Medical Device Software Distribution for a CE-marked medical device via a USB memory stick

S

sbjorn

#1
Question; if one distributes a software upgrade for a CE-marked medical device via a USB memory stick, is it true that the memory stick must be controlled as a medical device including being labeled as a medical device (in compliance with MDD/MDR labeling requirements with CE-mark), and be specifically identified on the declaration of conformity?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
The point is not the USB stick.
The point is what "a software upgrade" means. It might be a SaMD - depends on what it does in relation to the existing CE marked medical device. It might also be other things - not enough information on hand to determine.
Is the person providing this "upgrade" the same as the original device Manufacturer?
 

yodon

Staff member
Super Moderator
#3
I'm going to say that the stick itself isn't / wouldn't be considered a device / need CE marking.

Assuming whomever is distributing the software is the legal manufacturer, it certainly needs to be controlled! How do you, for example, ensure that the contents isn't changed (in general or maliciously)? How do you know that the software upgrade was done and done successfully?
 
S

sbjorn

#4
The point is not the USB stick.
The point is what "a software upgrade" means. It might be a SaMD - depends on what it does in relation to the existing CE marked medical device. It might also be other things - not enough information on hand to determine.
Is the person providing this "upgrade" the same as the original device Manufacturer?
Thank you, Ronen and Yodon your feedback is quite helpful!

The software distributed on the stick would be a software upgrade to the operating system of a Class IIb device. The software would thus also be Class IIb under MDR. Trying to understand why the USB stick with software, would not be an accessory to a medical device under MDR. Is the USB stick is essence not like packaging of a traditional medical device?
 

SKM.Sunil

Involved In Discussions
#6
Thank you, Ronen and Yodon your feedback is quite helpful!

The software distributed on the stick would be a software upgrade to the operating system of a Class IIb device. The software would thus also be Class IIb under MDR. Trying to understand why the USB stick with software, would not be an accessory to a medical device under MDR. Is the USB stick is essence not like packaging of a traditional medical device?
As YODON mentioned it is true.

but if any scenario, you are using this USB stick attached to the MD while it is operating for its intended purpose then, please consider as an integral part of the MD. (I think this is highly impossible)

now the main software is an integral part, not the medium you carrying to upgrade. ( CD, DVD, USB, Internet etc..)
 

Kim B

Starting to get Involved
#7
Question in relation to this thread:

Do all software point releases/software patch releases require registration activities world wide?

How does industry manage this activity?
 

JoshuaFroud

Involved In Discussions
#8
Question in relation to this thread:

Do all software point releases/software patch releases require registration activities world wide?

How does industry manage this activity?
It depends on the significance of the change and the country involved. For smaller point release or patches the requirement to re-register is either covered in a statement during the development cycle or a Note To File against the relevant regulatory agency deeming the change "insignificant".

Obviously if the change is deemed significant then there may well be regulatory and registration implications.

Many regulatory agencies have existing guidance documents published on assessment of "significant change"
 

Kim B

Starting to get Involved
#9
It depends on the significance of the change and the country involved. For smaller point release or patches the requirement to re-register is either covered in a statement during the development cycle or a Note To File against the relevant regulatory agency deeming the change "insignificant".

Obviously if the change is deemed significant then there may well be regulatory and registration implications.

Many regulatory agencies have existing guidance documents published on assessment of "significant change"
Thank you Josh! Very helpful.
 
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