Donawa Maria E
Donawa Lifescience Counsulting, Piazza Albania 10, I-00156 Rome, Italy.
Med Device Technol. 2009 Sep;20(5):22, 24-5.
The European Commission has recently updated an important guidance document on determining whether or not a medical product is subject to medical device or medicinal product regulations. In addition, a new manual that provides practical examples has also been issued. This article discusses these documents.
欧盟委员会最近更新了一份关于确定医疗产品是否受医疗器械或药品法规监管的重要指导文件。此外，还发布了一份提供实际案例的新手册。本文将对这些文件进行讨论。
