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
1 | Machinery Directive | 2006/42/EC |
2 | Low Voltage Directive | 2014/35/EU |
3 | EMC Directive | 2014/30/EU |
4 | Medical Devices Directive | 93/42/EEC |
5 | Personal Protective Equipment Directive | 89/686/EEC |
6 | Construction Products Regulation | Regulation(EU)No 305/2011 |
7 | Pressure Equipment Directive | 201/68/EU |
8 | RoHS | Directive 2011/65/EU |
9 | Waste Electrical and Electronic Equipment Directive | 2012/19/EU |
10 | ATEX Directive | 2014/34/EU |
11 | Toy Directive | 2009/48/EC |
12 | Radio Equipment Directive | 12014/53/EU |
13 | Recreational Craft Directive | 94/25/EC |
14 | Active Implantable Medical Devices Directive | 90/385/EEC |
15 | Explosive for Civil Use Directive | 93/15/EEC |
16 | Noise Emission in the Environment Directive | 2000/14/EC |
17 | Gas Appliances Directive | 2009/142/EC |
18 | Lifts Directive | 1995/16/EC |
19 | Pyrotechnic Directive | 2007/23/EC |
20 | Measuring instruments (MID) | 2014/32/E |
Applicable Products
CE validation applies to product projects covered by EU directives, generally including:
- Measuring instruments
- Gas equipment products
- Manned cable system
- Low voltage products/equipment
- Building products
- Hot water boiler
- Household refrigerators and refrigerators
- Elevator
- Equipment
- Medical equipment
- Active implantable medical device
- Non-automatic weighing instrument
- Radio and communication terminal equipment
- Personal protective equipment
- Simple pressure vessel
- Pressure equipment
- Recreational boat
- Toy
- Packaging materials and waste
- Equipment and protection systems for explosive atmospheres
- General civilian explosives (non-military/police)
Verification Application Process
The application process is roughly as follows:
- Identify all applicable EU directives
- Evaluate whether the product complies with the "essential requirements" in the directive
- Choose a suitable compliance assessment mode: for example, self-verification, manufacturer self-declaration, or other assessment modes that require third-party verification
- Choose appropriate standards: international standards, European standards, or national standards
- If necessary, choose a designated testing agency (Notified Body) to conduct product compliance assessment
- If possible, find an authorized representative for the company in the European Union
- Prepare a technical file, including a user manual, especially for high-risk products
- Collect the required recognition and certificates and prepare a conformity declaration for each directive
- Affix the CE mark in accordance with regulations
- 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.
- 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.
- 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
-Intertek
-TÜV SÜD Group in southern Germany
-SGS
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.
Benefits
-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.