EU Declaration of Conformity (DoC)

The Declaration of Conformity is the formal, legally binding statement from the manufacturer that their product fulfills the requirements of the applicable EU legislation. It is the final step in the conformity assessment procedure before the CE marking can be affixed. The content of the DoC is specified in the relevant directives but generally includes essential information for traceability and verification. This includes the name and address of the manufacturer, a unique identification of the product (e.g., model or serial number), a list of the New Approach Directives the product complies with, and references to the harmonized standards or other technical specifications used to demonstrate conformity.

The document must be signed by an individual with the authority to bind the company, thereby taking legal responsibility for the product’s compliance. The DoC must be kept as part of the technical documentation for at least ten years after the last product was manufactured and must be made available to market surveillance authorities upon request. For some product categories, a copy of the DoC must accompany each product sold. The DoC is a critical element of the CE marking system as it shifts the burden of proof and responsibility squarely onto the economic operator who places the product on the market, rather than on government pre-approval bodies.