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This document declares that the specified Hydrocolloid Dressings by T&L Co., Ltd. comply with the provisions of the Medical Devices Directive 93/42/EEC. It includes details on device classification,
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How to fill out declaration of conformity
How to fill out declaration of conformity
01
Begin with the title 'Declaration of Conformity'.
02
Identify the manufacturer, including name, address, and contact details.
03
Specify the product or products covered by the declaration.
04
List the applicable European Union directives and regulations.
05
Provide details of the harmonized standards used for conformity assessment.
06
Include the name of the notified body, if any, that carried out testing or certification.
07
State the compliance claim with relevant regulations.
08
Sign and date the declaration, including the name and position of the signatory.
Who needs declaration of conformity?
01
Manufacturers of products that must meet EU safety, health, and environmental protection standards.
02
Importers bringing products into the EU market.
03
Distributors of products that are subject to regulations requiring a declaration of conformity.
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What is declaration of conformity?
A declaration of conformity is a document issued by a manufacturer or a representative, affirming that a product meets the required standards and regulations of a specific market or region.
Who is required to file declaration of conformity?
Manufacturers, importers, and authorized representatives of products are typically required to file a declaration of conformity to ensure compliance with applicable regulations.
How to fill out declaration of conformity?
To fill out a declaration of conformity, you must include specific details such as the manufacturer's name, product specifications, applicable standards, and safety requirements, along with an affirmation of compliance.
What is the purpose of declaration of conformity?
The purpose of a declaration of conformity is to demonstrate that a product adheres to legislative requirements, ensuring its safety and compliance for consumers and regulatory authorities.
What information must be reported on declaration of conformity?
The information typically reported includes the manufacturer's name and address, product identification, specified standards and directives met, and a signature from the responsible party affirming compliance.
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