Donawa M E
Donawa and Associates Ltd, Rome, Italy.
Med Device Technol. 1998 May;9(4):33-5.
The implementation of the European medical devices Directives by Member States is introducing a significant regulatory uniformity to the European regulation of medical devices. However, Member States are not required to implement the Directives in an identical manner. As a result, it is important to be aware of national variations. This article will discuss the implementation of the Medical Device Directive in Italy.
成员国对欧洲医疗器械指令的实施正在给欧洲医疗器械监管带来显著的监管一致性。然而,并不要求成员国以完全相同的方式实施这些指令。因此,了解各国之间的差异很重要。本文将讨论意大利对医疗器械指令的实施情况。