One of the final and most visible steps of CE marking is the EU Declaration of Conformity (DoC) — the document in which the manufacturer, under its own responsibility, declares the product's conformity. Although this seemingly simple, one-page document looks straightforward, it is the legal summary of all the engineering work behind it, and preparing it incorrectly can lead to serious consequences. In this article we cover the content and format of the declaration of conformity, who should sign it, and the points to watch during preparation.
What Is the EU Declaration of Conformity, and Why Is It Required?
The EU Declaration of Conformity is an official, signed document in which the manufacturer states: "this product complies with the essential requirements of the stated EU directives and regulations." Under the logic introduced by the New Approach framework (Regulation (EC) 765/2008 and Decision 768/2008/EC), conformity for most product groups rests not on the approval of an independent body, but on the manufacturer's own declaration. This declaration is the legally binding element that gives the system its reliability: when the manufacturer signs this document, it is expected to have already prepared and kept the technical evidence (i.e. the technical file) it will stand behind.
The importance of the declaration lies less in it being a formality and more in it making legal responsibility concrete. Following an accident related to a product, or during a market surveillance inspection, this declaration is among the first documents examined; whether it references the correct directives, whether it was signed by the right person, and whether it is consistent with the technical file are all checked.
The Content of the Declaration of Conformity
Under the model format recommended by Decision 768/2008/EC, an EU Declaration of Conformity must, at a minimum, contain the following elements. The table below summarizes these elements and why each one matters.
| Element | Description |
|---|---|
| Serial Number | The product's unique identifier (model, type, batch or serial number) |
| Manufacturer Information | The name and full address of the manufacturer (or authorized representative) |
| Statement of Responsibility | An explicit statement that the declaration is issued under the manufacturer's sole responsibility |
| Product Description | A description sufficient to ensure the product's traceability; a photo where necessary |
| Applied Legislation | References to all relevant EU directives/regulations |
| Referenced Standards | The number and year of publication of the applied harmonized standards |
| Notified Body Information | Where applicable, the name, number and certificate reference of the participating notified body |
| Signature Information | Place and date of issue, the signatory's name, role and signature |
Who Can Sign?
The person signing the declaration on behalf of the manufacturer needs to be authorized within the company to make a binding commitment on the matter — usually a quality manager, technical director, or someone from senior management. The signature is not a symbolic formality; the signatory is confirming that they stand behind the declared conformity. This is why the person signing the declaration is expected to know the content of the technical file and to know that the product genuinely meets the claimed standards; signing purely as a procedural step is risky both during audits and in terms of liability.
The Simplified Declaration of Conformity
Under some legislation — particularly the Radio Equipment Directive (RED) 2014/53/EU — a "simplified declaration of conformity" can be used where there is limited space on the product. This format allows a short statement ("This device complies with [directive]") to be provided together with the product, with the full declaration made accessible via a web address. When choosing the simplified format, it's important to remember that the stated web address needs to remain accessible for the entire sales life of the product — a practical obligation some companies overlook.
Products Under Multiple Directives
Many products fall under several directives at once; for example, a motorized machine may be subject to both the Machinery Directive and other applicable directives because of its electronic control unit. In this case, preparing a single EU Declaration of Conformity referencing all relevant directives is a more practical and legislation-compliant approach than issuing separate declarations. What matters is that a genuine assessment (standard application, testing, risk analysis) has actually been carried out for every directive referenced in the declaration.
Language and Format Requirements
The declaration must be presented in the official language of the member state where the product is placed on the market, or translated into that language. The original declaration is usually prepared in English and translated into the required languages for each market it is sold into. Whether the declaration is presented in paper or digital format depends on the product group; options include including it in the user manual, providing it as a separate document, or making it accessible via a website.
Relevant Directives and Standards
The concept of the EU Declaration of Conformity is a shared requirement of the New Approach framework and appears with a similar logic across almost all CE directives. The Machinery Directive 2006/42/EC (and Machinery Regulation (EU) 2023/1230, which will take its place, in force from 20 January 2027), the Low Voltage Directive 2014/35/EU and the Radio Equipment Directive 2014/53/EU all define a model declaration of conformity format in their own annexes. These formats are all derived from the generic model in Decision 768/2008/EC, which is why declarations under different directives look quite similar to each other — the differences mainly appear in the referenced legislation and standard references.
Step by Step
- Determine the product's unique identifier (model, serial, batch).
- Confirm all the EU directives/regulations that apply to the product.
- List the applied harmonized standards with their current number and year.
- Add the relevant certificate information if notified body involvement was required.
- Draft the declaration according to the model format the directive requires.
- Check the draft's consistency with the technical file content.
- Have it reviewed and signed by an authorized person.
- Translate it into the required languages and put it into the format to be provided with the product/manual.
- Archive the signed declaration together with the technical file.
Most Common Mistakes
- Having the declaration signed by a person without the authority to do so.
- Writing standard references without specifying the current year/version.
- Forgetting to update the declaration after a design revision.
- Referencing a directive irrelevant to the product, or one that is no longer valid.
- Not keeping the web address up to date when using the simplified declaration.
- Preparing the declaration with a different standard list than the technical file, inconsistently.
- Skipping translation and providing the declaration in only one language.
- Never providing the declaration together with the product, or making it inaccessible.
Frequently Asked Questions
What is the EU declaration of conformity, and who signs it?
The EU declaration of conformity is the official document in which the manufacturer declares, under its own responsibility, that the product complies with the relevant EU directives and regulations. It is signed by a person authorized to sign on behalf of the manufacturer, usually from senior management.
In which language should the declaration of conformity be?
The declaration of conformity must be provided in the language of the member state where the product is placed on the market or made available, or translated into that language. The original is usually kept in English, with a translation added for the official language of each market sold into.
Should the declaration of conformity be shipped together with the product?
For most product groups, a copy of the declaration is expected to be provided together with the product; for some product groups, it is acceptable for the declaration to be included in the user manual or made available at an easily accessible web address.
Is a single declaration sufficient for a product falling under multiple directives?
Yes, if a product falls under more than one EU directive (for example the Machinery Directive and the Radio Equipment Directive), a single EU declaration of conformity can be prepared referencing all the relevant directives.
What is a simplified declaration of conformity?
Some legislation, such as the Radio Equipment Directive, defines an abbreviated declaration format that can be used where there is limited space on the product, accepted on the condition that the full declaration is made accessible via a web address.
Which information must be present on a declaration of conformity?
At minimum: the product's unique identifier, the manufacturer's name and address, a statement that the declaration is issued under the manufacturer's sole responsibility, a description of the product, references to the relevant directive/standards, notified body information where applicable, the place and date of signing, and the name and role of the signatory.
Can a declaration of conformity be unsigned?
No, the declaration must be signed by a person authorized to sign on behalf of the manufacturer. A declaration that is unsigned or signed by an unauthorized person has questionable legal validity.
What is the relationship between the declaration of conformity and the technical file?
The declaration of conformity is prepared based on the risk analysis, standard application and test results contained in the technical file; a copy of it must also be kept as part of the technical file. The declaration is the technical file's summary and official declaration form.
For how many years should the declaration of conformity be kept?
The general rule is the same as for the technical file — at least 10 years, starting from the date the product is placed on the market; this period can differ under product-specific legislation.
Can an importer prepare a declaration of conformity?
The responsibility for preparing and signing the declaration rests primarily with the manufacturer. The importer is only obligated to confirm that the declaration exists, is accurate and is accessible; the importer does not issue a new declaration under its own name.
What happens if there is an error in the declaration of conformity?
An incorrect or incomplete declaration can be assessed as a non-conformity during a market surveillance inspection, and can result in a request for corrective action, suspension of sales, or administrative sanctions.
Should the declaration of conformity be published on a website?
Some directives (for example, the simplified declaration under RED) allow the declaration to be made accessible via a web address. As a general rule, the declaration needs to be easily accessible; the mandatory publication method depends on the directive.
Conclusion
Although the EU Declaration of Conformity is the visible face of the CE process, its content and accuracy are just as important as the technical file behind it. A declaration prepared with the correct directive and standard references, signed by an authorized person and consistent with the technical file, strengthens both legal compliance and the company's position during a possible audit. We also recommend reviewing the technical file and risk analysis processes that the declaration relies upon.
Contact us as part of our CE consultancy service to prepare your declaration of conformity accurately and ready for inspection.
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