In GSPR clause 23,4 it reads that manual must contain:
(d) where applicable, links to the summary of safety and clinical performance referred to in Article 32;,
Does this mean that I have to place a line that states: “For safety and Clinical performance summary- see link ###”. But this can be highly confidential information that I don’t want to share with user or potential competitors.
How shall this be written in the IFU/manual?
According to the Article 32. Safety and clinical performance must be performed only for implantable devices and for class III devices, other than custom-made or investigational devices. Therefore, this article and this requirement from GSPR are not applicable to you.