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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#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
 

Marcelo

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