This Directive regulates the electromagnetic compatibility of equipment. It aims to ensure the functioning of the internal market by requiring equipment to comply with an adequate level of electromagnetic compatibility.
1. This Directive shall apply to equipment as defined:
(1) ‘equipment’ means any apparatus or fixed installation;
(2) ‘apparatus’ means any finished appliance or combination thereof made available on the market as a single functional unit, intended for the end-user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance;
(3) ‘fixed installation’ means a particular combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location;
For the purposes of this Directive, the following shall be considered as apparatus:
(1) ‘components’ or ‘sub-assemblies’ intended for incorporation into an apparatus by the end-user, which are liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance;
(2) ‘mobile installations’ defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations.
2. This Directive shall not apply to:
(a) equipment covered by Directive 1999/5/EC;
(b) aeronautical products, parts and appliances as 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 establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC ( 2 );
(c) radio equipment used by radio amateurs within the meaning of the Radio Regulations adopted in the framework of the Constitution of the International Telecommunication Union and the Convention of the International Telecommunication Union ( 1 ), unless the equipment is made available on the market;
(d) equipment the inherent nature of the physical characteristics of which is such that:
(i) it is incapable of generating or contributing to electromagnetic emissions which exceed a level allowing radio and telecommunication equipment and other equipment to operate as intended; and
(ii) it operates without unacceptable degradation in the presence of the electromagnetic disturbance normally consequent upon its intended use;
(e) custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.
For the purposes of point (c) of the first subparagraph, kits of components to be assembled by radio amateurs and equipment made available on the market and modified by and for the use of radio amateurs are not regarded as equipment made available on the market.
1. General requirements
Equipment shall be so designed and manufactured, having regard to the state of the art, as to ensure that:
(a) the electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended;
(b) 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.
2. Specific requirements for fixed installations
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.
Conformity assessment procedures for apparatus
Compliance of apparatus with the essential requirements set out in Annex I shall be demonstrated by means of either of the following conformity assessment procedures:
(a) internal production control set out in Annex II;
(b) EU type examination that is followed by Conformity to type based on internal production control set out in Annex III.
The manufacturer may choose to restrict the application of the procedure referred to in point (b) of the first paragraph to some aspects of the essential requirements, provided that for the other aspects of the essential requirements the procedure referred to in point (a) of the first paragraph is applied.
EU declaration of conformity
1. The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in Annex I has been demonstrated.
2. The EU declaration of conformity shall have the model structure set out in Annex IV, shall contain the elements specified in the relevant modules set out in Annexes II and III and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the apparatus is placed or made available on the market.
3. Where apparatus is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned including their publication references.
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the apparatus with the requirements laid down in this Directive.
Rules and conditions for affixing the CE marking
1. The CE marking shall be affixed visibly, legibly and indelibly to the apparatus or to its data plate. Where that is not possible or not warranted on account of the nature of the apparatus, it shall be affixed to the packaging and to the accompanying documents.
2. The CE marking shall be affixed before the apparatus is placed on the market.
3. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
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