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Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast) (Text with EEA relevance)
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Equipment shall be so designed and manufactured, having regard to the state of the art, as to ensure that:
the electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended;
it has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use.
Installation and intended use of components
A fixed installation shall be installed applying good engineering practices and respecting the information on the intended use of its components, with a view to meeting the essential requirements set out in point 1.
The manufacturer shall perform an electromagnetic compatibility assessment of the apparatus, on the basis of the relevant phenomena, with a view to meeting the essential requirements set out in point 1 of Annex I.
The electromagnetic compatibility assessment shall take into account all normal intended operating conditions. Where the apparatus is capable of taking different configurations, the electromagnetic compatibility assessment shall confirm whether the apparatus meets the essential requirements set out in point 1 of Annex I in all the possible configurations identified by the manufacturer as representative of its intended use.
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the apparatus conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the apparatus. The technical documentation shall, wherever applicable, contain at least the following elements:
a general description of the apparatus;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
results of design calculations made, examinations carried out, etc.;
test reports.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured apparatus 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.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer’s obligations set out 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.
The application shall specify the aspects of the essential requirements for which examination is requested and shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
a written declaration that the same application has not been lodged with any other notified body;
the technical documentation. The technical documentation shall make it possible to assess the apparatus conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the apparatus. The technical documentation shall contain, wherever applicable, at least the following elements:
a general description of the apparatus;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
results of design calculations made, examinations carried out, etc.;
test reports.
The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured apparatus with the examined type to be evaluated and to allow for in-service control.
Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the apparatus with the essential requirements of this Directive or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which 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 and/or additions thereto. On 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 body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured apparatus with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer’s obligations set out 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.
Signed for and on behalf of:
(place and date of issue):
(name, function) (signature):
(referred to in Article 45)
Directive | Time-limit for transposition | Date of application |
---|---|---|
2004/108/EC | 20 January 2007 | 20 July 2007 |
Directive 2004/108/EC | This Directive |
---|---|
Article 1(1) | Article 1 and Article 2(1) |
Article 1(2) | Article 2(2)(a) to (c) |
Article 1(3) | Article 2(2)(d) |
Article 1(4) | Article 2(3) |
Article 1(5) | Article 2(4) |
Article 2(1)(a) | Article 3(1)(1) |
Article 2(1)(b) | Article 3(1)(2) |
Article 2(1)(c) | Article 3(1)(3) |
Article 2(1)(d) | Article 3(1)(4) |
Article 2(1)(e) | Article 3(1)(5) |
Article 2(1)(f) | Article 3(1)(6) |
Article 2(1)(g) | Article 3(1)(7) |
Article 2(1)(h) | Article 3(1)(8) |
Article 2(2) | Article 3(2) |
Article 3 | Article 4 |
Article 4 | Article 5 |
Article 5 | Article 6 |
Article 6 | Article 13 |
Article 7 | Article 14 |
Article 8 | Articles 16 and 17 |
Article 9(1) | Article 7(5) |
Article 9(2) | Article 7(6) |
Article 9(3) | Article 18(1) |
Article 9(4) | Article 18(2) |
Article 9(5) | Article 18(3) |
Articles 10 and 11 | Articles 37, 38 and 39 |
Article 12 | Chapter 4 |
Article 13 | Article 19 |
Article 14 | Article 45 |
Article 15 | Article 43 |
Article 16 | Article 44 |
Article 17 | Article 46 |
Article 18 | Article 47 |
Annex I | Annex I |
Annex II and point 1 of Annex IV | Annex II |
Annex III | Annex III |
Point 2 of Annex IV | Annex IV |
Annex V | Articles 16 and 17 |
Annex VI | Article 24 |
Annex VII | Annex VI |
It is optional for the manufacturer to assign a number to the declaration of conformity.
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