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EU Authorised Representative (EC-REP)

Mandatory for manufacturers based outside the EU who CE-mark medical devices or IVDs for sale in any EU member state.
Appoint us as your EC-REP
  • EU Market, Medical Devices & IVDs

What are EU Authorised Representative services

Fixed Annual Fee
UKALIA Ltd

Any manufacturer incorporated outside the European Union who places CE-marked medical devices or IVDs on EU markets must appoint an EU Authorised Representative. This is a legal requirement under EU MDR (2017/745) and IVDR (2017/746). The EC-REP is named on the Declaration of Conformity and on device labelling, and carries defined legal liability under EU law.

UKALIA Ltd acts as EC-REP and is registered in Belfast, Northern Ireland. Under the Northern Ireland Protocol, Northern Ireland maintains alignment with EU medical device regulations — meaning an EC-REP registered in Belfast provides access to all EU-27 markets while retaining UK regulatory standing. This is a structural advantage not available from a continental EU-only representative.

Fixed annual fee. Defined scope. No additional charges for routine regulatory correspondence within the agreed appointment.

What we do

  • Act as your appointed EC-REP — named on your Declaration of Conformity and device labelling
  • Register with the relevant EU competent authority on your behalf
  • Manage serious incident reporting under MDR Article 87 and IVDR Article 82
  • Maintain required Declaration of Conformity documentation
  • Co-ordinate with Notified Bodies where applicable
  • Support EUDAMED actor and device registration (see EUDAMED service)

Who needs this?

  • Medical device manufacturers (Class I–III) incorporated outside the EU
  • IVD manufacturers outside the EU seeking CE marking under IVDR
  • UK manufacturers post-Brexit placing CE-marked products on EU markets
  • US, Australian, Japanese, and Asian manufacturers placing devices in any EU member state
  • Manufacturers requiring both a UKRP (UK) and an EC-REP (EU) from a co-ordinated single engagement

What you'll receive

Formal EC-REP appointment documentation. Competent authority registration confirmation. Structured communication and reporting framework. Fixed annual fee with no open-ended billing.
Appoint us as your EC-REP
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