The importance of being authorized

Medical device companies located outside the European Economic Area (EEA) and without subsidiaries in the EEA will need to designate authorized representatives to perform certain duties under the European medical device Directives. The duties and responsibilities of those representatives should be clearly understood by medical device companies and prospective authorized representatives before any designation contract is signed. This article will discuss the role of the authorized representative as specified in the published Directives and as defined in the proposed European Directive on in vitro diagnostic medical devices.