Please explain MDR Rule 11 to me

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Ronen E

Problem Solver
Staff member
Moderator
#42
Another possible interpretation of the implementation rules (which makes more sense in my opinion) is that the part "Software, which drives a device or influences the use of a device, shall fall within the same class as the device"only applied to embedded software.
That would make sense, however the MDR's text doesn't indicate that this was the actual intention.
 

dgrainger

Trusted Information Resource
#43
That would make sense, however the MDR's text doesn't indicate that this was the actual intention.
I agree, it's a mess!

Implementing rule 3.3 contradicts 3.2 :( :

3.2 - If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices.​
vs
3.3 - Software, which drives a device or influences the use of a device, shall fall within the same class as the device.​

HOWEVER you have to apply 3.5 and apply all the rules and take the strictest rule. - easy!:)
 

kreid

Involved In Discussions
#44
The same way you do with the other - analyzing the rule. If your device (in this case of rule 11, as I mentioned it has to be a SaMD) if the intended use fits into the first two paragraphs, it's class is like defined in the paragraph. If not, it's a class I.
But analysing the rule I see the following:

"Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:"
&
"Software intended to monitor physiological processes is classified as class IIa,"

Do not the two quotes above just about define a medical device? Hence, an software medical device has to be Class IIa or above.

I do understand dgrainger's point about accessories.
 

Marcelo

Inactive Registered Visitor
#45
But analysing the rule I see the following:

"Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:"
&
"Software intended to monitor physiological processes is classified as class IIa,"

Do not the two quotes above just about define a medical device? Hence, an software medical device has to be Class IIa or above.

I do understand dgrainger's point about accessories.
What defines what is a medical device, is the medical device definition in article 2(1). Classification does not define if a device is a medical device or not.

Did you read document IMDRF/SaMD WG/N12 FINAL:2014? It has several examples.

Unfortunately, I don't think you can truly understand Rule 11 without having an in depth understanding of the 4 IMDRF SaMD documents (in particular, the first on definitions and this one I mentioned), even if the MDR does not follow strictly the IMDRF documents.
 

kreid

Involved In Discussions
#46
What defines what is a medical device, is the medical device definition in article 2(1). Classification does not define if a device is a medical device or not.

Did you read document IMDRF/SaMD WG/N12 FINAL:2014? It has several examples.

Unfortunately, I don't think you can truly understand Rule 11 without having an in depth understanding of the 4 IMDRF SaMD documents (in particular, the first on definitions and this one I mentioned), even if the MDR does not follow strictly the IMDRF documents.
Yes, know the IMDRF SaMD docs well, the point I was trying to make (badly) was that the two parts of Rule 11 that I quoted are very similar to that which defines a medical device in article 2, if a device is used in diagnosis, therapies or monitoring of disease, injury or disability, then it is a medical device. So how do you get to Class I and still be a medical device.

I guess this is a philosophical discussion, but in practical terms, I am telling my clients that if they have an SaMD, it is difficult to see how it can be classified as anything less than a Class IIa device, if Rule 11 is the classification rule used.
 

Marcelo

Inactive Registered Visitor
#47
Yes, know the IMDRF SaMD docs well, the point I was trying to make (badly) was that the two parts of Rule 11 that I quoted are very similar to that which defines a medical device in article 2, if a device is used in diagnosis, therapies or monitoring of disease, injury or disability, then it is a medical device. So how do you get to Class I and still be a medical device.

I guess this is a philosophical discussion, but in practical terms, I am telling my clients that if they have an SaMD, it is difficult to see how it can be classified as anything less than a Class IIa device, if Rule 11 is the classification rule used.
I'm still not sure why you are claiming that software can only be Class IIA.

If the software is NOT intended to provide information which is used to take decisions with diagnosis or therapeutic purposes and is NOT intended to monitor physiological processes, but is still a SaMD, it will be class I as per the rule.

I think the confusion here is exactly you trying to link to the medical device definition.

If you look closely to what Rule 11 says, is says "provide information which is used to take decision with diagnosis or therapeutic purposes". This is not in the medical device definition (the diagnosis and therapeutic purposes are). The same for monitoring in the second part of Rule 11.

If you look at the definition of a medical device (bold emphasis is from me)
diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations

Not all aspects of the definition of medical devices matches what is in rule 11 (basically, only the ones in bold). If the SaMD, in principle, is not related to ones in bold, it will in principle be Class I. I mean in principle because it's not automatic, you would need to check some other aspects, but an initial analysis should have this conclusion.
 

dgrainger

Trusted Information Resource
#48
The interpretation of rule 11 is that all software that is a medical device will be covered by Rule 11 - "information which is used to take decision with diagnosis or therapeutic purposes" covers everything listed in the medical device definition.
The non-bold items listed are considered to be either diagnostic or therapeutic purposes.
 

Marcelo

Inactive Registered Visitor
#49
The interpretation of rule 11 is that all software that is a medical device will be covered by Rule 11 - "information which is used to take decision with diagnosis or therapeutic purposes" covers everything listed in the medical device definition.
The non-bold items listed are considered to be either diagnostic or therapeutic purposes.
Interpretation from who? You?
 
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