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GSPR and IFU/manual
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?
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Sep 06, 2021
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.
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Sep 06, 2021
Sep 06, 2021
Sep 06, 2021