EU Declaration of Conformity
What is an EU Declaration of Conformity?
An EU Declaration of Conformity (DoC) is a formal document in which a manufacturer declares, under their sole responsibility, that a product meets all applicable EU regulatory requirements. It is a mandatory document for products requiring CE marking and must be drawn up and signed by the manufacturer — or their EU Authorised Representative — before a CE mark can be affixed and a product placed on the EU market.
Why It Matters
The EU Declaration of Conformity is the manufacturer’s formal commitment that a product complies with all relevant EU legislation. It is not a certificate issued by a third party — it is a legal declaration made by the manufacturer themselves, backed by the evidence contained in their technical documentation and any third-party conformity assessment carried out.
Market surveillance authorities, distributors, and importers may request the EU Declaration of Conformity at any point. An absent, incomplete, or inaccurate declaration can render a product’s CE marking invalid and expose the manufacturer or their Authorised Representative to enforcement action.
For manufacturers placing regulated products on the EU market, drawing up and maintaining an accurate EU Declaration of Conformity is a fundamental compliance obligation.
Key Requirements
Who Is Required to Draw Up an EU Declaration of Conformity?
An EU Declaration of Conformity must be drawn up by:
- The manufacturer placing the product on the EU market, or
- The EU Authorised Representative acting on behalf of a non-EU manufacturer where permitted under the applicable legislation
This requirement applies across multiple regulatory frameworks covering product categories including:
- General product safety
- Electrical and electronic equipment
- Machinery and industrial equipment
- Personal protective equipment
- Toys and children’s products
- Medical devices and in vitro diagnostics
A separate EU Declaration of Conformity must be drawn up for each product or product family, and must be updated whenever changes are made that affect the product’s compliance.
Responsibilities Relating to the EU Declaration of Conformity
While specific content requirements depend on the applicable legislation, an EU Declaration of Conformity commonly includes:
- The name and address of the manufacturer and, where applicable, the EU Authorised Representative
- A description of the product, including its identification details
- A statement that the product meets all applicable EU legislation and requirements
- References to the relevant harmonised standards or common specifications applied
- Details of any Notified Body involved in the conformity assessment, including their identification number and the certificate issued
- The date, place, and signature of the person authorised to sign on behalf of the manufacturer
EU Declaration of Conformity and Technical Documentation
The EU Declaration of Conformity does not stand alone. It is supported by and must be consistent with the manufacturer’s technical documentation. Together, these records form the complete compliance file for a product. Where a market surveillance authority requests evidence of compliance, both the declaration and the underlying technical documentation will typically be reviewed.
Need GPSR compliance support?
Euverify provides EU Authorised Representative services for manufacturers and ecommerce sellers placing products on the EU market. Our team supports documentation review, regulatory communication, and ongoing compliance management.
Further Reading
