标准简介
CE 标志（Conformité Européenne，即欧洲合格认证）是在欧洲经济区（EEA）销售产品的强制性合格标志。该标志由欧盟理事会指令 93/68/EEC 于 1993 年 7 月引入，1995 年 1 月起强制实施，表明产品符合欧盟健康、安全和环境保护要求。CE 标志涵盖 25 项以上欧盟指令和法规管辖的产品，包括低电压指令（LVD）用于电气安全、EMC 指令用于电磁兼容、机械指令、无线电设备指令（RED）、医疗器械法规（MDR）、个人防护设备（PPE）法规和玩具安全指令。与第三方认证不同，CE 标志主要是一种自我声明过程，由制造商对合规性负责。
CE 标志流程包括识别适用的欧盟指令、通过协调的欧洲标准（EN 标准）确保产品符合基本要求、执行符合性评估程序、编制技术文件、起草欧盟符合性声明（DoC）并加贴 CE 标志。超过 90% 的产品，制造商可以自我认证，无需公告机构介入。但某些高风险产品（医疗器械、压力设备、ATEX 设备）需要由 NANDO 数据库中列出的认可公告机构进行第三方符合性评估。近期更新包括 2025 年 8 月生效的无线电设备指令网络安全新要求、2027 年 1 月适用的新机械法规（EU）2023/1230，以及欧盟人工智能法案下高风险人工智能系统的 CE 标志要求。不合规产品可能被撤出欧盟市场，制造商可能面临最高 4 万欧元或年营业额 4% 的罚款（取决于成员国）。
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).