Summary of safety and performance (SSP) IVDR 2017/746

#1
Hello,
EU IVDR 2017/746 includes a requirement to write a summary of safety and performance (SSP) for Class C and D IVDs. This is a new requirement that wasn’t included in IVDD.
I started drafting one and i wanted to know if it is necessary to integrate this document into our QMS, and if it is the case, in which procedure it shall be integrated?

Thank you
 
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yodon

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#2
There are no "rules" for what procedures you have so it's not possible to answer the last question. I think most companies have some sort of postmarket procedures document and this would be suitable for that procedure. I think you probably DO want to document it in your QMS since it's one of those "applicable regulatory requirements."
 
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