Donawa M E
Donawa and Associates Ltd., Rome, Italy.
Med Device Technol. 1998 Sep;9(7):12-4, 16-8.
The European Directives for medical devices impose significant responsibilities on manufacturers, Member States and Notified Bodies. However, the Directives define far fewer responsibilities for importers and distributors. As a result, manufacturers and distributors do not always have a clear concept of these responsibilities nor of those specified by national laws and regulations. This article will discuss these responsibilities and some issues that should be considered in determining them.
欧洲医疗器械指令对制造商、成员国和公告机构规定了重大责任。然而，该指令对进口商和经销商规定的责任要少得多。因此，制造商和经销商对这些责任以及国家法律法规规定的责任并不总是有清晰的概念。本文将讨论这些责任以及在确定责任时应考虑的一些问题。
