SaMD: Post Market Surveillance after Decomissioning

Auxilium

Involved In Discussions
#1
Stand-alone Software as Medical Device:
The MDR includes clear guidelines regarding Trend Reporting, Post Market Surveillance etc.
If a manufacturer plans to decommission the old MDD product and wants to go live with the MDR product, then according to Guideline MDCG 2021-25, Articles 93-100 apply to "old devices".
Question: Is it safe to say that one has to create the last Periodic Safety Update Report for the "opened" year?
I am not sure what exactly is required regarding Post Market Surveillance and Post Market Clinical Followup.
Can anyone help?
 
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ECHO

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#2
Is it safe to say that one has to create the last Periodic Safety Update Report for the "opened" year?
When you say "opened" year, do you mean the last year when the SaMD was available in the market?

If so, I think this will depend on how much control you have over the obsoletion of the SaMD. For example, if this SaMD is cloud hosted and by pulling the plug on the server, you eliminate all future uses of the SaMD, I think doing 1 last update makes sense. But if your product is like an app that is downloaded on other devices, then I think you need to treat this SaMD like any other medical device that gets obsoleted.
 

Auxilium

Involved In Discussions
#3
When you say "opened" year, do you mean the last year when the SaMD was available in the market?

If so, I think this will depend on how much control you have over the obsoletion of the SaMD. For example, if this SaMD is cloud hosted and by pulling the plug on the server, you eliminate all future uses of the SaMD, I think doing 1 last update makes sense. But if your product is like an app that is downloaded on other devices, then I think you need to treat this SaMD like any other medical device that gets obsoleted.
Thats a very good thought and makes sense! Thank you very much
 
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