Müller-Lierheim W G
Müller-Lierheim Group, Munich, Germany.
Med Device Technol. 1997 Nov;8(9):38-40.
Medical device regulations in Germany are changing. The first amendment of the Medical Device Law, the MPG, is in preparation. Four decrees on medical devices are also being discussed by the Bundesrat, the Federal Council. This article summarizes what manufacturers, distributors and users should know about the German device regulations.
德国的医疗器械法规正在发生变化。《医疗器械法》(MPG)的首次修订正在筹备中。联邦参议院(Bundesrat)也在讨论四项关于医疗器械的法令。本文总结了制造商、经销商和用户应该了解的德国器械法规内容。