Your EU Authorised Representativefor Medical Devices
ANTEX supports medical device manufacturers established outside the European Union with EU REP representation, MDR market access and EUDAMED readiness.
A regulatory partner inside the European Union.
Clear mandates, structured regulatory data and a direct EU-side interface for non-EU manufacturers.
Medical device manufacturers established outside the EU
Under Article 11 MDR, a manufacturer not established in a Member State must designate a sole Authorised Representative before its device can be placed on the Union market.
Non-EU manufacturer
Your organisation is established outside the European Union and intends to place medical devices on the EU market.
Written mandate
The Authorised Representative relationship is established through a written mandate accepted by the EU REP.
EU regulatory interface
The representative performs the regulatory tasks defined by the MDR and the agreed mandate.
A clear path to EU representation
Initial review
Manufacturer, device portfolio and regulatory scope.
Documentation
Review the core regulatory information required for onboarding.
Mandate
Formalise the EU Authorised Representative relationship.
Ongoing support
Maintain an EU regulatory interface throughout the relationship.
Built around European medical device market access
EU Authorised Representative
Germany-based EU REP / EC REP services under Regulation (EU) 2017/745.
Learn more →The EU REP role is more than an address on the label
The MDR assigns specific minimum tasks to the Authorised Representative under its written mandate.
- Verify required declarations and regulatory documentation.
- Keep required documents available to competent authorities.
- Support applicable actor-registration obligations.
- Respond to competent-authority requests.
- Cooperate regarding corrective or preventive actions.
- Forward relevant complaints and suspected incident reports.
EUDAMED is now an operational requirement
Actor Registration and UDI/Device Registration are among the EUDAMED modules that became mandatory on 28 May 2026.
EUDAMED support →Typical data areas
- Manufacturer identity
- EU REP information
- Mandate data
- Actor ID / SRN
- Basic UDI-DI
- UDI / Device information
Common EU REP questions
Does a non-EU manufacturer need an EU Authorised Representative?
Under the MDR, a manufacturer not established in an EU Member State must designate a sole Authorised Representative before placing covered devices on the Union market.
Is EC REP the same as EU REP?
EC REP remains a familiar industry term. The MDR uses the term Authorised Representative, and EU REP is increasingly used as corresponding terminology.
Is EUDAMED mandatory?
The Actor Registration and UDI/Device Registration modules became mandatory to use on 28 May 2026 together with two other modules.
Does the EU REP replace the manufacturer?
No. Manufacturer responsibilities remain with the manufacturer. The EU REP performs the tasks assigned by the MDR and the mandate.
Planning EU market access?
Tell us where your company is based and what medical devices you manufacture.