Publications : Regulation

How the MDR will impact your regulatory watch

Have you thought about the impacts of the Regulation (EU) 2017/745 on your regulatory and normative watch? The Regulation (EU) 2017/745 on medical devices, together with the ISO 13485: 2016 standard, require manufacturers to implement a monitoring system in order to...

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ANSM

New version of the list of regulatory positions and classifications of MDs and IVDs On January 22, 2016, the ANSM published a new version of the “FAQ” on regulatory positions and classifications of medical devices and in vitro diagnostic medical devices (dated...

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