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What is the EU declaration of conformity?

1. What is an EU Declaration of Conformity?

An EU Declaration of Conformity (also called a Declaration of Conformity or DoC) is a mandatory document that you, as a manufacturer, must draw up and sign if you are manufacturing, importing or distributing products intended for use in the EU.

You must first draw up the technical documentation for the product, which includes, supports and justifies the DoC.

There are four main parties — known as Economic Operators — involved in the EU Declaration of Conformity for the trading of products within the EU:

Ø  Manufacturer.

Ø  Authorized representative (AR).

Ø  Importer.

Ø  Distributor.

By drawing up and signing the EU Declaration of Conformity, either the manufacturer or their authorized representative (AR) becomes responsible for the product’s CE marking process.

If the manufacturer is based in the EU then the situation is simple. The manufacturer would be responsible for all aspects of compliance. Faulty goods and incorrect paperwork are entirely the manufacturer’s responsibility.

The situation becomes more complex if the manufacturer of the product is based outside of the EU. In this case, the manufacturer would need an AR based in the EU, and importers and distributors would also then have DoC obligations.

An authorized representative is a person (natural or legal) “who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks”, according to the EU’s Market Surveillance Regulations.

A “natural person” is an identifiable person, whereas a “legal person” is a corporate body such as a limited company.

Note that the appointment of an authorized representative is optional but recommended since it gives the most flexibility. However, manufacturers can also appoint an importer or Fulfilment Service Provider as their Economic Operator within the EU.

According to the EU’s Blue Guide, if an Economic Operator other than the manufacturer places the product on the market under his own name or trademark or modifies them, he automatically takes over the manufacturer’s responsibilities.

Furthermore, when products are imported from, for example, China, the Economic Operator responsible for first placing the product on the market in the EU — whether under his own name/trademark or not, and is usually the importer would most likely have to keep a copy of the DoC for 10 years after the goods have been placed on the market.

The EU’s New Legislative Framework (NLF) says nothing about the relationship between an importer and the manufacturer’s AR but the primary function of an AR is to act as a contact point through which the market surveillance authorities (MSA) can obtain the technical documentation for the goods from the manufacturer.

Distributors also have DoC obligations, mainly in regards to ensuring that goods bear CE marking and comply with all requirements, among others.

By signing the EU Declaration of Conformity, you declare that your products comply with European legal safety requirements. You also declare that you are fully responsible for ensuring that your product complies with the applicable EU legislation.

This article will go through why you would need an EU declaration of Conformity, how you prepare it and the obligations of each party involved in the selling and marketing of a product in the EU.

If you have any questions regarding the EU Declaration of Conformity, you can always contact us.

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2.Which products need an EU Declaration of conformity (DoC)?

The EU Declaration of Conformity is required, among other things, to trade and market a product within the European Union.

An EU Declaration of Conformity is required for 25 product groups, including:

Ø  Toys.

Ø  Electronic products.

Ø  Personal protection equipment (PPE).

Ø  Medical devices.

Ø  Machinery.

Ø  Pyrotechnic products.

Ø  Measuring inst