How should you label devices for the EU market (EU AR indication requirements)?

## How Should You Label Devices for the EU Market? MDR and IVDR provide clear rules for EU AR indication on device labels, packaging, and accompanying documents. Understanding these requirements is critical to avoid compliance issues and market access delays. ### EU AR Indication Requirements Under MDR and IVDR, devices must clearly indicate the EU AR on: - **Device label** - Directly on the device (if space permits) - **Packaging** - On the outer packaging - **IFU (Instructions for Use)** - In the accompanying documentation - **Accompanying documents** - Other documentation that accompanies the device ### Required Information The labeling must include: 1. **EU AR Name** - The complete legal name of the authorized representative 2. **EU AR Address** - The complete address where the EU AR is established 3. **Clear Identification** - The EU AR must be clearly identified as the "authorized representative" ### Labeling Format The regulations allow flexibility in how the EU AR is indicated: - You can use text such as "Authorized Representative" or "AR" - The EU AR information must be clearly distinguishable from manufacturer information - The information must be in a language easily understood by end users ### Manufacturer Indication **Important**: The manufacturer must always be indicated on the label. The EU AR indication is in addition to (not instead of) the manufacturer information. **Label Hierarchy:** 1. Manufacturer name and address (required) 2. EU AR name and address (required for non-EU manufacturers) 3. Importer indication (if applicable, under MDR/IVDR rules) ### Practical Best Practice To reduce regulatory risk and ensure compliance: **Put EU AR details on:** 1. **Packaging** - At minimum, include on outer packaging 2. **IFU/accompanying document** - Include in Instructions for Use or other accompanying documents 3. **Device label** - If space permits and your device type allows **Why this approach?** - Ensures information is always accessible - Meets MDR/IVDR requirements regardless of which document is reviewed - Provides redundancy in case one label/document is missing - Aligns with best practices for international regulatory compliance ### Labeling Checklist Before printing labels for the EU market, verify: - ✅ Manufacturer name and address is present - ✅ EU AR name and address is present - ✅ EU AR address is a complete address (not just PO box) - ✅ Information appears on packaging and/or IFU - ✅ Text is legible and in appropriate language(s) - ✅ Labeling complies with other MDR/IVDR requirements (language, UDI, etc.) ### Common Mistakes to Avoid - ❌ Using only a PO box for EU AR address - ❌ Omitting manufacturer information - ❌ Placing EU AR info only on device label (may not have space) - ❌ Using incomplete or incorrect EU AR address - ❌ Forgetting to update labeling when switching EU ARs ### Coordination with EU AR Before finalizing your labeling: 1. **Confirm EU AR details** - Get the exact name and complete address from your EU AR 2. **Review with EU AR** - Some EU ARs have specific preferences for how their information is displayed 3. **Plan for updates** - If you switch EU ARs, you'll need to update all labeling—plan your label print runs accordingly ### Next Steps 1. Coordinate labeling requirements with your EU AR provider 2. **[Compare EU Authorized Representative providers & request quotes](https://cruxi.ai/regulatory-directories/eu_ar)** - Find providers that offer labeling support and guidance --- *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 10, Article 11](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#d1e1000-1-1)