Is an ethernet port part of the User Interface

DanMann

Starting to get Involved
#1
As simple as the title - my colleagues and I are having a debate about the definition of "User Interface" from IEC 62366, my assertion is that it is any means by which the User and the Medical Device interact in any way, including (for example) plugging in an ethernet cable; does anyone have any thoughts or guidance that might help on this?
 
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Tidge

Trusted Information Resource
#2
Do any of the users identified in your user specification interact with the ethernet port?

My guess is that you have a very limited set of users and use scenarios that involve engaging with the ethernet port, if you have no users that engage with it, remove it from the design. If some users have to engage with it, you probably want to establish that it is accessible, etc.
 

DanMann

Starting to get Involved
#3
Do any of the users identified in your user specification interact with the ethernet port?

My guess is that you have a very limited set of users and use scenarios that involve engaging with the ethernet port, if you have no users that engage with it, remove it from the design. If some users have to engage with it, you probably want to establish that it is accessible, etc.
Thanks Tidge - yes it would be used to connect our device to the internet by our main user group, which I believe means it would be part of the user interface; is that correct?
 

Tidge

Trusted Information Resource
#4
It's just me, but the range of user interaction with the port seems to be there, but it is not absent.

For such a feature, I would expect that during summative testing you will have your sample users make the connection. Depending on the complexity of your other user interfaces, it's probably not the end of the world if you 'forgot' to include it as a user interface. If you get a complaint that the user can't make the connection for some reason like "ethernet port is blocked" or "cable keeps disconnecting by itself" there will be egg on teh faces of everyone who poo-pooed the idea of needing to test it with users.

I see this as a small addition to the Use Cases, no one should fight it.
 

DanMann

Starting to get Involved
#5
The problem is less one of testing and more of what constitutes a "User Interface". The EU guidance on "Significant Change" (MDCG 2020-3) states that a "New User Interface" is a significant change (and so would require a medical device to transition to the new regulation immediately on the change rather than at a later deadline), so everyone is happy to test, but we cannot agree on whether it is a significant change (and we are a General IVD Manufacturer, so we don't have a NB to check with yet, so we are working on our own).
 

Tidge

Trusted Information Resource
#6
If you are actually adding an ethernet connector, I feel like the design is very likely undergoing a significant change (*1). If the connector was already there, then you aren't making a significant change, you would just be updating your own records, and I am sure you can rationalize to yourself to not immediately transition.

(*1) My cybersecurity alarm bells are ringing.
 
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