Do EU manufacturers also need a UK RP to sell in the UK?

## Do EU Manufacturers Also Need a UK RP? **Yes—EU manufacturers absolutely need a UK RP to sell in the UK**, even though they may already have CE marking under EU MDR/IVDR and an EU Authorized Representative. ### Why This Surprises People Many EU manufacturers assume that because: - The UK was part of the EU until Brexit - They already have CE marking and an EU Authorized Representative - The regulatory frameworks were harmonized ...they don't need a separate UK representative. However, this is a common misconception post-Brexit. ### The Reality: UK's Independent Market Access Requirements Since Brexit, the UK has established its own regulatory framework separate from the EU. UK MDR 2002 (as amended) treats **all manufacturers not established in the UK as "foreign"** for regulatory purposes, regardless of whether they're from the EU/EEA or elsewhere. ### Post-Brexit Regulatory Landscape For EU manufacturers, entering the UK market now requires: 1. **A packaging and labeling exercise** - You'll need to add UK RP information to your labels, packaging, and IFU 2. **A contract and mandate exercise** - You must establish a written mandate with a UK-based UK RP 3. **A registration exercise** - The UK RP (and potentially you as importer) must register with MHRA 4. **A vigilance coordination exercise** - You'll need to ensure UK-specific reporting flows are established 5. **UKCA marking consideration** - Depending on your timeline, you may need UKCA marking in addition to or instead of CE marking **Your CE conformity work remains relevant** - you don't need to completely re-certify your devices, but you must establish the UK economic-operator chain. ### Key Distinction - **EU AR**: Required for EU/EEA market access (handles EU MDR/IVDR compliance) - **UK RP**: Required for UK market access (handles UK MDR 2002 compliance) These are separate roles that cannot be combined, even though the underlying regulations are similar. ### Transitional Arrangements The UK has implemented transitional arrangements for certain devices, but these are time-limited. It's important to: - Understand which transitional arrangements apply to your devices - Plan for full UK MDR 2002 compliance - Engage a UK RP early to ensure continuity ### Next Steps 1. Understand that EU AR and UK RP are separate requirements 2. Plan for UK market entry as a distinct regulatory exercise 3. **[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 - Post-Brexit Medical Device Regulations](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency)