標準簡介
CE 標誌（Conformité Européenne，即歐洲合格認證）是在歐洲經濟區（EEA）銷售產品的強制性合格標誌。該標誌由歐盟理事會指令 93/68/EEC 於 1993 年 7 月引入，1995 年 1 月起強制實施，表明產品符合歐盟健康、安全和環境保護要求。CE 標誌涵蓋 25 項以上歐盟指令和法規管轄的產品，包括低電壓指令（LVD）用於電氣安全、EMC 指令用於電磁相容、機械指令、無線電設備指令（RED）、醫療器材法規（MDR）、個人防護設備（PPE）法規和玩具安全指令。與第三方認證不同，CE 標誌主要是一種自我聲明過程，由製造商對合規性負責。
CE 標誌流程包括識別適用的歐盟指令、透過協調的歐洲標準（EN 標準）確保產品符合基本要求、執行符合性評估程序、編製技術文件、起草歐盟符合性聲明（DoC）並加貼 CE 標誌。超過 90% 的產品，製造商可以自我認證，無需公告機構介入。但某些高風險產品（醫療器材、壓力設備、ATEX 設備）需要由 NANDO 資料庫中列出的認可公告機構進行第三方符合性評估。近期更新包括 2025 年 8 月生效的無線電設備指令網路安全新要求、2027 年 1 月適用的新機械法規（EU）2023/1230，以及歐盟人工智慧法案下高風險人工智慧系統的 CE 標誌要求。不合規產品可能被撤出歐盟市場，製造商可能面臨最高 4 萬歐元或年營業額 4% 的罰款（取決於成員國）。
Self-Declaration
For most products, manufacturers self-declare conformity without third-party involvement — you sign the Declaration of Conformity yourself.
25+ Directives
Covers products under more than 25 EU directives including Low Voltage, EMC, Machinery, Radio Equipment, Toys, and Medical Devices.
Notified Bodies
Higher-risk products require assessment by EU-designated Notified Bodies listed in the NANDO database.
list_alt Key EU Directives
- Low Voltage Directive (2014/35/EU)
- EMC Directive (2014/30/EU)
- Machinery Regulation (EU) 2023/1230
- Radio Equipment Directive (2014/53/EU)
- Toy Safety Directive (2009/48/EC)
- Medical Devices Regulation (EU) 2017/745
- PPE Regulation (EU) 2016/425
- Pressure Equipment Directive (2014/68/EU)
Who Needs to Comply?
Any manufacturer or importer placing products covered by CE directives on the European Economic Area (EEA) market — all 27 EU member states plus Iceland, Liechtenstein, and Norway.
Key Requirements
Identify Applicable Directives
Determine which EU directives apply to your specific product. A single product may fall under multiple directives (e.g., a wireless speaker needs RED, LVD, and RoHS).
Conformity Assessment
Follow the appropriate conformity assessment module — Module A (self-assessment) for most products, or Modules B-H involving Notified Bodies for higher-risk products.
Technical Documentation
Compile and maintain a technical file including product description, design drawings, test reports, risk assessment, and applied harmonised standards. Keep for 10 years.
EU Declaration of Conformity
Draft and sign a legal document declaring the product meets all applicable directive requirements. Must include product ID, applicable directives, standards used, and authorized signatory.
Affix CE Mark
Apply the CE marking to the product (minimum 5mm height, correct proportions). If a Notified Body was involved, add their 4-digit ID number next to the CE mark.
Penalties & Enforcement
Non-compliant products seized at customs, mandatory market recalls, fines up to EUR 40,000 or 4% of annual turnover depending on member state, and public listing on the EU Safety Gate (RAPEX).