EU Authorized Representative
The term and responsibilities of the “Authorized Representative” (AR) have been coined by the European Parliament and the Council and is outlined in the Medical Device Directives. Thus, the Authorized Representative is a regulatory requirement applicable to manufacturers wishing to do business within the EU but not having a registered place of business within a Member State.
The European Commission has outlined a number of Guidelines which are easily legible and of a practical approach to accompany the Medical Device Directives, with a focus on actual application of the Medical Device Directives.
In short, the Authorized Representative is the door to Europe (EEA, Switzerland and Turkey) and a regulatory requirement for CE-marked medical devices in addition to investigational medical devices i.e. devices in clinical investigations.