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Old 11th July 2018, 12:29 PM
Mark Meer

Total Posts: 891
Re: Clinical investigation - Role of Notified Body (NB)

In Reply to Parent Post by Marcelo Antunes View Post

Just to prevent confusion, you mean performance study, right? Clinical investigation is only applicable to non-IVD devices. The related term that applies to IVDs are performance studies. ...

Hi Marcelo,
Curious: do you know why the authors opted to define different terms?

I understand there are differences, but they are largely talking about the same thing, no? It seems to me that creating another (quite different) term just lends itself to more confusion. Why not just prefix the MDR term with "IVD" (i.e. an "IVD Clinical Investigation") to refer to the specific type of investigation?

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