Before a product can be sold on the european market, more is required than just a good idea and solid design. An important step in the process is ensuring that the product meets all legal requirements.
The EU Declaration of Conformity (DoC) is a crucial part of a product’s journey to market. It shows that the manufacturer takes responsibility for ensuring the product complies with relevant EU requirements—often as part of CE marking. It is a legally mandated document required for many product categories and involves not only manufacturers but also importers and distributors. In this post, we clarify what an EU Declaration of Conformity is, when it is required, who is responsible for it, and how it should be structured. We also go through common mistakes and show what such a declaration might look like in practice.
What is an EU declaration of conformity?
An EU Declaration of Conformity (DoC) is a legal document in which the manufacturer declares that a product meets applicable requirements under relevant EU legislation. It serves as a type of certificate for authorities and customers that the product complies with applicable rules and that the manufacturer has the documentation to prove it. It is a key document in the CE marking process and is often one of the first documents examined during market surveillance checks.
When is an EU declaration of conformity required?
The declaration is required when a product falls under an EU directive or regulation that mandates CE marking. Examples include the Machinery Directive, the Toy Safety Directive, and the Low Voltage Directive. In these cases, the declaration is not just a formality—it is a legal requirement for the product to be sold within the EU. It must also be available to market surveillance authorities upon request.
Who is responsible for the document?
The manufacturer is primarily responsible for preparing and signing the EU Declaration of Conformity. Importers must ensure that the document exists before placing the product on the market. Distributors have an indirect responsibility—they must check that the product is CE marked and may be required to provide documentation if something goes wrong.
What should the declaration of conformity (DoC) include?
A valid declaration should include:
Product identification (model, type, article number)
Manufacturer’s name and address
References to applicable directives/regulations and harmonised standards
Description of the conformity assessment procedure
Name, position, and signature of the authorised person
Date and place of signing
Some rules may also require technical annexes or references to a Notified Body (an independent third party) if one was involved. In some cases, there are specific requirements—for example, a toy might need a colour image, and for radio products, software versions must be indicated if they are relevant to the product’s compliance.
How long should the EU declaration of conformity be retained?
The EU Declaration should generally be kept for at least 10 years after the last product has been placed on the market. During this period, the document must be made available to authorities upon request. The responsibility for retaining the document lies with the manufacturer—or the importer, if the manufacturer is located outside the EU. This is also important in the case of business transfers or organisational changes.
Common mistakes—and how to avoid them
Common mistakes include:
Incorrect or incomplete references to legislation (directives and regulations)
The wrong person signing the declaration, or it not being signed at all
Failing to update the declaration when rules change
Missing date of signature
Missing product identification
Failing to update the version of standards or omitting version numbers altogether
You can avoid these by using clear templates, keeping up with legislative changes, and ensuring responsible parties have the right expertise.
Unsure whether your product requires a declaration?
At Certify & Comply, we help you determine the exact requirements for your specific products. Contact us for advice or download our free EU Declaration of Conformity template. Having the correct documentation is crucial to avoid sales bans or legal issues during inspections.
Would you like a downloadable template? Contact us and we’ll send you an EU Declaration of Conformity template.
