Changes to OS - Significant change under MDR

[Junn1992]

Hi fellow covers,

Wanted to check on something in MDCG 2020-3. Our web application (legacy device) currently runs on an old version of Ubuntu. We want to upgrade to the latest version of Redhat. Is this considered a significant change, even though Ubuntu and Redhat are both linux-like? I know the final answer will probably be check with NB, but Love to hear your thoughts, thank you!

 

[yodon]

I expect if you ask, they can only say it is. You may want to do a risk analysis based on the changes to the OS and then make the conclusion (one way or the other). If you conclude it's not then you'll have data justifying the decision. They can still disagree but they can't argue with the approach.

My personal thought would be that yes, an OS change like you describe would be a significant change.

 

[Junn1992]

Thanks yodon once again for the great replies regarding software questions!

Time for us to bring forward the MDR transition I guess...either we do it proactively, or the NB points this out during next surveillance, and that wouldn't be a pleasant experience.

 

[mihzago]

How much codebase do you have to rewrite?

I think you have two options, ask for forgiveness or permission.
In the first option, go ahead with the changes, document your rationale that it's not a significant change and hope your NB doesn't see it until you upgrade to MDR or does not make stink about it. If they do, be prepared to either pull the product or roll-back the OS.
Option 2 is to write up strong justification and try to sell it to your NB before you implement it.

You have to weigh the risk.

 

[Junn1992]

NB doesn't see it until you upgrade to MDR

This is probably not possible as our NB is pretty good and reviews technical documentation during surveillance as well. In our specs, the OS is declared, so it's quite an obvious change.

If they do, be prepared to either pull the product or roll-back the OS.

Most probably product pull as unable to roll-back after

How much codebase do you have to rewrite?

According to IT guy there's a change to architecture as well, so it dosen't pass question 2 in Flowchart C of MDCG 2020-3 anyways, but management is focussed on the OS question for now.

Thanks for your comments! =)

 

[mihzago]

yea, I didn't think the first option would be viable, but I always like to present and consider all possible options.
If you have to rewrite the code and it also affects the architecture then I don't see how you could justify this change as not significant.

 

[Junn1992]

Additional question: does MDCG 2020-3 apply to MDR devices as well? So 'significant change' to MDR certified devices is also assessed using the same criteria?

 

[mihzago]

In the absence of a guidance document for devices under the MDR, MDSG 2020-3 and NBOG BPG 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System, are probably your best bet.
It's also good to check with the NB, because often each has different interpretation.

 

[Junn1992]

Thank you @mihzago