Donawa M
Med Device Technol. 2001 Oct;12(8):21-4.
The European medical device Directives require the establishment of a centralised database for storing regulatory information and data on medical devices. The work to establish this system is progressing and the database may be operational within 18 to 24 months. This article discusses the work that has been done to establish the database, the types of data to be stored in it, and the current status of the project.
欧洲医疗器械指令要求建立一个集中式数据库，用于存储医疗器械的监管信息和数据。建立该系统的工作正在推进，该数据库可能在18至24个月内投入使用。本文讨论了为建立该数据库所做的工作、将存储在其中的数据类型以及该项目的当前状态。
