Hello,
very unusual question : we will commercialise a System/Procedure Pack (article 22 MDR) which is composed of:
- a medical device software installed in an off-the-shelf computer
- other off-the-shelf hardware products.
The hardware products therefore need to be connected (via cables) for the procedure pack to be used (and in fine the medical device software).
In order to facilitate the installation of the procedure pack, we want to add a quick start guide inside the box.
However, the medical device software has warnings/cautions associated to it and they can be found in its eIFU.
my question is thus following -> do we need to add the warnings / cautions of the medical device software inside the Quick Start Guide ? Or the presence of Warning/cautions inside the eIFU is sufficient ?
Thanks for your help !
very unusual question : we will commercialise a System/Procedure Pack (article 22 MDR) which is composed of:
- a medical device software installed in an off-the-shelf computer
- other off-the-shelf hardware products.
The hardware products therefore need to be connected (via cables) for the procedure pack to be used (and in fine the medical device software).
In order to facilitate the installation of the procedure pack, we want to add a quick start guide inside the box.
However, the medical device software has warnings/cautions associated to it and they can be found in its eIFU.
my question is thus following -> do we need to add the warnings / cautions of the medical device software inside the Quick Start Guide ? Or the presence of Warning/cautions inside the eIFU is sufficient ?
Thanks for your help !