Donawa Maria E
Med Device Technol. 2003 May;14(4):19-21.
Under the In Vitro Diagnostic (IVD) Directive, a manufacturer of IVD medical devices located outside the European Economic Area must designate an Authorized Representative before placing those products on the European market. This article discusses the responsibilities of Authorized Representatives under the IVD Directive and some of the important differences of the role as it is defined in the Medical Device Directive.
根据体外诊断（IVD）指令，位于欧洲经济区以外的IVD医疗器械制造商在将其产品投放欧洲市场之前，必须指定一名授权代表。本文讨论了授权代表在IVD指令下的职责，以及该角色在《医疗器械指令》中所定义的一些重要差异。
