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EU Declaration of Conformity

Last reviewed: May 2026 · Legal status verified against EUR-Lex.

The EU Declaration of Conformity (commonly 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. The manufacturer issues a single Declaration covering all applicable acts. By signing the DoC, the manufacturer takes legal responsibility for the conformity of the product (Decision No 768/2008/EC, Annex III).

The DoC is distinct from a Notified Body certificate. A certificate (for example an EU type-examination certificate under Module B) attests to the result of a third-party assessment of design or quality system; the DoC is the manufacturer's own undertaking, drawing on those certificates where applicable. Authorities and customers may rely on the DoC as the principal evidence of CE conformity.

Legal basis

Mandatory contents

Annex III of Decision 768/2008/EC specifies the minimum elements. Every EU Declaration of Conformity must contain:

  1. Product model / product (product, type, batch or serial number). Identification sufficient to allow traceability between the Declaration and a specific unit or production run. A photograph may be attached where text alone is insufficient.
  2. Name and address of the manufacturer and, where applicable, of its authorised representative.
  3. "This declaration of conformity is issued under the sole responsibility of the manufacturer." The exact wording from Annex III.
  4. Object of the declaration (identification of the product allowing traceability). It may include a colour image of sufficient clarity where necessary for product identification.
  5. "The object of the declaration described above is in conformity with the relevant Union harmonisation legislation" — followed by the list of acts (titles, numbers, OJ references).
  6. References to the relevant harmonised standards used (with dated edition), or references to the other technical specifications in relation to which conformity is declared. The list must be precise — generic references are insufficient.
  7. Where applicable, the Notified Body — name, four-digit identification number from NANDO, conformity assessment procedure performed, and certificate(s) issued (number, date).
  8. Additional information. Specific text required by sectoral acts goes here (see below).
  9. Signed for and on behalf of: place and date of issue; name, function, and signature of the signatory.
Single declaration, multiple acts. A product covered by the Low Voltage Directive, EMC Directive, RoHS Directive, and Radio Equipment Directive has one Declaration of Conformity, listing all four acts. Issuing four separate Declarations is permitted in some acts but is not the model. The single-document approach is the Commission's preferred form (Blue Guide 2022, §4.4).

Sector-specific additions

Each act may add specific items to "Additional information" or modify the model. The principal examples:

Machinery Regulation (EU) 2023/1230

Annex V (declaration for machinery) requires, beyond the Annex III baseline: the business name, full address, and signatory function of the person authorised to compile the technical file (who must be established in the EU); the conformity assessment procedure followed; where applicable, the reference of the EU type-examination certificate. Article 16(5) requires a separate "EU Declaration of Incorporation" for partly completed machinery, with its own model in Annex V Part B.

Medical Devices Regulation (EU) 2017/745

Article 19 and Annex IV require: the Basic UDI-DI of the device; the name and Single Registration Number of the manufacturer; references to the conformity assessment procedure and the Notified Body certificate(s); the address where the technical documentation is kept; and any conditions of validity of the Declaration. The MDR's Annex IV expands the baseline to nine specific elements.

Toy Safety Regulation (EU) 2025/2509

Article 17 and Annex V require: the toy's identification reference; the chemical substances of concern declared in the file; from 1 January 2026, the unique identifier of the toy's Digital Product Passport where the toy is in scope.

Radio Equipment Directive 2014/53/EU

Article 18 requires the Declaration to be made available with the radio equipment, and Annex VI requires inclusion of: the frequency band(s) in which the equipment operates; the maximum radio-frequency power transmitted in those bands. Since the implementation of Commission Delegated Regulation (EU) 2022/30, RED equipment must also reference compliance with the cybersecurity essential requirements where applicable.

Construction Products Regulation (EU) 2024/3110

Construction products use a different instrument — the "Declaration of Performance" (DoP) — rather than the EU Declaration of Conformity. The DoP states the product's declared performance for each essential characteristic, by reference to a European Assessment Document or harmonised technical specification. See Construction Products Regulation 2024/3110.

Signatory and signature

The Declaration must be signed by a natural person authorised to act on behalf of the manufacturer or authorised representative. The signatory's name, function, and place and date of signing are mandatory. Electronic signatures meeting the requirements of Regulation (EU) No 910/2014 (eIDAS) are accepted; the Blue Guide §4.4 also confirms that a typed name with the date is acceptable in practice for electronic distribution, provided the source is traceable to the manufacturer.

The signatory does not need to be the same person who compiled the technical file. The signatory takes responsibility for the Declaration; the technical file must be available from the person identified in Annex V (Machinery) or the equivalent provision.

Language

The Declaration must be translated into the language(s) required by the Member State in which the product is placed on the market or made available. The requirement is set by each sectoral act and by national transposing legislation. Common cases:

In practice, manufacturers provide the Declaration in English plus the language of each Member State of destination. The Declaration must travel with the product to each market; the language obligation cannot be shifted onto the distributor or end user.

Electronic format

Several recent acts permit electronic distribution of the Declaration:

For acts not yet allowing electronic-only Declarations, a paper copy in the appropriate language(s) must accompany the product.

Retention and access

The Declaration is part of the technical file and must be retained for the same period — ten years from the last unit placed on the market for most acts, fifteen years for implantable medical devices. The signed Declaration must be made available to market surveillance authorities on reasoned request.

Common errors

Consequences of a false or missing Declaration

An incorrect or missing Declaration is a formal non-compliance in its own right. Under Article 16 of Regulation (EU) 2019/1020, a market surveillance authority finding a missing or non-compliant Declaration may require the economic operator to bring the product into conformity, withdraw it, or recall it. A false Declaration is treated as a misleading statement and may attract criminal liability under the implementing legislation of individual Member States (e.g., §40 of the German Produktsicherheitsgesetz; Articles L. 521-1 et seq. of the French Code de la consommation). See penalties for incorrect CE marking.

Worked example

A manufacturer placing on the EU market a battery-powered consumer Wi-Fi router would issue one Declaration listing: Radio Equipment Directive 2014/53/EU (with frequency bands and maximum RF power), RoHS Directive 2011/65/EU, Battery Regulation (EU) 2023/1542, and — where the device draws power from a separate mains adapter sold with it — the Low Voltage Directive 2014/35/EU and EMC Directive 2014/30/EU on that adapter. The Declaration identifies the model and serial-number range, cites EN 301 489-1, EN 301 489-17, EN 300 328 (for Wi-Fi 2.4 GHz), EN 62311 (RF exposure), EN IEC 63000 (RoHS technical documentation), and the relevant Battery Regulation standards once published in the OJEU.

Sources

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