Medical Devices EU Authorised Representative (MDR)

EU authorised representative under Regulation (EU) 2017/745 for non-EU manufacturers. IberTrust is registered in EUDAMED with an SRN.

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What it is

Under Regulation (EU) 2017/745 (MDR), manufacturers established outside the EU must designate an authorised representative established in the Union. The representative is registered in EUDAMED, acts as contact point for competent authorities and keeps the technical documentation available. IberTrust already holds an EUDAMED SRN as authorised representative.

What we do

Article 11 authorised representative mandate
EUDAMED actor registration already in place (SRN)
Point of contact for competent authorities
Custody of technical documentation and EU declaration of conformity at the disposal of authorities
From €800/year for Class I (higher classes quoted by risk class)

Who needs it

Non-EU manufacturers of medical devices placing products on the EU market under MDR 2017/745 who need an EU-established authorised representative. IberTrust is registered in EUDAMED with an SRN.

What you provide

Company details and written AR mandate
Device list with class and Basic UDI-DI / UDI where available
EU declaration of conformity and technical documentation
Label / IFU showing the authorised representative

Common problems we help with

Missing EUDAMED actor or mandate link
Authorities requesting technical documentation at short notice
Unclear device classification before appointment

How it works

Send the device list, class and available documentation
We confirm scope and send a written proposal
Sign the authorised representative mandate
We link the mandate in EUDAMED and act as contact point
We hold documentation for authorities and support vigilance correspondence

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