EU Declaration of Conformity – requirements & template

What the law requires (and who it applies to)

EU harmonisation legislation requires a signed Declaration of Conformity before CE marking; the manufacturer bears responsibility for it.

CE marking shows that a product complies with the EU legislation that applies to it, so it can move freely across the European Economic Area. For products that fall under EU harmonisation legislation — for example machinery, electrical equipment, toys, medical devices or personal protective equipment — the manufacturer must draw up and sign an EU Declaration of Conformity (DoC) before placing the product on the market and affixing the CE marking.

The DoC is a legally binding statement. In it the manufacturer declares, under its sole responsibility, that the product meets all the requirements of the relevant Union legislation. The manufacturer is legally responsible for the declaration and for the product's conformity whether it is based inside or outside the EU. A non-EU manufacturer may appoint an EU authorised representative for certain tasks, and an importer must check the declaration exists before placing the product on the EU market.

The exact list of mandatory elements is set by each piece of legislation, but the core is the same across them and is summarised on the European Commission's own CE-marking and declaration-of-conformity guidance. A copy of the declaration must be kept for 10 years after the product is placed on the market and shown to authorities on request.

What must an EU Declaration of Conformity contain?

Product ID, manufacturer, sole-responsibility statement, EU legislation, harmonised standards, Notified Body where applicable, place, date and signatory.

These are the elements the declaration must include. The wording is set per legislation, but every compliant DoC covers all of the following.

Who is responsible for the declaration?

The manufacturer — inside or outside the EU. A non-EU maker can appoint an EU authorised representative; the importer must verify the DoC.

The manufacturer draws up, signs and stands behind the Declaration of Conformity, and is responsible for the product's conformity. This holds whether the manufacturer is in the EU or not. A manufacturer outside the EU can appoint an EU authorised representative to carry out specific tasks, but responsibility for conformity stays with the manufacturer. The importer bringing the product into the EU must make sure the manufacturer has drawn up the DoC and the technical documentation before placing it on the market.

Do I need a Notified Body?

Only where the applicable legislation requires it — often for higher-risk products. Otherwise the manufacturer self-assesses.

Whether a Notified Body is needed depends on the product and the legislation that covers it. For many product types the manufacturer can self-assess conformity, apply the harmonised standards and issue the DoC without any third party. For higher-risk categories the legislation requires an accredited Notified Body to carry out or verify part of the conformity assessment. When a Notified Body is involved, its name, identification number and the assessment it performed must be stated on the declaration — never invent a number.

How to draw up a Declaration of Conformity

Identify the applicable legislation, run the conformity assessment, compile the technical file, sign the DoC, then affix CE and keep the copy.

1. 1

   Identify which EU legislation applies

   Work out which directives or regulations cover your product (e.g. Machinery, EMC, Low Voltage, RoHS). A product can fall under several at once, and each brings its own requirements.

2. 2

   Run the conformity assessment

   Follow the assessment route the legislation requires — self-assessment, or involving a Notified Body where the product type demands it. Apply the relevant harmonised standards.

3. 3

   Compile the technical documentation

   Assemble the technical file that shows how the product meets the requirements: design, test results, standards applied, risk assessment. It must be kept and made available to authorities.

4. 4

   Draw up and sign the declaration

   Fill in every mandatory element — object, manufacturer, sole-responsibility statement, legislation, standards, Notified Body where applicable, place, date, and the signatory's name and function.

5. 5

   Affix the CE marking and keep the DoC

   Affix the CE marking to the product and keep a copy of the declaration for 10 years after the product is placed on the market, ready to show market-surveillance authorities.

EU Declaration of Conformity template

A copyable DoC skeleton with every mandatory element as a fill-in line — object, manufacturer, sole-responsibility statement, legislation, standards, Notified Body, signature.

Copy the skeleton below and fill in each line. It follows the standard structure of an EU Declaration of Conformity — adapt the legislation and standards to your product.

EU DECLARATION OF CONFORMITY (No. ____)
1. Product model / product (object of the declaration): ____
   Product identification allowing traceability (type / batch / serial no.): ____
2. Name and address of the manufacturer: ____
   (or the EU authorised representative, if the manufacturer is outside the EU): ____
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the declaration (may include an image): ____
5. The object described above is in conformity with the relevant Union harmonisation legislation: ____
6. References to the relevant harmonised standards used, or references to the other technical specifications: ____
7. Where applicable — the Notified Body ____ (name, number) performed ____ and issued the certificate: ____
8. Additional information: ____
Signed for and on behalf of: ____
Place and date of issue: ____
Name, function and signature: ____

Filled-in example

A short filled-in example for a portable band saw covered by the Machinery and EMC Directives, self-assessed by the manufacturer.

Common mistakes

The usual gaps: no sole-responsibility line, missing signatory function, an invented Notified Body number, or no EU representative for non-EU makers.

• Leaving out the statement that the declaration is issued under the sole responsibility of the manufacturer.
• Signing without stating the signatory's function (role) — the name alone is not enough.
• Listing a Notified Body or a number where none was involved, or omitting one that was.
• Referencing standards that don't cover all the applicable requirements, or an outdated harmonised standard version.
• A non-EU manufacturer failing to name an EU authorised representative / responsible person.
• Affixing the CE marking without a complete DoC and technical file behind it.
• Not keeping the signed declaration accessible for 10 years for market-surveillance authorities.

What the Tedrix ce-doc check returns

Tedrix reads your DoC and returns a structured check: mandatory elements present/missing/unclear, declared directives, an attention flag and a to-complete list, as GREEN/YELLOW/RED.

Here is what the ce-doc check returns after reading a real Declaration of Conformity. It marks each mandatory element present, missing or unclear, reads off the declared directives and standards, flags inconsistencies, and lists what to complete — as a GREEN/YELLOW/RED readout. It checks the document; it never certifies the product or decides which directives apply.

How Tedrix automates this

Upload your Declaration of Conformity — Tedrix reads it, checks every mandatory element and flags what's missing before you issue it.

If you draw up DoCs for products you make, import or distribute, the ce-doc check does the reading. You upload the declaration (and optionally a label photo or a technical-file page); the tool extracts the product, manufacturer, declared directives and standards, checks each mandatory element, and flags inconsistencies and what to complete. Reviewing a declaration by hand against the requirements is easy to get slightly wrong under time pressure; a pre-read completeness check turns it into a quick review before you sign. You keep full responsibility for conformity — the tool never certifies the product.

Frequently asked questions

What is an EU Declaration of Conformity?

An EU Declaration of Conformity (DoC) is the document in which the manufacturer declares, under its sole responsibility, that a product meets all the applicable EU requirements. It is drawn up and signed before the product is placed on the EU market, lists the Union legislation and harmonised standards used, and must be kept available to authorities. The CE marking on the product is the visible sign that this declaration exists.

What must an EU Declaration of Conformity contain?

It must contain: the object of the declaration (the product, identified so it can be traced); the manufacturer's name and address; a statement that it is issued under the sole responsibility of the manufacturer; the relevant Union legislation; the harmonised standards used; the Notified Body details where applicable; the place and date of issue; and the name, function and signature of the person signing for the manufacturer.

Who is responsible for the declaration of conformity?

The manufacturer is legally responsible for drawing up and signing the DoC and for ensuring the product meets EU requirements — whether the manufacturer is inside or outside the EU. A non-EU manufacturer can appoint an EU authorised representative for certain tasks, and the importer must check the DoC exists before placing the product on the market. Responsibility for conformity itself stays with the manufacturer.

Do I need a Notified Body for CE marking?

Not always. For many product types the manufacturer can self-assess conformity and does not need a Notified Body. A Notified Body is required only where the applicable legislation says so — typically for higher-risk products. When one is involved, its name, identification number and the assessment it carried out must appear on the declaration.

Is the declaration of conformity the same as the CE marking?

No. The CE marking is the visible mark affixed to the product; the Declaration of Conformity is the written, signed document behind it. Affixing CE without a valid, complete DoC and technical file is not compliant. The marking says 'this product conforms'; the declaration is the manufacturer's formal, traceable statement of exactly which rules it conforms to and how.

How long must I keep the declaration of conformity?

A copy of the EU Declaration of Conformity must be kept for 10 years after the product is placed on the EU market, unless the specific legislation sets another period. It must be made available to market-surveillance authorities on request, together with the technical documentation. Keeping it accessible and up to date is part of the manufacturer's ongoing obligations.

What happens if the declaration is incomplete or missing an element?

An incomplete DoC — for example missing the sole-responsibility statement, a Notified Body reference, or the signatory's function — can mean the product is treated as non-compliant if authorities check it. Market-surveillance authorities can require corrective action, restrict sale, or order a recall. Because the declaration is a legally binding statement, small omissions carry real risk, which is why a completeness check before issue is worthwhile.

Do I need a separate declaration for the UK (UKCA)?

Yes — UKCA is a separate Great Britain marking with its own declaration, distinct from the EU CE marking and the EU Declaration of Conformity. This guide and the Tedrix ce-doc check cover the EU DoC and CE marking only. If you place products on the GB market you will generally need to handle UKCA conformity separately.