EU Authorized Representative In EUDAMED
Your Pathway To The European Union Medical Device Market
What Is EUDAMED Registration?
EUDAMED is the European Databank on Medical Devices, a centralized database that will contain information on medical devices and the entities involved in their supply chain in the EU. In EUDAMED, an Authorised Representative (AR) is a person or entity appointed by a manufacturer based outside of the EU to act on their behalf in relation to specific tasks related to conformity assessment procedures and related duties. The AR is responsible for ensuring that the manufacturer fulfills its obligations under EU medical device regulations.