Please explain MDR Rule 11 to me

Asia78

Involved In Discussions
#1
Dear experts,
Anyone who can explain me rule 11?
I think it applies to standalone sw only but what is exactly a stand alone sw? Our device is probably considered a stand alone software (radiation planning) by itself, but it is used then by other software for treatment. So...is it really a standalone??
The two software have two separate DoC. What do you think? Does rule 11 still applies?
 
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SKM.Sunil

Involved In Discussions
#3
Dear experts,
Anyone who can explain me rule 11?
I think it applies to standalone sw only but what is exactly a stand alone sw? Our device is probably considered a stand alone software (radiation planning) by itself, but it is used then by other software for treatment. So...is it really a standalone??
The two software have two separate DoC. What do you think? Does rule 11 still applies?

I think you can call a Heart Rate monitoring SW used in smart/portable devices are "stand-alone" but the same software, when used in operation theatre, may not be called as "stand-alone". In such instance your device is not a stand-alone, it works with so many similar devices to function or give its intended use.

Your device may fall under "Class-IIb" as per the rule-11 statement "a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb."
 

Asia78

Involved In Discussions
#4
Thanks, we are thinking about that indeed as second option. First would be to use the implementation rule "Software which drives a device or influence the use of a device, shall fall within the same class as the device". But I don't know if here the device is meant one part of the same DoC or not.. in our case it is not, it is a device from another manufacturer, a Linac (class IIb).

Is there anything about the interpretation? It is a very new rule and I would like to find sth more written around but I haven't found anything
 

SKM.Sunil

Involved In Discussions
#5
Thanks, we are thinking about that indeed as second option. First would be to use the implementation rule "Software which drives a device or influence the use of a device, shall fall within the same class as the device". But I don't know if here the device is meant one part of the same DoC or not.. in our case it is not, it is a device from another manufacturer, a Linac (class IIb).

Is there anything about the interpretation? It is a very new rule and I would like to find sth more written around but I haven't found anything

As I have gone through the new rules, I could understand that "Your device shall be classified as per the risk it carries. as the supportive sw is not your and may the manufacture be XYZ, your device still falls under the section I mentioned (without knowing how it works independently or combined with others), You should submit substantial data to support the claim.

Your file will be independent, however, the claim for the complete working of the device will be compiled with reference to the device/SW that you refer to work with to give a complete function (be it XYZ from ABC company). Your technical file should demonstrate the function, that it mean to deliver.
 

yodon

Staff member
Super Moderator
#6
I think you can call a Heart Rate monitoring SW used in smart/portable devices are "stand-alone" but the same software, when used in operation theatre, may not be called as "stand-alone". In such instance your device is not a stand-alone, it works with so many similar devices to function or give its intended use.
Maybe gettind off on a bit of a tangent here, but I can't say I agree with this. By definition, if software is used IN a device, it's not stand-alone.

Examples of stand-alone software include image analysis software, surgical planning software, etc.
 

SKM.Sunil

Involved In Discussions
#7
Maybe gettind off on a bit of a tangent here, but I can't say I agree with this. By definition, if software is used IN a device, it's not stand-alone.

Examples of stand-alone software include image analysis software, surgical planning software, etc.
I certainly agree with you. but I just gave a basic example.
 

Watchcat

Trusted Information Resource
#8
By definition, if software is used IN a device, it's not stand-alone.
Examples of stand-alone software include image analysis software, surgical planning software, etc.
Are you saying that image analysis software, surgical planning software, etc, can be used without any hardware?
 

Watchcat

Trusted Information Resource
#10
Yes, of course. If the IMDRF hadn't established a definition for SaMDs that excluded the hardware on which they run, that could have opened the door to any PC, mobile device, etc, on which the SaMD ran being regulated as a medical device. Ouch.

Now we wait to see if a problem with an unregulated host causes a regulated SaMD to malfunction and harm patients. If that should happen, definitions are likely to be revisited.
 
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