Summary:
[Introduction to CE Certification] The term "CE" is an abbreviation derived from the French "Conformite Europeene," meaning European Conformity. The "CE" mark is a safety certification mark and is regarded as a passport for manufacturers to open and enter the European market. In the EU market, the "CE" mark is a mandatory certification mark. Whether products are produced by companies within the EU or from other countries, to circulate freely in the EU market, they must bear the "CE" mark to indicate that the products meet the basic requirements of the EU's "New Approach to Technical Harmonization and Standardization" directives. This is a mandatory requirement imposed by EU law on products. [CE Certification Process] This process applies to all products covered by CE: Step 1: Determine the directives and harmonized standards applicable to the product. Different directives cover different ranges of products, and the directives list the basic requirements for the covered products. EU harmonized standards are detailed technical documents used to guide products in meeting the basic requirements of the directives. Step 2: Determine the detailed requirements that the product must meet. You must ensure that your product meets the basic requirements of relevant EU laws. A product is considered compliant with the relevant basic requirements only if it meets all applicable harmonized standards. The applicability of harmonized standards is entirely voluntary; you may also choose other ways to meet the corresponding basic requirements. Step 3: Determine whether the product requires the involvement of a notified body for inspection. There are detailed regulations regarding whether your product needs to be audited by a third-party notified body for CE. Not all products are required to be certified by a notified body, so it is very important to determine whether the involvement of a notified body is truly necessary. These notified bodies are authorized by the European Commission and are listed in detail in the NANDO (New Approach Notified and Designated Organizations) database. Step 4: Test the product and verify its compliance. Manufacturers are responsible for testing their products and checking whether they comply with EU regulations (compliance assessment process). Risk assessment is a fundamental rule in the assessment process, and only after meeting the requirements of relevant EU harmonized standards can you potentially meet the basic requirements of EU official regulations. Step 5: Draft and maintain the technical documentation required by the directives. Manufacturers must establish the technical documentation (TCF) for the product based on the requirements of the directives it complies with and the needs of the risk assessment. If required by the relevant authorized body, manufacturers must submit the technical documentation and the EC Declaration of Conformity for inspection. Step 6: Affix the CE mark to your product and make the EC Declaration of Conformity. The CE mark must be affixed to the product by the manufacturer or their authorized representative. The CE mark must be affixed clearly and permanently to the product or its nameplate according to its standard pattern. If a notified body is involved in the product certification, the CE mark must include the notified body's identification number. The manufacturer is obliged to draft the EC Declaration of Conformity and sign it to certify that the product meets CE requirements. After completing these six steps, your product bearing the CE mark can circulate smoothly in the European market. [CE Directives] Name Directive Number Pressure Equipment 2014/68/EU Toys 2009/48/EC Construction Products No. 305/2011-CPR Electromagnetic Compatibility 2014/30/EU Machinery 2006/42/EC Personal Protective Equipment PPE EU 2016/425 Gas Appliances 2016/426 (GAR) Explosive Atmospheres Directive ATEX 2014/34/EU General Medical Devices 93/42/EEC Radio Equipment 2014/53/EU (RED) Measuring Instruments Directive MID 2014/32/EU Ningbo Shangdu Certification Company has rich experience in certification consulting and is committed to providing comprehensive one-stop certification services for major enterprises across the country. If you want to learn more about this certification or obtain a certification quote, please call 13736130593 (24 hours), and we will respond to you as soon as possible.
Introduction to CE Certification
The letters "CE" are an abbreviation of the French "Conformite Europeene", meaning European Community. The "CE" mark is a safety certification mark and is regarded as a passport for manufacturers to open and enter the European market.
In the EU market, the "CE" mark is a mandatory certification mark. Whether products are produced by companies within the EU or from other countries, to circulate freely in the EU market, they must bear the "CE" mark to indicate that the products meet the basic requirements of the EU's "New Approach to Technical Harmonization and Standardization" directives. This is a mandatory requirement imposed by EU law on products.
CE Certification Process
This process applies to all products covered by CE:
Step 1: Determine the directives and harmonized standards applicable to the product.
Different directives cover different ranges of products, and the directives list the basic requirements for the products covered. EU harmonized standards are detailed technical documents used to guide products in meeting the basic requirements of the directives.
Step 2: Determine the detailed requirements that the product should meet.
You must ensure that your product meets the basic requirements of relevant EU laws. A product is considered to meet the relevant basic requirements only if it complies with all applicable harmonized standards. The applicability of harmonized standards is entirely voluntary; you may also choose other ways to meet the corresponding basic requirements.
Step 3: Determine whether the product requires the involvement of a notified body for inspection.
There are detailed regulations regarding whether your product needs to be audited by a third-party notified body for CE. Not all products are required to be certified by a notified body, so it is very important to determine whether the involvement of a notified body is truly necessary. These notified bodies are authorized by the European Commission and have a detailed list in the NANDO (New Approach Notified and Designated Organizations) database.
Step 4: Test the product and verify its compliance.
Manufacturers are responsible for testing the product and checking its compliance with EU regulations (conformity assessment process). Risk assessment is the fundamental rule in the assessment process. After meeting the requirements of relevant EU harmonized standards, you may then meet the basic requirements of EU official regulations.
Step 5: Draft and maintain the technical documentation required by the directives.
Manufacturers must establish the technical documentation (TCF) for the product based on the requirements of the directives it complies with and the needs of the risk assessment. If required by the relevant authorized body, manufacturers must submit the technical documentation and the EC Declaration of Conformity for inspection.
Step 6: Affix the CE mark to your product and make the EC Declaration of Conformity.
The CE mark must be affixed to the product by the manufacturer or their authorized representative. The CE mark must be affixed clearly and permanently to the product or its nameplate according to its standard pattern. If a notified body is involved in the product certification, the CE mark must include the notified body's identification number. The manufacturer is obliged to draft the EC Declaration of Conformity and sign it to certify that the product meets CE requirements.
After completing the above six steps, your product with the CE mark can circulate smoothly in the European market.
CE Directives
|
Name |
Directive Number |
|
2014/68/EU |
|
|
Toys |
2009/48/EC |
|
Construction Products |
No 305/2011-CPR |
|
Electromagnetic Compatibility |
2014/30/EU |
|
Machinery |
2006/42/EC |
|
Personal Protective Equipment (PPE) |
EU2016/425 |
|
Gas Appliances |
|
|
Explosive Atmospheres Directive (ATEX) |
2014/34/EU |
|
General Medical Devices |
93/42/EEC |
|
Radio Equipment |
2014/53/EU (RED) |
|
Measuring Instruments Directive (MID) |
2014/32/EU |
Ningbo Shangdu Certification Company has rich experience in certification consulting and is committed to providing comprehensive one-stop certification services for major enterprises across the country. If you want to learn more about this certification information or obtain a certification quote, please call 13736130593 (24 hours), and we will respond to you as soon as possible.
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