Can my importer or distributor act as my EU Authorized Representative?

## Can My Importer or Distributor Act as My EU Authorized Representative? **Typically no for the same devices**—EU MDR/IVDR require separation of certain roles, and combining roles can create conflicts of interest. However, the regulations do allow some flexibility in specific circumstances. ### The Legal Framework Article 11 of MDR and IVDR states that the authorized representative **cannot be the importer or distributor for the same device**. This separation is required to prevent conflicts of interest and ensure proper regulatory oversight. ### Why Separation Is Required The separation exists because: 1. **Different Obligations** - The EU AR, importer, and distributor have distinct regulatory obligations: - **EU AR**: Regulatory compliance, documentation access, vigilance reporting - **Importer**: Supply chain verification, complaint handling, market surveillance - **Distributor**: Commercial verification, complaint handling 2. **Conflict of Interest Prevention** - If one entity serves multiple roles, there's a risk that commercial interests could conflict with regulatory obligations. For example, an importer might be reluctant to report issues that could affect sales. 3. **Regulatory Oversight** - Separation ensures that each economic operator can be independently audited and held accountable for their specific obligations. ### Exceptions and Flexibility However, the regulations do allow: - **Different Devices**: A company can act as EU AR for one manufacturer's devices and importer/distributor for another manufacturer's devices - **Different Product Lines**: A company can serve as EU AR for certain products and importer for others (from different manufacturers) - **Separate Legal Entities**: Related companies can serve different roles, as long as they're legally separate entities ### Practical Implications If you're considering using your importer or distributor as your EU AR: 1. **Verify Legality** - Confirm with legal counsel that your specific structure complies with MDR/IVDR 2. **Document Separation** - Even if legally separate, clearly document how roles are separated operationally 3. **Consider Alternatives** - Many manufacturers use an independent EU AR to avoid any potential conflicts ### Best Practice Recommendation Most manufacturers use an **independent EU AR** that is not their importer or distributor. This approach: - Eliminates conflict of interest concerns - Provides clearer regulatory oversight - Simplifies compliance documentation - Aligns with regulatory best practices ### Next Steps 1. Understand the separation requirements for your specific situation 2. **[Compare EU Authorized Representative providers & request quotes](https://cruxi.ai/regulatory-directories/eu_ar)** - Find an independent EU AR provider that meets your needs --- *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, Article 14](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#d1e1000-1-1)