June 18, 2024

CE Marking for EU Market Access

Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.‍

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 requirementsdetermine whether you can assess your product by yourself or if you have to involve a notified bodyput together a technical dossier documenting conformity: find out about technical documentationdraft 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.