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Understand CE certification in one article

Understand CE certification in one article

25 May 2020


CE certification, which is limited to the basic safety requirements of products that do not endanger the safety of humans, animals and goods, rather than general quality requirements, the harmonized directive only stipulates the main requirements, which are standard tasks. Therefore, the accurate meaning is: the CE mark is a safety mark instead of a quality mark. It is the "main requirement" that forms the core of the European Directive.

The "CE" mark is a safety certification mark and is regarded as a passport for manufacturers to open and enter the European market. CE stands for European Unification (CONFORMITE EUROPEENNE).

The "CE" mark in the EU market is a mandatory certification mark. Whether it is a product produced by an enterprise within the EU or a product produced by another country, if it is to be circulated freely in the EU market, it must be affixed with the "CE" mark to indicate that the product It meets the basic requirements of the EU "Technical Coordination and Standardization New Method" directive. This is a mandatory requirement imposed on products by EU law.

Applicable countries:

Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom, Bulgaria, Romania, Croatia, Turkey.

necessity:

CE certification provides unified technical specifications for the trade of products of various countries in the European market, and simplifies the trade procedures. Any product from any country that enters the European Union or the European Free Trade Zone must undergo CE certification and affix the CE mark to the product. Therefore, CE certification is a pass for products to enter the EU and European Free Trade Zone countries. CE certification indicates that the product has reached the safety requirements stipulated in the EU directive, which is a commitment of the company to consumers, which increases the consumer's trust in the product. Products with the CE mark will reduce the risk of sales in the European market. These risks include:

1. The risk of being detained and investigated by the customs;

2. Risks investigated by the market supervision agency;

3. The risk of being accused by peers for competitive purposes.

benefit:

1. EU laws, regulations and harmonized standards are not only large in number, but also very complex in content, so it is a wise move to save time, effort and reduce risks by obtaining help from EU designated agencies

2. Obtain a CE certification from a designated agency of the European Union to maximize the trust of consumers and market surveillance agencies;

3. Can effectively prevent the occurrence of irresponsible allegations;

4. In the face of litigation, the CE certification of the EU designated agency will become legally effective technical evidence;

5. Once punished by EU countries, the certification body will bear the risk with the enterprise, thus reducing the risk of the enterprise.

Process:

This process applies to all products covered by all CEs:

Step 1: Determine the directives and harmonized standards that the product complies with

Products covered by more than 20 directives need to be affixed with the CE mark. These directives cover different scopes of products, and the directive lists the basic requirements of the products covered. The EU harmonized standards are detailed technical documents used to guide products to meet the basic requirements of the directive.

Step 2: Determine the detailed requirements that the product should meet

You must ensure that your products meet the basic requirements of the relevant EU laws. Products that meet the requirements of all applicable harmonized standards are considered to be in compliance with the relevant basic requirements. Whether or not the application of the harmonized standards is entirely voluntary, you can also choose other ways to meet the corresponding basic requirements.

Step 3: Determine whether the product needs to be notified by the notified body

Every instruction related to your product has detailed regulations on whether a third-party announcement agency is required to participate in the CE audit. Not all products are required to be certified by the notified body, so it is very important to determine whether the notified body is really required to participate. These notified bodies are authorized by the European Commission and have a detailed list in the files of NANDO (New Method Directive Notified Bodies and Designated Bodies).

Step 4: Test the product and check its compliance

It is the responsibility of the manufacturer to test the product and check whether it complies with EU regulations (conformity assessment process). Risk assessment is the basic rule in the assessment process. After meeting the requirements of the relevant EU harmonized standards, you are likely to meet the official EU regulations Basic requirements.

Step 5: Draft and save the technical documents required by the directive

The manufacturer must establish the technical document (TCF) of the product according to the requirements of the directive and risk assessment required by the product. If required by the relevant authorized department, the manufacturer must submit the technical documentation and EC declaration of conformity together for inspection.

Step 6: Put the CE mark on your product and make an EC Declaration of Conformity

The CE mark must be affixed to the product by the manufacturer or its authorized representative. The CE mark must be clearly and permanently attached to the product or its nameplate according to its standard drawing. If the notified body participates in the certification of the product, the CE mark must carry the bulletin number of the notified body. The manufacturer is obliged to draft an EC declaration of conformity and sign it to prove that the product meets CE requirements.

After the above six steps, products with the CE mark can be circulated smoothly in the European market.

This process is applicable to the process for manufacturers to find a third-party laboratory to apply for CE certification:

The first party is a laboratory within the organization, which tests / calibrates the products produced by itself, or entrusts a laboratory to test / calibrate the products produced by itself on its behalf. The data is used by me to improve and control the quality of the products produced by me. The second party is also a laboratory within the organization, calibrating / testing the product provided by the supplier, or entrusting a laboratory to provide the product on behalf of its testing / calibration supplier. The data is for my use and the purpose is to provide and control the quality of the supplier ’s product. The third party is a laboratory that is independent of the first and second parties and provides testing / calibration services for the society. The data is used by the society to provide and control the quality of social products. In addition, the first, second, and third party laboratories can be converted to each other, the third party can become the first and second parties, and the first party can also be the second party. If a laboratory is a department in an institution that is engaged in testing or calibration and only provides internal services for the institution, the laboratory is a typical first-party laboratory.

1. The manufacturer's relevant laboratory (hereinafter referred to as the laboratory) submits a preliminary application, oral or written.

2. The applicant fills out the CE-marking application form, and sends the application form, product instruction manual and technical documents to the laboratory (if necessary, the applicant company is required to provide a prototype).

3. The laboratory determines the inspection standards and inspection items and quotes.

4. The applicant confirms the quotation and sends the samples and relevant technical documents to the laboratory.

5. The applicant provides technical documents.

6. The laboratory sends a charge notice to the applicant, and the applicant pays the certification fee according to the charge notice.

7. The laboratory conducts product testing and review of technical documents.

8. Technical document review includes:

a. Whether the file is complete.

b. Whether the document is written in the official language of the European Community (English, German or French).

9. If the technical documents are incomplete or the prescribed language is not used, the laboratory will notify the applicant of the improvement.

10. If the test fails, the laboratory will notify the applicant in time and allow the applicant to improve the product. So, until the test passes. Applicants should modify the technical information in the original application to reflect the actual situation after the change.

11. For the rectification costs involved, the laboratory will issue a supplementary charge notice to the applicant.

12. The applicant shall pay the rectification fee according to the supplementary charge notice.

13. The laboratory provides the applicant with a product test report or technical document (TCF), CE certificate of conformity (COC), and CE mark.

14. The applicant signs the CE guarantee self-declaration and attaches the CE mark on the product.

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