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How to apply for CE marking for manufacturing products?

CE marking is a mandatory certification for products sold in the European Economic Area (EEA) that indicates conformity with health, safety, and environmental protection standards. Here’s a step-by-step guide to apply for CE marking for your manufacturing products:

1. Determine Applicable EU Directives

  • Identify the European Union directives and regulations relevant to your product (e.g., Machinery Directive, Low Voltage Directive, EMC Directive, etc.).
  • A product may fall under more than one directive.

2. Identify Relevant Harmonized Standards

  • Check for harmonized European standards (EN standards) that apply to your product.
  • Compliance with these standards simplifies the CE marking process.

3. Conduct a Conformity Assessment

  • Perform a risk analysis and assess your product against the essential requirements of the relevant directives and standards.
  • Depending on the directive, you may need to:
    • Perform self-assessment.
    • Engage a Notified Body if required (for high-risk products).

4. Prepare Technical Documentation

  • Compile a technical file that includes:
    • Product description.
    • Design and manufacturing details.
    • Risk assessment.
    • Test results and certificates.
    • Instructions for use.
    • Declaration of conformity.

5. Perform Product Testing

  • Test the product to ensure it meets all applicable standards.
  • Testing can be done in-house or at accredited laboratories.

6. Engage a Notified Body (if required)

  • For certain products (e.g., medical devices, pressure equipment), a Notified Body must verify conformity.
  • Find an appropriate Notified Body through the EU NANDO (New Approach Notified and Designated Organisations) database.

7. Draft a Declaration of Conformity

  • Write a Declaration of Conformity (DoC) stating that the product complies with the relevant EU directives and standards.
  • Include:
    • Manufacturer’s name and address.
    • Product details and description.
    • Applied directives and standards.
    • Manufacturer’s signature.

8. Affix the CE Mark

  • Place the CE mark on the product, packaging, or accompanying documentation as per the directive requirements.
  • The mark must be visible, legible, and indelible.

9. Maintain Ongoing Compliance

  • Keep the technical file and DoC for at least 10 years (or as required by the directive).
  • Regularly review product compliance, especially if standards or directives are updated.

10. Market the Product

  • Once CE marking is in place, you can sell the product in the EEA.
  • Ensure that user instructions, labeling, and packaging comply with EU regulations.

Key Notes:

  • Language Requirements: User manuals and documentation must be in the official language(s) of the country where the product is sold.
  • Penalties for Non-Compliance: Selling products without CE marking or with improper marking can lead to fines, recalls, or bans.

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