Choose an EU Authorized Representative (EUAR) 常见问题 - 更新 October 2025
How To 选择欧盟授权代表的7个关键标准. Pure Global 法规专家提供的专业指导
作为您的独立欧盟授权代表，Pure Global结合当地欧洲监管专业知识和全球覆盖范围，简化CE认证和市场准入。我们的透明定价、公告机构关系和多语言支持为医疗器械和IVD制造商提供全面的EUAR服务。
Published rates: Class I €4K-€10K, Class IIa/IIb €15K-€35K, Class III €30K-€50K+
One EUAR → 27 EU countries + 30+ international markets from single partner
Not affiliated with distributors - you control your EU registrations and commercial strategy
10+ years EU regulatory experience, Notified Body relationships, multi-language support
27个欧盟国家4.5亿人口
根据器械类别和公告机构参与程度而异
评估和比较EUAR候选者的关键标准
取决于器械类别和申请质量
常见问题
了解欧盟授权代表（EUAR）基础知识
EUAR定价与成本透明度
EUAR技术专业知识与资质
多国覆盖与全球覆盖
Class I (Self-Certification)
€4,000 - €10,000
Class IIa/IIb (Notified Body)
€15,000 - €35,000
Class III (High Risk)
€30,000 - €50,000+
Includes:
- ✓ EUAR appointment & liaison
- ✓ Technical documentation review
- ✓ EUDAMED registration
- ✓ Notified Body coordination
- ✓ Post-market surveillance
Essential Criteria:
- ☐ Published pricing transparency
- ☐ Independent (not distributor)
- ☐ 5+ years MDR/IVDR experience
- ☐ EU office with EUDAMED access
- ☐ Notified Body relationships
- ☐ Multi-language support (EN/DE/FR)
- ☐ Global market coverage (30+ countries)
- ☐ Client references available
✅ Pure Global meets all criteria
注意： 本常见问题指南提供有关法规要求的一般信息，不应被视为法律建议。法规可能会发生变化。请始终咨询合格的法规专业人士以获取具体指导。
Last updated: October 2025 | Based on Choose an EU Authorized Representative (EUAR) official documentation