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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
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基本信息
標(biāo)準(zhǔn)編號： EU MDCG 2020-3 : 2020
標(biāo)準(zhǔn)類別：Standard
出版單位：European Union
標(biāo)準(zhǔn)頁數(shù)：14
標(biāo)準(zhǔn)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.
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