How do you draw up an EU declaration of conformity?
The EU declaration of conformity is a formalised document with fixed mandatory content: manufacturer, product identification, the statement of sole responsibility, all applied legislation, the standards used with their editions, where applicable the notified body, plus place, date and the signature of an authorised person. It accompanies the machine and is kept with the technical documentation for ten years.
Which mandatory content must the declaration contain?
What is the difference from the declaration of incorporation?
| EU declaration of conformity | Declaration of incorporation | |
|---|---|---|
| Applies to | Machinery, assembly of machinery, safety component | Partly completed machinery |
| Statement | The product meets all applicable requirements in full | The applicable essential requirements have been applied, the product is not yet complete |
| Accompanying document | Instructions for use | Assembly instructions |
| CE marking | Is affixed | Is not affixed |
| Putting into service | Permitted | Only after incorporation into conform final machinery |
| Additional statement | Prohibition of putting into service until the final machinery is declared conform |
Which mistakes come up most often during checks?
- Standards cited without their edition, or standards that have been withdrawn or superseded.
- Missing legislation that applies in addition, typically EMC for electrically operated machinery.
- Product identification so vague that the declaration would fit any machine.
- Signed by someone without authority to represent the company, or the name and function are missing.
- A declaration of conformity issued for partly completed machinery instead of a declaration of incorporation.
- The declaration is not available in the language of the country of destination.
- Standards listed that were never used in the risk assessment.
In which language, and for how long?
The declaration has to be provided in the official language of the member state in which the machine is placed on the market. If you deliver to several countries, you need a corresponding number of language versions.
The original is drawn up in the language in which it was signed. Translations have to be identified as such and attached to the original.
Retention period: at least ten years from placing the machine on the market, together with the technical documentation. For series products the period runs from the last unit delivered, which in practice means the archive has to outlast the product life.
Sources and standards
- Machinery Regulation (EU) 2023/1230: EU declaration of conformity, declaration of incorporation
- Machinery Directive 2006/42/EC (valid until 19 January 2027)
- German Social Accident Insurance (BGHM) FAQ on the combined declaration of conformity
Editions of standards and their harmonised status change continuously. Check standard numbers and editions against the current list in the Official Journal of the EU before applying them. This article is a technical classification and does not replace legal advice.
Frequently asked questions
May a single declaration refer to both the Machinery Directive and the Machinery Regulation?
Yes. Parallel application is not possible, but a manufacturer may refer to both legal acts in one declaration and state the respective periods of application. That is useful for series products manufactured beyond 20 January 2027.
Does the declaration have to physically accompany the machine?
The declaration of conformity has to accompany the machine. For digital forms of provision, check the current state of the Machinery Regulation and the requirements of your country of destination.
Who may sign?
A person entitled to represent the manufacturer with legal effect. Name and function belong on the document. A signature without authority to represent leaves the declaration open to challenge.
What happens after a substantial modification?
A new machine comes into being. Whoever carried out the modification issues a new declaration of conformity under their own name. The original manufacturer's declaration does not cover the modified state.
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This article was produced with AI assistance and reviewed for technical accuracy before publication. Editorial responsibility within the meaning of Art. 50(4) of the AI Act (EU) 2024/1689 lies with Heinrich Knutas.
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