摘要
本文着重研究欧盟医疗器械指令MDD93/42/EEC的第五次修订部分,从临床、医疗器械符合性评估路径、CE认证技术文档记录保存等方面对此次修订部分进行综述和分析。
Focusing on the 5th amended parts of MDD 93/42/EEC, which is 2007/47/EC, this paper reviewed and analyzed clinical elements, conformity assessment procedures, CE technical file retained and other aspects of the amendment.
出处
《中国医疗器械信息》
2010年第7期31-33,共3页
China Medical Device Information
