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Royal Decree 186/2016, Of 6 May, By Which The Electromagnetic Compatibility Of Electrical And Electronic Equipment Is Regulated.

Original Language Title: Real Decreto 186/2016, de 6 de mayo, por el que se regula la compatibilidad electromagnética de los equipos eléctricos y electrónicos.

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ry, Energy and Tourism, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of the 6th of May 2016,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object.

This royal decree regulates the electromagnetic compatibility of electrical and electronic equipment in order to ensure the functioning of the European Union's internal market, requiring equipment to comply with a standard suitable for electromagnetic compatibility.

Article 2. Scope.

1. The provisions of this Royal Decree shall apply to electrical and electronic equipment as defined in Article 3.

2. This royal decree will not apply to:

(a) The radio equipment referred to in Royal Decree 188/2016 of 6 May 2016 approving the Regulation laying down the requirements for the placing on the market, putting into service and use of radio equipment, and the procedure for conformity assessment, market surveillance and the sanctioning regime of telecommunications equipment is regulated.

(b) The aeronautical products, components and equipment referred to in Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and on the creates a European Aviation Safety Agency, and repeals Council Directive 91 /670/EEC, Regulation (EC) No 1592/2002 and Directive 2004 /36/EC.

(c) Radio equipment used by radio amateurs, within the meaning of the Radio Regulations adopted in the framework of the Constitution and the International Telecommunication Union Convention, except that the equipment are marketed.

d) Equipment whose physical characteristics are such that:

1. No may generate or contribute to electromagnetic emissions that exceed a level that allows radio and telecommunications equipment, and other equipment, to operate as intended; and

2. º. It works without unacceptable degradation in the presence of normal electromagnetic disturbances derived from its intended use.

e) Evaluation kits, manufactured by order, intended to be used by professionals exclusively in research and development facilities for such purposes.

For the purposes of paragraph (c) above, no equipment shall be considered to be placed on the market for components kits to be mounted by radio amateurs and equipment placed on the market and modified by and for the use of such equipment. radio amateurs.

3. Telecommunications equipment which is not radio equipment shall be subject to this royal decree, with the exception of the provisions of Chapters IV, V and VI, relating to the notification of conformity assessment bodies, the market surveillance and sanctioning regime, matters which will be governed by the rules laid down in the sectoral telecommunications legislation, by means of Royal Decree 188/2016 of 6 May 2016 on the Regulation establishing the requirements for the placing on the market, putting into service and use of radio equipment, and regulating the the procedure for the assessment of conformity, market surveillance and the sanctioning system of telecommunications equipment.

In the event that an apparatus of any nature incorporates a telecommunications equipment for its operation or for any auxiliary activity thereof, the telecommunications equipment shall be applied to the law established in the Law 9/2014, 9 May, General Telecommunications and its development regulations.

4. The present royal decree will not prevent the application of the legislation of the European Union or national governing the safety of the equipment, understanding as such relative to the protection to the health and safety of the users.

Article 3. Definitions.

1. For the purposes of implementing this royal decree,

following definitions shall apply:

a) "Equipment": Any apparatus or fixed installation;

(b) "Apparatus" means any finished apparatus, or a combination of them marketed as a single functional unit intended for the end user, and which can generate electromagnetic disturbances, or whose operation may be affected for these disturbances;

(c) "Fixed installation" means a combination of several types of apparatus and, where applicable, other devices, assembled, installed and intended for permanent use on a predefined site;

d) "Electromagnetic Compatibility": Ability to make a team function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances for other equipment in that environment;

e) "Electromagnetic disturbance": Any electromagnetic phenomenon that can create operating problems for a team; an electromagnetic disturbance may consist of an electromagnetic noise, an unwanted signal or a modification of the means of propagation itself;

(f) "Immunity" means the aptitude of a team to function in the intended form without experiencing degradation in the presence of electromagnetic disturbances;

g) "Security Fines": The purposes of protecting human life or property;

h) "Electromagnetic environment": All observable electromagnetic phenomena at a given site;

(i) "Marketing" means any supply, paid or free, of equipment for distribution, consumption or use on the Union market in the course of a commercial activity;

(j) "Market Introduction": The first placing on the market of appliances on the Union market;

k) "Manufacturer" means any natural or legal person who manufactures appliances or who is responsible for the design or manufacture of such apparatus and places such equipment on the market under his name or registered trademark;

(l) "authorised representative" means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf on specific tasks;

m) "Importer" means any natural or legal person established in the Union who places in the Union market apparatus of a third country;

n) "Distributor" means any natural or legal person integrated in the distribution chain, other than the manufacturer or importer, who places an appliance on the market;

n) "Economic agents": The manufacturer, the authorised representative, the importer and the distributor;

or) "Technical Specification": A document that defines the technical requirements of a team;

p) "harmonised standard": harmonised standard as defined in point (c) of point 1 of Article 2 w 9/2014 of 9 May 2014, General Telecommunications.

According to the provisions of Article 24.1.c) of Law 50/1997 of 27 November 1997, the present provision has been submitted to the hearing, referring to the industrial sectors concerned. The competent bodies of the Autonomous Communities have also been consulted.

This royal decree is issued in accordance with the provisions of Article 149.1.13 of the Constitution, which attributes to the State the competence to determine the bases and coordination of the general planning of economic activity, without prejudice to the powers of the Autonomous Communities in the field of industry, and Article 149.1.21. of the Constitution, which confers exclusive competence on the State in the field of telecommunications.

In its virtue, on the proposal of the Minister of Economy and Competitiveness, by the Minister of Industturer can be contacted. The contact details shall be at least in Spanish.

7. Manufacturers shall ensure that the apparatus is accompanied by the instructions and the rest of the information set out in Article 18 at least in Spanish. Such instructions and information, as well as any labelling, shall be clear, comprehensible and intelligible.

8. Manufacturers who consider or have reason to believe that an apparatus which they have placed on the market is not in conformity with the provisions of this Royal Decree shall immediately take the necessary corrective measures to ensure that they are in conformity, by removing it from the market or recovering it, if necessary. In addition, where the apparatus presents a risk, manufacturers shall immediately inform the Ministry of Industry, Energy and Tourism for the telecommunications equipment and the autonomous communities for the other equipment, in which they are Demarcation on the market and providing details, in particular, on non-compliance and the corrective measures taken.

9. In response to a reasoned request from the Ministry of Industry, Energy and Tourism for telecommunications equipment and autonomous communities for the rest of the equipment, manufacturers shall provide all information and documentation. necessary, in paper or electronic format, to demonstrate the conformity of the apparatus with the present royal decree, at least in Spanish. At the request of the Ministry of Industry, Energy and Tourism or the Autonomous Communities, they shall cooperate in any action aimed at eliminating the risks posed by the apparatus which they have placed on the market.

Article 8. Authorised representatives.

1. Manufacturers may, by any means valid in law, designate an authorised representative of the representation in question.

The obligations laid down in Article 7.1 and the obligation to draw up technical documentation referred to in Article 7.2 shall not form part of the mandate of the authorised representative.

2. The authorised representatives shall carry out the tasks specified in the mandate received from the manufacturer. The power granted by the manufacturer shall allow the authorised representative to perform at least the following tasks:

(a) Maintain the EU declaration of conformity and the technical documentation at the disposal of the Ministry of Industry, Energy and Tourism for telecommunications equipment and the competent authorities of the Autonomous Communities for the rest of the equipment, for a period of 10 years after the appliance has been placed on the market;

(b) In response to a reasoned request from the Ministry of Industry, Energy and Tourism for telecommunications equipment or autonomous communities for other appliances, to provide that authority with all information and documentation necessary to demonstrate the conformity of the appliance;

(c) Cooperate with the Ministry of Industry, Energy and Tourism or with the autonomous communities, upon request of these Administrations, in any action aimed at eliminating the risks posed by the apparatus of the authorized representative.

Article 9. Obligations of importers.

1. Importers shall only place compliant appliances on the market.

2. Before placing an appliance on the market, importers shall ensure that the due process of conformity assessment has been carried out by the manufacturer, within the framework of those referred to in Article 14. They shall ensure that the manufacturer has drawn up the technical documentation, that the apparatus bears the CE marking and is accompanied by the necessary documents, and that the manufacturer has complied with the labelling requirements laid down in the Article 7, paragraphs 5 and 6.

Where an importer considers or has reason to believe that an appliance is not in conformity with the essential requirements of Annex I, it shall not place such apparatus on the market until it is compliant. In addition, where the apparatus presents a risk, the importer shall inform the manufacturer, as well as the Ministry of Industry, Energy and Tourism for the telecommunications equipment and the autonomous communities for the other equipment, in this respect.

3. Importers shall indicate on the apparatus their name, registered trade name or registered trade mark and their postal address of contact or, where that is not possible, on their packaging or in a document accompanying the appliance. The contact details shall be at least in Spanish.

4. Importers shall ensure that the apparatus is accompanied by the instructions and information referred to in Article 18 at least in Spanish.

5. Importers shall ensure that, while they are responsible for an appliance, the conditions of their storage or transport do not jeopardise the fulfilment of the essential requirements of Annex I.

6. Importers who consider or have reason to believe that an apparatus which they have placed on the market is not in conformity with this royal decree shall immediately take the corrective measures necessary to bring it into conformity, by withdrawing it from the market. or by recovering it, if necessary. In addition, where the apparatus presents a risk, importers shall immediately inform the Ministry of Industry, Energy and Tourism for the telecommunications equipment and the autonomous communities for the other equipment in which they are placed. trade and provide details, in particular, on non-compliance and any corrective measures taken.

7. For 10 years after the appliance has been placed on the market, importers shall keep a copy of the EU declaration of conformity at the disposal of the Ministry of Industry, Energy and Tourism or the competent authorities of the autonomous communities and shall ensure that, upon request, such authorities receive a copy of the technical documentation.

8. In response to a reasoned request from the Ministry of Industry, Energy and Tourism for telecommunications equipment and autonomous communities for the rest of the equipment, importers shall provide all information and documentation. necessary, in paper or electronic format, to demonstrate the conformity of the apparatus with the present royal decree, at least in Spanish. At the request of the Ministry of Industry, Energy and Tourism or the Autonomous Communities, they shall cooperate in any action aimed at eliminating the risks posed by the apparatus which they have placed on the market.

Article 10. Obligations of distributors.

1. When placing an appliance on the market, distributors shall act with due diligence in relation to the requirements of this royal decree.

2. Before placing an appliance on the market, distributors shall ensure that the apparatus bears the CE marking, accompanied by the required documents and the instructions and information referred to in Article 18 at least in Spanish, and the manufacturer and the importer have complied with the requirements laid down in Article 7.5 and 6 and in Article 9.3 respectively.

Where a distributor considers or hastype, batch or serial number or any other element which permits their identification or, if the size or nature of the apparatus does not permit, that the Required information is contained in the packaging or in a document accompanying the appliance.

6. Manufacturers shall indicate on the apparatus their name, registered trade name or registered trade mark and their postal address of contact or, where that is not possible, on their packaging or in a document accompanying the product. The address must indicate a single place where the manufac enable the apparatus to be used in accordance with the intended purpose shall be included in the instructions accompanying the apparatus. These instructions must be written in Spanish at least.

Article 19. Fixed installations.

1. The apparatus placed on the market and which can be incorporated into a fixed installation must comply with all the requirements laid down in this royal decree.

However, the requirements of Articles 6 to 12 and 14 to 18 shall not be mandatory in the case of an apparatus intended to be incorporated into a specific fixed installation and which otherwise would not be placed on the market.

In such cases, the accompanying documentation shall identify the fixed installation and its electromagnetic compatibility characteristics and indicate the precautions to be taken for the incorporation of the apparatus into the installation. does not compromise the conformity of that installation. It shall also include the information referred to in Article 7.5 and 6 and Article 9.3.

Good engineering practices referred to in point 2 of Annex I shall be documented and the person or persons responsible shall keep such documentation at the disposal of the competent authorities for the purposes of inspection during the operation of the fixed installation.

2. Where there are indications of the non-compliance of the fixed installation, in particular where there are complaints about disturbances which it generates, the competent authorities may request evidence of the conformity of the fixed installation and, where proceed, perform an assessment.

Where non-compliance is demonstrated, competent authorities shall impose appropriate measures to ensure that the fixed installation complies with the essential requirements set out in Annex I.

3. The conformity of a fixed installation with the conditions and requirements required under this royal decree and its maintenance shall be the responsibility of the owner and, where appropriate, of the owner of the installation.

CHAPTER IV

Notification of control bodies

Article 20. Notification.

The control bodies which comply with the legally required conditions shall be notified to the European Commission and the other Member States to carry out the conformity assessment tasks regulated in this area. decree.

Article 21. Notifying authority.

The Ministry of Industry, Energy and Tourism is designated as notifying authority, which shall be responsible for the establishment of the procedures necessary for the assessment and notification of the control bodies and the monitoring of them, taking into account the compliance with the provisions of Article 22 of this royal decree, informing them, as well as any changes that occur, to the European Commission, through the General Secretariat of Industry and Small and Medium Enterprises.

Article 22. Notified control bodies.

1. The control bodies notified by the Ministry of Industry, Energy and Tourism will have to comply with the provisions of Royal Decree 2200/1995 of 28 December, approving the Regulation of the Infrastructure for Quality and Safety Industrial. These bodies must in any event comply with the following minimum requirements:

(a) The control body shall have legal personality.

(b) The control body shall be independent of the organisation or team it assesses. It may be a body belonging to a business association or a professional federation representing undertakings involved in the design, manufacture, supply, assembly, use or maintenance of equipment or equipment. (a) a joint assessment, provided that its independence and the absence of conflicts of interest are demonstrated.

c) The control body, its top management and the staff responsible for carrying out the conformity assessment tasks shall not be the designer, the manufacturer, the supplier, the installer, the buyer, the owner, the the user or the person in charge of the maintenance of the equipment or assemblies they evaluate, or the representative of any of them. This shall not preclude the use of the equipment or sets assessed as necessary for the conformity assessment activities.

(d) The control body, its top management and the personnel responsible for carrying out the conformity assessment tasks shall not directly intervene in the design, manufacture or construction, the placing on the market, installation, use or maintenance of such equipment or assemblies, or represent the parties involved in these activities. They shall not engage in any activity that may conflict with their independence of criteria or their integrity in relation to the conformity assessment activities for which they are notified. This shall apply in particular to consultancy services.

(e) Control bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of their conformity assessment activities.

f) the control bodies and their staff shall carry out the activities of conformity assessment with the highest level of professional integrity and with the required technical competence for the specific field, and shall be free of any pressure or incentive, in particular of a financial nature, which may influence its assessment or the outcome of its conformity assessment activities, in particular that which may be exercised by persons or groups of persons who have some interest in the results of these activities.

(g) The control body shall be capable of carrying out all the conformity assessment tasks assigned to it in accordance with the provisions of Article 14 and Annex III and for which it has been notified, whether you perform the tasks of the body itself or are carried out on your behalf and under your responsibility. At all times, in respect of each conformity assessment procedure and for each type or category of equipment for which it has been notified, the control body shall have:

1. The required personnel with sufficient technical knowledge and experience to perform the conformity assessment tasks.

2. of the descriptions of the procedures under which conformity assessment is carried out, ensuring the transparency and the possibility of reproduction of these procedures, and of strategies and appropriate procedures to distinguish between tasks carried out as a control body and any other activity.

3. Procedures for carrying out their activities taking due account of the size of the companies, the sector in which they operate, their structure, the degree of complexity of the technology of the product concerned and whether the production process is serial.

(h) The control body shall have the necessary means to perform the technical and administrative tasks related to conformity assessment activities appropriately and shall have access to the entire equipment or the facilities you need. In particular, the personnel carrying out the conformity assessment tasks shall have:

2. Equipment in which compliance with the essential requirements laid down in Annex I, point 1 is not guaranteed in residential areas shall be accompanied by a clear indication of this restriction of use, which shall also appear, if comes in the packaging.

3. The information necessary to

The notified control bodies shall carry out their activities taking due account of the size of the undertakings, the sector in which they operate, their structure, the degree of complexity of the equipment technology and whether the process of production is serial.

However, they will respect the degree of rigour and the level of protection required for the apparatus to comply with this royal decree.

(c) If a notified control body finds that the apparatus does not meet the essential requirements set out in Annex I or the relevant harmonised standards or other technical specifications, it shall require the manufacturer to take appropriate corrective action and will not issue a certificate.

(d) If in the course of the follow-up of the conformity in succession to the issue of the certificate, a notified inspection body finds that the apparatus is no longer compliant, it shall require the manufacturer to take the corrective measures. appropriate and, if necessary, suspend or withdraw its certificate.

e) If no corrective action is taken or the corrective measures are not taken, the notified control body shall restrict, suspend or withdraw any certificate, as appropriate.

Article 28. Complaints against the decisions of the notified control bodies.

When a notified control body issues a protocol, minutes, report or certification with a negative result in compliance with the regulatory requirements, the person concerned may claim to express his/her disagreement. with the same before the body itself and, in case of disagreement, before the competent administration, in accordance with the provisions of article 16.2 of Law 21/1992, of 16 July, of Industry.

Article 29. Obligation of information of the notified control bodies.

1. The notified control bodies shall inform the autonomous communities and, if appropriate, the General Secretariat of Industry and Small and Medium-sized Enterprises:

a) Of any denial, restriction, suspension, or withdrawal of certificates;

(b) Any circumstances affecting the scope and conditions of notification;

(c) Any request for information on the conformity assessment activities that they have received from the competent market surveillance authorities;

(d) Upon request, of the conformity assessment activities carried out within the scope of its notification and any other activities carried out, including cross-border activities and subcontracting.

2. The notified control bodies shall provide the other notified bodies in accordance with this Royal Decree with similar conformity assessment activities and which provide for the same apparatus, the information relevant to issues related to negative results and, upon request, with positive results of the conformity assessment.

CHAPTER V

Market surveillance of the European Union, control of equipment entering the European Union market and safeguard procedure

Article 30. Market surveillance and control of devices entering the market.

1. They shall apply to appliances falling within the scope of this Royal Decree, Article 15 (3) and Articles 16 to 29 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008.

2. The market surveillance of the equipment included in the scope of this royal decree, will be carried out by the competent bodies of the autonomous communities, in accordance with the provisions of Law 21/1992, of July 16, of Industry.

3. In accordance with the provisions of Article 14.2 of Law 21/1992 of 16 July 1992, of Industry, without prejudice to the actions of inspection and control which the autonomous communities competent in the field develop in their territorial area, the Ministry of Industry, Energy and Tourism may promote, in collaboration with the respective autonomous communities, national plans and campaigns of verification by sampling, of the conditions of protection of the equipment and assemblies referred to in Article 2.1 of this royal decree.

Article 31. Appliances presenting a risk at national level.

1. Where the competent market surveillance authorities have sufficient reason to believe that an apparatus subject to this Royal Decree poses a risk to the aspects of the protection of the public interest indicated in the requirements essential, they shall carry out an assessment related to the apparatus in question on the basis of all the relevant requirements set out in this Royal Decree. To this end, the relevant economic operators shall cooperate in accordance with the requirements with the market surveillance authorities.

When, in the course of the assessment referred to above, the competent market surveillance authorities find that the apparatus does not meet the requirements set out in this royal decree, the agent shall be requested without delay. (a) relevant economic operator taking all appropriate corrective measures to adapt the apparatus to those requirements, to withdraw it from the market or to recall it within a reasonable period of time, proportionate to the nature of the risk, prescribe.

The competent market surveillance authorities shall report to the relevant notified control body in case it has intervened in the conformity assessment of the appliance.

Article 21 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

2. Where the competent authorities of market surveillance consider that the non-compliance is not limited to the national territory, they shall inform the Commission and the other Member States, through the Ministry of Industry, Energy and Tourism, of the the results of the assessment and the measures they have requested from the economic operator to take.

3. The economic operator shall ensure that all relevant corrective measures are taken in relation to all appliances which it has placed on the market throughout the European Union.

4. If the relevant economic operator does not take appropriate corrective action within the time limit, the Autonomous Communities shall take all appropriate provisional measures to prohibit or restrict the placing on the market of the apparatus in question. national market, remove it from that market or recover it.

The affected autonomous communities shall communicate to the Ministry of Industry, Energy and Tourism the provisional measures taken and shall inform the European Commission and the other Member States of such measures.

5. The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant apparatus, the origin of the apparatus, the nature of the alleged non-conformity and the risk posed, and the nature and duration of the national measures taken, as well as the arguments put forward by the relevant ecoures be taken.

Article 27. Operational obligations of the notified control bodies.

In any case the notified control bodies shall comply with the following operational obligations:

(a) The notified control bodies shall carry out conformity assessments in accordance with the conformity assessment procedures set out in Annex III.

(b) Compliance assessments shall be carried out in a proportionate manner, avoiding the imposition of unnecessary burdens on economic operators. developments, will ensure:

(a) that the electromagnetic disturbances generated are limited to a level that allows radio and telecommunications equipment or other equipment to operate for the purpose for which they have been intended;

b) A level of protection against foreseeable electromagnetic disturbances that allows the equipment to operate without unacceptable degradation in its intended use.

When, in the case of one of the teams referred to in Article 2.1 of this royal decree, there is other European Union legislation regulating in a more specific way all or part of the essential requirements that are set out in paragraph 1, with regard to those requirements, that legislation shall apply from the date to be determined therein.

2. Specific requirements for fixed installations

Installing and intended use of components:

Fixed installations shall be installed in accordance with good engineering practice and with information on the intended use of their components in order to meet the essential requirements set out in point 1.

ANNEX II

Module A: Internal production control

1. The internal control of production is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 3, 4 and 5 of this Annex, and ensures and declares, under his sole responsibility, that the apparatus in question satisfies the requirements of this royal decree that apply to it.

2. Assessment of electromagnetic compatibility.

The manufacturer shall carry out an assessment of the electromagnetic compatibility of the apparatus, based on the relevant phenomena, in order to meet the essential requirements set out in point 1 of Annex I.

The assessment of electromagnetic compatibility shall take into account all the normal operating conditions. In cases where the apparatus may have different configurations, the electromagnetic compatibility assessment shall confirm whether the apparatus complies with the essential requirements set out in point 1 of Annex I in all configurations. identified by the manufacturer as representative of its intended use.

3. Technical documentation.

The manufacturer will produce the technical documentation. The documentation shall allow the assessment of whether the apparatus meets the relevant requirements and shall include an appropriate risk assessment and assessment.

The technical documentation shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, the design, manufacture and operation of the apparatus. The technical documentation shall include, where appropriate, at least the following elements:

a) A general description of the appliance;

b) The design and manufacturing plans and the schemas of the components, subassemblies, circuits, etc.;

(c) The descriptions and explanations necessary for the understanding of such drawings and schemes and the operation of the apparatus;

(d) A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where such harmonised standards have not been applied, the description of the solutions adopted to meet the essential requirements of this Royal Decree, including a list of other relevant technical specifications applied; in the case of harmonised standards which are applied in part, they shall be specified in the technical documentation of the parts that have been applied;

e) The results of the design calculations performed, the examinations performed, etc.; and

f) The reports on the trials.

4. Manufacturing.

The manufacturer shall take all necessary steps to ensure that the manufacturing process and its monitoring ensure the conformity of the equipment manufactured with the technical documentation referred to in point 3 of this Annex and with the essential requirements set out in point 1 of Annex I.

5. CE marking and EU declaration of conformity.

5.1 The manufacturer shall affix the CE marking to each appliance that satisfies the applicable requirements of this royal decree.

5.2 The manufacturer shall draw up an EU declaration of conformity for each appliance model and keep it, together with the technical documentation, at the disposal of the competent authorities for a period of 10 years after the introduction of the apparatus into the market. The EU declaration of conformity shall identify the apparatus for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

6. Authorized representative.

The manufacturer's obligations referred to in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate of the manufacturer.

ANNEX III

PART A

Module B: EU Type Exam

1. The EU type examination is the part of the conformity assessment procedure whereby a notified control body examines the technical design of an appliance and verifies and attests that its technical design meets the essential requirements. listed in point 1 of Annex I.

2. The EU-type examination shall be carried out by assessment of the adequacy of the technical design of the apparatus, by examination of the technical documentation referred to in point 3, without examining a sample (type of design). It may be restricted to certain aspects of the essential requirements in accordance with what the manufacturer or his authorised representative specifies.

3. The manufacturer shall submit an EU type examination application to a single notified control body of his choice.

This application shall specify the aspects of the essential requirements for which the examination is sought and shall include:

(a) The name and address of the manufacturer and, if the application is submitted by the authorised representative, also the name and address of the authorised representative;

(b) A written declaration specifying that the same application has not been filed with another notified body of control;

c) The technical documentation. The technical documentation shall enable the conformity of the apparatus to be assessed with the applicable requirements of this royal decree and shall include an appropriate analysis and assessment of the risks, specify the applicable requirements and refer to the the extent to which it is relevant for the assessment, design, manufacture and operation of the apparatus. The technical documentation shall include, where appropriate, at least the following elements:

i) A general description of the appliance;

FELIPE R.

The Minister of Industry, Energy and Tourism,

P. S. (Royal Decree 160/2016, of April 15),

The Minister of Economy and Competitiveness,

LUIS DE GUINDOS JURADO

ANNEX I

Essential Requirements

1. General requirements

The design and manufacture of equipment, taking into account the latestfor the identification of the device.

5. The purpose of the statement described above is in accordance with the relevant harmonisation legislation of the European Union.

6. References to the relevant harmonised standards used, including the dates of the standards, or references to the other technical specifications, including the dates of the specifications, for which conformity is declared:

7. If applicable, the notified body ... (name, number) ... has carried out ... (description of the intervention) ... and issues the certificate:

8. Additional information:

Signed on behalf of:

(Place and date of issue):

(Name, charge) (signature):

(1) The manufacturer will be optional to assign a number to the compliance declaration.

="parrafo">vi) The reports on the trials.

4. The notified control body shall examine the technical documentation to assess the adequacy of the technical design of the appliance in relation to the aspects of the essential requirements for which the examination is requested.

5. The notified inspection body shall draw up an assessment report to take into account the activities carried out in accordance with point 4 and its results. Without prejudice to its obligations with regard to the notifying authority, the notified body shall only disclose the content of this report, in full or in part, with the agreement of the manufacturer.

6. If the type meets the requirements of this royal decree which apply to the apparatus in question, the notified control body shall issue the manufacturer with an EU-type examination certificate. This certificate shall include the name and address of the manufacturer, the conclusions of the examination, the aspects of the essential requirements which are the subject of the examination, the conditions of validity (where applicable) and the data necessary to identify the approved type. One or more annexes may be attached to the EU-type examination certificate.

The EU type-examination certificate and its annexes shall contain all relevant information to assess the conformity of the devices manufactured with the type examined and to allow the control in service.

If the type does not satisfy the applicable requirements of this royal decree, the notified control body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly. in detail its refusal.

7. The notified control body shall be kept informed of changes in the generally recognised state of the art which indicate that the approved type can no longer meet the applicable requirements of this royal decree, and shall determine whether such changes Changes require further research. In that case, the notified control body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified control body that the technical documentation relating to the EU-type examination certificate on any modification of the approved type which may affect conformity has in its possession the apparatus with the essential requirements of this royal decree or the conditions of validity of the said certificate. Such modifications shall require additional approval in the form of addition to the original EU-type examination certificate.

8. Each notified inspection body shall inform its notifying authority of the EU type-examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, on a regular basis or upon request, make available to it notifying authority the list of such certificates and/or additions thereto which have been rejected, suspended or otherwise restricted.

Each notified control body shall inform the other notified bodies of the EU type-examination certificates and/or any additions thereto which it has rejected, withdrawn, suspended or otherwise restricted and, upon request, on such certificates and/or any additions thereto it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU type-examination certificates or their additions. Upon request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified inspection body. The notified inspection body shall be in possession of a copy of the EU-type examination certificate, its annexes and additions, as well as of the technical file containing the documentation submitted by the manufacturer until the end of the validity of the that certificate.

9. The manufacturer shall keep at the disposal of the competent authorities a copy of the EU-type examination certificate, its annexes and additions, as well as the technical documentation for a period of 10 years after the introduction of the the market.

10. The authorised representative of the manufacturer may submit the application referred to in point 3 and fulfil the obligations referred to in points 7 and 9, provided that they are specified in his mandate.

PART B

Module C: Compliance with type based on internal production control

1. Conformity with the type based on the internal control of production is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares, under its sole responsibility, which the appliances in question are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this royal decree which apply to them.

2. Manufacturing.

The manufacturer shall take all necessary measures to ensure that the manufacturing process and its monitoring ensure the conformity of the manufactured appliances with the approved type described in the EU-type examination certificate and with the requirements of this royal decree that apply to them.

3. CE marking and EU declaration of conformity.

3.1 The manufacturer shall affix the CE marking to each appliance that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this royal decree.

3.2 The manufacturer shall draw up an EU declaration of conformity for each appliance model and keep it at the disposal of the competent authorities for a period of 10 years after the appliance has been placed on the market. The EU declaration of conformity shall identify the apparatus for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

4. Authorized representative.

The manufacturer's obligations referred to in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate of the manufacturer.

ANNEX IV

EU Declaration of Conformity (n. XXXX)(1)

1. Apparatus/Product Model (product number, type, batch or series):

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer.

4. The purpose of the declaration (identification of the device allowing traceability); may include an image in sufficient sharpness of colour if necessary