The mandate and liability
What the AR agreement covers.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
Since Brexit, manufacturers established in the UK are non-EU manufacturers under the MDR and IVDR. To place devices on the EU market they need an EU Authorised Representative.
| Market | Rules | Representative for a non-local manufacturer |
|---|---|---|
| EU Member States | MDR / IVDR | EU Authorised Representative |
| Northern Ireland | MDR / IVDR under the Windsor Framework | For a manufacturer based in Great Britain: an Authorised Representative in the EU or Northern Ireland |
| Great Britain | UK medical devices regulations | UK Responsible Person, for manufacturers outside the UK |
No. The Authorised Representative must be established in the EU. For Northern Ireland, a representative in Northern Ireland is also possible for manufacturers based in Great Britain.
No. The UK Responsible Person is a Great Britain role for manufacturers outside the UK; the EU Authorised Representative is required for the EU market.
Yes, under the Windsor Framework.
What the AR agreement covers.
Label requirements for non-EU manufacturers.
Economic operator registration.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Specific obligations depend on your device and company structure. Last reviewed 30 September 2026.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.