Medical Device Software Requirements for Labeling

A

AlisonGillies

#1
I am trying to find out if there are any specific regulations for either Medical device software or IVD device software to display the version number of the software? I was of the understanding that this must be displayed in the initial "flash" screen and also the "about" dialogue box but can't find a specific reference in either EU directives, harmonized standards or FDA guidance.

Is there a minimum time that the "flash" screen should be displayed?

Also, what happens if there are "plug ins" that are optional to the user of the device?

Thanks, any help would be appreciated.....
 
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Stijloor

Staff member
Super Moderator
#2
I am trying to find out if there are any specific regulations for either Medical device software or IVD device software to display the version number of the software? I was of the understanding that this must be displayed in the initial "flash" screen and also the "about" dialogue box but can't find a specific reference in either EU directives, harmonized standards or FDA guidance.

Is there a minimum time that the "flash" screen should be displayed?

Also, what happens if there are "plug ins" that are optional to the user of the device?

Thanks, any help would be appreciated.....
Can someone help Alison?

Thank you!!

Stijloor.
 
S

sueliu - 2012

#3
We only have the version number in About box, and no question was raised by the CE mark reviewer.
 

Peter Selvey

Staff member
Super Moderator
#4
There are no requirements that I am aware of, and any attempt to set such a requirement for display of the version to the user would be difficult because of the variable nature of software. We cannot assume, for example, that an application of medical device software even has a display for the user to see :)

Reading IEC 62304, there is a clear need to be able to identify the version, so you should have some way to access this, e.g. in an About screen.

Also note that for serial number labelling in MDD Annex I, 13.1 (d), it is not required that a serial number is easily visible at all times of use (e.g. for large installed equipment the serial number label can often be at the rear of the equipment). So this would also imply that software version number is not required to be visible at all times.
 
E

Erik Vollebregt

#5
Legally I would always advise that one should be able to determine if the particular release of the software is covered by the CE mark if the software can be updated, so that presumes that the version number of the software release can be found e.g. in the "about" box.

Of course, as others mentioned in this thread, being able to identify versions makes a lot of sense. Think about a vigilance scenario, e.g. recall that affects only a certain release). Serial numbers are also used for corrective action purposes, so software you should treat you version number as a serial number in the text of the EU medical devices directive.
 
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