In the European market, the CE certification is the most crucial part of all the entry requirements. Without CE certification, most products will not be able to be sold in the European Union and the European Economic Area (EEA). 

The fundamental purpose of CE certification is to ensure safety. It mainly assesses whether the product will cause harm to people, animals or property, and does not involve requirements for the general quality of the product. The relevant directives set the basic safety threshold, and the specific technical details are often further clarified by the corresponding harmonized standards. 

It is essential to note that the CE mark is essentially a safety compliance mark, not a quality mark. It is a mandatory threshold for products to enter the European Union and over 30 countries in the European Economic Area, indicating that the product has met the most basic safety standards.

The European Union has formulated different directives for different product categories, for instance: 
Low Voltage Directive (LVD): Applicable to electrical equipment with a rated voltage ranging from 50V to 1000V. 
Electromagnetic Compatibility Directive (EMC): Applicable to equipment that may generate electromagnetic interference or is affected by electromagnetic interference. 
Mechanical Instruction (MD): Applicable to machinery, interchangeable equipment, safety components, etc. 
Medical Devices Directive (MDD): Applies to medical devices and their accessories. 
Application materials for CE certification of electronic products 
Three test samples 
2. Product Model Difference Table 
3. Product manual or user guide 
4. Application Form 
5. List of Key Components 

Steps for applying for CE certification 
Determine the product category and applicable directives 
Clearly identify the category to which the product belongs (for example, if it is a medical device, it should be classified under MDR; if it is an electronic or electrical product, it should be classified under LVD/EMC). 
Search for the corresponding EU directives and standards (such as the EN 60335 standard for household appliances). 

2. Prepare technical documents 
Required documents: Product design drawings, circuit schematic diagrams, BOM tables, user manuals, risk assessment reports, test reports, etc. 
Key requirement: Compliance evidence covering the entire product life cycle (design, production, testing). 

3. Product Testing and Evaluation 
Laboratory testing: The samples will be sent to an EU-recognized laboratory for safety, EMC, environmental protection, and other tests. 
Risk assessment: Based on standards such as ISO 14971, analyze the potential risks of the product and formulate control measures. 

4. Select the certification path 
Self-declaration (applicable to low-risk products): The enterprise signs the conformity declaration (DoC) by itself, without the need for the involvement of a certification body. 
Announcement Institution Audit (applicable to high-risk products): It requires an audit by an EU announcement institution (Notified Body) and the issuance of a certificate (such as for Class II/III medical devices). 

5. Submitting the Application and Review Process 
Submit the technical documents and application form to the certification authority and pay the fee. 
The certification body conducts a technical review of the documents and may request additional materials or on-site inspections. 

6. Issuance of Certificates and Affixing of CE Mark 
After the review is approved, the CE certificate will be obtained and the CE mark will be affixed to the product, along with a conformity declaration (DoC). 
Some products need to be registered in the EU database (such as EUDAMED). 

The CE mark is applicable to 80% of the industrial and consumer goods in the European market, as well as 70% of the imported products in the EU. According to EU laws, CE certification is a mandatory certification. Therefore, if a product has not undergone CE certification and is exported to the EU without authorization, it will be regarded as an illegal act.