RUO and IVD

REG12

Starting to get Involved
#1
Hi

Can a manufacturer sell a device which is cleared for use labelled as "IVD" within its scope of the intended use but also sell the same device not with IVD label but with "RUO" label to allow it's exploration in the market?

Thanks
 
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dgrainger

Trusted Information Resource
#2
They will have different intended purposes so won't really be the same device.
Which market are you exploring? Research or medical?
 
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