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Declaration of Conformity
According to Directive 98/79/EC on invitrodiagnostic devices, Annex III
product number:
product name:
classification:
manufacturer:243103N20
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How to fill out ec-declaration of conformity
How to fill out ec-declaration of conformity
01
To fill out an EC Declaration of Conformity, follow these steps:
02
Start by including the company information, including the name, address, and contact details of the manufacturer or authorized representative.
03
Identify the product that the declaration is being issued for. Include details such as the product's name, model number, or any other relevant identification information.
04
Specify the applicable European directives or regulations that the product complies with. These directives will vary depending on the type of product.
05
Provide a description of the conformity assessment procedure that was followed to demonstrate compliance. Include details of any third-party testing or certification that was obtained.
06
Declare that the product meets all the necessary requirements and is compliant with the applicable directives and regulations.
07
Include the name and signature of the person responsible for the declaration, along with the date it was issued.
08
Optionally, include any additional information or documentation that supports the declaration, such as test reports or technical documentation.
09
Ensure that the declaration is written in the official language(s) of the country or countries where the product will be placed on the market.
10
Keep a copy of the EC Declaration of Conformity on file and make it available to relevant authorities upon request.
Who needs ec-declaration of conformity?
01
The EC Declaration of Conformity is typically required by manufacturers or authorized representatives who intend to place products on the European market.
02
It is necessary for products covered by European directives or regulations that require a conformity assessment procedure.
03
Importers, distributors, and retailers may also need access to the EC Declaration of Conformity in order to ensure that the products they sell comply with European legal requirements.
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What is ec-declaration of conformity?
The EC Declaration of Conformity is a document where the manufacturer or importer declares that a product complies with applicable EU regulations and standards.
Who is required to file ec-declaration of conformity?
Manufacturers or importers placing products on the EU market are required to file the EC Declaration of Conformity.
How to fill out ec-declaration of conformity?
To fill out the EC Declaration of Conformity, the manufacturer or importer must list the relevant product information, compliance details, and sign the document to declare conformity with EU regulations.
What is the purpose of ec-declaration of conformity?
The purpose of the EC Declaration of Conformity is to demonstrate that a product meets the necessary requirements for placement on the EU market and ensures consumer safety.
What information must be reported on ec-declaration of conformity?
Information such as product name, model number, manufacturer details, conformity assessment procedures, and directives or regulations complied with must be reported on the EC Declaration of Conformity.
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