EU MDCG 2020-3 : 2020被替代
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
出版：European Union
专家解读视频
基本信息
标准编号： EU MDCG 2020-3 : 2020
标准类别：Standard
出版单位：European Union
标准页数：14
标准简介
This guidance document is intended to provide clarification on the changes to a device that should be considered a “significant change in design or a significant change in the intended purpose” under MDR Article 120(3). Assessments should be made on a case-by-case basis.
替代本标准的新标准
