TL;DR: CE marking is mandatory for most products sold in the EU/EEA. It's a manufacturer's declaration of conformity, not a government-issued certificate. Cost: $2,000–$15,000 depending on product type. Timeline: 4–12 weeks. Many Chinese factories have experience with CE and can coordinate testing.
What Is CE Marking?
CE (Conformité Européenne) marking indicates that a product meets EU health, safety, and environmental requirements. It's required for products in categories covered by specific EU directives — most manufactured goods fall into at least one. CE marking is NOT a quality mark or certification — it's the manufacturer's own declaration that they've met all applicable requirements.
Key EU Directives
| Directive | Covers | Products |
|---|---|---|
| LVD (2014/35/EU) | Electrical safety | Electrical equipment 50–1000V AC |
| EMC (2014/30/EU) | Electromagnetic compatibility | All electronic devices |
| RED (2014/53/EU) | Radio equipment | WiFi, Bluetooth, cellular devices |
| RoHS (2011/65/EU) | Hazardous substances | Electrical and electronic equipment |
| MD (2006/42/EC) | Machinery safety | Machines with moving parts |
| Toy Safety (2009/48/EC) | Children's toys | All toys for children under 14 |
CE Marking Process (Step by Step)
- Identify applicable directives: Determine which EU directives apply to your product category.
- Find harmonised standards: Each directive references specific EN standards that provide presumption of conformity.
- Design and manufacture: Ensure the product meets the essential requirements of all applicable directives.
- Testing: Have the product tested at an accredited lab (e.g., SGS, TÜV, Bureau Veritas, Intertek). Many of these have labs in Shenzhen.
- Technical documentation: Compile a technical file including test reports, design drawings, risk assessment, and user instructions.
- Declaration of Conformity (DoC): Draft and sign a DoC listing the product, applicable directives, standards, and responsible person.
- Affix CE mark: Place the CE mark on the product, packaging, and documentation.
- Appoint EU Authorised Representative: Required if you don't have an EU presence — someone in the EU who can respond to market surveillance authorities.
Costs and Timeline
| Product Type | Typical Cost | Timeline |
|---|---|---|
| Simple electronics (no wireless) | $2,000 – $5,000 | 4–6 weeks |
| Wireless/Bluetooth products | $5,000 – $10,000 | 6–10 weeks |
| Medical devices | $10,000 – $50,000+ | 3–12 months |
| Toys | $3,000 – $8,000 | 4–8 weeks |
Common Mistakes
- Treating CE as a one-time certificate: CE is an ongoing obligation. Any design change may require re-testing.
- Using a "CE certificate" from the factory: There's no official "CE certificate." If a factory shows you a certificate, it's likely just a test report from a lab. The DoC is what matters.
- Forgetting the Authorised Representative: Non-EU importers must appoint an EU-based representative.
- Not keeping the technical file: You must maintain documentation for 10 years after last product is placed on the market.