CE certification (Conformité Européenne, European Conformity) is a mark indicating that a product complies with the safety, health, and environmental requirements of the European Union (EU). CE certification is a mandatory requirement under EU law, and all products entering the EU market, such as electronic products, machinery, medical devices, automobiles, etc., must obtain CE certification.
- Machinery: Electric tools, elevators, forklifts, etc.
- Electrical Equipment: Household appliances, lighting equipment, electric bicycles, etc.
- Toys: Plastic toys, wooden toys, electronic toys, etc.
- Personal Protective Equipment: Helmets, safety glasses, gas masks, etc.
- Medical Devices: Blood pressure monitors, thermometers, X-ray machines, etc.
- Building Materials: Doors, windows, flooring, paints, etc.
- Pressure Equipment: Boilers, pressure vessels, etc.
- Wireless Communication Devices: Mobile phones, Bluetooth devices, Wi-Fi routers, etc.
- Notified Body Certification
This is issued by an EU-designated notified body, which has a unique notification number. These bodies are EU-recognized and conduct independent evaluation and certification of products.
- Self-Declaration
This is a self-declaration made by the manufacturer, where they take responsibility for ensuring that the product complies with CE standards. No external notified body is involved, but the manufacturer must ensure compliance with relevant standards.
- CoC Type (Certificate of Conformity)
This is a formal certification issued by an EU notified body after assessing the product. It serves as external, authoritative proof that the product meets the required standards.
- DoC Type (Declaration of Conformity)
This is a self-declaration by the manufacturer, confirming that the product complies with relevant EU standards and regulations. It is a self-responsibility approach.
1. Determine Applicable Directives
First, identify the EU directives applicable to the product. Different product categories have different directives, such as the Low Voltage Directive (LVD), Electromagnetic Compatibility Directive (EMC), Toy Safety Directive, etc.
2. Conduct Risk Assessment
Based on the applicable directives, perform a risk assessment to ensure that the product meets all safety, health, and environmental requirements.
3. Select Certification Mode
Choose the appropriate certification mode based on the product type and applicable directive. Common modes include self-declaration, third-party testing, and notified body certification.
4. Testing and Evaluation
Send the product to an EU-accredited third-party laboratory for testing and evaluation to ensure compliance with relevant standards.
5. Prepare Technical Documentation
Based on the test results, prepare detailed technical documentation, including product descriptions, design drawings, test reports, etc.
6. Issue CE Declaration
Based on the test results and technical documentation, prepare and sign the CE Declaration of Conformity (DoC).
7. Apply the CE Mark
Apply the CE mark to the product and its packaging to indicate compliance with EU requirements.
The validity of a CE certificate depends on the risk level of the product. CE certification is based on the risk associated with the product, as well as the relevant standards, directives, and whether there have been any significant changes in the manufacturing process or raw materials. If there are no major changes, the certificate remains valid. However, for higher-risk products, continuous Factory Production Control (FPC) is required annually to maintain the validity of the certificate.
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