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The CE marking process is designed to ensure that products sold within the EEA meet essential health, safety, and environmental requirements. While it is primarily a self-certification process, the involvement of Notified Bodies for certain products adds an additional layer of verification. Manufacturers must maintain rigorous documentation and ensure ongoing compliance to uphold the integrity of the CE marking.

Role of notified bodies

For certain products and directives, an independent third-party organization known as a Notified Body may be required to participate in the conformity assessment process. These bodies are designated by EU member states and are responsible for conducting audits, inspections, and tests to verify compliance. However, for many products, the CE marking process is indeed a self-certification process carried out by the manufacturer.

 CE marking process

  1. Determine Applicable Directives and Standards:
    • Manufacturers must identify all relevant EU directives and harmonized standards that apply to their product. These directives outline the essential requirements that the product must meet.
  2. Conduct Risk Assessment:
    • Manufacturers perform a risk assessment to identify potential hazards associated with the product and ensure that appropriate safety measures are in place.
  3. Design and Manufacture to Comply:
    • The product is designed and manufactured in a way that ensures it meets the essential requirements of the applicable directives.
  4. Testing and Evaluation:
    • Manufacturers conduct necessary tests and evaluations, either in-house or through accredited laboratories, to verify compliance with the directives.
  5. Prepare Technical Documentation:
    • A comprehensive technical file is prepared, which includes:
      • Product specifications
      • Design and manufacturing drawings
      • Descriptions and explanations necessary for understanding the drawings and the operation of the product
      • Results of design calculations and risk assessments
      • Test reports
      • User manual
  6. Issue Declaration of Conformity:
    • The Declaration of Conformity (DoC) is a legal document issued by the manufacturer. It declares that the product complies with all relevant EU legislation and includes:
      • Name and address of the manufacturer
      • Description of the product
      • Reference to the applicable directives and standards
      • Statement of conformity
      • Signature and date
  7. Affix CE Marking:
    • The CE marking is affixed to the product or its packaging. It must be visible, legible, and permanent. The CE marking indicates that the product is compliant and can be sold in the EEA.

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© 2012-2024 GTG Group. All rights reserved.