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AUSTRALIAN MEDICAL DEVICES GUIDANCE DOCUMENT NUMBER 5 The Declaration of Conformity 30 October 2003 DISCLAIMER This document is provided for guidance only. It should not be relied upon to address

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What is manufacturer39s declaration of conformity?

Manufacturer's declaration of conformity is a document in which the manufacturer declares that the product meets all the relevant European Union (EU) regulations and standards.

Who is required to file manufacturer39s declaration of conformity?

The manufacturer or authorized representative of the product is required to file the manufacturer's declaration of conformity.

How to fill out manufacturer39s declaration of conformity?

To fill out the manufacturer's declaration of conformity, the manufacturer needs to provide information about the product, its characteristics, and the applicable regulations and standards it complies with.

What is the purpose of manufacturer39s declaration of conformity?

The purpose of the manufacturer's declaration of conformity is to demonstrate that the product conforms to the regulatory requirements, ensuring its safety and compliance before it is placed on the market.

What information must be reported on manufacturer39s declaration of conformity?

The manufacturer's declaration of conformity must include information such as the product's identification, description, technical specifications, any applicable standards, and the name and address of the manufacturer or authorized representative.

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