EU Declaration of Conformity and CE Marking – What You Need to Know

What is the EU Declaration of Conformity?

The EU Declaration of Conformity is a legal document in which the manufacturer or their authorised representative declares that a product complies with the essential requirements of applicable EU directives. It is a mandatory step before affixing the CE marking to a product.

What Are the New Approach Directives?

New Approach Directives are EU regulations that require products to carry the CE mark and have a corresponding EU Declaration of Conformity (or the older EC Declaration of Conformity). These directives ensure that products meet safety, health, and environmental protection standards. To fulfil these obligations, the manufacturer must compile technical documentation.

Technical Documentation for CE Compliance

The Declaration of Conformity must include the following standard elements, as outlined in the relevant EU legislation:

• Product model or type (including product number, batch or serial number)

• Name and address of the manufacturer or authorised representative

• A statement confirming that the declaration is issued under the sole responsibility of the manufacturer

• Identification of the product (with visual references, such as a colour illustration)

• Reference to specific EU directives or regulations

• Reference to applicable harmonised standards

• Optional information (e.g., name and ID number of the notified body that carried out testing)

• Signature of the company representative

The manufacturer must retain the Declaration of Conformity for at least 10 years after the last unit of the product has been placed on the market. In the case of machinery or construction products, this document must accompany the product during sale and be available upon request by market surveillance authorities.

Is the Declaration of Conformity Mandatory?

Yes. Products that require CE marking – such as machinery, medical devices, electrical equipment, toys, building products, and pressure equipment – must have an EU Declaration of Conformity before being sold in the European Economic Area (EEA). The declaration must be written in the official language of the country where the product is placed on the market.

Who Is Responsible for Issuing the Declaration?

Only the manufacturer or an authorised representative based in the EU can issue and sign the Declaration of Conformity. Third-party organisations are not authorised to do so, unless they are designated notified bodies involved in specific conformity assessment procedures.

Does the Declaration Need Updating?

The Declaration remains valid indefinitely, provided that:

• The product's design and manufacturing process have not changed

• Relevant EU directives and standards have not been revised

CE Certificate vs Declaration of Conformity

A CE certificate is issued by a notified body after product testing and conformity assessment. However, it is not the same as the Declaration of Conformity. The CE certificate confirms that the product meets EU safety standards, while the declaration is a legal commitment by the manufacturer taking full responsibility for compliance.

Summary: EU Declaration of Conformity

• Required for CE-marked products

• Must be prepared before entering the EU market

• Issued and signed by the manufacturer

• Confirms compliance with harmonised EU legislation

• Must be available in the local language

For rubber products with CE compliance documentation, visit Power Rubber – see our contact section for support.