Many products require CE marking before they can be sold in the EU or in Iceland, Lichtenstein or Norway. CE marking proves that your product had been assessed and meets EU safety, health and environmental protection requirements. It is valid for products manufactured both inside and outside the EU, that are then marketed inside the EU.
CE marking is valid only for products for which EU-wide specifications have been introduced.
To obtain the CE marking for your product, you must put together a technical dossier proving that your product fulfils all the EU-wide requirements. As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. Once your product bears the CE marking, you might have to provide your distributors and/or importers with all the supporting documentation concerning CE marking.
How to obtain CE marking?
1. Identify the EU-wide requirements for your product
The EU-wide requirements are laid down in directives that cover different products, for example:
- electrical and mechanical equipment
- medical devices.
These directives lay down the essential requirements that products have to fulfil. In addition, harmonised European standards detail the technical requirements your product must meet. To date, some 20,000 European standards have been published.
2. Check whether your product meets the specific requirements
It is up to you to make sure your product meets all the EU-wide legal requirements. If harmonised European standards exist for your product and you follow them in the production process, your product will automatically comply with the relevant EU directives.
The use of standards is voluntary - you cannot be obliged to use them. You could also opt for other technical solutions to fulfil the essential requirements set out in the relevant directive.
3. Check whether your product must be tested by an independent national authority
For some products, special authorities ("notified bodies") must verify that your product meets the specific technical requirements. This is not obligatory for all products. Use the "Nando" database to identify which notified body to contact in your case.
4. Test your product
If your product doesn't need to be verified by an independent authority, then it is up to you to check that it conforms with the technical requirements. This includes estimating and documenting the possible risks when using your product.
5. Compile the technical dossier
Your technical dossier should include all the documents that prove that your product conforms with the technical requirements.
6. Affix the CE marking and draft a declaration of conformity
Finally you can put the CE marking on your product. The marking must be visible, legible and indelible. If you had to involve a notified body in step 3, you should also put the identification number of this authority on the product. You must also draft and sign an EC declaration of conformity stating that your product meets all legal requirements.
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