Donawa M
Med Device Technol. 2000 May;11(4):37-40.
This article discusses the Notified Body recommendations issued by the European Forum of Notified Bodies Medical Devices and its subcommittee, the Notified Bodies Recommendations Group. Most of these recommendations represent more detailed guidance documents than the consensus statements issued by this group, which were discussed in a previous article. Some of the recommendations form the basis of the European-level MEDDEV guidance documents.
本文讨论了欧洲公告机构医疗器械论坛及其小组委员会——公告机构建议小组发布的公告机构建议。与该小组发布的共识声明相比,这些建议大多代表了更详细的指导文件,前一篇文章中已对共识声明进行过讨论。其中一些建议构成了欧洲层面MEDDEV指导文件的基础。