Every CE-marked product needs one. The EU Declaration of Conformity is a signed legal statement in which the manufacturer takes sole responsibility for the product's compliance with every applicable EU act. Annex III of Decision No 768/2008/EC sets out nine mandatory items. Here is what each one means, with a free template you can fill in.
Download it, fill in the bracketed fields, delete the guidance notes. No form, no signup.
Most declarations fail on form, not substance. These are the errors that show up most often.
The declaration asserts conformity with every act you list. Adding the Low Voltage Directive to a battery product outside its voltage range makes the declaration false. Omitting an act that does apply makes the product non-compliant on documentary grounds, however safe it is.
"EN 60204-1" is ambiguous. "EN 60204-1:2018" identifies the dated edition published in the Official Journal. Every act requires the dated reference, and a generic citation is treated as no citation.
A declaration signed in advance and applied to a later product, or issued with no date, fails the formal requirements of Annex III. The date of issue is part of the legal record.
These two are constantly confused and they are not interchangeable. The distinction decides who is legally on the hook.
Written and signed by the manufacturer. Self-issued, mandatory for every CE-marked product, and the principal evidence of conformity that authorities and customers rely on. No third party is involved unless the applicable act requires one.
Not a defined term in EU product legislation. In practice it means one of three different things: a Notified Body certificate such as an EU type-examination certificate, a supplier's quality assurance document, or a vehicle Certificate of Conformity used for registering cars. None of them replaces the declaration.
If you place a CE-marked product on the EU market, you need a Declaration of Conformity. You may also hold a Notified Body certificate, which you then reference inside the declaration. A supplier's certificate is evidence you keep in the technical file, not something you issue to the market.
A fill-in-the-blanks Word document following the Annex III model, with a note on each field explaining what authorities expect to see.
Every field from Annex III in order, with placeholders for your product, company and legislation details.
A short note under each section explaining what is required and what makes it fail.
Example act references and dated standard citations you can pattern-match against.
Where Machinery, Medical Devices and Radio Equipment add mandatory fields, the template says so.
Place, date, name, function and signature block, plus the ten-year retention rule.
Editable .docx, so you can put it on your own letterhead and reuse it per product.
Any product covered by EU harmonisation legislation needs a declaration. The acts that come up most often:
A declaration is not a document you write once. Standards get superseded, new acts come into scope, products change — and the law requires the declaration to be kept up to date. Most providers hand you a PDF and stop there. We use AI to do the work in hours instead of weeks, publish what it costs, and keep watching after you have signed.
Quick answers to the most common questions about the EU Declaration of Conformity
The EU Declaration of Conformity, usually abbreviated DoC, is a signed legal statement issued by the manufacturer or its authorised representative declaring that a product complies with every applicable EU harmonisation act. It is required for every CE-marked product. By signing it, the manufacturer takes sole legal responsibility for the conformity of the product. The model and minimum contents are set out in Annex III of Decision No 768/2008/EC.
Nine items: the product model, type, batch or serial number; the name and address of the manufacturer and, where applicable, its authorised representative; the statement that the declaration is issued under the sole responsibility of the manufacturer; the object of the declaration; the statement of conformity followed by the list of applicable Union legislation; references to the harmonised standards used, with dated editions; where applicable the Notified Body name, four-digit NANDO number, procedure and certificate; any additional sector-specific information; and the place and date of issue with the name, function and signature of the signatory.
A Declaration of Conformity is issued by the manufacturer and is mandatory for CE-marked products. "Certificate of conformity" is not a defined term in EU product law and means different things in different contexts: a Notified Body certificate such as an EU type-examination certificate, a supplier's quality document, or a vehicle Certificate of Conformity used for registering cars. A certificate never replaces the declaration. Where a Notified Body certificate exists, it is referenced inside the declaration.
A natural person authorised to act on behalf of the manufacturer or its authorised representative. The signatory's name, function, and the place and date of signing are all mandatory. The signatory does not have to be the person who compiled the technical file. Electronic signatures meeting eIDAS requirements are accepted.
No. One declaration should cover every Union act that applies to the product, listing them all. A router covered by the Radio Equipment Directive, RoHS and the Battery Regulation has a single declaration listing all three. Issuing a separate declaration per directive is permitted under some acts but is not the model, and the single-document form is what the Commission's Blue Guide prefers.
Get a €399 product compliance assessment →Ten years from the date the last unit was placed on the market for most acts, and fifteen years for implantable medical devices. The declaration forms part of the technical file and must be produced for market surveillance authorities on reasoned request.
Declarations fail because the wrong acts are listed, not because the format is wrong. A €399 product compliance assessment maps every applicable directive, regulation and dated standard for your product and markets in 48 hours — and once your declaration is written, we keep watching it for you.
Get a €399 assessment48 hours. Fixed price. No obligation.
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