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The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA), consisting of the 27 member states of the EU and European Free Trade Association countries Iceland, Liechtenstein and Norway. The CE marking is necessary for many products and attests the verification by a manufacturer that these products meet EU safety, health or environmental necessities.
This guide provides an introduction to CE marking and the many situations in which it applies. You can also find information about what products CE marking applies to, how to use it successfully and how to ensure that you obey with all relevant regulations.
As a manufacturer, this will lead you through the procedure of affixing the CE marking to your precise product, by clearly illustrating the key steps to undertake from the beginning to the trading of the manufactured goods. If you are a distributor or importer you will have to know the requirements that the products you are importing or distributing must meet to be traded freely within the EEA.
Before you affix a CE marking to manufactured goods, you need to establish which EU New Approach Directives apply to your product. You must not attach a CE marking to a manufactured goods outside the possibility of the Directives.
1. Identify the directive(s) and harmonized standards applicable to the manufactured goodsThere are more than 20 directives setting out the manufactured goods categories needful CE marking. The important requirements that products have to fulfill, e.g. safety, are harmonized at EU level and are set out in general terms in these directives. Harmonized European standards are issued with reference to the applied directives and express in detailed technical terms the important requirements.
2. Verify the product-specific requirementsIt is up to you to confirm that your product complies with the essential requirements of the relevant EU legislation. Full compliance of a product to the harmonized standards provides a product the supposition of conformity with the relevant essential requirements. The use of harmonized standards remains voluntary. You may decide to choose other ways to fulfill these essential requirements.
3. Identify whether an independent conformity assessment is required from a Notified BodyEach directive covering your product specifies whether an authorized third party (Notified Body) must be involved in the conformity assessment procedure necessary for CE marking. This is not obligatory for all products, so it is essential to check whether the involvement of a Notified Body is indeed required. These Bodies are authorized by national authorities and officially ‘notified’ to the European Commission and listed in the NANDO (New Approach Notified and Designated Organizations) database.
4. Test the manufactured goods and check its conformityTesting the product and checking its conformity to the EU legislation (Conformity Assessment Procedure) is the responsibility of the manufacturer. One part of the procedure is, as a general rule, a risk assessment. By applying the relevant harmonized European standards, you will be able to fulfill the important legislative requirements of the directives.
5. Draw up and keep available the required technical documentationThe manufacturer has to establish the technical documentation required by the directive(s) for the assessment of the product’s conformity to the relevant requirements, and for the risk assessment. Together with the EC DoC, the technical certification must be presented on request to the relevant national authorities.
6. Affixation of the CE marking to your product and EC Declaration of ConformityThe CE marking must be affixed by the manufacturer, or by his authorized representative within the EEA or Turkey. It must be affixed according to its legal format visibly, legibly and indelibly to the product or its data plate. If a Notified Body was involved in the production control phase, its identification number must also be displayed. It is the manufacturer’s responsibility to draw up and sign an ‘EC DoC’ proving that the product meets the necessities. That’s it - your CE-marked product is prepared for the market.