What is an EU Authorized Representative (EC REP), and when do you need one?

## What is an EU Authorized Representative (EC REP)? An **EU Authorized Representative (EC REP or EU AR)** is a legal entity established within the European Union that acts as the regulatory interface for manufacturers not established in the EU. According to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), the EU AR represents the manufacturer for regulatory compliance matters related to placing medical devices and IVDs on the EU market. ### When Do You Need an EU AR? You typically need an EU AR if: 1. **Your legal manufacturer address is outside the EU/EEA** - This includes manufacturers based in the United States, Asia, Switzerland, or any other country outside the EU/EEA. The MDR and IVDR treat all non-EU manufacturers as requiring an EU AR. 2. **You want to place medical devices or IVDs on the EU/EEA market** - The EU AR requirement applies to: - Medical devices regulated under EU MDR 2017/745 - In vitro diagnostic medical devices (IVDs) regulated under EU IVDR 2017/746 - All device classes (Class I, IIa, IIb, III for medical devices; Class A, B, C, D for IVDs) ### Legal Basis Article 11 of both MDR and IVDR explicitly states that **manufacturers not established in the Union must designate a single authorized representative established in the Union**. This is not optional—it's a mandatory requirement for market access. ### Practical Takeaway If you ship medical devices or IVDs into the EU/EEA under your non-EU manufacturer name, you **must** have an EU AR. The requirement is independent of whether you have CE marking or other certifications—the EU AR is a separate regulatory obligation that must be met. **Important Note**: The EU AR must be established in an EU member state. They cannot be based in the UK (post-Brexit), Switzerland, or other non-EU countries. ### Next Steps 1. Verify your manufacturer location and distribution model 2. Confirm your device classification (medical device vs. IVD) 3. Engage a qualified EU AR provider before placing devices on the market 4. **[Compare EU Authorized Representative providers & request quotes](https://cruxi.ai/regulatory-directories/eu_ar)** - Get quotes from multiple providers to find the best fit --- *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) - [Regulation (EU) 2017/746 (IVDR) - Article 11](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746#d1e1000-1-1)