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EU Declaration of Conformity: Step-by-Step Guide

The EU Declaration of Conformity is the manufacturer's formal declaration that a product meets CRA requirements. This guide covers the nine mandatory fields in Article 30, retention obligations, and common mistakes to avoid.

CRAReady Team·

What Is the EU Declaration of Conformity?

The EU Declaration of Conformity (EU DoC) is the legal document through which a manufacturer declares that their product meets all applicable EU regulations. For products subject to the CRA, drawing up a valid EU DoC is a prerequisite for CE marking — without it, the product cannot legally be placed on the EU market from December 2027.

The Nine Mandatory Fields (Article 30)

Article 30 of the CRA specifies nine mandatory elements:

  1. Product identification — name, model, version, batch or serial number
  2. Manufacturer details — full legal name, registered address, and if applicable, EU authorised representative details
  3. Statement of sole responsibility — the manufacturer takes sole responsibility for the declaration
  4. Regulatory reference — cite Regulation (EU) 2024/2847
  5. Harmonised standards applied — list any European standards used, with the specific clauses referenced
  6. Conformity assessment module — typically Module A (self-assessment) for default products; notified body details for Class I/II important products
  7. Notified body details (if applicable) — name, address, notification number, certificate number
  8. Place and date of issue — when and where the DoC was signed
  9. Authorised signatory — name, title, and signature of the person signing on behalf of the manufacturer

Before You Sign

The EU DoC must only be signed after the conformity assessment is complete. Signing beforehand — before the technical file is assembled and the assessment is done — creates a false declaration and invalidates CE marking.

Checklist before signing:

  • Technical file is complete and current
  • Gap analysis against Annex I is documented
  • SBOM is generated and current
  • CVD policy is published
  • All identified gaps have been remediated
  • Conformity assessment module has been correctly identified and followed

Retention and Translation

The EU DoC must be retained for at least 10 years after the product was last placed on the market. It must be translated into the official language(s) of the member states where the product is sold, though a single document can reference multiple languages.

Common Mistakes

  • Signing before completing the conformity assessment
  • Listing harmonised standards you have not fully applied
  • Failing to update when the product changes significantly
  • Omitting the notified body reference for Class II products
  • Not retaining a version history of the DoC

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