OBL-ART13-11Binding

Draw up an EU Declaration of Conformity (EU DoC)

適用於
Manufacturer
來源引用
Art. 13(11)Art. 28Annex V
產品類別
default, important-class-i, important-class-ii, critical
Last reviewed

通俗語言

Before you affix the CE mark you must formally declare, in writing, that your product meets CRA requirements. Annex V lists exactly what the declaration must say. Keep a copy for ten years, make it accessible online, and update it if anything changes.

Legal text

Article 13(11) of Regulation (EU) 2024/2847 requires that manufacturers shall draw up the EU Declaration of Conformity in accordance with Article 28 and shall affix the CE marking in accordance with Article 30.

Article 28 specifies that by drawing up the EU DoC, the manufacturer takes responsibility for the conformity of the product with digital elements with this Regulation.

Annex V sets out the required content of the EU DoC.

Required content of the EU DoC (Annex V)

  1. Product name, type, batch, serial number, or other identifier
  2. Name and address of the manufacturer
  3. Statement that the EU DoC is issued under the sole responsibility of the manufacturer
  4. Object of the declaration (product description sufficient for traceability)
  5. Reference to the relevant harmonised standards, European cybersecurity schemes, or common specifications to which conformity is declared
  6. Where applicable: name and notified body number, certificate reference
  7. Additional information (e.g. support period end date)
  8. Signed for and on behalf of the manufacturer, with date and place

Key requirements

  1. Drawn up before CE marking — the DoC must exist before the CE mark is affixed
  2. Annex V completeness — all elements listed in Annex V must be present
  3. 10-year retention — kept at the disposal of market surveillance authorities
  4. Online availability — manufacturers are encouraged to make the DoC publicly accessible (e.g. via a URL on the product page or packaging)
  5. Updated on change — a new or revised DoC must be issued if the product is substantially modified

Evidence you may need

  • Signed EU DoC for each product and version
  • Records showing the DoC was available before the CE mark was affixed
  • URL where the DoC is publicly accessible
  • Revision history of DoC updates
Draw up an EU Declaration of Conformity (EU DoC) — CRA 合規中心