Before your products can be sold on the European market they must fulfil the requirements of relevant European product directives and bear the CE marking. As a manufacturer, or importer if the manufacturer is based outside of the EU, you must always provide proper documentation as a basis for CE marking, which proves that the product meets the requirements of the applicable standard:
- Technical Documentation (Technical File) to show the product’s compliance with applicable essential requirements and conformity assessment procedures of the applicable directive. The Technical File must include a test report for the product, design drawings and instructions for use. Some directives also demand a risk analysis.
- A "declaration of conformity" in which you declare that your product fulfils the requirements of the applicable directive.
- According to some directives you must also receive a specific certificate from a Notified Body.
When you affix a CE marking to your product this means that you certify for the authorities that the product meets the EU safety requirements. CE marking does not give the consumer any information, as it says nothing about the quality of the product. The CE marking does not show any evidence of third-party testing and shouldn't be confused with any independent certification mark.
The CE marking process
Navigating the CE marking process does not have to be complicated. Daily we guide manufacturers, exporters, importers or retailers through all the steps of the CE marking process, from product testing to preparing a technical file and declaration of conformity to developing a monitoring and reporting system. You can depend on our experience to reach the whole EU market quickly and cost-effectively.
For more information, please contact us
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