MDCG-2020-3 (about the software of UI)

[Kevin Hung]

Hi everyone:
I am reading the MDCG-2020-3, as the chart below (software), I have few question,
1. If the we change the appearance of user interface (UI) without affect the performance and safety. What's the direction of flow In Chart C (C5)? Yes or NO?
The reason I want to ask this question is, in C6, the minor change without impact to diagnosis or treatment delivered may include:
A. Appearance of the user interface,
B. Changes to enhance the user interface without changes in performance.
If any change of UI is belonged to "Yes"(like A)in C5, there is no one can go to C6. I think C6 and C5 are contradictory.
2. For the Presentation of data, it is connected to medical data which are presented in a "new format" or by a new dimension or measuring unit. Does it mean the presentation of data in diagnosis report or in UI? What's the mean of "new format"? If we add the item in diagnosis report, does it belong to "new format"?


Thanks a lot.

 

[yodon]

I guess if you follow the flowchart and answer 'Yes' to C5 then you've already concluded the change is significant (and no need to go on to C6). But, you're right, that's not very clear at all.

Maybe take a step back and consider what the impact of the change may be. How will your users (especially legacy users) react to the change? Is your UI still understandable and (per 62366) "promoting safe and effective use?" Ultimately, you have to defend your decision so either take a very conservative approach and go with significant or have good rationale why not significant (don't just walk the flowchart).

 

[sibelyum]

You will only change the image, not add information. The change you make doesn't seem to significant. However, if you say yes according to Chart C, it will result in a significant change, and if you say no, it will not be correct.
In my opinion, the best method is to continue by notifying the Notified Body with the details. If you can convince yourself that there is no change in the software or you don't add new information, you only make changes in appearance, Notified Body will allow you to make this change.
You need a well-prepared documentation.

 

[Ed Panek]

Do you have a close customer you can perform a validation test? If you can demonstrate that legacy and new users reacted properly to the change you could argue its a low risk change