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What does a Declaration of Conformity mean? It is a formal declaration by a manufacturer, or the manufacturers representative, that the product to which it applies meets all relevant requirements of all product safety directives applicable to that product.
How to draw up a declaration of conformity your name and full business address or that of your authorised representative. the products serial number, model or type identification. a statement, stating you take full responsibility. means of identification of product allowing traceability this can include an image.
A EU Declaration of Conformity (also called a CE Certificate, EC Declaration of Conformity, or CE Declaration of Conformity) is the document confirming that the product complies with the applicable CE marking directives or regulations.
A Declaration of Conformity (DoC) is a required self-docHubing document created by the medical device manufacturer to state that a device or a series of devices complies with the conformity requirements of a particular countrys regulations.
The Declaration of Conformity must be issued by the manufacturer or their authorised representative. However, this is not necessarily the person or company who actually made the product.
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Manufacturer/ importers identification such as the legal name, address and contact number. List of all safety regulations/standards that the product must pass. List of certificates awarded to manufacturer that the product has been tested and is compliant. The date and place where the product was manufactured.
Sometimes a Declaration of Conformity is referred to as a CE Statement or CE certificate. This is because the DoC is the official document that states that a product meets all EU health and safety requirements and can therefore legally bear the CE mark.
This period starts from the date of placing on the market of the product. Drawing up the DoC is the responsibility of the manufacturer or the authorised representative. For imported products, the importer must verify that the Declaration of Conformity is available. If not, the importer must draw one up.

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