Can I change my EU Authorized Representative, and what's the process?

## Can I Change My EU Authorized Representative? **Yes, you can change your EU AR**, but the process requires coordination. The new EU AR must be appointed before the previous one is terminated, and you must notify the competent authority in the EU member state where the new EU AR is established. ### The Legal Framework Article 11(4) of MDR and IVDR states that manufacturers can change their authorized representative, but the process must ensure continuity of regulatory compliance. ### The Process #### 1. **Appoint New EU AR First** - Engage and contract with your new EU AR - Ensure the new EU AR is ready to take over responsibilities - Complete the written mandate with the new EU AR #### 2. **Notify Competent Authority** - Notify the competent authority in the EU member state where the new EU AR is established - Provide information about the change - Ensure proper registration in EUDAMED (when fully operational) #### 3. **Coordinate Transition** - Transfer technical documentation to new EU AR (if applicable) - Transfer ongoing vigilance cases - Update labeling and packaging with new EU AR information - Ensure continuity of regulatory obligations #### 4. **Terminate Previous EU AR** - Provide proper notice to previous EU AR (per contract terms) - Ensure all obligations are fulfilled - Complete any outstanding regulatory activities ### Key Considerations #### Market Continuity Devices can typically remain on the market during transition, but you must: - Ensure regulatory obligations continue to be met - Have a valid EU AR at all times - Not have a gap in EU AR coverage #### Documentation Transfer - Technical documentation must be accessible to new EU AR - Ongoing vigilance cases must be transferred - Historical records may need to be retained #### Labeling Updates - All labeling must be updated with new EU AR information - This includes device labels, packaging, and IFU - Plan label print runs accordingly #### Timeline - Allow sufficient time for transition (typically 30-90 days) - Coordinate with both old and new EU ARs - Ensure no regulatory gaps ### Common Reasons for Changing EU ARs Manufacturers change EU ARs for various reasons: 1. **Service Issues** - Poor responsiveness, lack of support 2. **Cost** - Pricing changes, budget constraints 3. **Strategic Reasons** - Geographic preferences, additional services needed 4. **Compliance Concerns** - Regulatory issues, quality problems 5. **Business Changes** - Company restructuring, new requirements ### Best Practices 1. **Plan Ahead** - Don't wait until the last minute 2. **Coordinate Carefully** - Ensure smooth handover 3. **Document Everything** - Keep records of the transition 4. **Update All Materials** - Ensure labeling is updated promptly 5. **Maintain Compliance** - Never have a gap in EU AR coverage ### Red Flags - ⚠️ New EU AR not ready to take over immediately - ⚠️ Gap in EU AR coverage - ⚠️ Incomplete documentation transfer - ⚠️ Delayed labeling updates - ⚠️ Unclear transition timeline ### Next Steps 1. Plan your EU AR transition carefully 2. **[Compare EU Authorized Representative providers & request quotes](https://cruxi.ai/regulatory-directories/eu_ar)** - Find a new 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](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#d1e1000-1-1)