility (refonte) ;
Vu le Consumer codeincluding articles L. 214-1 and L. 214-2;
Vu le Customs Codeincluding article 38;
Vu le Post and electronic communications codeincluding articles L. 32 and L. 34-9;
Vu le Decree No. 2008-1401 of 19 December 2008 relating to accreditation and conformity assessment;
The State Council (section of public works) heard,
Decrete:

  • Chapter I: General provisions Article 1 Learn more about this article...


    I. - This Order applies to equipment as defined in section 2.
    II. - This Order does not apply:
    (a) At telecommunications terminal equipment and radio equipment defined at 10° and 11° of Article L. 32 and atArticle L. 34-9 of the Post and Electronic Communications Code ;
    (b) To the aeronautical products, parts and equipment mentioned in the regulations of 20 February 2008 referred to above;
    (c) To radio equipment used by radio operators within the meaning of the radiocommunication regulations adopted in the framework of the constitution of the International Telecommunication Union and the International Telecommunication Union Convention, unless such equipment is available on the market;
    (d) Equipment whose physical characteristics involve by their very nature:
    (i) That they are unable to produce or contribute to the production of electromagnetic emissions that exceed a level allowing radio and telecommunications equipment and other equipment to operate as intended; and
    (ii) That they function without unacceptable degradation in the presence of electromagnetic disturbances normally present during intended use;
    (e) For custom assessment kits intended to be used by professionals only in research and development facilities for such purposes.
    For the purpose of the c, the components kits intended to be assembled by radio amateurs and equipment available on the market and modified by and for radio amateurs are not considered to be equipment available on the market.
    III. - Where, for equipment referred to in I, the essential requirements set out in Schedule I are provided in full or in part in a more specific manner by other provisions of the Union's legislation, this Order shall not apply or cease to apply to such equipment in respect of those requirements as of the date of the implementation of the said provisions of the Union's legislation.
    IV. - This decree is without effect on the application of the legislation of the Union or the Member States regulating the safety of equipment.

    Article 2 Learn more about this article...


    I. - For the purposes of this decree:
    1° "equipment": any device or fixed installation;
    2° "aircraft": any finite device or combination of such devices available on the market as an independent functional unit, intended for the end user and likely to produce electromagnetic disturbances, or whose operation can be affected by such disturbances;
    3° "fixed installation": a special combination of several types of appliances and, where applicable, other devices that are assembled, installed and intended to be used permanently in a predefined place;
    4° "electromagnetic compatibility": the ability of equipment to function in their electromagnetic environment satisfactorily without producing inlerable electromagnetic disturbances for other equipment in this environment;
    5° "electromagnetic disturbance": any electromagnetic phenomenon likely to create equipment operating disorders; an electromagnetic disturbance may be an electromagnetic noise, an unwanted signal or a modification of the propagation medium itself;
    6° "immunity": the ability of equipment to function as intended, without degradation in the presence of electromagnetic disturbances;
    7° "for security purposes": to preserve human life or property;
    8° "electromagnetic environment": all electromagnetic phenomena observed in a given place;
    9° "available on the market": any supply of a device intended to be distributed, consumed or used on the Union market as part of a commercial activity, either expensive or free of charge;
    10° "marketing": the first provision of a device on the Union market;
    11° "Manufacturer": any natural or legal person who manufactures a device or makes or manufactures a device, and markets this device under its name or brand;
    12° "agent": any natural or legal person established in the Union having received a written mandate from the manufacturer to act on his or her behalf for the purpose of performing specified tasks;
    13° "importer": any natural or legal person established in the Union that puts a device from a third country on the Union market;
    14° "distributor": any natural or legal person that is part of the supply chain other than the manufacturer or importer, who makes a device available on the market;
    15° "Economic operators": manufacturer, agent, importer and distributor;
    16° "technical specifications": a document setting the technical requirements to be met by a device;
    17° "Harmonized Standard": a harmonized standard within the meaning of c of 1 of Article 2 of the above-mentioned Regulation of 25 October 2012;
    18° "accreditation": accreditation within the meaning of 10 of Article 2 of the aforementioned Regulation of 9 July 2008;
    19° "national accreditation body": a national accreditation body within the meaning of Article 11 of the above-mentioned Regulation of 9 July 2008;
    20° "conformity assessment": the process that demonstrates whether the essential requirements of this Order have been met;
    21° "conformity assessment body": an organization that conducts conformity assessment operations, such as calibration, testing, certification and inspection;
    22° "remember": any measure to obtain the return of a device that has already been made available to the end user;
    23° "removal": any measure to prevent the availability of a device in the supply chain on the market;
    24° " Union harmonization legislation": any EU legislation aimed at harmonizing the conditions of marketing of products;
    25° CE marking: the marking by which the manufacturer indicates that the device complies with the applicable provisions of the Union's harmonization legislation providing for its application.
    II. - For the purposes of this decree, the following products are considered to be devices:
    1° The "components" or "sub-assemblies" intended to be incorporated into a device by the end user and which are likely to cause electromagnetic disturbances or whose operation may be affected by these disturbances;
    2° The "mobile installations" defined as a combination of devices and, where applicable, other devices, intended to be moved and to operate in different locations.

    Article 3 Learn more about this article...


    I. - Equipment may not be imported, detained for sale or distribution on a free basis, made available for sale, sold or distributed on a free basis, made available on the market on a free or expensive basis or made available only if they are in compliance with this decree as long as they are properly installed, maintained and used in accordance with the intended purposes.
    II. - Equipment that do not comply with the provisions of this Order may be exhibited or demonstrated at trade fairs, exhibitions or similar events, provided that a visible indication clearly specifies that such equipment cannot be made available on the Union market or put into service before being brought into compliance with the provisions of the Directive 2014/30/EU of 26 February 2014 referred to above. Demonstrations can only take place if adequate measures have been taken to avoid electromagnetic disturbances.

    Article 4 Learn more about this article...


    Equipment meets the essential requirements set out in Appendix I.

  • Chapter II: Obligations of Economic Operators Article 5 Learn more about this article...


    Manufacturers are subject to the following obligations:
    1° Manufacturers ensure, when placing their devices on the market, that they have been designed and manufactured in accordance with the essential requirements set out in Appendix I;
    2° Manufacturers shall prepare the technical documentation referred to in Schedule II or Appendix III and shall implement or implement the relevant conformity assessment procedure referred to in Article 12.
    When it has been demonstrated, using this procedure, that the device complies with the applicable requirements, manufacturers establish a EU compliance declaration and apply the CE marking;
    3° Manufacturers retain technical documentation and EU compliance declaration for ten years from the launch of the aircraft market;
    4° Manufacturers shall establish procedures to ensure that production in series is consistent with this decree. It is duly taken into account the modifications to the design or characteristics of the device as well as the modifications to the harmonized standards or other technical specifications in relation to which the aircraft's compliance is declared;
    5° Manufacturers put on the market devices bearing a type, lot or serial number, or another element allowing their identification or, where the size or nature of the device does not permit, that the required information is on the packaging or in a document accompanying the device;
    6° Manufacturers indicate their name, social reason or registered trademark and the postal address to which they can be contacted on the device or, where not possible, on its packaging or in a document accompanying the device. The address specifies a unique location where the manufacturer can be contacted. The coordinates are written in a language easily understandable by end users and market surveillance authorities;
    7° Manufacturers attach the instructions and information referred to in Article 15, written in French for devices intended to be made available in France. These instructions and information as well as any labelling are clear, understandable and intelligible. They may also appear in one or more other languages;
    8° Manufacturers who consider or have reason to believe that a device they have put on the market is not in accordance with this Order shall immediately take the necessary corrective measures to bring it into conformity, withdraw or recall, if necessary. In addition, if the device presents a risk, manufacturers immediately inform the competent national authorities of the Member States in which they have made this device available on the market, providing details, including, on non-compliance and any corrective action taken.

    Article 6 Learn more about this article...


    The manufacturer may designate an agent by a written warrant.
    The obligations set out in 1° of Article 5 and the obligation to establish the technical documentation referred to in 2° of Article 5 cannot be entrusted to the agent.
    The agent performs the tasks specified in the manufacturer ' s mandate. The mandate must at least authorize the agent to hold the EU compliance declaration and technical documentation available to the inspection officers for ten years from the time the aircraft was marketed.

    Article 7 Learn more about this article...


    Importers are subject to the following obligations:
    1° Importers only put on the market devices conforming to the provisions of this decree;
    2° Before placing a device on the market, importers ensure that the appropriate conformity assessment procedure referred to in section 12 has been applied by the manufacturer. They ensure that the manufacturer has prepared the technical documentation, that the device carries the CE marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in 5° and 6° of Article 5.
    Where an importer considers or has reason to believe that a device is not in compliance with the essential requirements set out in Schedule I, the importer only puts the device on the market after it has been brought into compliance. In addition, if the aircraft presents a risk, the importer shall inform the manufacturer and the inspection officers of the risk;
    3° Importers indicate their name, social reason or registered trademark and the postal address to which they can be contacted on the device or, where not possible, on its packaging or in a document accompanying the devices. The coordinates are written in a language easily understandable by end users and market surveillance authorities;
    4° Importers verify that the aircraft is accompanied by the instructions and information referred to in Article 15, written in French for devices intended to be made available in France. They may also appear in one or more other languages;
    5° Importers ensure that, as long as a device is under their responsibility, its storage or transport conditions do not compromise its compliance with the essential requirements set out in Appendix I;
    6° Importers who consider or have reason to believe that a device they have put on the market is not in accordance with this Order shall immediately take the necessary corrective measures to bring it into conformity, withdraw or recall, if necessary. In addition, if the aircraft presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they have made this device available on the market, providing details, inter alia, on non-compliance and any corrective action taken;
    7° For a period of ten years from the aircraft's market, importers hold a copy of the EU declaration of compliance to the control officers and ensure that technical documentation can be provided to these officers upon request.

    Article 8 Learn more about this article...


    Distributors are subject to the following obligations:
    1° When making a device available on the market, distributors shall act with due diligence with respect to the requirements of this Order;
    2° Before making a device available on the market, the distributors verify that it carries the CE marking, that it is accompanied by the required documents, as well as the instructions and information mentioned in Article 15, written in French for the devices intended to be sold or distributed free of charge in France, and that the manufacturer and the importer have complied with the requirements set out in 5° and 6° of Article 5 and 3° of Article 7. Instructions and information may also be included in one or more other languages.
    When a distributor considers or has reason to believe that a device is not in compliance with the essential requirements set out in Appendix I, it only makes this device available on the market after it has been brought into compliance. In addition, if the aircraft presents a risk, the distributor shall inform the manufacturer or importer and the inspection officers;
    3° Distributors ensure that, as long as a device is under their responsibility, its storage or transport conditions do not compromise its compliance with the essential requirements set out in Appendix I;
    4° Distributors who consider or have reason to believe that a device that they have made available on the market is not in accordance with this Order-in-Council shall ensure that the necessary corrective measures are taken to bring it into conformity, remove it or remind it, if necessary. In addition, if the aircraft presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they have made this device available on the market, by providing details, inter alia, on non-compliance and any corrective action taken.

    Article 9 Learn more about this article...


    An importer or distributor is considered to be a manufacturer for the purposes of this Order and is subject to the obligations of the manufacturer, as set out in Article 5, if it puts on the market a device under its name or mark or if it modifies a device already put on the market in such a way that its compliance with this Order may be affected.

    Article 10 Learn more about this article...


    Economic operators identify, at the request of the control officers:
    (a) Any economic operator who provided them with a device;
    (b) Any economic operator to whom they provided a device.
    Economic operators must be able to communicate this information for ten years from the date the device was provided to them and for ten years from the date they provided the device.

  • Chapter III: Equipment Compliance Article 11 Learn more about this article...


    Equipment conforming to harmonized standards or parts of harmonized standards whose references have been published in the Official Journal of the European Union are presumed to comply with the essential requirements set out in Annex I that are covered by these standards or parts of standards.

    Article 12 Learn more about this article...


    Compliance with the essential requirements set out in Appendix I is demonstrated using one of the following compliance assessment procedures:
    (a) The internal control of manufacturing, as set out in Appendix II;
    (b) The EU type examination, followed by type compliance on the basis of internal manufacturing control, as set out in Annex III.
    The manufacturer may choose to restrict the application of the procedure referred to in (b) to certain aspects of essential requirements, provided that, for other aspects of essential requirements, the procedure referred to in (a) is applied.

    Article 13 Learn more about this article...


    The EU Declaration of Compliance certifies that compliance with the essential requirements set out in Appendix I has been demonstrated.
    The EU Declaration of Compliance is prepared according to the model in Annex IV, contains the elements specified in the corresponding modules in Annexes II and III and is continuously updated. It is written or translated into French for devices intended to be made available on the French market.
    When a device falls under several acts of the Union imposing the establishment of a EU declaration of conformity, it is established only one EU declaration of conformity for all such acts. The declaration must mention the titles of the acts of the Union concerned and the references of their publication.
    By establishing the EU Declaration of Compliance, the manufacturer assumes responsibility for the conformity of the aircraft with the requirements set out in this Order.

    Article 14 Learn more about this article...


    The CE marking is subject to the general principles set out in Article 30 of the above-mentioned Regulation of 9 July 2008.
    The CE marking is affixed before the device is placed on the market.
    The CE marking is displayed in a visible, legible and indelible manner on the device or on its signal plate. When this is not possible or is not guaranteed in respect of the nature of the device, it is affixed to the packaging and accompanying documents.

    Article 15 Learn more about this article...


    The device is accompanied by information on any specific precautions to be taken during the installation, installation, maintenance or use of the device, so as to ensure that, once operational, the device complies with the essential requirements set out in item 1 of Schedule I.
    Devices for which compliance with the essential requirements set out in item 1 of Schedule I is not ensured in residential areas are accompanied by a clear indication of this restriction of employment, which is also shown on the packaging.
    The information necessary to allow the device to be used in accordance with the intended purpose of the device is contained in the instructions accompanying it.

    Article 16 Learn more about this article...


    Devices available on the market and which may be incorporated in a fixed facility shall be subject to all provisions of this decree applicable to devices.
    However, the requirements of sections 4 to 10 and 12 to 15 are not mandatory in the case of devices intended to be incorporated into a particular fixed facility and which are not otherwise available on the market.
    In such cases, the accompanying documentation identifies the fixed installation as well as its electromagnetic compatibility characteristics and indicates the precautions to be taken to incorporate the appliances so as not to compromise the conformity of the installation. The documentation also includes the information referred to in 5° and 6° of Article 5 and at 3° of Article 7.
    Good engineering practices referred to in item 2 of Schedule I are documented and the responsible person(s) shall make such documentation available to the competent authorities for inspection as long as the fixed facility works.
    Any person, physical or legal, who conducts the realization or modification of a fixed facility within the meaning of 3° of section 2 is responsible for establishing compliance with the essential requirements set out in Appendix I.

  • Chapter IV: Compliance assessment organizations Article 17 Learn more about this article...


    I. - The Minister for Industry is the notifying authority within the meaning of sections 21 and 22 of Directive 2014/30/EU of February 26, 2014 referred to above.
    II. - The EU type examination referred to in Article 12 shall be entitled to be carried out by the bodies accredited to this effect by the French Accreditation Committee (COFRAC) and notified to the European Commission and the bodies designated for this purpose by another Member State of the European Union, a State Party to the Agreement on the European Economic Area or Turkey.
    Organizations notified by the Minister responsible for industry participate in the normalization and coordination of the relevant notified bodies.
    III. - Compliance assessment bodies that can justify compliance with the requirements set out in the II submit their notification request to the Minister responsible for the industry.

    Article 18 Learn more about this article...


    The notified bodies provide the Minister of Industry with the following:
    (a) Any refusal, restriction, suspension or withdrawal of a type EU examination certificate;
    (b) Any circumstance affecting the scope or conditions of the notification;
    (c) Any request for information received from the monitoring officers regarding conformity assessment activities;
    (d) On request, the conformity assessment activities carried out as part of their notification and any other activities carried out, including cross-border activities and subcontracts.
    Notified organizations provide other notified organizations that conduct similar compliance assessment activities covering the same aircraft with relevant information on issues related to the negative results of the conformity assessment and, on request, to positive results.

  • Chapter V: Penalties Article 19 Learn more about this article...


    Is punished with penaltiesArticle L. 214-2 of the Consumer Code the fact:
    1° Import or market a device that has not been subject to the conformity assessment provided for in Article 12 free or expensive;
    2° For a manufacturer or importer not to be able to communicate to the inspection officers the EU compliance declaration referred to in Article 13;
    3° For a manufacturer not to be able to communicate to the inspection officers the technical documentation set out in Schedule II or III and for an importer, not to be able to obtain it;
    4° To import, to put on the market free of charge or expensive, to hold for sale or distribution free of charge, to sell, sell or distribute a device that does not comply with the provisions set out in Article 14 free of charge;
    5° Provide on a device, on its packaging or on the accompanying documents, notices or instructions, inscriptions that create confusion with the CE marking or impair its visibility or readability;
    6° To import, to put on the market as expensive or free of charge, to hold for sale or distribution free of charge, to sell, sell or distribute a device that does not carry the information mentioned in 5° and 6° of Article 5 and 3° of Article 7 or not being accompanied by the instructions and information mentioned in Article 15;
    7° To exhibit at trade fairs, trade fairs, exhibitions or similar events of equipment that, while not in conformity with the provisions of Article 5, do not comply with the provisions of Article 3, II.

  • Chapter VI: Transitional and final provisions Rule 20 Learn more about this article...


    The provisions of this Decree come into force on 20 April 2016.
    However, equipment conforming to the provisions of Decree No. 2006-1278 of 18 October 2006 concerning the electromagnetic compatibility of electrical and electronic equipment and which were put on the Union market before 20 April 2016 can continue to be sold or distributed free of charge.

    Article 21 Learn more about this article...


    The Decree No. 2006-1278 of 18 October 2006 on electromagnetic compatibility of electrical and electronic equipment is repealed as of 20 April 2016.
    In all existing regulatory provisions, references to Decree No. 2006-1278 of 18 October 2006 concerning the electromagnetic compatibility of electrical and electronic equipment are replaced by references to this decree effective 20 April 2016.

    Article 22 Learn more about this article...


    The guard of the seals, Minister of Justice, and the Minister of Economy, Industry and Digital Affairs are responsible, each with respect to it, for the execution of this decree, which will be published in the Official Journal of the French Republic.

  • Annex


    ANNEXES


    Annex I
    ESSENTIAL EXIGENCES


    1. General requirements.
    Equipment must be designed and manufactured, in accordance with the state of the technology, to ensure:
    (a) That the electromagnetic disturbances produced do not exceed the level beyond which radio and telecommunications equipment or other equipment cannot operate as intended;
    (b) That they have a level of immunity to electromagnetic disturbances that must be expected as part of the intended use that allows them to operate without unacceptable degradation of the said use.
    2. Specific requirements for fixed installations.
    Planned implementation and use of components.
    Fixed installations must be mounted in accordance with good engineering practices and in compliance with information on the intended use of their components, to meet the essential requirements set out in point 1.

  • Annex


    ANNEX II
    MODULE A: INTERNAL FABRICATION CONTROL


    1. The internal control of the manufacture is the conformity assessment procedure by which the manufacturer fulfils the obligations set out in paragraphs 2, 3, 4 and 5 of this annex, and shall, under its sole responsibility, ensure and declare under its sole responsibility that the aircraft concerned meet the requirements of this Order that apply to them.
    2. Evaluation of electromagnetic compatibility.
    The manufacturer shall conduct an assessment of the electromagnetic compatibility of the apparatus, based on the phenomena to be taken into account, to meet the essential requirements set out in Appendix I, point 1.
    The assessment of electromagnetic compatibility must take into account all normal operating conditions. In cases where devices can take multiple configurations, the assessment of electromagnetic compatibility must determine whether they meet the essential requirements set out in Appendix I, point 1, in all possible configurations identified by the manufacturer as representative of the intended use.
    3. Technical documentation.
    The manufacturer shall prepare the technical documentation. The documentation allows the aircraft to be evaluated from the point of view of its compliance with the relevant requirements, and includes an appropriate analysis and assessment of the risk(s).
    It specifies the applicable requirements and covers, to the extent necessary for the evaluation, design, manufacture and operation of the device. Technical documentation includes, where appropriate, at least the following:
    (a) A general description of the device;
    (b) Drawings of design and manufacture as well as diagrams of components, sub-assemblies, circuits, etc.;
    (c) The descriptions and explanations necessary to understand these drawings and diagrams as well as the operation of the device;
    (d) A list of harmonized standards, implemented in whole or in part, whose references have been published in the Official Journal of the European Union and, where these harmonized standards have not been applied, the description of the solutions adopted to meet the essential requirements of this decree, including a list of other relevant technical specifications applied. Where harmonized standards have been applied in part, the technical documentation specifies the parts applied;
    (e) The results of the design calculations, the controls performed, etc.;
    (f) Test reports.
    4. Manufacturing.
    The manufacturer shall take all necessary measures to ensure that the manufacturing process and its monitoring ensure compliance with the equipment manufactured with the technical documentation referred to in paragraph 3 of this annex and the essential requirements set out in Annex I, item 1.
    5. CE Marking and EU Declaration of Compliance.
    5.1. The manufacturer shall apply the CE marking on each device that meets the applicable requirements set out in this Order.
    5.2. The manufacturer shall prepare, in writing, an EU statement of compliance with a model of aircraft and shall, together with the technical documentation, be made available to the inspection officers for a period of ten years from the time the aircraft was placed on the market. The EU Declaration of Compliance specifies the device for which it was established.
    A copy of the EU compliance declaration is made available to the inspection officers upon request.
    6. Agent.
    The obligations of the manufacturer referred to in point 5 may be fulfilled by his or her agent, on his or her behalf and under his or her responsibility, provided that they are specified in the warrant.

  • Annex


    ANNEX III
    PART A
    MODULE B: EU MODEL REVIEW


    1. The EU type examination is part of the conformity assessment procedure by which a notified body examines the technical design of a device and verifies and certifies that it meets the essential requirements set out in Annex I, item 1.
    2. The EU type examination consists of an assessment of the adequacy of the technical design of the device by a review of the technical documentation referred to in item 3, without examination of a sample (design type). It may be limited to certain aspects of the essential requirements as specified by the manufacturer or its agent.
    3. The manufacturer introduces a type EU application to a single notified body of its choice.
    The application specifies the aspects of the essential requirements for which the review is requested and includes:
    (a) The name and address of the manufacturer and the name and address of the agent if the application is filed by the agent;
    (b) A written statement certifying that the same application was not filed with another notified body;
    (c) Technical documentation. The technical documentation allows the evaluation of the aircraft from the point of view of its compliance with the applicable requirements of this Order and includes an appropriate analysis and assessment of the risk(s). It specifies the applicable requirements and covers, to the extent necessary for the evaluation, design, manufacture and operation of the device. Technical documentation includes, where appropriate, at least the following:
    i. a general description of the device;
    ii. design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.;
    iii. the descriptions and explanations necessary to understand these drawings and diagrams as well as the operation of the device;
    iv. a list of harmonized standards, applied entirely or partially, whose references have been published in the Official Journal of the European Union and, where these harmonized standards have not been applied, the description of the solutions adopted to meet the essential requirements of this decree, including a list of other relevant technical specifications applied. Where harmonized standards have been applied in part, the technical documentation specifies the parts applied;
    v. the results of the design calculations, the controls performed, etc.;
    vi. Test reports.
    4. The notified body examines the technical documentation to assess the adequacy of the aircraft's technical design with respect to aspects of the essential requirements for which the examination is requested.
    5. The notified organization shall prepare an evaluation report that shall reflect the activities carried out in accordance with item 4 and their results. Without prejudice to its obligations to the notifying authorities, the notified body only discloses the contents of this report, in whole or in part, with the agreement of the manufacturer.
    6. When the type meets the requirements of this decree that are applicable to the device concerned, the notified body shall issue a type EU examination certificate to the manufacturer. This certificate contains the name and address of the manufacturer, the conclusions of the examination, the aspects of the essential requirements covered by the examination, the conditions (possible) of its validity and the data required for the identification of the approved type. One or more annexes may be attached to the EU type examination certificate.
    The type EU examination certificate and its annexes contain all the information necessary to allow the assessment of the conformity of the aircraft manufactured to the type examined and the control in service.
    When the type does not meet the applicable requirements of this Order, the notified body refuses to issue a type EU certificate of examination and informs the applicant of the reasons for its refusal.
    7. The notified body follows the evolution of the state of the generally recognized technique; where this development suggests that the approved type may no longer be in compliance with the applicable requirements of this Order, it determines whether further reviews are required. If so, the notified body shall inform the manufacturer.
    The manufacturer shall inform the notified body that holds the technical documentation relating to the Type EU examination certificate of all modifications of the approved type that may challenge the aircraft's compliance with the essential requirements of this Order or the conditions of validity of that certificate. These amendments require further approval in the form of a supplement to the initial EU type examination certificate.
    8. Each notified body shall inform the notifying authority of the type and/or supplements that it has issued or withdrawn and shall transmit to it, periodically or upon request, the list of certificates and/or supplements that it has refused, suspended or subject to other restrictions.
    Each notified body shall inform the other notified bodies of the type and/or supplements that it has refused, withdrawn, suspended or subject to other restrictions and, upon request, of the certificates and/or supplements that it has issued.
    The notified body shall, upon request, provide the European Commission, Member States and other notified bodies with a copy of the EU type and/or supplements certificates. The notified body shall, upon request, provide the European Commission and Member States with a copy of the technical documentation and the results of the examinations it has conducted. The notified body retains a copy of the type EU examination certificate, its annexes and supplements, as well as the technical file, including the documentation provided by the manufacturer, for a period of up to the end of the validity of the certificate.
    9. The manufacturer shall have at the disposal of the inspection officers a copy of the EU type examination certificate, its annexes and supplements and the technical documentation, for a period of ten years from the time the aircraft was placed on the market.
    10. The manufacturer's representative may apply the application referred to in point 3 and perform the obligations referred to in points 7 and 9 as long as they are specified in the warrant.


    PART B
    MODULE C: CONFORMITY TO THE TYPE ON THE BASE OF THE FABRICATION CONTROL


    1. Compliance with the type on the basis of internal manufacturing control is the part of the conformity assessment procedure by which the manufacturer fulfils the obligations set out in paragraphs 2 and 3 and ensures and declares that the aircraft concerned are in accordance with the type described in the EU type examination certificate and meet the requirements of this decree that apply to them.
    2. Manufacturing.
    The manufacturer shall take all necessary measures to ensure that the manufacturing process and the monitoring thereof ensure the conformity of the equipment manufactured to the approved type described in the Type EU Examination Certificate and the requirements of this Order which apply to them.
    3. CE Marking and EU Declaration of Compliance.
    3.1. The manufacturer shall apply the CE marking on each device that conforms to the type described in the EU Type Examination Certificate and meets the applicable requirements of this Order.
    3.2. The manufacturer shall, in writing, issue a EU statement of compliance with each aircraft model and shall be made available to the national authorities for a period of ten years from the time the aircraft was placed on the market. The EU Declaration of Compliance specifies the device model for which it was established.
    A copy of the EU compliance declaration is made available to the inspection officers upon request.
    4. Agent.
    The obligations of the manufacturer referred to in item 3 may be fulfilled by his or her agent, on his or her behalf and under his or her responsibility, provided that they are specified in the warrant.

  • Annex


    ANNEX IV
    MODEL DECLARATION EU CONFORMITY
    EU Declaration of Compliance (No. XXXX) (1)


    1. Device/product model (product, type, lot or serial number).
    2. Name and address of manufacturer or agent.
    3. This compliance statement is prepared under the sole responsibility of the manufacturer.
    4. Purpose of the declaration (identification of the device allowing its traceability; if necessary, a sufficiently clear color image can be attached to identify the device).
    5. The purpose of the declaration described above is consistent with the applicable Union harmonization legislation.
    6. References of the relevant harmonized standards applied, including the date of the Harmonized Standards, or other technical specifications, including the date of the Harmonized Standards, against which compliance is declared.
    7. If so, the notified body ........................ (name, number) performed ..................... (description of the intervention) and established the certificate.
    8. Additional information.
    Signed by and on behalf of
    Date and place of establishment
    Name, function
    Signature

    (1) The award of a number to the compliance declaration is optional for the manufacturer.


Done on August 27, 2015.


Manuel Valls

By the Prime Minister:


Minister of Economy, Industry and Digital,

Emmanuel Macron


The Seal Guard, Minister of Justice,

Christiane Taubira


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