Many products require CE marking before they can be sold in the EEA ( EU + Iceland, Lichtenstein and 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 EEA, that are then marketed inside the EEA.
CE marking is valid only for products for which EU specifications have been introduced.
To affix the CE marking to 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?
There are different steps for manufacturers :
1. Identify the EU requirements for your product
The EU-wide requirements are laid down in directives that cover different products or product sectors, for example:
- Electrical equipment
- Medical devices
- Personal Protective Equipment
These directives lay down the essential requirements that products have to fulfil.
2. Check whether your product meets 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.
The use of standards is voluntary - you are not obliged to use them. You can also opt for other technical solutions to fulfil the essential requirements set out in the relevant EU directive.
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. 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 body, 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 affix 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 body on the product. You must also draft and sign an EU declaration of conformity stating that your product meets all legal requirements.
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 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.