【CE认证】欧盟CE认证怎么做 欧盟ce认证怎么办理【费用 周期 机构 报告】

CE认证核心步骤
产品分类：根据欧盟指令（如电子电器需符合LVD/EMC指令，医疗器械按风险等级划分）确定适用标准

技术文件：准备设计图纸、测试报告、风险评估（需英文版本），缺件可能面临高额罚款

认证模式：
低风险产品（如插线板）：企业自我宣告即可贴标
高风险产品（如医疗设备）：需欧盟公告机构（如TUV）审核，周期可达半年

具体办理流程
申请准备：提交产品说明书、填写申请表，检测机构确认项目并报价

测试与审核：寄送样品至实验室（如CNA5预测试可节省成本），通过后颁发证书

文件归档：技术文件需保存10年，欧盟可随时抽查

注意事项
机构资质：确认机构在Eudamed数据库可查，避免“假公告号”
标准更新：如EN 62368-1已取代EN 60950，需使用最新版本
费用范围：约3000-20000元，高风险产品费用更高

Core steps of CE certification
Product classification: Determine applicable standards based on EU directives (such as LVD/EMC directives for electronic appliances and risk classification for medical devices)
Technical documents: Prepare design drawings, test reports, risk assessments (English version required), missing parts may face high fines
Authentication mode:
Low risk products (such as power strips): Companies can self declare and label them
High risk products (such as medical equipment): need to be audited by EU notified bodies (such as TUV), with a cycle of up to six months
Specific processing procedures
Preparation for application: Submit product manual, fill out application form, confirm project with testing agency and provide quotation
Testing and Review: Send samples to the laboratory (such as CNA5 pre testing which can save costs), and issue certificates after passing
File archiving: Technical documents need to be kept for 10 years, and the EU can conduct spot checks at any time
Precautions
Institutional Qualification: Confirm that the institution is searchable in the Eudamed database to avoid "false announcement numbers"
Standard update: If EN 62368-1 has replaced EN 60950, the latest version must be used
Cost range: Approximately 3000-20000 yuan, with higher costs for high-risk products