8.3 EU Declaration of Conformity

Overview

The EU Declaration of Conformity (DoC) is the formal document by which the manufacturer declares that its product meets the requirements of the CRA. It is a prerequisite for affixing the CE marking.

LEGAL BASIS

Art. 28 CRA: "The manufacturer shall draw up an EU Declaration of Conformity in accordance with Annex V and retain it for at least 10 years."

Annex V CRA defines the minimum content of the EU Declaration of Conformity.

Content in accordance with Annex V CRA

The EU Declaration of Conformity must contain at least:

1. Name and address of the manufacturer and, where applicable, of the authorised representative
2. Statement that the Declaration of Conformity is issued under the sole responsibility of the manufacturer
3. Product identification (name, type, version, batch number, serial number, or other identifier)
4. Statement that the product complies with the essential requirements of the CRA
5. References to the harmonised standards or other technical specifications applied
6. Name and identification number of the notified body (if involved)
7. Additional information (if applicable)
8. Place and date of issue
9. Signature of the responsible person, including name and function
10. Support period of the product

Template

A fillable template is available at: → EU Declaration of Conformity Template

CE Marking

After issuing the EU Declaration of Conformity, the CE marking shall be affixed:

For Physical Products

• On the product or its packaging
• Visible, legible, and indelible

For Software Products

• In the product documentation
• In the user interface (recommended)
• In the README / release notes
• On the product website

Requirements for the CE Marking

• Minimum height of 5 mm (for physical products)
• Proportions in accordance with EU requirements
• Identification number of the notified body (if involved)
• Next to the CE marking: postal address of the manufacturer

Retention

Document	Retention Period	Storage Location
EU Declaration of Conformity	10 years after placing on the market	This repository
Technical documentation	10 years after placing on the market	This repository
Conformity Assessment records	10 years after placing on the market	This repository

Provision to Authorities

Pursuant to Art. 28(5) CRA, the EU Declaration of Conformity must be made available to market surveillance authorities upon request:

• Electronically via this repository
• As a PDF upon request
• In the language of the requesting authority (at least English)

Updates

The EU Declaration of Conformity must be updated in the event of:

• Substantial changes to the product (new version with modified security functions)
• Changes to applied standards
• Changes to Regulation (EU) 2024/2847 (Delegated/Implementing Acts)
• Expiry of the assessment period (in the case of external assessment)