Eu Declaration of Conformity - DoC

An EU Declaration of Conformity (also known as a Declaration of Conformity or DoC) is a mandatory document that you, as a manufacturer, must produce and sign if you manufacture, import, or distribute products for use in the EU. You must first draw up the technical documentation for the product, which includes, supports, and justifies the DoC

By drawing up and signing the EU Declaration of Conformity, the manufacturer becomes responsible for the product’s CE Marking Process.

This declaration must cover one or more products manufactured, clearly identified by means of product name, product code, or other unambiguous references, and must be kept by the manufacturer, or his EU Representative if the manufacturer is based outside the EU.

The following information must be included in the EU declaration of conformity:

1. The name and full address of the company and its authorized representative.
2. A declaration that the manufacturer is solely responsible for issuing the EU declaration of conformity.
3. The Basic UDI-DI and SRN if applicable.
4. Product and trade name, product code, catalogue number, or other unambiguous reference allowing identification and traceability of the device including a photograph, if appropriate, and the device's intended use.
5. The device's risk class is in accordance with the rules.
6. The harmonized standards or relevant directives the product complies to.
7. A declaration stating that the product complies with relevant directives and that the manufacturer takes full responsibility for the product.
8. The full name and signature of the person authorized to do so on behalf of the manufacturer.
9. The date the declaration was issued.

It is the responsibility of the manufacturer or Authorised Representative (AR) to ensure that the information provided in a Declaration of Conformity is relevant and up to date. The contact information of the manufacturer/AR is indicated on the DoC You can use this information to take up contact with the responsible party directly to ensure that the product meets all relevant European health and safety standards.

The DoC must be kept for 10 years after the product has been placed on the market.

The manufacturer must translate the EU declaration of conformity into the language or languages required by the EU country in which your product is sold.

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