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CE marking products compliance

Which products need CE marking?

CE marking is only mandatory for products for which EU specifications exist and require the affixing of CE marking. Manufacturers and traders should ensure their product complies with all the relevant requirements before affixing the CE marking to it and bring the product into EU market.

How to obtain CE marking?

The product’s manufacturer or trader bears sole responsibility for declaring and ensuring conformity with all relevant EU-wide requirements. Based on the applicable regulations and directives as well as product classification a self-assessment procedure or involvement of a notified body should be determined.

In the case of self-assessment technical documentation should be prepared before the product is placed on the market. This includes estimating and documenting the possible risks when using the product. Finally, an official EU declaration of conformity should be drafted and signed.

All the information and technical documentation should be made available to the market surveillance authorities in request as soon as the product is placed on the market. The technical documentation is necessary to prove the product meets the essential requirements and therefore justify and support the EU declaration of conformity.

For some cases, if the applicable legislation to your product requires an independent assessment by a notified body, the manufacturer or trader needs to involve a notified body to do the product testing. When a notified body is obligatory, the CE marking must be accompanied by the identification number of the notified body.

Cost of CE marking

For some products under specific classifications of the applicable regulations/directives, the conformity assessment can be carried out by the manufacturer himself. This is, in general, the cheapest way to attain the CE marking. If the manufacturer or trader opts to use the services of a notified body, or if the EU specifications applicable to the product require the independent assessment by a notified body, then the manufacturer or trader must pay the notified body for the service they provide. The cost depends on the applicable certification procedure and the complexity of the product etc.

Affixing of CE marking

If your product is subject to several EU directives/regulations which require a CE marking to be affixed, the accompanying documents, package, and labels must indicate that your product conforms to all applicable EU directives/regulations.