What is an EU Declaration of Conformity?

Dutch term: EU-conformiteitsverklaring | Legal basis: Decision 768/2008/EC + sector-specific legislation

An EU Declaration of Conformity (DoC) is a formal document in which the manufacturer (or authorised representative) states that a specific product complies with all applicable EU harmonised legislation. The DoC identifies the product, lists the applicable directives and regulations, references the harmonised standards or other technical specifications applied, and is signed by a responsible person within the manufacturer's organisation.

The DoC must accompany the product or be made available to market surveillance authorities on request, depending on the applicable legislation. It must be kept available for at least ten years after the last product has been placed on the market. The format is standardised in Decision 768/2008/EC and sector-specific legislation. A single DoC can cover multiple directives and regulations applicable to the same product.

Why it matters for international businesses

For manufacturers and importers, the EU Declaration of Conformity is the cornerstone document of the compliance file. An incomplete, inaccurate or missing DoC is one of the most common findings in market surveillance inspections.