Declaration of Conformity 101 — what it is, who needs it, how it's signed

An EU Declaration of Conformity is the manufacturer's statement that the identified product meets the applicable Union harmonisation legislation. It follows the assessment and evidence; a signature alone does not establish conformity. First determine which acts apply and which declaration structure they require.

Start with the product and the applicable acts

Record intended use, responsible manufacturer, target markets, placing date and the exact hardware and firmware configuration. A radio product normally follows RED for its safety, EMC and spectrum requirements; standalone LVD and EMC do not also apply to that radio equipment. RoHS and other independently applicable acts still need assessment. A separate mains adapter can have its own scope and evidence.

GPSR is not a general CE-marking or EU DoC regime. CRA product-conformity duties generally apply from 11 December 2027; manufacturer Article 14 reporting already applies from 11 September 2026. MDR devices are excluded from CRA under Article 2(2). Do not copy the same list of legislation to every electronic product.

Use the correct declaration annex

For radio equipment, RED Article 18 and Annex VI set the declaration structure. For equipment within their respective scopes, LVD Article 15 and EMC Article 15 use Annex IV of each directive; RoHS Article 13 uses Annex VI. CRA Article 28 requires the Annex V model structure and the elements specified in the applicable Annex VIII conformity assessment procedure, when those duties apply. MDR Article 19 and Annex IV set a different device-specific structure. Check each applicable act rather than relying on a universal count of nine fields.

Typically identify the product, manufacturer and any representative required by the applicable structure; state manufacturer responsibility; list the applicable legislation and the standards or specifications actually used, with the identification, version and date details required by that structure; include relevant notified-body and certificate details; and record issue place/date and the authorised signatory's name, function and signature. RED Annex VI also requires, where applicable, a description of accessories, components and software covered by the declaration. MDR Annex IV requires device-specific information including the Basic UDI-DI and risk class.

Where more than one act requires a declaration, follow the applicable single-declaration rules. Include only relevant legislation. A proposed standard, an unperformed test or a supplier certificate for a different configuration is not evidence that your finished product conforms.

Language and delivery are separate checks

RED Article 18(2), CRA Article 28(2) and MDR Article 19(1) refer to languages required by the Member State concerned. This does not create a universal duty to translate every declaration into all 24 EU languages.

Check how each act requires information to reach users. RED Article 10(9) requires each item of radio equipment to be accompanied by a copy of the full declaration or the Annex VII simplified declaration. The simplified declaration must contain the exact internet address for the full text; RED Article 18(2) also requires that full text to be available there in the languages required by the Member State concerned. This arrangement is different from instructions and safety information under Article 10(8), and from an authority's request for technical documentation. See our translation guide.

Who signs, and who represents the manufacturer?

The authorised signatory acts for the manufacturer. Do not describe every company signatory as automatically personally liable for every later defect: corporate, individual and criminal liability depend on the facts and applicable law. eIDAS Article 25 distinguishes general legal recognition of electronic signatures from the express handwritten-equivalent effect of a qualified electronic signature. See our signature guide.

An authorised representative is not universally mandatory for every non-EU CE-marked product. RED Article 11 and CRA Article 18 permit appointment by written mandate. For products in its scope, Regulation 2019/1020 Article 4 requires a responsible economic operator established in the EU: an EU manufacturer, an importer, a representative with the relevant written mandate, or a fulfilment service provider where none of the preceding operators is established in the EU. MDR Article 11 has a specific mandatory representative rule for a non-EU manufacturer.

Retain evidence and reassess changes

Keep the issued declaration, configuration mapping and supporting technical documentation. RED Article 10(4) requires retention for ten years after the radio equipment has been placed on the market. When applicable, CRA Article 13(13) requires at least ten years after the product has been placed on the market or the support period, whichever is longer. MDR Article 10(8) requires at least ten years after the last device covered by the declaration has been placed on the market, or at least fifteen years for implantable devices.

Keeping a declaration current is a legal duty: RED Article 18(2) and MDR Article 19(1) require continuous updating; CRA Article 28(2) requires updating as appropriate when it applies. LVD Article 15(2), EMC Article 15(2) and RoHS Article 13(2) also require updates.

A design change, new intended use, evidence gap or legislation change needs assessment. An amendment does not automatically invalidate every previously placed unit on its entry-into-force date; check application dates, transitional rules and the facts stated in the declaration. Keep superseded versions and their covered units traceable.

Primary references

• RED: Articles 10, 11, 18 and Annexes VI–VII — consolidated 30 May 2026
• LVD: Article 15 and Annex IV — consolidated 30 May 2026
• EMC: Articles 2 and 15 and Annex IV — consolidated 30 May 2026
• RoHS: Article 13 and Annex VI — consolidated 1 July 2026
• CRA: Articles 2, 13, 14, 18, 28, 69 and 71 and Annexes V, VI and VIII
• Commission: CRA reporting obligations
• MDR: Articles 10, 11, 19 and Annex IV — consolidated 19 July 2026
• Market Surveillance Regulation: Article 4 — consolidated 12 August 2026
• eIDAS: Article 25 — consolidated 18 October 2024
• GPSR: scope and responsible economic operator — consolidated 29 May 2026