An EU Declaration of Conformity: content, signature and documents to prepare is the document through which a manufacturer declares, under its sole responsibility, that a CE-marked product meets all applicable EU requirements. Prepare it after conformity assessment, support it with a complete technical file, and have it signed by a person authorised to bind the manufacturer.
Key takeaways
- The manufacturer must draw up the EU Declaration of Conformity, including where the manufacturer is established outside the European Union.
- A declaration is valid only for the precisely identified product and the CE legislation that genuinely applies to it.
- A signature does not replace testing, risk assessment or the technical documentation that supports conformity.
- Importers and distributors must check that required documents exist, but cannot declare conformity in place of the manufacturer.
- An incomplete or unsupported declaration can lead to a document request, a blocked listing or market-surveillance action.
Who must draw up an EU Declaration of Conformity?
The manufacturer must prepare and sign an EU Declaration of Conformity where applicable EU legislation requires CE marking. That responsibility remains with the manufacturer even when production, import or sales are handled by other businesses.
A manufacturer is the person or company that makes a product, or has it designed or made, and markets it under its own name or trade mark. This has a practical consequence that is often missed. A UK or French brand that has a lamp made in Vietnam may be the manufacturer if it places its own brand on the lamp or its packaging.
The common EU framework assigns responsibility for conformity assessment, technical documentation and the declaration to the manufacturer. Decision No 768/2008/EC on a common framework for the marketing of products sets out the economic-operator responsibilities reflected in many sector-specific product laws.
Importer, distributor and authorised representative: different roles
An importer places a product from a third country on the EU market. It must, among other things, ensure that the manufacturer has followed the appropriate conformity-assessment procedure and that the product carries the required information. It should not draft a declaration in the manufacturer's name merely because the factory has stopped responding or a marketplace has requested a document.
A distributor must act with due care when making a product available. If it modifies the product, repackages it in a way that may affect conformity, or sells it under its own name, it may take on the manufacturer's obligations.
A non-EU manufacturer may appoint an authorised representative in the Union where the relevant sector legislation permits or requires this. The mandate must be written and specific. A CE authorised representative can perform the tasks set out in that mandate, but does not replace the manufacturer's conformity assessment, testing, technical file or EU Declaration of Conformity.
EU Seller Kit — If you manufacture outside the EU or sell under your own brand, consider the CE authorised representative service where the applicable legislation permits representation under a written mandate. It becomes active only after file acceptance, entity assignment, a signed mandate and active payment.
Which products require an EU Declaration of Conformity: content, signature and documents to prepare?
An EU Declaration of Conformity is required for products covered by one or more EU harmonisation laws that require CE marking. It is not a universal document for every product sold in Europe.
CE marking applies to certain product categories, including toys, electrical equipment, radio equipment, machinery and personal protective equipment. The European Commission's CE marking guidance makes clear that CE marking is neither a quality label nor a commercial approval issued by the European Union.
One product may fall under several legal acts
A Bluetooth speaker, for example, may fall within the Radio Equipment Directive, electrical-safety rules and electromagnetic-compatibility rules. Its declaration must cover every applicable act, not just the one the supplier chose to mention.
For radio equipment, Directive 2014/53/EU on radio equipment (RED) provides the sector framework. For certain electrical products, Directive 2014/35/EU on low-voltage electrical equipment (LVD) and Directive 2014/30/EU on electromagnetic compatibility (EMC) may also be relevant.
By contrast, a consumer product outside CE legislation may still be subject to Regulation (EU) 2023/988, the General Product Safety Regulation (GPSR). GPSR does not itself create a general obligation for an EU Declaration of Conformity or CE marking. It does, however, impose safety, traceability and information requirements for covered consumer products. Before your first sale, an EU Market Entry Compliance Assessment can help you identify the issues to check: CE, GPSR, VAT, customs, packaging, WEEE and Digital Product Passport data.
What must an EU Declaration of Conformity contain?
The declaration must identify the product, manufacturer and legal requirements clearly enough for an authority to link the document to the product actually placed on the market. The precise template depends on the applicable sector legislation, so always check the relevant annex or provisions.
In practice, a sound declaration will usually include:
- product identification: name, model, type, batch or another reference that distinguishes the version sold;
- the manufacturer's name and postal address and, where relevant, those of its authorised representative;
- a statement that the declaration is issued under the sole responsibility of the manufacturer;
- the subject of the declaration, described with sufficient precision;
- the complete list of applicable harmonisation directives and regulations;
- harmonised standards or other technical specifications used, where they have been applied;
- identification of the notified body and its intervention, but only where the procedure requires it;
- place and date of issue, plus the name, role and signature of the person authorised to sign for the manufacturer.
Do not add standards at random
Naming a standard in the declaration means the manufacturer genuinely relies on it. A vague, outdated reference, or one unrelated to the product version, weakens the file. Harmonised standards can help demonstrate conformity, but they do not remove the need to assess the requirements that apply to the product.
Example: a seller receives a PDF headed “CE Certificate” for a night light. That document alone does not show that the night light being sold, including its adaptor, packaging and commercial reference, is covered by the relevant rules. Check the model identity, tests, standards cited and consistency with the declaration.
Before placing an order or changing supplier, use Supplier Check to centralise identity, payment and delivery information and flag inconsistencies for review. It does not validate CE conformity, but it helps make document collection more reliable.
How do you prepare the declaration step by step?
Prepare the declaration at the end of the conformity process, never as a marketing document created after a listing goes live. The right sequence is to define the product, assemble the evidence, then sign a declaration that accurately reflects that evidence.
1. Identify the product and its intended use
Define the product as it will be sold: reference, variants, accessories, power supply, embedded software or radio function, intended user and reasonably foreseeable use. A different battery, charger or wireless function can change the rules that apply.
If you ship from Shenzhen to an Amazon FBA warehouse in Germany, do not rely only on the supplier's listing. Compare the sample, production photographs, packaging reference and the model description in test reports.
2. Identify the applicable legislation and assessment procedure
List the applicable CE legislation and establish whether self-assessment is available or a notified body must be involved. Notified-body involvement depends on the product category and procedure; it is not automatically required for every CE-marked product. Our guide to when a notified body is required for CE marking helps distinguish these cases.
3. Build the technical file and risk assessment
Collect the documents that demonstrate conformity: product description, relevant drawings or diagrams, risk assessment, list of requirements assessed, test reports, calculations, instructions, labelling and production controls. The European Commission's 2022 Blue Guide explains the approach to technical documentation and economic-operator obligations.
For a practical collection structure, see the guide to CE technical documentation and evidence. It is particularly useful where a supplier provides several reports but does not show which product version each report covers.
4. Draft the declaration from verified evidence
Use the exact information in the technical file. Do not copy a generic declaration found online. Where a product falls under several legal acts, one declaration may cover them all, provided every applicable requirement is clearly identified.
5. Sign, archive and make it available
The signatory must be authorised to bind the manufacturer. Retain the declaration with the technical file and keep a controlled version: issue date, product reference, report version and internal owner. If an authority or marketplace requests it, you need to provide the correct version promptly.
Checklist before signing
- The named manufacturer is the entity marketing the product under its own name or trade mark.
- The product reference, model and variants match the product actually sold.
- Every applicable CE law has been identified and listed.
- Any standards cited match the reports, product version and intended use.
- Test reports, risk assessment, instructions and labelling are retained in the technical file.
- A notified body is named only where it genuinely took part in the applicable procedure.
- The signatory has authority through their role or delegation to bind the manufacturer.
- The online listing contains the required conformity and traceability information.
Which documents must you retain with the declaration?
The declaration is the legal summary of the technical file; it is not, by itself, proof of conformity. Retain the materials that show why the product meets the applicable requirements.
The exact contents vary by sector, but a technical file commonly includes:
- a general description of the product and its variants;
- relevant drawings, diagrams, bills of materials and operating descriptions;
- the risk assessment and measures taken to reduce identified risks;
- applicable legislation and the standards or methods selected;
- test reports, certificates or notified-body documents where required;
- instructions, warnings, translations and labelling artwork;
- production-control procedures and traceability records;
- the signed EU Declaration of Conformity and earlier versions where the product has changed.
A common mistake is accepting a test report for a similar model. A different colour may have no effect, but a change to a circuit, charger, material, dimensions or software can make the evidence insufficient. Assess the effect of the change; do not assume equivalence.
For distance sales, the information visible on the product listing also matters. Regulation (EU) 2023/988 on general product safety includes specific requirements for online offers of covered products. A Marketplace Product Compliance Scanner can flag traceability, safety and compliance information to verify before publication on Amazon, eBay, Etsy or Shopify.
EU Seller Kit — Use the Marketplace Product Compliance Scanner before publishing or relaunching a listing. It reviews visible compliance information and identifies points to check; it does not replace your technical file.
How much work is involved and which mistakes should you avoid?
The effort depends mainly on product complexity, the number of applicable legal acts and the quality of the supplier's evidence. It is not simply a matter of completing a declaration template.
For a simple, unchanged and well-documented product, the work may be limited to checking existing documents, their consistency and the sales information. For an electrical, connected or multi-part product, you will often need a wider review of testing, hardware versions, warnings and requirements under several legal acts.
Mistakes that create the greatest exposure
Signing before evidence is available. A declaration dated before testing, or unsupported by a coherent file, leaves the manufacturer exposed if an authority asks for evidence.
Confusing a certificate with a declaration. A supplier's “CE certificate” is not automatically a valid EU Declaration of Conformity. The declaration is issued under the manufacturer's responsibility; a test report is only one piece of supporting evidence.
Reusing a template for another reference. A generic declaration that does not distinguish product variants may not cover the product actually shipped.
Overlooking non-CE obligations. CE marking does not remove the need to consider GPSR, labelling, packaging, WEEE, batteries, VAT or applicable national requirements. For an overview by establishment, storage, origin and destination country, Country Compliance organises the checks you need to review.
Assuming a subscription automatically appoints a representative. It does not. GPSR responsible-person and CE authorised-representative services become active only after acceptance, entity assignment, a signed mandate and active payment.
The cost in effort is therefore not limited to producing one document. It may include collecting data, arranging necessary tests, translating documents, adapting labels and monitoring product changes. To compare SaaS plans and add-on services without assuming a price, see EU Seller Kit pricing and plans.
Which special cases need extra care?
Imported products, white-label goods, connected products and production changes need closer review. The declaration must follow the real product, not the supplier's commercial promise.
White-label products and manufacturing outside the EU
Imagine a US manufacturer orders a massage device from a Chinese factory, adds its logo and sells it in several EU countries. If it markets the device under its own brand, it must act as the manufacturer for the applicable obligations. It can obtain documents from the factory, but remains responsible for judging whether they are relevant.
If the transaction involves importing stock, plan customs and tax formalities too. An EORI number identifies the operator for customs formalities; it does not prove CE conformity. The European Commission explains the EORI system, while the guide to importing stock into the EU covers the EORI, customs and VAT steps to plan.
Product changes after signature
A new battery supplier, different adaptor, radio update or material change may require a new assessment. Put change control in place: no new version should be shipped under an old declaration without a documented review.
Products sold online
You do not always need to display the full declaration on the sales page, but information required for distance sales and traceability must be available under the applicable rules. Marketplaces may also request the declaration, reports or label photographs before or after publication. Read Amazon GPSR compliance information for sellers if you sell through Amazon.
Where you are unsure about regulatory classification, an assessment procedure or the scope of a test report, check with the competent authority or a qualified professional before signing.
Tools and services to take action
- EU Market Entry Compliance Assessment — Use this before a first shipment or multi-country launch to identify CE, GPSR, customs, VAT and environmental checks that need review.
- CE Authorised Representative — Use this where a non-EU manufacturer needs a written authorised-representative mandate under applicable CE legislation; it does not replace the manufacturer's evidence.
- Supplier Check — Use it before ordering to centralise supplier identity and commercial information, then identify inconsistencies for further investigation.
- Marketplace Product Compliance Scanner — Use it before publishing a listing to review visible compliance, safety and traceability information.
Frequently asked questions
Is an EU Declaration of Conformity required for every product?
No. It is required where a product falls under EU harmonisation legislation that requires CE marking. A non-CE product may still need to comply with other rules, including GPSR, labelling and extended producer responsibility requirements.
Can an importer sign the declaration instead of the manufacturer?
Normally, no. The declaration is issued under the manufacturer's responsibility. An importer must check that the manufacturer has completed the required steps and obtain or retain required documents, but cannot present itself as the manufacturer without genuinely taking on those obligations.
Is a CE certificate from the factory enough to sell the product?
No, not on its own. Check who issued it, which product and version it covers, which rules it addresses and which technical evidence supports it. The EU Declaration of Conformity must be issued by the manufacturer responsible for the product being marketed.
Do I need a separate declaration for every colour or variant?
It depends on whether the variation affects conformity. A purely cosmetic variation may sometimes be covered by one declaration where the product is clearly identified, but a change in material, battery, circuit, dimensions or function may require a new assessment and additional evidence.
Does the EU Declaration of Conformity need to be translated?
Language requirements depend on the applicable legislation and the national authorities concerned. Prepare a version that is understandable in the languages required in the markets where you make the product available, and check sector-specific rules before sale.
How long must I retain the declaration and technical file?
The retention period depends on the applicable sector legislation; many CE laws require retention for a specified period after the product is placed on the market. Check the rule for your product category and keep organised, accessible records linked to each version sold.
Official sources
- Decision No 768/2008/EC — common framework for the marketing of products — general responsibilities of manufacturers, importers and distributors in the EU framework.
- Commission Notice — The 'Blue Guide' on the implementation of EU product rules (2022) — technical documentation, conformity assessment, CE marking and economic-operator roles.
- Your Europe — CE marking — practical overview of CE marking and manufacturer obligations.
- Directive 2014/53/EU — radio equipment (RED) — requirements for radio equipment, including certain connected products.
- Directive 2014/35/EU — low voltage electrical equipment (LVD) — electrical-safety framework for covered equipment.
- Directive 2014/30/EU — electromagnetic compatibility (EMC) — electromagnetic-compatibility requirements for covered products.
- Regulation (EU) 2023/988 — General Product Safety Regulation (GPSR) — safety and information requirements for covered consumer products, including distance sales.
- European Commission — Economic Operators Registration and Identification (EORI) — the role of EORI identification in customs formalities.
This content provides general information and does not constitute legal advice.