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EU Declaration of Conformity

Last reviewed: October 2026 · Sources listed at the end of this page.

An EU Declaration of Conformity (DoC) is the signed document in which the manufacturer states that a product meets every EU harmonisation act that applies to it. It is often called a CE declaration, or an EC declaration under older directives. It is needed for almost every CE-marked product and must exist before the mark is affixed. Where several acts apply, one single Declaration covers them all. By drawing it up, the manufacturer assumes responsibility for the product's compliance (Decision No 768/2008/EC, Annex I, Article R10(3)).

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.

At a glance. The DoC is the manufacturer's own document, issued by it or its authorised representative. No authority or Notified Body issues it, although a body's certificate may be cited in it. Status: the Annex III model applies now; machinery moves to Annex V of Regulation (EU) 2023/1230 on 20 January 2027. Keep it for 10 years after the last product of the model is placed on the market, unless the act says otherwise.

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 unrelated Declarations is not the model: Article 5 of Decision 768/2008/EC calls for a single Declaration, which may take the form of a dossier containing the individual declarations (Blue Guide 2022, §4.4).

EU Declaration of Conformity template

The structure below follows the model in Annex III of Decision 768/2008/EC. It is filled in for a hypothetical mains-powered electrical product; replace the bracketed fields and the list of acts and standards with those that apply to your product. Sectoral acts may require extra items (see below). Standards are shown as examples only: always cite the edition whose reference is currently published in the Official Journal.

EU DECLARATION OF CONFORMITY

1. Product model / product: [model name, type, batch or serial number range]
2. Name and address of the manufacturer: [legal name, postal address]
   Authorised representative (where applicable): [name, address]
3. This declaration of conformity is issued under the sole
   responsibility of the manufacturer.
4. Object of the declaration: [description allowing traceability;
   a colour image may be included]
5. The object of the declaration described above is in conformity
   with the relevant Union harmonisation legislation:
   - Directive 2014/35/EU (Low Voltage Directive)
   - Directive 2014/30/EU (EMC Directive)
   - Directive 2011/65/EU (RoHS), as amended by Directive (EU) 2015/863
6. References to the relevant harmonised standards used, or to the
   other technical specifications in relation to which conformity
   is declared:
   - EN IEC 62368-1:2020+A11:2020
   - EN 55032:2015+A11:2020, EN 55035:2017+A11:2020
   - EN IEC 63000:2018
7. Notified body (where applicable): [name, four-digit number]
   performed [module / procedure] and issued certificate
   [number, date].
8. Additional information: [anything a sectoral act requires]

Signed for and on behalf of: [company]
[Place and date of issue]
[Name, function]                              [Signature]

Where no Notified Body was involved (Module A), item 7 is omitted or marked “not applicable”. A product covered by several acts gets one Declaration listing all of them. To draft one from your own details, use the DoC generator.

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 Part A sets the contents of the EU Declaration of Conformity for machinery and related products, including the conformity assessment procedure followed and, where applicable, the Notified Body and the reference of the EU type-examination certificate. Unlike Directive 2006/42/EC, the Regulation does not require the Declaration to name a person authorised to compile the technical file. Partly completed machinery receives an EU Declaration of Incorporation instead, with its own model in Annex V Part B.

Medical Devices Regulation (EU) 2017/745

Article 19 and Annex IV set ten specific elements, including: the manufacturer's name and, if issued, Single Registration Number; the Basic UDI-DI; the product and trade name or other unambiguous reference; the risk class; any common specifications used; and, where applicable, the Notified Body, the procedure performed and the certificates issued.

Toy Safety Regulation (EU) 2025/2509

Until 1 August 2030, toys follow Directive 2009/48/EC, whose Annex III sets the Declaration's contents. From that date the Regulation abolishes a separate EU Declaration of Conformity for toys: the Digital Product Passport (Articles 19–23 and Annex VI) takes over its function, and by creating the passport the manufacturer assumes responsibility for the toy's compliance. See Toy Safety Regulation.

Radio Equipment Directive 2014/53/EU

Annex VI sets the model. It adds, where applicable, a description of accessories and components, including software, that allow the equipment to operate as intended. The frequency bands and maximum radio-frequency power go in the information accompanying the equipment (Article 10(8)), not in the Declaration. Since 1 August 2025, and until its repeal on 11 December 2027, Commission Delegated Regulation (EU) 2022/30 applies the cybersecurity requirements of Article 3(3)(d), (e) and (f) to the equipment it covers, so a Declaration for such equipment must cover them too.

Construction Products Regulation (EU) 2024/3110

Construction products use a different instrument — under Regulation 2024/3110, the combined "Declaration of Performance and Conformity", which replaces the Declaration of Performance (DoP) of Regulation 305/2011 — rather than the standard EU Declaration of Conformity. Its structure is in Annex V (Article 15). Product families not yet moved across still use the Declaration of Performance under Regulation 305/2011, parts of which remain until 8 January 2040. 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 part of the model. The Blue Guide (§4.4) speaks of a "signature and title or an equivalent marking of authorised person", who may be the managing director or another delegated representative and need not be domiciled in the EU. Electronic signatures under Regulation (EU) No 910/2014 (eIDAS) are a recognised form of signature.

The signatory does not need to be the same person who compiled the technical file. Under Directive 2006/42/EC the Declaration names the person authorised to compile the technical file; Regulation (EU) 2023/1230 drops that item.

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:

EU law does not always say who must translate; the Blue Guide (§4.4) notes this should logically be the manufacturer or another operator making the product available.

Electronic format

Several acts permit electronic access to the Declaration:

Acts on machinery, ATEX equipment, radio equipment, measuring instruments, recreational craft and lifts, among others, require the product to be accompanied by the Declaration (Blue Guide 2022, §4.4). Where such an act allows no electronic alternative, a paper copy in the appropriate language(s) must be supplied. Under acts such as the LVD and the EMC Directive, the Declaration need not accompany the product; it is kept and made available to authorities on request.

Change pending: the “Omnibus IV” proposals (2025/0133(COD)) would allow a digital Declaration across much of EU product law. A provisional agreement was reported on 9 June 2026, but no adopted act had been published in the Official Journal as of 31 October 2026, so the rules above continue to apply.

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

A missing or incorrect Declaration is a formal non-compliance in its own right (Decision 768/2008/EC, Annex I, Article R34). If it persists, the product can be restricted, withdrawn or recalled. Under Article 16 of Regulation (EU) 2019/1020, a market surveillance authority can require corrective action. Member States must also provide penalties, which may include criminal sanctions for serious infringements (Regulation 765/2008, Article 30(6)). See penalties for incorrect CE marking.

Worked example

A manufacturer placing on the EU market a consumer Wi-Fi router with a mains adapter would issue one Declaration listing the Radio Equipment Directive 2014/53/EU and the RoHS Directive 2011/65/EU. The Declaration identifies the model and serial-number range. Its standards might include EN 301 489-1 and EN 301 489-17 (EMC), EN 300 328 (2.4 GHz Wi-Fi), EN 62311 (RF exposure), and EN IEC 63000 (RoHS technical documentation), with exact editions as cited in the OJEU, plus the cybersecurity requirements that have applied since 1 August 2025. The adapter, if it is a separate product, has its own compliance position under the Low Voltage and EMC Directives. If the router contained a battery, the battery would have its own conformity route under the Battery Regulation (EU) 2023/1542.

Frequently asked questions

Is an “EC declaration of conformity” the same as an “EU declaration of conformity”?

Yes, it is the same document under an older name. Acts adopted before the Lisbon Treaty, such as Machinery Directive 2006/42/EC, still say “EC declaration of conformity”. Acts aligned with the New Legislative Framework say “EU declaration of conformity”. For machinery, the Declaration becomes an EU Declaration under Regulation (EU) 2023/1230 from 20 January 2027.

Does a Declaration of Conformity need a company stamp?

No. Annex III of Decision 768/2008/EC requires the place and date of issue, and the name, function and signature of the person signing on the manufacturer's behalf. A stamp is a local business custom, not a legal requirement.

Who may sign the Declaration?

A person empowered to bind the manufacturer or its authorised representative. The signatory takes on responsibility for the declaration, so it should be someone with authority over compliance, not an external consultant or test laboratory.

Can a test lab or Notified Body issue the Declaration for me?

No. The Declaration is issued under the sole responsibility of the manufacturer. A test report or Notified Body certificate supports it but cannot replace it.

Is there an official EU template?

Annex III of Decision 768/2008/EC sets out the model structure, and most sectoral acts repeat it in their own annex. The template above follows that model. Check the specific act for extra mandatory items.

What is the difference between a Declaration of Conformity and a CE certificate?

The Declaration is the manufacturer's own signed statement and is what the law requires. A “CE certificate” has no legal status unless it is a certificate from a Notified Body under a specific module. See how to check a CE mark or certificate.

Where can I get the Declaration of Conformity for a product I bought?

Ask the manufacturer, importer or seller, and check the product documents or manufacturer's website, since some acts require a copy or web address to accompany the product. Under acts such as the LVD, the duty is to supply it to authorities, so a buyer may have to ask.

Sources

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