Medical device software - GSPR 6 device lifetime

TomQA

Involved In Discussions
Hello,

we just received the comments from our notified body for the MDR submission of our Medical device software and we have a NC concerning the GSPR 6 regarding the demonstration that "the characteristics and perfomances of the device are maintained throughout the whole lifetime of the device".
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First of all, I am having a hard time to define the lifetime of our medical device software (which is a webApp). How do we define it ? For instance, our WebApp runs on a browser that runs on windows 10 which will no longer be supporter after october 2025.. Does that determine our lifetime ?
Or is the device lifetime determined on the most "critical SOUP" in our device? For instance if a SOUP becomes obsolete ? So we need to check the "enf-of-life" date for each of our SOUPs ?
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Thank you !
 

yodon

Leader
Super Moderator
You define the expected lifetime of your device (software). You need to plan for OS changes. The SOUP question has several answers - and it doesn't relate just to "critical" SOUP, it needs to be comprehensive of all SOUP. Presumably, you should have already looked at known issues with SOUP items (e.g., reviewing issues posted by the provider). You need to have a process in place to monitor for new issues. If the provider makes an update to the SOUP item, you need a plan to determine whether to incorporate it or not. And, yes, you need to plan on what happens if the SOUP item is no longer supported by the provider (obsoleted).

Ideally, there's also a plan for retiring the product. You probably need to coordinate with end users on how they safely stop using the product. There may be data that needs to be dealt with (worse if you're collecting PHI / PPI). Regulatory bodies need to be notified.

If you haven't already addressed it, part of maintaining for the life is change management. You'll get issues / feedback that may drive changes. How do you roll those out? When & how do you notify users & regulatory bodies? How do you ensure that users transition to the current release? Will there need to be any data migration / validation activities?

Of course, there are also document and record retention requirements. Depending on the jurisdictions you're in, you may need to have a plan for retaining info for years after the life.

Software lifetime is a bit difficult to pin down. I think a reasonable approach is to coordinate with marketing on how long they believe this will be a viable product. When will technology leapfrog it? Maybe even you have a roadmap that makes the app obsolete in some number of years.
 

TomQA

Involved In Discussions
Hi @yodon ! Thanks for the very detailed response.
Ok I see that the different points you mention are also found in the team NB guidance regarding this topic (page 7).
I think, and will need confirmation with the software engineers and the marketing team, we will give an "arbitrary" lifetime of 3-5 years and discuss the different points you mentioned and that are described in the team NB guidance.

We agree that the device lifetime is for a given version of the software correct ? Thanks !
 
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