How to Prepare EU Declaration of Conformity?

How to Prepare a CE Declaration of Conformity?

One of the most important stages of the CE certification process is the preparation of the EU Declaration of Conformity. This document is an official statement in which the manufacturer declares that their product complies with the relevant European Union legislation.

Once the CE certification process is completed, the product can be affixed with the CE mark together with this declaration prepared by the manufacturer.

In this article, we explain how to prepare a CE Declaration of Conformity, what information it must include, and what manufacturers should pay attention to during this process.

What Is a CE Declaration of Conformity?

The CE Declaration of Conformity is a document in which the manufacturer officially declares that their product complies with the relevant European Union directives or regulations.

With this document, the manufacturer:

• Declares that the product complies with applicable legislation
• Confirms that the necessary tests and assessments have been carried out
• Assumes responsibility for the use of the CE mark

The Declaration of Conformity is one of the core documents in the CE certification process.

Why Is the CE Declaration of Conformity Important?

The CE Declaration of Conformity serves the following purposes:

• Demonstrating compliance with European Union legislation
• Providing information to competent authorities during market surveillance and inspections
• Documenting the manufacturer’s responsibility for product safety

Preparing a Declaration of Conformity is mandatory for products bearing the CE mark.

Information Required in a CE Declaration of Conformity

The Declaration of Conformity must include specific information:

1. Manufacturer Information

The declaration must include the manufacturer’s:

• Company name
• Address
• Contact details

If the manufacturer is located outside the European Union, the details of the authorized representative may also be included.

2. Product Description

The product must be clearly identified in the declaration. This typically includes:

• Product name
• Model or serial number
• Product type

These details ensure product traceability.

3. Applicable EU Legislation

The declaration must specify the EU directives or regulations applicable to the product. For example:

• Machinery Regulation
• Low Voltage Directive (LVD)
• Electromagnetic Compatibility Directive (EMC)
• Construction Products Regulation (CPR)

A product may be subject to more than one piece of legislation.

4. Applied Standards

The harmonized standards used to demonstrate compliance must also be listed in the declaration. These standards show how product safety has been ensured.

5. Notified Body Information (If Applicable)

For certain product groups, a Notified Body is involved in the conformity assessment process. In such cases, the declaration must include:

• The name of the Notified Body
• Its identification number

6. Authorized Signatory

The CE Declaration of Conformity must:

• Be signed by an authorized person
• Include the date of signature

This person is typically a representative of the manufacturer.

How Long Should the Declaration Be Retained?

Within the scope of CE certification, the Declaration of Conformity and the technical file must be kept for at least 10 years after the product has been placed on the market.

Competent authorities may request these documents when necessary.

Common Mistakes When Preparing a Declaration of Conformity

Companies may make mistakes when preparing the declaration. The most common ones include:

• Specifying incorrect legislation
• Failing to list applicable standards
• Providing insufficient product description
• Missing an authorized signature

Such errors may result in the CE certification process being considered invalid.

Conclusion

The CE Declaration of Conformity is one of the most important documents in the CE certification process. It enables the manufacturer to officially declare that their product complies with European Union legislation.

A properly prepared declaration forms the basis for the use of the CE mark and ensures that the product can be safely evaluated during market surveillance inspections.

As Sertifike, we continue to support manufacturers in managing their CE certification and CE marking processes with confidence.