Sorrel S
MedPass International, Paris, France.
Med Device Technol. 1997 May;8(4):22-6.
Clinical investigations in Europe of non-CE-marked medical devices are subject to the controls imposed by the European Directives. At the national level, this creates problems for manufacturers primarily because of country-to-country differences in transposing the Directives into national laws. This article will illustrate some of these differences using two case studies.
在欧洲，对未获得CE认证的医疗器械进行临床研究需遵循欧洲指令所规定的管控措施。在国家层面，这给制造商带来了问题，主要原因是各国在将指令转化为国内法律方面存在差异。本文将通过两个案例研究来说明其中的一些差异。
