What does an EU Authorized Representative actually do (and what they don't do)?

## What Does an EU Authorized Representative Actually Do? Think of the EU AR as your **EU compliance interface**, not your commercial distributor. Understanding the distinction between their regulatory responsibilities and what they don't do is critical for setting proper expectations. ### Common EU AR Responsibilities According to Article 11 of MDR and IVDR, the EU AR has several key responsibilities: #### 1. **Documentation Management** - **Holding or ensuring access to key compliance artifacts** - The EU AR must either: - Physically hold the technical documentation, OR - Contractually ensure the manufacturer can provide it to competent authorities upon request - Ensuring technical documentation can be provided to competent authorities quickly when requested - Maintaining documentation in a format accessible to competent authorities #### 2. **Mandate Governance** - Ensuring the relationship is governed by a **written mandate** with the manufacturer - The mandate must clearly define scope, responsibilities, and operational procedures - The mandate must comply with MDR/IVDR requirements #### 3. **Vigilance and Safety Reporting** - Supporting and ensuring required reporting flows to competent authorities for: - **Serious incidents** occurring in the EU - **Field Safety Corrective Actions (FSCAs)** in the EU - **Trend reporting** as required - The EU AR is responsible for ensuring reports are sent to competent authorities (not just facilitating) #### 4. **Regulatory Cooperation** - Cooperating with competent authorities on preventive and corrective actions when needed - Responding to competent authority inquiries and requests for information - Maintaining communication channels with regulatory authorities - Providing information to competent authorities upon request #### 5. **Registration and Compliance** - Registering in EUDAMED (when fully operational) if required - Maintaining compliance with MDR/IVDR economic operator obligations - Ensuring proper device registration and UDI compliance ### What an EU AR Usually Is NOT #### ❌ Not Automatically Your Importer of Record The EU AR and importer are **separate legal roles** with distinct obligations under MDR/IVDR. A company can serve as both, but they must: - Meet both sets of obligations - Clearly distinguish the roles in their operations - Register separately for each role if required #### ❌ Not Your Commercial Seller Unless you specifically contract them to do so, the EU AR is not your distributor or sales agent. Their role is regulatory, not commercial. #### ❌ Not Your Quality System Auditor The EU AR doesn't audit your quality system or manufacturing processes. They rely on your existing certifications and documentation. #### ❌ Not Your Legal Representative for Commercial Disputes The EU AR represents you for regulatory matters with competent authorities, not for commercial or legal disputes with customers or partners. ### Practical Implications When selecting an EU AR, ask: - Do they hold technical files or rely on contractual manufacturer submission? - What is their vigilance reporting process and response time? - How do they handle competent authority inquiries and requests? - What documentation and support do they provide? - Do they offer additional services (PRRC, EUDAMED support, etc.)? ### Next Steps 1. Evaluate EU AR providers based on their service model and capabilities 2. **[Compare EU Authorized Representative providers & request quotes](https://cruxi.ai/regulatory-directories/eu_ar)** - Review multiple providers to find the right fit for 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](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#d1e1000-1-1)