Do I need a UK Responsible Person if I have a UK importer?

## Do I Need a UK Responsible Person If I Have a UK Importer? **Yes, if you are a non-UK manufacturer placing devices on the UK market, you generally need a UK Responsible Person** regardless of whether you have an importer. The importer and the responsible person are different economic operators with different obligations. ### The Legal Framework UK MDR 2002 states that **manufacturers not established in the UK must designate a UK Responsible Person**. This requirement is independent of whether you have an importer. ### Different Roles, Different Obligations The UK RP and importer have distinct responsibilities: #### UK Responsible Person - **Regulatory role** - Represents manufacturer for regulatory compliance - **Key responsibilities**: - Hold or ensure access to technical documentation - Ensure vigilance reporting to MHRA - Cooperate with MHRA on regulatory matters - Maintain written mandate with manufacturer #### UK Importer - **Supply chain role** - Places device from outside UK on UK market - **Key responsibilities**: - Verify device has appropriate markings and documentation - Verify manufacturer and UK RP (if applicable) are identified - Maintain complaint registers - Cooperate with MHRA on market surveillance - Register with MHRA if required ### Why Both Are Needed Even if you have a UK importer, you still need a UK RP because: 1. **Different Obligations** - The importer focuses on supply chain verification, while the UK RP focuses on regulatory compliance and documentation 2. **Regulatory Interface** - The UK RP serves as your regulatory interface with MHRA 3. **Documentation Access** - The UK RP must ensure technical documentation is available to MHRA 4. **Vigilance Reporting** - The UK RP is responsible for ensuring vigilance reports are submitted ### Can They Be the Same Company? **Typically no for the same devices**—UK MDR 2002 requires separation of these roles to prevent conflicts of interest. However, a company can serve as UK RP for one manufacturer and importer for another. ### Practical Implications If you have a UK importer: 1. **You still need a UK RP** - The importer doesn't replace the UK RP requirement 2. **Coordinate between both** - Ensure both parties understand their roles 3. **Separate contracts** - You'll need separate agreements with each 4. **Different registrations** - Each may need separate MHRA registrations ### Best Practice Most manufacturers use: - **An independent UK RP** for regulatory compliance - **A separate importer** (or distributor) for supply chain activities This approach: - Eliminates conflict of interest concerns - Provides clearer regulatory oversight - Simplifies compliance documentation - Aligns with regulatory best practices ### Next Steps 1. Understand that UK RP and importer are separate requirements 2. **[Compare UK Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/uk_rp)** - Find a qualified UK RP for your UK market access --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [MHRA - Economic Operator Roles](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency)