Declaration of Conformity

What Is Declaration of Conformity?

A Declaration of Conformity (DoC) is a document that states that a product meets the requirements of applicable European Union (EU) directives and regulations. It is a legally binding document that is issued by the manufacturer or importer of a product and is used to demonstrate that the product complies with the relevant safety, health, and environmental protection standards. The DoC is an important part of the CE marking process, which is required for products sold in the EU.

Description

A Declaration of Conformity is a document that states that a product meets the requirements of applicable European Union (EU) directives and regulations.

Usage and Examples

The Declaration of Conformity is an important part of the CE marking process, which is required for products sold in the EU. The DoC must be issued by the manufacturer or importer of the product and must include the following information: the name and address of the manufacturer or importer, the product name and type, the applicable EU directives and regulations, and a statement that the product meets the requirements of the applicable directives and regulations. The DoC must also be signed by a representative of the manufacturer or importer.

For example, a manufacturer of a medical device must issue a Declaration of Conformity that states that the device meets the requirements of the Medical Device Directive (MDD). The DoC must include the name and address of the manufacturer, the product name and type, the applicable EU directives and regulations, and a statement that the product meets the requirements of the applicable directives and regulations. The DoC must also be signed by a representative of the manufacturer.