How to get CE marking before they can be sold in the EEA. CE marking proves that your product has been assessed and meets EU safety, health and environmental protection requirements.
1. Identify the requirements for your product
The EU market requirements are laid down in directives that cover different products or product sectors: Toys, Electrical, Equipment, Machinery, Medical devices, Lifts, Personal Protective Equipment. You need to check the kind of your products to determine whether they are needed requirements or not.
2. Check the specific requirements
It is up to you to make sure your product meets all the EU legal requirements. If harmonised European standards exist for your product and you follow them in the production process, your product will be presumed to be in conformity with the requirements laid down in the relevant EU directives.
3. Check whether your product must be tested by a Notified Body
For some products, special conformity assessment bodies (‘Notified Bodies’) must verify that your product meets the specific technical requirements. This is not obligatory for all products.
4. Test your product
If your product doesn’t need to be verified by an independent body, then it is up to you to check that it complies with the technical requirements. This includes estimating and documenting the possible risks when using your product.
5. Compile the technical dossier
6. Affix the CE marking and draft a declaration of conformity
Last steps, you can affix the CE marking on your product. The marking must be visible, legible and indelible. If you had to involve a notified body, you should also put the identification number of this body on the product. You must also draft and sign an EU declaration of conformity stating that your product meets all legal requirements.
For Importers
While manufacturers are responsible for ensuring product compliance and affixing the CE marking, importers must make sure that the products they place on the market comply with the applicable requirements and do not present a risk to the European public. The importer has to verify that the manufacturer outside the EU has taken the necessary steps and that the documentation is available upon request.
Distributors
Distributors must have a basic knowledge of the legal requirements – including which products must bear the CE marking and the accompanying documentation – and should be able to identify products that are clearly not in compliance. They must also be able to demonstrate to national authorities that they have acted with due care and have affirmation from the manufacturer or the importer that the necessary measures have been taken. Furthermore, a distributor must be able to assist national authorities in their efforts to receive the required documentation.
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