CE Approval Guide for Manufacturers <12>
Manufacturers play a crucial role in ensuring that products placed on the extended single market of the European Economic Area (EEA) are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.
If you are a manufacturer, you have to follow these 6 steps to affix a CE marking to your product:
- Identify the applicable directive(s) and harmonised standards
- Verify product specific requirements
- Identify whether an independent conformity assessment (by a notified body) is necessary
- Test the product and check its conformity
- Draw up and keep available the required technical documentation
- Affix the CE marking and draw up the EU Declaration of Conformity (27 KB).
These 6 steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.
For products that present higher safety risks such as gas boilers, safety cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. The manufacturer may affix the CE marking to the product only once this has been done.
Product groups
Low voltage
Directives
If your product(s) fall(s) within the sector of low voltage electrical equipment, Directive 2014/35/EU applies.
- Directive 2014/35/EU on Low Voltage
- For further information on low voltage devices, please also visit the Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs website dedicated to this subject by following this link: http://ec.europa.eu/growth/sectors/electrical-engineering/lvd-directive_en
- Directive 2014/35/EU which repealed the old Directive 2006/95/EC is aligned to the New Legislative Framework policy. Nevertheless, Directive 2014/35/EU keeps the same scope and safety objectives as Directive 2006/95/EC.
Other Directives may additionally apply depending on specific products.
Verify requirements
The New Approach Directives for the 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 2014/35/EU on Low Voltage Devices specifies in detail the essential requirements the product must meet in order for the manufacturer to affix the CE marking.
Directive 2014/35/EU is intended to remove all obstacles to the sale of low voltage electrical equipment within the EU, while at the same time ensuring that they offer the highest possible level of safety.
‘Low voltage electrical equipment’ are defined as any equipment designed for use with a voltage rating between 50 and 1,000 V for alternating current and between 75 and 1,500 V for direct current. Annex II to the Directive contains a list of equipment not covered, including electrical components of lifts, electricity meters, plugs and socket outlets for domestic use.
The Directive 2014/35/EU specifies that equipment must not endanger the safety of people, animals or property ‘when properly installed and maintained and used in applications for which it was made’. The key safety objectives for equipment covered are listed in Annex I.
It is necessary to consult the Directive in order to ensure that the product complies with all the essential requirements.
Need for notified body?
When placing the electrical equipment on the EU market, the manufacturer has the responsibility to ensure and to declare that the products conform to the applicable legislative requirements. Directive 2014/35/EU does not require notified bodies to carry out the conformity assessment procedure.
Check conformity
Conformity assessment for products covered by the Low Voltage Directive takes the form of an internal production control procedure carried out by the manufacturer himself, without the involvement of a third party. The details of this procedure are set out in Annex III to the Directive.
The manufacturer or his authorised representative in the EU must draw up and sign the EU Declaration of Conformity.
Annex IV of the Directive describes the content of the Declaration of Conformity as follows:
- Product model/product (product, type, batch or serial number);
- Name and address of the manufacturer or his authorised representative,;
- This declaration of conformity is issued under the sole responsibility of the manufacturer;
- Object of the declaration (identification of electrical equipment allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the electrical equipment);
- References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared;
- Additional information.
The declaration of conformity must be drawn up in at least in one of the official languages of the Union.
Technical documentation
After completion of the assessment of the product, the assessment procedure must be documented as set out in Directive 2014/35/EU, Annex III, Nr. 2.
The technical documents must enable the assessment of conformity of the product with the requirements of the Directive. It must, as far as it is relevant for such an assessment, cover the design, manufacture and operation of the electrical equipment. The technical file should comprise at least:
- a general description of the electrical equipment,
- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the electrical equipment,
- a list of the harmonised standards applied in full or in part or international or national standards referred to in Articles 13 and 14 and, where those harmonised standards or international or national standards have not been applied, descriptions of the solutions adopted to meet the safety objectives of the Directive, including a list of other relevant technical specifications applied;
- results of design calculations made, examinations carried out, etc.; and
- test reports.
The manufacturer or his authorised representative established in the European Union is requested to keep the technical documentation for a period of 10 years after the electrical equipment has been 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 above graduated drawing must be adhered to.
When the product is subject to other Directives covering other aspects that 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 must 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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