The Northern Ireland Gateway: Your Simplest Path to Both UK and EU MedTech Markets
For international medical device and IVD manufacturers (based outside the UK/EU), market access can feel like a tangled compliance knot since Brexit. You need both a UK Responsible Person (UKRP) for Great Britain and an EU Authorised Representative (EU AR) for the EU Single Market.
What if you could consolidate your regulatory foothold and simplify logistics?
Our consultancy is uniquely positioned, operating as your EU Authorised Representative through Northern Ireland (NI). This strategic choice offers a powerful dual-market advantage:
Dual Access Simplified: Devices placed on the NI market (CE Marked under MDR/IVDR) are considered 'Qualifying NI Goods.' These goods benefit from unfettered access to the Great Britain market, allowing you to bypass the full UKCA marking hurdles until the 2028/2030 deadlines.
EU Passport: By being established in NI, we provide a valid EU AR service, giving your device a full passport to the entire EU Single Market.
One Point of Contact: By partnering with us for both your UKRP and NI-based EU AR, you gain a single, expert compliance partner, simplifying your administrative burden, Post-Market Surveillance (PMS) reporting, and Competent Authority communication.
Stop paying for multiple regulatory anchors. Let's leverage the NI advantage to streamline your market strategy for 2026.
Action: If you are an international manufacturer seeking an efficient solution for UK and EU market access, connect with me or send a quick DM.
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