EU Declaration of Conformity (DoC) Compliance

The European Parliament and the Council of the European Union issued Regulation No 768/2008/EC on July 9, 2008, which outlines certification and market surveillance requirements related to product sales. According to this regulation, the EU Declaration of Conformity (DoC) must follow the exemplary structure specified in Annex III. Manufacturers are required to include elements specified in Annex II modules in their Declaration of Conformity and continuously update them. By issuing the EC Declaration of Conformity, manufacturers assume responsibility for the conformity of their products.

What is DoC?

DoC stands for EU Declaration of Conformity, a formal document drafted and signed by the manufacturer, declaring that their product meets all relevant safety requirements before entering the European market. The DoC compliance declaration is a mandatory document. Additionally, the EU Declaration of Conformity must be translated into one or more languages required by the country/region of product sales.

Which products does DoC apply to?

It applies to all coordinated legislation under framework directives, including but not limited to toys, electrical products, personal protective equipment, machinery, construction products, gas appliances, leisure and private boats, pressure equipment, and measuring instruments.

- Toys: Products designed or intended for use in play by children under 14 years of age, must comply with harmonized standards.

- Construction Products: Products permanently incorporated into construction works or parts thereof, affecting the performance of those works, must comply with harmonized standards.

- Personal Protective Equipment: Equipment designed and manufactured to protect individuals from hazards must comply with harmonized standards.

- Electrical and Electronic Equipment: Equipment relying on electric currents or electromagnetic fields for normal operation must comply with harmonized standards.

For detailed standards and references, visit the [European Commission's official website](https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en).

What is the relationship between DoC and the CE mark?

The CE mark is a safety mark for goods entering the European single market and serves as the manufacturer's declaration that their product complies with relevant EU directives. Before placing a product on the market, manufacturers must ensure that its design and manufacture comply with regulatory requirements. Manufacturers are responsible for drafting the EU Declaration of Conformity as per regulations and affixing the CE mark to the product.

How is a DoC document written?

Before completing the DoC, the manufacturer must determine the product type, identify which EU coordinated legislation applies, and undergo the corresponding conformity assessment as required by regulations. Following the conformity assessment procedure applicable to the product, the manufacturer completes the relevant information in the DoC template provided by the regulation and signs the declaration.

When drafting the Declaration of Conformity, manufacturers must ensure it includes all necessary information required by regulations. If multiple coordinated legislations apply simultaneously, all requirements of those legislations must be met.

What are the common mandatory fields in a DoC for products?

- Toys Safety: CE-Toy requirements, compliance declaration documents as per Directive 2009/48/EC.

- Low Voltage LVD: CE-LVD requirements, compliance declaration documents as per Directive 2014/35/EU.

- Electromagnetic Compatibility EMC: CE-EMC requirements, compliance declaration documents as per Directive 2014/30/EU.

- Radio Equipment: CE-RED requirements, compliance declaration documents as per Directive 2014/53/EU.

- Restriction of Hazardous Substances RoHS: CE-RoHS requirements, compliance declaration documents as per Directive 2011/65/EU.

- Machinery: CE-MD requirements, compliance declaration documents as per Directive 2006/42/EC.

- Measuring Instruments: Compliance declaration documents as per Directive 2014/32/EU.

For more details on filling out DoC for different product categories, refer to the https://ec.europa.eu