Donawa M
Donawa and Associates Ltd, Rome, Italy.
Med Device Technol. 1999 Dec;10(10):24-7.
In a remarkably short time, the European regulatory landscape for medical devices has changed dramatically and permanently. The speed of this change will continue to accelerate until a fully matured body of rules is in place. This article will examine the current status of regulations in Europe, and some areas that will need to be addressed in the next century.
在极短的时间内，欧洲医疗器械监管格局发生了巨大且永久性的变化。这种变化的速度将持续加快，直至一套完全成熟的规则体系就位。本文将审视欧洲法规的现状以及下个世纪需要解决的一些领域。
