EU CE Guide for EMC Device
EU Market Access for EMC
The EMC Directive 2014/30/EU applies to a vast range of equipment encompassing electrical and electronic appliances, systems and installations.
- Directive 2014/30/EU on electromagnetic compatibility
- For more information see the webpage on the EMC Directive
- See the webpage on harmonised standards for electromagnetic compatibility
Other directives may additionally apply depending on specific products.
The New Approach Directives for CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.
Directive 2014/30/EU on Electromagnetic Compatibility (EMC) specifies in detail the essential requirements the product has to meet in order for the manufacturer to affix the CE marking.
Directive 2014/30/EU is intended to ensure that equipment liable to generate or to be affected by electromagnetic disturbance can be used in the electromagnetic environment for which it has been designed without causing disturbances to other equipment or being affected by them. The 2014 directive updated and replaced Directive 2004/108/EC, which had previously regulated this area.
The essential requirements regarding electromagnetic compatibility for equipment are set out in Annex I of the directive.
The EMC Directive covers apparatus sold as single functional units to end users, which are either liable to generate electromagnetic disturbance, or could see their performance affected by it. It does not cover equipment which is specifically intended to be incorporated into a fixed installation and is not otherwise commercially available.
The EMC Directive does not apply to equipment covered by Directive 1999/5/EC. Aeronautical products and radio equipment used by radio amateurs are also excluded from the scope of the directive.
Need for notified body?
Under the EMC conformity assessment procedures, the manufacturer is obliged to perform an EMC assessment of the apparatus. The EMC Directive does not require the intervention of a notified body. However, the manufacturer or his authorised representative in the EU can present technical documentation to a notified body which will review it and assess whether the technical documentation properly demonstrates that the requirements of the directive have been met. If this is the case, the notified body will issue a statement confirming it. This statement shall be part of the technical documentation.
Then the manufacturer draws up the declaration of conformity (DoC) to declare on his sole responsibility conformity to the relevant directive. The establishment of the DoC is a legal obligation.
The declaration of conformity must include
- a reference to the directive
- an identification of the apparatus
- the manufacturer’s details such as name and address
- a dated reference of the specifications under which conformity is declared
- the date of the declaration
- the identity and signature of the person empowered to bind the manufacturer or his authorised representative
To find the notified bodies appointed by the Member States to carry out conformity assessment, the manufacturer should consult the NANDO database – the New Approach Notified and Designated Organisations. They can search for notified bodies by directive or by country via the NANDO homepage.
The conformity assessment process for apparatus covered by this directive consists of an internal production control procedure carried out by the manufacturer. This entails checking that the equipment meets the electromagnetic compatibility requirements set out in Annex I, or that the relevant European harmonised standards have been correctly applied.
Details of these 2 procedures are provided in Annexes II and III of the directive.
The manufacturer draws up and signs the EU declaration of conformity.
Once the chosen conformity assessment process is complete, the manufacturer can affix the CE marking to the equipment. This must be done in accordance with the instructions set out in Articles 16 and 17 of the directive.
Annex II to the EMC Directive requires the manufacturer to establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the directive. The technical documentation should comprise
- 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
- Evidence of compliance with the harmonised standards, if any, applied in full or in part
- Where the manufacturer has not applied harmonised standards, or has applied them only in part, a description and explanation of the solution adopted to meet the essential requirements of the directive, including a list of other relevant technical specifications applied
- results of design calculations made, examinations carried out, test reports, etc
- A statement from the notified body, when the procedure referred to in Annex III has been followed
The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed on the market.
Affix CE marking
Once the necessary steps have been successfully completed, the CE marking must be affixed to the product.
The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:
The various components of the CE marking must have the same vertical dimension, and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.
When the product is subject to other directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other directives.
However, when one or more of those directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking has to indicate conformity only with the directives applied by the manufacturer. In this case, the particularities of the directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the directives and accompanying such products.
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