EU Declaration of Conformity

## EU Declaration of Conformity The EU Declaration of Conformity is the document in which the manufacturer, or the authorised representative, declares under its sole responsibility that a product satisfies the applicable EU harmonisation legislation. It identifies the product, the legislation and standards applied, and any notified body involved. It must be kept with the technical documentation and produced for market surveillance authorities on request. ### Key facts - The declaration is drawn up by the manufacturer under its sole responsibility; it is a legal attestation, not a certificate issued by an authority or test laboratory. - Its content follows a model structure set in the New Legislative Framework: product identification, manufacturer details, the declaration statement, applicable legislation, referenced harmonised standards, notified body details where relevant, and signature. - A single declaration may cover multiple applicable directives and regulations, provided it identifies each one and the product's conformity with all of them. - The declaration must be kept for ten years after the last product is placed on the market, alongside the technical documentation. - It must be translated into the languages required by the member states where the product is made available, and supplied with the product where the legislation requires. - Market surveillance authorities can demand the declaration at any time; failure to produce it is itself a non-compliance, separate from any product defect. - An authorised representative keeps the declaration and makes it available under the written mandate, but does not assume authorship of the manufacturer's statement. ### What the EU Declaration of Conformity is The declaration is the legal hinge of the CE marking system. Conformity assessment produces evidence; the declaration converts that evidence into a binding statement of compliance. By signing it, the manufacturer asserts to the authorities, customers and courts of every member state that the identified product meets every listed instrument. The phrase "sole responsibility" is doing real work: it fixes accountability on the manufacturer regardless of who performed the testing, who supplied the components, or who advised on the standards. The model structure in Decision 768/2008/EC, replicated in each sector directive, requires specific elements. The product must be identified precisely enough to link the declaration to physical goods: type, batch or serial numbers. The manufacturer must be identified with name and address. The declaration must list each piece of harmonisation legislation complied with, each harmonised standard or other technical specification applied, and where a notified body participated, its name, number and the nature of its involvement. It must be signed, dated, and identify the signatory's function. The declaration's legal character matters in disputes. It is a statement of fact about the product's compliance, and a false declaration can ground enforcement action, contractual claims and, in serious cases, criminal liability under national law. It is also the document competitors and customers rely on: a distributor deciding whether to stock a product, or an authority deciding whether to investigate, starts with the declaration. ### Why it matters for market access The declaration is checked at every gate. Customs officers examining a consignment look for the declaration alongside the marking; market surveillance authorities request it as the first step of any product check; large retailers and distributors demand it before listing; and online marketplaces increasingly require it for regulated categories. A missing, incomplete or inaccurate declaration stops the product at each of these gates, regardless of the product's actual quality. Its accuracy determines enforcement exposure. Authorities compare the declaration against the technical file: do the cited standards match the test reports, does the notified body number correspond to a body designated for the task, does the product identification cover the variants actually sold? Discrepancies suggest the assessment was not properly done and trigger deeper investigation. A declaration citing a withdrawn standard version, or omitting an applicable directive, is evidence of non-compliance in itself. The declaration also has commercial significance beyond compliance. In B2B transactions it is the manufacturer's warranty of regulatory conformity, and contracts routinely require its provision as a condition of supply. In product liability litigation, the declaration and the technical file behind it are central evidence of whether the manufacturer met its obligations. Maintaining declarations with the same rigour as financial records is therefore both a legal duty and a business asset. ### Who it applies to Declaration duties follow the manufacturer role across EU harmonisation legislation: - Manufacturers, including non-EU manufacturers, who must draw up the declaration before affixing CE marking and placing the product on the market. - Authorised representatives, who keep the declaration and provide it to authorities under the written mandate, for the products and tasks the mandate covers. - Importers, who must ensure the manufacturer has drawn up the declaration correctly and must be able to make it available; an importer placing a product under its own name becomes the manufacturer for declaration purposes. - Persons modifying products in ways affecting compliance, who assume manufacturer duties including drawing up a new declaration. - Market surveillance authorities, which request, examine and act on declarations, and which can require translation into languages they understand. Every product unit placed on the market must be covered by a valid declaration. The declaration is typically drawn up per product type or model, and must reflect the legislation and standards actually applied to the units sold. ### Requirements and drawing up the declaration Producing a compliant declaration follows the conformity assessment to which it attests. 1. Complete the conformity assessment. The declaration may only be drawn up after the applicable procedure is finished: testing complete, technical file compiled, notified body tasks performed where required. A declaration signed before assessment is complete is false. 2. Identify the product precisely. The declaration must allow the product to be traced: model or type designation, and batch, serial or identification numbers where the legislation requires. Declarations covering undefined "product families" without identification criteria are defective. 3. List every applicable instrument. Each directive and regulation with which conformity is declared must be cited with its full reference. Omitting an applicable instrument, such as forgetting RoHS on an electronic product, means the product is not declared compliant with EU law as a whole. 4. Reference the standards and specifications. List the harmonised standards applied, with exact references matching the Official Journal citations, and any other technical specifications used. Where standards were not applied, the technical file must document the alternative solutions. 5. Record notified body involvement. Where the procedure required a notified body, identify it by name and four-digit number and describe its intervention: type examination certificate number, quality system approval, or production verification as applicable. 6. Sign, date, translate and keep. An identified person signs for the manufacturer, the declaration is dated, it is translated into required languages, and it is kept with the technical documentation for ten years after the last product is placed on the market. | Declaration element | Purpose | Frequent error | |---|---|---| | Product identification | Links statement to goods | Vague family descriptions | | Manufacturer details | Fixes responsibility | Outdated address after moves | | Legislation list | Defines compliance scope | Missing applicable directive | | Standards references | Shows assessment basis | Withdrawn versions cited | | Notified body details | Documents third-party role | Wrong number or missing certificate | | Signature and date | Legal attestation | Unsigned or predated | ### Market access relevance Declaration management should be a controlled process, not an administrative afterthought. Each product type needs a declaration owner, a template implementing the model structure, a review step linking the declaration to the technical file, and version control so that declarations evolve with design changes, new variants and updated standards. The declaration for a product family with many variants needs a clear identification scheme connecting each sold unit to the declaration covering it. Translation planning matters for multi-country launches. The declaration must be available in the languages the member states require, which typically means the language of each market where the product is made available. Preparing translations alongside the original avoids launch delays and ensures consistency of technical terminology. Distributor and marketplace onboarding should include declaration provision as a standard step. Retailers' compliance teams and marketplace verification systems increasingly reject listings without valid declarations for regulated categories; having declarations ready in the required languages accelerates ranging and reduces listing takedowns. Finally, the declaration is the visible tip of the technical file. Any investment in declaration quality is wasted if the file behind it is incomplete, and any gap in the file eventually surfaces through the declaration. The two should be reviewed together, on the same cycle as design changes and standards transitions. ### Common misconceptions | Misconception | Reality | |---|---| | "The test laboratory issues the declaration." | The manufacturer draws it up under sole responsibility. Laboratories provide test reports; they do not declare conformity. | | "One declaration lasts forever." | Design changes, new variants, updated standards and new legislation require review and reissue. The declaration must reflect current reality. | | "The authorised representative signs as manufacturer." | The representative keeps and provides the declaration under mandate; authorship and responsibility remain the manufacturer's. | | "A declaration is needed only for CE-marked products." | Sector legislation defines where declarations are required; the concept appears across harmonisation instruments wherever the model applies. | | "The declaration can reference 'all applicable directives' generally." | It must list each instrument specifically, with references. Generic statements do not satisfy the model structure. | | "Keeping the declaration means filing it with an authority." | It is kept by the manufacturer and produced on request. There is no general filing or registration, though specific sectors may add notification duties. | ### Frequently asked questions Who signs the EU Declaration of Conformity? A person identified by name and function, signing on behalf of the manufacturer. The signature attests the manufacturer's sole responsibility; signatory authority should be governed internally. Can one declaration cover several directives? Yes. A single declaration should cover all applicable harmonisation legislation for the product, listing each directive and regulation with its reference. Must the declaration accompany the product? It depends on the sector legislation: some require it to be supplied with the product, others require it to be kept available. In practice, providing it with B2B shipments and making it available for consumer products is standard. In which languages must it be available? In the languages required by the member states where the product is placed on the market. Verify the specific legislation's language provisions for each market. What if we discover an error in an issued declaration? Correct it, reissue, and ensure the corrected version reaches distributors and is available to authorities. Assess whether the error reflects a deeper assessment gap that needs remediation in the technical file. How does the declaration relate to UKCA? The UK has its own declaration of conformity for UKCA marking, with parallel structure under UK regulations. Products for both markets need both declarations, each referencing its own legislation and standards. ### Sources - European Commission, New Legislative Framework and the Blue Guide: https://single-market-economy.ec.europa.eu/single-market/goods/new-legislative-framework_en - Regulation (EU) 2019/1020 on market surveillance and compliance of products (EUR-Lex): https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng - UK Government guidance on CE marking: https://www.gov.uk/guidance/ce-marking