Authorised representatives in Hungary
Look up medical device manufacturers, authorised representatives, importers, and system producers registered across the EU.
An authorised representative acts within the EEA on behalf of a manufacturer based outside the EEA.
44 Authorised representatives in Hungary registered in EUDAMED
Role and obligations in EUDAMED
An authorised representative is an entity established in the European Economic Area that a manufacturer based outside the EEA appoints to act on its behalf for specified regulatory tasks. Registration in EUDAMED is required under Article 11 of the MDR (2017/745) and Article 11 of the IVDR — règlement (UE) 2017/746.
Medical device companies in Hungary
Top locations in Hungary: Budapest, Debrecen, Szeged, Budaörs, Győr.
Frequently asked questions
What is an authorised representative?
An authorised representative is an EEA-based entity appointed by a non-EEA manufacturer to act on its behalf for specified regulatory tasks under Article 11 of the MDR (2017/745).
When is an authorised representative required?
A manufacturer established outside the EEA must designate a single authorised representative before placing a device on the EU market.
Are authorised representatives listed in EUDAMED?
Yes. Authorised representatives register in EUDAMED and are linked to the manufacturers they represent.