How should you label devices for the UK market (UK RP indication requirements)?

## How Should You Label Devices for the UK Market? UK MDR 2002 provides clear rules for UK RP indication on device labels, packaging, and accompanying documents. Understanding these requirements is critical to avoid compliance issues and market access delays. ### UK RP Indication Requirements Under UK MDR 2002, devices must clearly indicate the UK RP on: - **Device label** - Directly on the device (if space permits) - **Packaging** - On the outer packaging - **IFU (Instructions for Use)** - In the accompanying documentation - **Accompanying documents** - Other documentation that accompanies the device ### Required Information The labeling must include: 1. **UK RP Name** - The complete legal name of the responsible person 2. **UK RP Address** - The complete address where the UK RP is established 3. **Clear Identification** - The UK RP must be clearly identified as the "responsible person" ### Labeling Format The regulations allow flexibility in how the UK RP is indicated: - You can use text such as "UK Responsible Person" or "UK RP" - The UK RP information must be clearly distinguishable from manufacturer information - The information must be in a language easily understood by end users (typically English) ### Manufacturer Indication **Important**: The manufacturer must always be indicated on the label. The UK RP indication is in addition to (not instead of) the manufacturer information. **Label Hierarchy:** 1. Manufacturer name and address (required) 2. UK RP name and address (required for non-UK manufacturers) 3. Importer indication (if applicable, under UK MDR 2002 rules) ### UKCA Marking Considerations If your devices require UKCA marking: - UKCA marking must be clearly visible on the device and/or packaging - UK RP information is separate from but complementary to UKCA marking - Both must be present for full UK market compliance ### Practical Best Practice To reduce regulatory risk and ensure compliance: **Put UK RP details on:** 1. **Packaging** - At minimum, include on outer packaging 2. **IFU/accompanying document** - Include in Instructions for Use or other accompanying documents 3. **Device label** - If space permits and your device type allows **Why this approach?** - Ensures information is always accessible - Meets UK MDR 2002 requirements regardless of which document is reviewed - Provides redundancy in case one label/document is missing - Aligns with best practices for international regulatory compliance ### Labeling Checklist Before printing labels for the UK market, verify: - ✅ Manufacturer name and address is present - ✅ UK RP name and address is present - ✅ UK RP address is a complete address (not just PO box) - ✅ Information appears on packaging and/or IFU - ✅ Text is legible and in appropriate language(s) - ✅ Labeling complies with other UK MDR 2002 requirements (language, UDI, etc.) - ✅ UKCA marking is present if required ### Common Mistakes to Avoid - ❌ Using only a PO box for UK RP address - ❌ Omitting manufacturer information - ❌ Placing UK RP info only on device label (may not have space) - ❌ Using incomplete or incorrect UK RP address - ❌ Forgetting to update labeling when switching UK RPs - ❌ Missing UKCA marking if required ### Coordination with UK RP Before finalizing your labeling: 1. **Confirm UK RP details** - Get the exact name and complete address from your UK RP 2. **Review with UK RP** - Some UK RPs have specific preferences for how their information is displayed 3. **Plan for updates** - If you switch UK RPs, you'll need to update all labeling—plan your label print runs accordingly ### Next Steps 1. Coordinate labeling requirements with your UK RP provider 2. **[Compare UK Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/uk_rp)** - Find providers that offer labeling support and guidance --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [MHRA - Labeling Requirements](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency)