CE Marking
The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.
Affects directly device Builders, Importer's and Users
CE marking for Manufacturers (general overview)
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
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EN•••
Verify product specific requirements
Identify whether an independent conformity assessment
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EN••• (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
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EN••• 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.
Electromagnetic compatability
Low voltage
Machinery
Restriction of Hazardous Substances in Electrical and Electronic Equipment
Guide for the CE marking
The Blue Guide for the CE marking version 2014
European Commission
For your own local language Blue guide version please visit:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52016XC0726%2802%29