Informational Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of

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pankracy

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#2
#2
Great find Marcelo!

Am I correct in thinking that the listing in the annex I and II in the document in the in the link is the listing of harmonised standards to the MDR and IVDR that will replace the current listing?

Regards
 
M

Marcelo

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#3
#3
Yes. Although this initial mandate has a focus on process standards, there will be another mandate with product standards.
 
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