What does a UK Responsible Person actually do (and what they don't do)?

## What Does a UK Responsible Person Actually Do? Think of the UK RP as your **UK compliance interface**, not your commercial distributor. Understanding the distinction between their regulatory responsibilities and what they don't do is critical for setting proper expectations. ### Common UK RP Responsibilities According to UK MDR 2002, the UK RP has several key responsibilities: #### 1. **Documentation Management** - **Holding or ensuring access to key compliance artifacts** - The UK RP must either: - Physically hold the technical documentation, OR - Contractually ensure the manufacturer can provide it to MHRA upon request - Ensuring technical documentation can be provided to MHRA quickly when requested - Maintaining documentation in a format accessible to MHRA #### 2. **Mandate Governance** - Ensuring the relationship is governed by a **written mandate** with the manufacturer - The mandate must clearly define scope, responsibilities, and operational procedures - The mandate must comply with UK MDR 2002 requirements #### 3. **Vigilance and Safety Reporting** - Supporting and ensuring required reporting flows to MHRA for: - **Serious incidents** occurring in the UK - **Field Safety Corrective Actions (FSCAs)** in the UK - **Trend reporting** as required - The UK RP is responsible for ensuring reports are sent to MHRA (not just facilitating) #### 4. **Regulatory Cooperation** - Cooperating with MHRA on preventive and corrective actions when needed - Responding to MHRA inquiries and requests for information - Maintaining communication channels with regulatory authorities - Providing information to MHRA upon request #### 5. **Registration and Compliance** - Registering devices with MHRA if required - Maintaining compliance with UK MDR 2002 economic operator obligations - Ensuring proper device registration and UDI compliance ### What a UK RP Usually Is NOT #### ❌ Not Automatically Your Importer of Record The UK RP and importer are **separate legal roles** with distinct obligations under UK MDR 2002. A company can serve as both, but they must: - Meet both sets of obligations - Clearly distinguish the roles in their operations - Register separately for each role if required #### ❌ Not Your Commercial Seller Unless you specifically contract them to do so, the UK RP is not your distributor or sales agent. Their role is regulatory, not commercial. #### ❌ Not Your Quality System Auditor The UK RP doesn't audit your quality system or manufacturing processes. They rely on your existing certifications and documentation. #### ❌ Not Your Legal Representative for Commercial Disputes The UK RP represents you for regulatory matters with MHRA, not for commercial or legal disputes with customers or partners. ### Practical Implications When selecting a UK RP, ask: - Do they hold technical files or rely on contractual manufacturer submission? - What is their vigilance reporting process and response time? - How do they handle MHRA inquiries and requests? - What documentation and support do they provide? - Do they offer additional services (PRRC, device registration support, etc.)? ### Next Steps 1. Evaluate UK RP providers based on their service model and capabilities 2. **[Compare UK Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/uk_rp)** - Review multiple providers to find the right fit for 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 - UK Responsible Person Obligations](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency)