What is EU CE Certification?
CE certification is a mandatory conformity assessment procedure for products in the European Union, serving as a passport for products to enter the European market. CE certification integrates multiple existing certification systems, applicable to a wide range of products in the European market, covering requirements such as safety, EMC, and energy efficiency.
CE Certification Benefits
The CE mark indicates that the product conforms to the essential requirements of Union Directives/Regulations and ensures its safety, health, environmental protection, and consumer protection within the Union.
After the product is found to be in compliance with the applicable directives and correctly affixed with the CE mark, it can be freely circulated within the Union.
CE Certification Process
Determine Directives and Standards
Determine the applicable Union Directives/Regulations and harmonized standards (such as LVD, EMC, RED, MD, RoHS, ErP, etc.) to identify the compliance path and evaluation modules.
- Product purpose and working environment definition
- Applicable harmonized standard list
- Determination of evaluation modules (such as module A self-declaration, module B+C, etc.)
- Planning of technical document list
Testing and Evaluation
Conduct conformity assessment tests based on harmonized standards; radio products need to be assessed for RF and RED requirements; mechanical and functional tests may be required.
- Electrical safety (such as IEC/EN 62368-1, 60335-1, etc.)
- EMC (such as EN 55032/55035/61000-4-x, etc.)
- Wireless and RED (such as EN 300 328, 301 489-1/-17, etc.)
- Energy efficiency/environmental protection (such as ErP, RoHS)
Technical Files and NB (if applicable)
Prepare the technical file (Technical File/TD), and submit it to the notified body (NB) for type examination or audit if necessary.
- Risk assessment and key safety analysis
- Electrical schematic diagram, layout diagram, BOM and key component list
- Test reports and conformity assessment records
- NB participation in evaluation/type examination (such as module B)
Sign DoC and Affix CE
Sign the EU Declaration of Conformity (DoC) and affix the CE mark correctly on the product, packaging, or nameplate, and implement continuous consistency control.
- EU DoC signing and retention
- CE mark usage and technical file retention (usually 10 years)
- Change evaluation and market supervision response
CE Certification Product Scope (Examples)
Certification Requirements
| Item | Requirement |
|---|---|
| Certification Cycle | Generally 4-8 weeks, depending on the applicable directives, test complexity, and whether NB participation is required |
| Certificate Validity | No fixed validity period, technical files and DoC must be retained long-term (usually 10 years) |
| Notified Body | Part of products/modules need NB participation (such as RED certain situations, MD complex machinery etc.) |
| Supervision Requirements | Need to respond to market surveillance and consistency maintenance |
| Marking Usage | Must be affixed to the product, packaging, or nameplate in accordance with the regulations and necessary information |
Application Materials
List of Required Materials
- Product manual, model differences, and function description
- Risk assessment report and basic safety requirements conformity statement
- Technical documents: Electrical schematic diagram, PCB/structural diagram, BOM and key component description
- Test reports (LVD/EMC/RED/ErP/RoHS/MD etc. as needed)
- EU Declaration of Conformity (EU DoC) and label/nameplate sample (with CE mark)
- Notified Body-related certificates and opinions (if applicable)
- Authorized Representative information and compliance responsible party information (if applicable)
Notice
Important Reminder
- According to the product category, select the correct EU directive/ regulation and evaluation module.
- Technical files must be obtainable in the EU and retained as required (usually 10 years).
- CE marks should be affixed to the product, packaging, or nameplate in accordance with the regulations and necessary information.
- Major changes to products require re-evaluation to maintain consistency with assessed samples.
- Wireless products must meet RED's comprehensive requirements for RF, EMC, and safety.
