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Short answer
A declaration of conformity (DoC) is a document in which the manufacturer states, under its own responsibility, that a product meets the applicable legal requirements. For EU product rules, the manufacturer drafts and signs an EU declaration of conformity before affixing the CE marking, and keeps it for at least 10 years after the product is placed on the market. It is the manufacturer’s statement, not a certificate issued by an outside body.
Definition and scope
Under the EU system described by the European Commission’s Your Europe business portal, a manufacturer must “draft and sign an EU declaration of conformity” as one of the steps toward CE marking. By affixing the CE marking, the manufacturer declares that the product was compliant with the relevant EU product rules at that moment. The declaration is therefore a dated statement about a specific product, made by the party responsible for it.
The same portal states that the declaration of conformity and the technical documentation behind it must be kept up to date and retained for at least 10 years after the product is placed on the market. When a change occurs, the declaration has to be reviewed and updated accordingly. For the wider picture of what the mark means, see what CE marking is.
How a declaration is used in practice
The EU does not use one universal form. Each piece of product legislation sets out a model for its own sector. The clearest openly readable example is Annex VI of Directive 2014/53/EU (radio equipment), whose model declaration has nine numbered items followed by a signature block. It is a sector example, not a template for every product, but it shows the logic that declarations follow.
The nine fields of the radio-equipment model
| Item | What the model asks for | What a reader can check |
|---|---|---|
| 1 | The product, type, batch or serial number | Whether the declaration names the product in front of you |
| 2 | Name and address of the manufacturer or its authorised representative | Who stands behind the claim |
| 3 | A statement that the declaration is issued under the sole responsibility of the manufacturer | That responsibility sits with the manufacturer |
| 4 | The object of the declaration, identified so that it can be traced (an image may be included where needed) | Traceability of the exact item covered |
| 5 | A statement that the object conforms with the relevant Union harmonisation legislation, naming it | Which legal act the claim is made against |
| 6 | References to the harmonised standards or other technical specifications used, with identification number and version and, where applicable, date of issue | Which standards, and which versions, were applied |
| 7 | Where applicable, the notified body, its number, what it did, and the certificate it issued | Whether an independent body was involved |
| 8 | Where applicable, accessories and components, including software, that allow the equipment to operate as intended and are covered by the declaration | Whether the declaration covers the full configuration |
| 9 | Additional information | Anything else the manufacturer chose to state |
The model ends with a signature block: signed for and on behalf of the manufacturer, with place and date of issue, and the name, function and signature of the signatory. The model’s own footnote makes numbering the declaration optional. Source: Annex VI of Directive 2014/53/EU on legislation.gov.uk, a retained copy of the EU text, checked 29 October 2026.
Declaration, CE marking and certificate are different things
Three documents and marks are often confused.
- The declaration of conformity is the manufacturer’s signed statement, naming the product, the legislation and, where used, the standards.
- The CE marking is the mark the manufacturer affixes. Affixing it is the act of declaring compliance.
- A notified-body certificate exists only where the governing legislation calls for an independent body. Item 7 of the model is where such a body is named. Where no notified body is involved, no external body reviews the file before the product reaches the market, as explained in our CE marking guide.
The independent route is covered in notified body designation and audits.
Where it matters for labs, clinics and supply decisions
A declaration is a document that can be read against the product it accompanies. Using the fields above, a reader can compare the product name or serial reference with the item the declaration identifies, see which legislation and which versions of standards it cites, and see whether a notified body is named. Because the manufacturer must keep the declaration and technical documentation for at least 10 years after placing the product on the market, a lab or clinic that holds equipment for a long time is dealing with a document that the manufacturer is expected to keep available for that period.
For medical devices, the authorised representative has its own documentation duties, covered in the authorised representative under MDR Article 11, and the technical file that supports the declaration is described in EU MDR technical documentation. In the United States, declarations of conformity to recognised standards play a different role in FDA premarket submissions; see FDA recognized consensus standards.
Common misunderstandings
- “The declaration means an authority approved the product.” It does not. The European Commission describes the CE marking as the manufacturer’s own declaration; the Your Europe portal notes there is no central EU body that gives permission or a certificate allowing use of the CE mark.
- “There is one standard layout.” The layout is set sector by sector. The radio-equipment model above is one example.
- “It is signed once and forgotten.” The Your Europe portal states it must be kept up to date and reviewed when changes occur.
FAQ
Is a declaration of conformity the same as a certificate?
No. A declaration is the manufacturer’s own signed statement. A certificate is issued by a notified body, and only where the legislation requires one. The radio-equipment model names the notified body and its certificate in a separate, “where applicable” item.
Who signs a declaration of conformity?
The manufacturer drafts and signs it. In the radio-equipment model, the signature block records who signed for and on behalf of the manufacturer, with their name, function, place and date of issue.
How long must a declaration of conformity be kept?
The Your Europe portal states that the declaration and technical documentation must be retained for at least 10 years after the product is placed on the market.
What must a declaration contain?
That depends on the product legislation. The radio-equipment model lists nine items, from product identification to additional information, plus a signature block.
Sources
- European Commission, Your Europe: CE marking, checked 29 October 2026.
- Directive 2014/53/EU, Annex VI (model EU declaration of conformity), as published on legislation.gov.uk, checked 29 October 2026.
