Do I need an EU Authorized Representative if I have an EU importer?

## Do I Need an EU Authorized Representative If I Have an EU Importer? **Yes, if you are a non-EU manufacturer placing devices on the EU market, you generally need an EU Authorized Representative** regardless of whether you have an importer. The importer and the authorized representative are different economic operators with different obligations. ### The Legal Framework Article 11 of MDR and IVDR states that **manufacturers not established in the Union must designate a single authorized representative established in the Union**. This requirement is independent of whether you have an importer. ### Different Roles, Different Obligations The EU AR and importer have distinct responsibilities: #### EU Authorized Representative - **Regulatory role** - Represents manufacturer for regulatory compliance - **Key responsibilities**: - Hold or ensure access to technical documentation - Ensure vigilance reporting to competent authorities - Cooperate with competent authorities on regulatory matters - Maintain written mandate with manufacturer #### EU Importer - **Supply chain role** - Places device from outside EU on EU market - **Key responsibilities**: - Verify device has appropriate markings and documentation - Verify manufacturer and EU AR (if applicable) are identified - Maintain complaint registers - Cooperate with competent authorities on market surveillance - Register in EUDAMED (when fully operational) ### Why Both Are Needed Even if you have an EU importer, you still need an EU AR because: 1. **Different Obligations** - The importer focuses on supply chain verification, while the EU AR focuses on regulatory compliance and documentation 2. **Regulatory Interface** - The EU AR serves as your regulatory interface with competent authorities 3. **Documentation Access** - The EU AR must ensure technical documentation is available to competent authorities 4. **Vigilance Reporting** - The EU AR is responsible for ensuring vigilance reports are submitted ### Can They Be the Same Company? **Typically no for the same devices**—MDR/IVDR require separation of these roles to prevent conflicts of interest. However, a company can serve as EU AR for one manufacturer and importer for another. ### Practical Implications If you have an EU importer: 1. **You still need an EU AR** - The importer doesn't replace the EU AR requirement 2. **Coordinate between both** - Ensure both parties understand their roles 3. **Separate contracts** - You'll need separate agreements with each 4. **Different registrations** - Each may need separate EUDAMED registrations ### Best Practice Most manufacturers use: - **An independent EU AR** for regulatory compliance - **A separate importer** (or distributor) for supply chain activities This approach: - Eliminates conflict of interest concerns - Provides clearer regulatory oversight - Simplifies compliance documentation - Aligns with regulatory best practices ### Next Steps 1. Understand that EU AR and importer are separate requirements 2. **[Compare EU Authorized Representative providers & request quotes](https://cruxi.ai/regulatory-directories/eu_ar)** - Find a qualified EU AR for your EU market access --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [Regulation (EU) 2017/745 (MDR) - Article 11, Article 13](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#d1e1000-1-1)