A mark required for many EU-marked products

If you want to trade in the EU, CE-marking is a mandatory conformity mark required for a wide variety of products. CE-marking indicates that your products comply with stringent EU product safety directives.
When is CE marking mandatory?
CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
Some products are subject to several EU requirements at the same time. You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it. It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking.
How to obtain CE marking?
As the product’s manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don’t need a license to affix the CE marking to your product, however, before doing so, you must:
- ensure conformity with all relevant EU-wide requirements
- determine whether you can assess your product by yourself or if you have to involve a notified body
- put together a technical dossier documenting conformity: find out about technical documentation
- draft and sign an EU declaration of conformity
Once your product bears the CE marking — if the competent national authority requests — you must provide them with all the information and supporting documentation concerning CE marking.
Do you need an independent assessment?
You need to check if your product has to be tested by a notified body. You can find this information in the relevant legislation applicable to your product: check the rules by product category.
This step is not obligatory for all products.
If you need to involve a notified body, the CE marking must be accompanied by the identification number of the notified body. The CE mark and the identification number can be affixed separately, as long as they appear clearly linked to each other.
You can use the Nando database to search for a notified body that can certify 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.
- Medical Device
- Electrical Device
- PPE/DPI
- Machinery