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This document declares that the Biohit Proline Electronic Pipette complies with the essential requirements of the IVD Directive and electromagnetic compatibility directives.
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How to fill out ec declaration of conformity

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How to fill out EC Declaration of Conformity

01
Identify the product for which you are creating the EC Declaration of Conformity.
02
List all applicable EU directives and regulations that apply to the product.
03
Gather relevant technical documentation, including test reports and risk assessments.
04
Ensure the product complies with all necessary safety and performance requirements.
05
Draft the Declaration of Conformity, including product details, manufacturer information, and applicable directives.
06
Sign and date the declaration, ensuring it is stored and made accessible if required.

Who needs EC Declaration of Conformity?

01
Manufacturers of products intended for sale within the European Economic Area (EEA).
02
Importers who bring products into the EEA from outside.
03
Distributors who place products on the EU market and need to ensure compliance.
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People Also Ask about

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.
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.
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.
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.
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.
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.
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.
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.

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The EC Declaration of Conformity is a formal statement by the manufacturer that their product meets the essential requirements of relevant European Union (EU) directives and regulations.
The manufacturer or their authorized representative within the EU is required to file the EC Declaration of Conformity.
To fill out the EC Declaration of Conformity, you must provide information such as the manufacturer's details, product identification, applicable directives, compliance statements, and authorized signature.
The purpose of the EC Declaration of Conformity is to confirm that the product complies with EU safety and health requirements, facilitating free movement of goods within the EU market.
The EC Declaration of Conformity must report information such as the product name, model/serial number, name and address of the manufacturer, applicable directives, and the standards used for compliance.
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