What is the CE Mark and How to apply the CE mark.
The CE mark is a mandatory verification mark of the European Union

Basic Information
The CE mark is a mandatory verification mark of the European Union and is considered a passport for manufacturers to open and enter the European market. Any product with the "CE" mark can be sold in the member states of the European Union without having to comply with the requirements of each member state, thereby achieving the free circulation of goods within the member states of the European Union. Products sold on the market that are required by the European Union's New Approach directives to comply with CE verification must themselves comply with the verification of the relevant EU directives and affix the CE mark on the product and instructions for use. Products with the CE verification mark indicate that they comply with EU directive specifications.

Regulatory Content
Refer to EU standards: https://ec.europa.eu/growth/single-market/european-standards_en

1Machinery Directive2006/42/EC
2Low Voltage Directive2014/35/EU
3EMC Directive2014/30/EU
4Medical Devices Directive93/42/EEC
5Personal Protective Equipment Directive89/686/EEC
6Construction Products RegulationRegulation(EU)No 305/2011
7Pressure Equipment Directive201/68/EU
8RoHSDirective 2011/65/EU
9Waste Electrical and Electronic Equipment Directive2012/19/EU
10ATEX Directive2014/34/EU
11Toy Directive2009/48/EC
12Radio Equipment Directive12014/53/EU
13Recreational Craft Directive94/25/EC
14Active Implantable Medical Devices Directive90/385/EEC
15Explosive for Civil Use Directive93/15/EEC
16Noise Emission in the Environment Directive2000/14/EC
17Gas Appliances Directive2009/142/EC
18Lifts Directive1995/16/EC
19Pyrotechnic Directive2007/23/EC
20Measuring instruments (MID)    2014/32/E

Applicable Products

CE validation applies to product projects covered by EU directives, generally including:

  1. Measuring instruments
  2. Gas equipment products
  3. Manned cable system
  4. Low voltage products/equipment
  5. Building products
  6. Hot water boiler
  7. Household refrigerators and refrigerators
  8. Elevator
  9. Equipment
  10. Medical equipment
  11. Active implantable medical device
  12. Non-automatic weighing instrument
  13. Radio and communication terminal equipment
  14. Personal protective equipment
  15. Simple pressure vessel
  16. Pressure equipment
  17. Recreational boat
  18. Toy
  19. Packaging materials and waste
  20. Equipment and protection systems for explosive atmospheres
  21. General civilian explosives (non-military/police)

Verification Application Process

The application process is roughly as follows:

  1. Identify all applicable EU directives
  2. Evaluate whether the product complies with the "essential requirements" in the directive
  3. Choose a suitable compliance assessment mode: for example, self-verification, manufacturer self-declaration, or other assessment modes that require third-party verification
  4. Choose appropriate standards: international standards, European standards, or national standards
  5. If necessary, choose a designated testing agency (Notified Body) to conduct product compliance assessment
  6. If possible, find an authorized representative for the company in the European Union
  7. Prepare a technical file, including a user manual, especially for high-risk products
  8. Collect the required recognition and certificates and prepare a conformity declaration for each directive
  9. Affix the CE mark in accordance with regulations

There are three ways to apply for CE:

  1. Self-declaration: the manufacturer inspects the product in accordance with CE regulations. After meeting all requirements, attach the required test reports, product characteristic information, and self-declaration statement to the product. The self-declaration statement must be signed by a representative of the European Union or an importer to have legal effect; the signer must be responsible for the product.
  2. Self-declaration, but also invite a third-party notary agency to verify that the manufacturer's product has passed the domestic laboratory test and then obtain a certificate from a reputable verification agency (Competent Body) to obtain better credibility.
  3. Invite a third-party notary agency to verify that the manufacturer's product must be certified by a Competent Body in accordance with EU regulations. The product must be sent to a verification agency within the European Union to obtain a report and attach the required test reports and product information. This method requires the product to be sent abroad, and it is difficult to control the time and cost if there are any problems to be dealt with.

Verification Unit

The following units are authorized by CE to conduct verification:

-Underwriters Laboratories Inc. in the United States
-LRV in the UK
-TÜV Rheinland Group in Germany
-TÜV SÜD Group in southern Germany

Verification Fees

Verification prices vary depending on the product. For example, the authorization service fee for personal protective equipment verification is 749 euros for the first year and 499 euros for the second year. The annual fee for toy authorization service verification is 199 euros. Different products still need to be based on each authorized agency.

-A product with a CE mark means that its manufacturer declares that the product meets the basic requirements of European health, safety, and environmental protection regulations and is safe for users, pets, property, and the environment. In fact, these regulations are mostly published in the form of product directives.
-A product with a CE mark also means that it is officially indicated to the European Union: the product can legally enter the unified market of the European Union.
-A product with a CE mark can ensure that the product can circulate freely in the unified market of the European Union.

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