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
專家解讀視頻
基本信息
標準編號： EU MDCG 2020-3 : 2020
標準類別：Standard
出版單位：European Union
標準頁數：14
標準簡介
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.
替代本標準的新標準
