Please explain MDR Rule 11 to me

Marcelo

Inactive Registered Visitor
#51
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.
Draft MDCG Software qualification & classification guidance for sign-off this week.
(I'm on the EC work group)
Thank you for this update. As the document is not published yet, I cannot comment on it.

But commenting on your comments, from the medical science literature, the itens I listed not in bold are not the same as diagnostic or therapeutic purposes (for people not aware of that, I suggest reading something like the (Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice, 3rd ed).

From the draft and final text of the MDR, my interpretation is that the regulations was created leaning towards Evidence-Based Medicine (which makes sense) and this can be seem, for example, on the systematic review framework the regulation (and the MDD and MDDDEV) defined for Clinical Evaluation.

The separation and granularity, on the definition of medical devices (eg. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease) also points to this, because they reflect much more what Evidence-Based Medicine uses for each.

Now, if you say the Software working group (hopefully there we physicians participating) is trying to change how the world treats these terms, and that the group is saying that all of them are under diagnostic or therapeutic purposes, even if the medical science literature clearly separates them, I would think the proposed document will same some problems being accepted (well, it's a guidance document anyway, so there is not a problem in itself, but I would really prefer that guidance documents are not technically wrong).
 
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Ronen E

Problem Solver
Staff member
Moderator
#52
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.
The bit where I see some incoherence is with Investigation of a physiological process. This can be for neither diagnostic nor therapeutic purposes. I actually worked on such a device line a few years back (at the time the SW was embedded in a physical device, but I can easily envisage a stand-alone version).
 

Marcelo

Inactive Registered Visitor
#54
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!:)
So, if this is the conclusion of the EC work group, does this mean that the group understand that this requirement is wrong? The only correction would be to change the regulation, right?
 

Watchcat

Trusted Information Resource
#55
dgrainger, do you know how long it will take for the MDCG guidance to be published?
For me this raises some higher tier questions about the whole process:

Will these guidances replace or augment (or conflict with ;)) the MEDDEVs? Are these the guidances the expert panels are supposed to provide input on?

Is an "EC work group" the same as an expert panel? Or what to do until the expert panels get here? It seems like the call for experts was issued too recently (and rumors abound that not nearly enough experts have answered the call) for them to have gotten reviewed, selected, organized and ready to contribute to guidances.
 

Marcelo

Inactive Registered Visitor
#56
For me this raises some higher tier questions about the whole process:

Will these guidances replace or augment (or conflict with ;)) the MEDDEVs? Are these the guidances the expert panels are supposed to provide input on?

Is an "EC work group" the same as an expert panel? Or what to do until the expert panels get here? It seems like the call for experts was issued too recently (and rumors abound that not nearly enough experts have answered the call) for them to have gotten reviewed, selected, organized and ready to contribute to guidances.
MEDDEVs right now are only applicable to the Directives, not the Regulations. Expert panels are a total separate issue, they serve several purposes (including some related to the MDCG), but they are not writing the MDCG guidances. The working group DGrainer mentioned is one of the working groups under the MDCG (I think it's WG 07 - New Technologies).
 

Watchcat

Trusted Information Resource
#57
Thanks, Marcelo. I think I'll start a separate discussion my interest in this topic, as it has nothing to do with Rule 11.
 

kreid

Involved In Discussions
#60
An extract from the dr
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.
I have seen a copy of the draft guidance, in it they use the risk classification matrix from the IMDRF N12 document. They have kept the axes the same and substituted in the EU classification set. However, they only use Class III down to Class IIa, so the bottom left hand corner is Class IIa, hence no Class I classification in the risk matrix.
I think this re-enforces the impression that I was trying to convey, Rule 11 seems exclude the concept of SaMD being anything less than Class IIa, except maybe accessories.
 

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