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And here the main difference between a declaration and a certificate is obvious: a declaration is a confirming document of the FIRST party (manufacturer), while a certificate is a document of the THIRD (independent) party.
The Declaration of Conformity typically should contain the following elements: Name and full address of the manufacturer and, if applicable, their Authorised Representative or name and address of the party authorised to compile the Technical File.
DoCs typically take two forms. First, a formal document or officially recognized report that details the standards and testing of the product, and secondly a stamp, logo, or mark on the product, its packaging, or marketing materials that indicates the products standard conformity to customers and the buying public.
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.
The Declaration of Conformity (DoC) for medical devices and in vitro diagnostic (IVD) devices is a key regulatory document required to market these products in various jurisdictions. It asserts that the device complies with relevant regulatory requirements, standards, and directives.
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Declarations of Conformity require the signee to take responsibility for a products compliance within that countrys rules and regulations. It also allows government authorities and regulatory bodies to identify who is legally responsible for a product and its regulatory activity, such as obtaining a CE mark.
Any party wishing to put products on the market within the European Union must make a declaration of conformity, if its product is covered by a corresponding Directive.

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