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This document serves as a declaration that the Biohit tips conform to the Essential Requirements of the EC Directive 98/79/EC, backed by relevant ISO certifications.
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How to fill out ec declaration of conformity
How to fill out EC Declaration of Conformity
01
Identify the product: Determine the specific product for which the EC Declaration of Conformity is being prepared.
02
Gather relevant EU directives: Research and collect the applicable EU directives and regulations that relate to your product.
03
Assess compliance: Evaluate the product against the requirements set forth in those directives to ensure compliance.
04
Prepare technical documentation: Compile all necessary technical documents that demonstrate the product meets the legal requirements.
05
Draft the declaration: Clearly outline the manufacturer’s details, product identification, applicable directives, and compliance statements in the declaration format.
06
Sign the declaration: Ensure the declaration is signed by an authorized representative of the manufacturer.
07
Keep records: Maintain a copy of the declaration and technical documentation for a designated period as required by law.
Who needs EC Declaration of Conformity?
01
Manufacturers who sell products within the European Economic Area (EEA).
02
Importers who distribute products within the EEA that are manufactured outside of the region.
03
Authorized representatives acting on behalf of manufacturers or importers.
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People Also Ask about
Can I make my own Declaration of Conformity?
It's important to note that while you can draft your own DoC, the process requires a thorough understanding of the applicable directives, regulations and standards.
What is the EC Declaration of Conformity?
A Declaration of Conformity is a self-issued document providing detailed information about a product and which EU regulations, directives, and standards this product complies with.
What is EC certification?
The certificate is only part of the CE-marking process We can say that the procedure for passing the audit by the notified body and obtaining the EC-certificate is the final check of what the manufacturer has done before in order to achieve compliance with European regulatory requirements.
What is an EC declaration?
The EU Declaration of Conformity previously was called an 'EC Declaration of Conformity'. Basically, the declaration is a one-page letter or document in which the manufacturer specifies which EU CE marking directives and standards his product complies with.
Is an EC Declaration of Conformity the same as a CE certificate?
Is Declaration of Conformity same as CE? No, the Declaration of Conformity (DoC) and the CE marking are related concepts but not exactly the same. The CE marking is a symbol that manufacturers affix to their products to indicate that they conform to the essential requirements of relevant European Union (EU) directives.
How do I write a CE Declaration of Conformity?
Contents of the Declaration of Conformity Name and business address of the product manufacturer or the authorised representative. Identification that allows the product's traceability. Notified body details, if applicable. A statement, saying that the manufacturer takes full responsibility for the product's compliance.
What is the difference between EC and CE Declaration of Conformity?
It is a EC declaration of conformity. A CE declaration does not exist formally. However, a product consists of the product itself, a User manual and an EC declaration of conformity. In general, the EC declaration of conformity is also called a CE Statement or CE certificate.
What is an EC Declaration of Conformity?
The manufacturer's EU Declaration of Conformity indicate that the product meets all the necessary requirements of the legislation applicable to the specific product. make sure it has the name and address of the manufacturer together with information about the product, for example brand and serial number.
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What is EC Declaration of Conformity?
The EC Declaration of Conformity is a document that a manufacturer or authorized representative prepares to declare that a product meets all relevant European Union (EU) legislation and standards.
Who is required to file EC Declaration of Conformity?
The manufacturer or their authorized representative who produces or imports products that are subject to EU regulations is required to file the EC Declaration of Conformity.
How to fill out EC Declaration of Conformity?
To fill out the EC Declaration of Conformity, one must provide details such as the product name, model number, applicable directives, technical standards met, the manufacturer's name and address, and declare that the product conforms to the relevant EU legislation.
What is the purpose of EC Declaration of Conformity?
The purpose of the EC Declaration of Conformity is to ensure that products comply with all necessary EU health, safety, and environmental protection legislation before they are marketed within the EU.
What information must be reported on EC Declaration of Conformity?
The EC Declaration of Conformity must report information such as the product identification, the manufacturer's details, the relevant directives and standards that apply, as well as a declaration of conformity to those directives.
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