Donawa M E
Donawa and Associates Ltd, Rome, Italy.
Med Device Technol. 1998 Nov;9(9):12-6.
The Medical Device Directive requires manufacturers or persons designated by them to provide Competent Authorities with certain types of information on some categories of medical devices. However, this requirement is often misinterpreted and there are some national variations related to the notification of Competent Authorities. This article will discuss Article 14 of the Directive, some frequent misinterpretations and, briefly, Germany's notification requirements.
《医疗器械指令》要求制造商或其指定人员向主管当局提供某些类别医疗器械的特定类型信息。然而，这一要求常常被误解，而且在向主管当局通报方面存在一些国家差异。本文将讨论该指令的第14条、一些常见的误解，并简要介绍德国的通报要求。
