Take the ISO 13485 course exam and get the ISO 9001 course exam for free
LIMITED-TIME OFFER – VALID UNTIL SEPTEMBER 30, 2021

Expert Advice Community

Guest

GSPR and IFU/manual

  Quote
Guest
Guest user Created:   Sep 06, 2021 Last commented:   Sep 06, 2021

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?

0 0

Assign topic to the user

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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.  

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Sep 06, 2021

Sep 06, 2021