EU Authorised Representative services for medical device and IVD manufacturers — registered in Belfast, Northern Ireland.
UKALIA Ltd acts as EU Authorised Representative for medical device and in vitro diagnostic manufacturers based outside the European Union.
Under EU MDR (2017/745) and IVDR (2017/746), any manufacturer outside the EU who places CE-marked products on EU markets must appoint an Authorised Representative. The AR is named on device labelling, registered with the relevant competent authority, and carries defined legal obligations under EU law.
UKALIA fulfils this role — providing a properly registered, legally accountable AR for manufacturers entering or currently operating in EU markets.
UKALIA Ltd is registered in Belfast, Northern Ireland. This is not simply a geographic detail — it is a regulatory positioning with specific practical value.
Under the Northern Ireland Protocol (Windsor Framework), Northern Ireland maintains alignment with EU medical device regulations while remaining part of the United Kingdom.
This means:
For non-EU manufacturers — particularly those based in the US, Japan, Australia, and Asia — this structure provides a single, properly-registered European foothold covering both the EU-27 and the unique NI market position.
Formal appointment as your EU Authorised Representative. Named on your Declaration of Conformity and device labelling. Registered with the relevant EU competent authority.
Management of regulatory authority communications, serious incident reporting, and FSCA co-ordination under MDR Article 87 / IVDR Article 82.
Actor and device registration support, UDI management, and ongoing EUDAMED data maintenance.
Technical documentation guidance, clinical evidence structure support, and compliance tracking across MDR/IVDR transition timelines.
Onsite and remote support for EU distributors and importers — site visits, inventory inspections, and regulatory liaison.
Contact UKALIA directly via the enquiry form or by email. Describe your product range, device class, and target EU markets.
We confirm scope, applicable MDR/IVDR requirements, and the mandate terms.
Mandate signed. AR appointment documented. Registration with competent authority initiated. EUDAMED actor registration actioned if not already in place.
We manage regulatory correspondence, reporting obligations, and EUDAMED data throughout the appointment period. Fixed annual fee. Defined scope.
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