Looking for SSCP file of IVD devices

[Brindha]

Dear Community

I am a first-time poster working as a student researcher Quality and regulatory. I am looking for a sample "Summary of safety and clinical performance" file for IVD devices.
Could anyone guide me where can I look for these files or if someone could provide me one? Any leads will be much appreciated.

Thanks!!

 

[florijanl]

Here, take a look at this guide: type this in Google - summary of safety and clinical performance mcdg

 

[dgrainger]

IVD's have "Summary of safety and performance" - Article 29.

SSCP is from the MDR - Article 32.
MDCG guidance is here: Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission - MDCG 2019-9 covers SSCP.

 

[Brindha]

Thank you for your Inputs.
I have looked at guidance documents it was helpful but I am looking particularly for an example of SSP file for an IVD

 

[Brindha]

Could anyone guide me on finding an example of a SSP file for an IVD device?

Thanks in advance

 

[florijanl]

Do you know that there is a template at the end of the guidance document? Also, there are no special requirements for IVD that I would know.
bicon.com/pdf/SSCP-002v01-SGFT.pdf - example of SSCP, but it's not IVD.

 

[Brindha]

Do you know that there is a template at the end of the guidance document? Also, there are no special requirements for IVD that I would know.
bicon.com/pdf/SSCP-002v01-SGFT.pdf - example of SSCP, but it's not IVD.

Thanks a lot for your inputs

 

[florijanl]

No problem