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欧盟委员会对医疗器械的监管由三个指令变为两个法规，是一个里程碑式的变化。为了给我国医疗器械监管提供可借鉴的信息，同时帮助在华企业分析研究欧盟法规变化对中国法规环境的影响，本文从六个方面加以探讨，提出建议。
<<The turning of 3 Directives into 2 Regulations over medical devices is a milestone in European Commission. In order to deliver referential information for medical device regulation in China，and help the industry study the impact over the Chinese regulatory environment due to this change，the article tries to discuss the matter and put forward suggestions in 6 aspects.
<<| Keywords： | EUMedical DeviceRegulation Development |
