CE Approval Guide for Manufacturers <16>
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.
Active implantable medical devices
Appliances burning gaseous fuels
Cableway installations designed to carry persons
Ecodesign of energy related products
Equipment and protective systems intended for use potentially explosive atmospheres
Explosives for civil uses
In vitro diagnostic medical devices
Noise emission in the environment
If your product(s) fall(s) within the sector of construction or gardening equipment, it might be subject to the Directive 2000/14/EC on Noise Emission in the Environment.
- Directive 2000/14/EC on Noise emission in the environment
- For further information on Directive 2000/14/EC on Noise emission, please visit the Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs webpage dedicated to this sector by following this link: http://ec.europa.eu/growth/sectors/mechanical-engineering/noise-emissions_en
- More on noise emission by outdoor equipment
Other Directives may additionally apply depending on specific products.
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 2000/14/EC on Noise Emission in the Environment specifies essential requirements regarding the permissible sound power level of specific equipment that the product must meet in order for the manufacturer to affix the CE marking.
Directive 2000/14/EC covers equipment such as machines and equipment used for construction, gardening and others. Article 12 lists the equipment subject to noise limits, Article 13 lists the equipment subject to noise labeling and Annex I lists all equipment types the Directive refers to. In this regard, certain equipment is subject to noise limits, whereas other equipment is subject to noise marking only. The detailed noise level permitted for the respective equipment is also listed in Article 12.
The first step a manufacturer should take to ensure that the equipment will be compliant with the Directive is to carry out an assessment procedure, with regard to the essential requirements. The Directive lays out different assessment procedures for that purpose: the internal production control assessment with periodical checking procedures, unit verification procedures or the full quality assurance procedure. The procedures are described in detail in Annexes V to VIII to the Directive (see art 14).
It is necessary to consult the Directive to ensure that the product complies with all the essential requirements.
Need for notified body?
Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you need to involve a Notified Body.
Directive 2000/14/EC on Noise Emission in the Environment foresees the involvement of a Notified Body (except in case of the procedure laid down under Annex V) .
A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.
When the Notified Body is convinced of product compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw 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 the manufacturer’s details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult your specific Directive.
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.
In accordance with basic noise emission standards referred to in Annex III, Part A and B, to the Directive, the manufacturer is required to test the noise emission of the respective equipment. The procedures and noise emission standards for each respective equipment category are laid out in the Directive. A Notified Body will then assess the conformity of the product to the requirements of Directive 2000/14/EC on Noise Emission in the Environment in one of the procedures laid out in Annexes VI to VII to the Directive.
In the procedure of internal production control with assessment of the technical documentation, the manufacturer carries out internal tests and draws up the required technical documentation for the Notified Body to assess. The Notified Body then confirms the successful fulfilment of the requirements of the Directive or in cases where deemed necessary, carries out periodical checks in order to verify continuing compliance of the manufactured equipment with the submitted technical documentation and with the requirements of the Directive.
Whether a Notified Body has been involved or not, the manufacturer needs to draw up and sign the EC Declaration of Conformity.
Additional processes are unit verification, which for instance includes noise tests carried out by the Notified Body, or full quality assurance. In the latter, the manufacturer must operate an approved quality assurance system for design, manufacture and final product inspection and testing, which will be assessed by the Notified Body.
Upon successful assessment, Directive 2000/14/EC on Noise emission in the environment requires a technical documentation as laid out in Annexes V – VIII (see art 14.3). The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The technical file should comprise:
- The name and address of the manufacturer or his authorised representative established in the Community
- A description of the equipment
- The trade name
- The type, series and numbers
- The technical data relevant for the identification of the equipment and the assessment of its noise emission, including, if appropriate, schematic drawings and any description and explanation necessary for their understanding
- The reference to the Directive
- The technical report of noise measurements carried out in accordance with the provisions of the Directive
- The technical instruments applied and the results of the evaluation of the uncertainties due to production variation and their relation to the guaranteed sound power level.
The file must also contain a copy of the EC declaration of conformity.
The manufacturer or their authorised representative is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
Affix CE marking
Once the necessary steps have been successfully completed, the logo must be affixed to the product.
The CE marking shall be accompanied by the indication of the guaranteed sound power level. A model of this indication is given in Annex IV. 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 must indicate conformity with the Directives applied by the manufacturer only. 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.
If a Notified Body is involved in the production control phase, its identification number must be also displayed.
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