Swiss Authorized Representatives for Medical Device ...
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Under the existing Mutual Recognition Agreement (MRA) between ... European Directives 93/42/EEC concerning medical devices (MDD), ... Date 05.02.2021 Author HelenaLacalle Category Knowledge ReadingTime:11minutes Swis
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- 1MDD Agreement
Have agreed as follow, regarding the safe handling of the medical devices (hereinafter called “P...
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現在BS EN ISO. 13485:2016 已經與MDD、AIMDD 及IVDD 調和,接下來需留意未來是否與MDR 調. 和。 新MDR 對合約製造商(contract manufactu...
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- 5Council Directive 93/42/EEC - EUR-Lex
of 14 June 1993 concerning medical devices. THE COUNCIL OF THE EUROPEAN COMMUNITIES,. Having rega...