EU Declaration of Conformity
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 I, Article R10(4)).
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
- Decision No 768/2008/EC, Article R10 and Annex III (model and minimum contents). The Annex III model is incorporated by every sectoral act.
- Sectoral Annexes — e.g., Annex IV of Directive 2014/35/EU (Low Voltage); Annex V of Regulation (EU) 2023/1230 (Machinery); Annex IV of Regulation (EU) 2017/745 (Medical Devices).
- Article R10(3) of Decision 768/2008/EC: a single Declaration covers all Union acts applicable to the product.
Mandatory contents
Annex III of Decision 768/2008/EC specifies the minimum elements. Every EU Declaration of Conformity must contain:
- 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.
- Name and address of the manufacturer and, where applicable, of its authorised representative.
- "This declaration of conformity is issued under the sole responsibility of the manufacturer." The exact wording from Annex III.
- Object of the declaration (identification of the product allowing traceability). It may include a colour image of sufficient clarity where necessary for product identification.
- "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).
- 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.
- Where applicable, the Notified Body — name, four-digit identification number from NANDO, conformity assessment procedure performed, and certificate(s) issued (number, date).
- Additional information. Specific text required by sectoral acts goes here (see below).
- Signed for and on behalf of: place and date of issue; name, function, and signature of the signatory.
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.
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 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
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
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 — 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. It 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:
- Machinery Regulation 2023/1230, Article 10(7) — Declaration translated into the official language(s) of the Member State.
- Low Voltage Directive 2014/35/EU, Article 15(2) — Declaration translated into the language(s) required by the Member State.
- Medical Devices Regulation 2017/745, Article 19(1) — Declaration in an official Union language or languages as required by the Member State(s) where the device is made available.
In practice, manufacturers provide the Declaration in English plus the language of each Member State of destination. Where an act requires the Declaration to accompany the product, the language obligation cannot be shifted onto the distributor or end user.
Electronic format
Several recent acts permit electronic distribution of the Declaration:
- Machinery Regulation 2023/1230, Article 10(7) — the Declaration may be provided in digital format. From 20 January 2027, when the Regulation applies, this is one of the principal procedural changes from Directive 2006/42/EC.
- Radio Equipment Directive 2014/53/EU, Article 10(9) and Annex VII — a simplified Declaration may accompany the equipment instead of the full text, giving the internet address at which the full Declaration is available.
- Toy Safety Regulation (EU) 2025/2509 — from 1 August 2030 the Digital Product Passport replaces the Declaration for toys altogether.
- Ecodesign Regulation (EU) 2024/1781 — Declarations and supporting documentation may be embedded in the Digital Product Passport from the application of relevant delegated acts.
Where an act requires a copy of the Declaration to accompany the product (for example Directive 2006/42/EC, the RED and the PPE Regulation 2016/425) and does not allow an 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.
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
- Listing acts that do not apply. Adding the Low Voltage Directive to the DoC of a battery-powered toy not within LVD's voltage range is a substantive error. The DoC declares conformity with every act listed; listing an inapplicable act creates a false declaration.
- Omitting an applicable act. A Declaration that lists only the Machinery Regulation for a machine that also contains a wireless module fails to declare compliance with the Radio Equipment Directive. The product is then non-compliant on documentary grounds regardless of physical compliance.
- Citing harmonised standards without the dated edition. "EN 60204-1" is ambiguous; "EN 60204-1:2018" identifies the dated edition. Each act requires the dated edition published in the OJEU.
- Naming a Notified Body for Module A. No Notified Body is involved in Module A. Listing one suggests an assessment route that did not occur.
- Pre-signed and undated Declarations. A Declaration signed in advance and applied to a later product, or without a date of issue, fails Annex III formal requirements. The date is part of the legal record.
- Generic "model number" descriptions. "Smart speaker" or "industrial pump" is not an object of declaration. Annex III requires identification sufficient for traceability.
- One Declaration per shipment instead of per product type. The Declaration covers a product type (or family), not a shipment. Issuing a fresh Declaration for each delivery is unnecessary; updating the Declaration when the product type changes is mandatory.
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.
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.
Sources
- Decision No 768/2008/EC, Article R10 and Annex III — EUR-Lex.
- Regulation (EU) 2023/1230 (Machinery), Article 10 and Annex V — EUR-Lex.
- Regulation (EU) 2017/745 (Medical Devices), Article 19 and Annex IV — EUR-Lex.
- Directive 2014/53/EU (Radio Equipment), Article 18 and Annex VI — EUR-Lex.
- Commission Notice — Blue Guide 2022, Section 4.4 — EUR-Lex.