Can I change my UK Responsible Person, and what's the process?

## Can I Change My UK Responsible Person? **Yes, you can change your UK RP**, but the process requires coordination. The new UK RP must be appointed before the previous one is terminated, and you must notify MHRA of the change. ### The Legal Framework UK MDR 2002 allows manufacturers to change their responsible person, but the process must ensure continuity of regulatory compliance. ### The Process #### 1. **Appoint New UK RP First** - Engage and contract with your new UK RP - Ensure the new UK RP is ready to take over responsibilities - Complete the written mandate with the new UK RP #### 2. **Notify MHRA** - Notify MHRA of the change - Provide information about the new UK RP - Ensure proper registration and device updates #### 3. **Coordinate Transition** - Transfer technical documentation to new UK RP (if applicable) - Transfer ongoing vigilance cases - Update labeling and packaging with new UK RP information - Ensure continuity of regulatory obligations #### 4. **Terminate Previous UK RP** - Provide proper notice to previous UK RP (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 UK RP at all times - Not have a gap in UK RP coverage #### Documentation Transfer - Technical documentation must be accessible to new UK RP - Ongoing vigilance cases must be transferred - Historical records may need to be retained #### Labeling Updates - All labeling must be updated with new UK RP 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 UK RPs - Ensure no regulatory gaps ### Common Reasons for Changing UK RPs Manufacturers change UK RPs 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 UK RP coverage ### Red Flags - ⚠️ New UK RP not ready to take over immediately - ⚠️ Gap in UK RP coverage - ⚠️ Incomplete documentation transfer - ⚠️ Delayed labeling updates - ⚠️ Unclear transition timeline ### Next Steps 1. Plan your UK RP transition carefully 2. **[Compare UK Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/uk_rp)** - Find a new UK RP 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: - [MHRA - Changing UK Responsible Person](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency)