What is a CE Marking?

CE stands for Conformité Européenne, which translates from French to English as ‘European Conformity’. CE marking states that a product meets the requirements of all applicable EU directives. While for some products, CE marking can be carried out by the manufacturer themselves, other products must be tested by a company that offers CE marking services.

CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.

CE certification was defined by the European Union to control the quality of products as well as possible. It is necessary to include this certificate on products that are produced in Europe or imported into EU member states.

Why is CE Marking important?

CE marking assures your product can enter the European Union and allows free movement throughout the nearly 30 countries that make up the European Economic Area, giving you direct access to over 500 million consumers. If a product that should display a CE mark is found not to have one, the manufacturer or distributor could be fined and face expensive product recall – so compliance is essential.

Obtaining CE Certification

CE certification is unlike other comparable certification marks in that no single authorizing body or organization grants certification. Manufacturers are responsible for ensuring the CE marking is used appropriately and that products are compliant with all applicable directives and regulations.

Manufacturers must follow these steps to affix a CE marking:

• Identify applicable directives and harmonized standards.
• Verify the specific product requirements.
• Collect applicable supply chain data for necessary technical files.
• Determine whether an independent conformity assessment by a notified body is necessary.
• Test the product and check its conformity.
• Create and maintain all necessary technical documentation.
• Affix the CE marking and draw up an EU Declaration of Conformity.

How to draw up the technical documentation?

The technical documentation should include at least:

1. your name and address, or those of any authorised representatives
2. a brief description of the product
3. identification of the product, for example, the product's serial number
4. the name(s) and address(es) of the facilities involved in the design and manufacture of the product
5. the name and address of any notified body involved in assessing the conformity of the product
6. a statement of the conformity assessment procedure that has been followed
7. the EU declaration of conformity
8. label and instructions of use
9. a statement of relevant regulations to which the product complies
10. identification of technical standards with which compliance is claimed
11. list of parts
12. test results

As a manufacturer, you should be able to demonstrate where and how the various parts of the document are held and maintained.

There are 24 directives that dictate which products require CE marking. These directives carry different requirements, and several directives may apply to a single product. These products include, but are not limited to:

• Electronics.
• Medical devices.
• Toys.
• Household refrigerators and freezers.
• Personal protective equipment.
• Radio and telecommunications terminal equipment.

updated on: 2024/01/03

To receive more information about the CE certificate, contact Sohatoos consultants.