Donawa Maria
Donawa Lifescience Consulting, Rome, Italy.
Med Device Technol. 2009 Nov-Dec;20(7):18-21.
The requirements for conducting medical device clinical studies in Europe are not identical in all Member States. That is, variations exist in the way that the requirements in the European Directives are interpreted and enforced. This article provides an overview of the requirements that currently apply in Italy.
在欧洲，各成员国开展医疗器械临床研究的要求并不完全相同。也就是说，欧洲指令中的要求在解释和执行方式上存在差异。本文概述了意大利目前适用的要求。
