What is a UK Responsible Person (UK RP), and when do you need one?

## What is a UK Responsible Person (UK RP)? A **UK Responsible Person (UK RP)** is a legal entity established within the United Kingdom that acts as the regulatory interface for manufacturers not established in the UK. According to UK MDR 2002 (as amended), the UK RP represents the manufacturer for regulatory compliance matters related to placing medical devices and IVDs on the UK market. ### When Do You Need a UK RP? You typically need a UK RP if: 1. **Your legal manufacturer address is outside the UK** - This includes manufacturers based in the EU/EEA, United States, Asia, or any other country outside the UK. UK MDR 2002 treats all non-UK manufacturers as requiring a UK RP. 2. **You want to place medical devices or IVDs on the UK market** - The UK RP requirement applies to: - Medical devices regulated under UK MDR 2002 - In vitro diagnostic medical devices (IVDs) regulated under UK MDR 2002 - All device classes (Class I, IIa, IIb, III for medical devices; Class A, B, C, D for IVDs) ### Legal Basis UK MDR 2002 (as amended post-Brexit) explicitly requires that **manufacturers not established in the UK must designate a UK Responsible Person**. This is not optional—it's a mandatory requirement for market access. ### Post-Brexit Changes Since Brexit, the UK has its own regulatory framework separate from the EU: - **UKCA marking** is required for devices placed on the UK market (with some transitional arrangements) - **UK RP** is required for non-UK manufacturers (similar to EU AR for EU market) - **MHRA** is the UK's competent authority (replacing EU competent authorities for UK market) ### Practical Takeaway If you ship medical devices or IVDs into the UK under your non-UK manufacturer name, you **must** have a UK RP. The requirement is independent of whether you have CE marking or UKCA marking—the UK RP is a separate regulatory obligation that must be met. **Important Note**: The UK RP must be established in the UK. They cannot be based in the EU, EEA, or other countries. ### Next Steps 1. Verify your manufacturer location and distribution model 2. Confirm your device classification (medical device vs. IVD) 3. Engage a qualified UK RP provider before placing devices on the market 4. **[Compare UK Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/uk_rp)** - 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: - [MHRA - UK Responsible Person Guidance](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency) - [UK MDR 2002 - Medical Devices Regulations](https://www.gov.uk/guidance/medical-devices-regulation)