Class I MDSW CE Mark

RegulatoryUS_EU

Starting to get Involved
#1
Hi all,

I am struggling to understand which types of software will be classified as Class I in the EU. The only example provided in the guidelines is related to this app for fertility.

Does someone have experience on positioning other software as Class I MD?

Does someone could provide recommendations on which types of claims can be made to be classified as a Class I in the EU and avoid being a Class IIa (with therapeutic purposes)

Thanks a lot in advance!!!
Best
J
 
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Raisin picker

Quite Involved in Discussions
#2
MDR, Annex VIII (emphasis by me):
6.3. Rule 11
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:
— death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
— a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.
Under MDD, most software was considered class I. Under MDR, almost no software can be considered class I anymore.
It seems that "therapeutic purposes" and "class I" exclude each other. But you might find something in the MDCG documents (e.g. MDCG 2019-11).

Disclaimer: I'm not a classification expert, but I've come across several SAMD that have been classified as IIa where I thought they should be class I or no MD at all.
 

dgrainger

Trusted Information Resource
#3
MDCG 2019-11 implies that you're looking at a minimum IIa for all software with a medical purpose (so ok for 'accessories for a medical device' & Annex XVI software products):

"The wording “intended to provide information which is used to take decisions with diagnosis or
therapeutic purposes” describes, in very general terms, the “mode of action” which is characteristic of
all MDSW. Therefore, this sub-rule is generally applicable to all MDSW (excluding those MDSW
that have no medical purpose).
Sub-rule 11a), states that MDSW (which is intended to provide information which is used to take
decisions with diagnosis or therapeutic purposes) is classified as class IIa. "

In my opinion, the fertility tracking example should be class IIa as it is monitoring a physiological processes and is therefore class IIa.
 

RegulatoryUS_EU

Starting to get Involved
#4
Hi all, thanks for all your answers! Appreciate that!

Indeed, the product that we're investigating is a software (SW) thas has "digitalized" some already validated tests that were only used at clinical sites. So, now, the cognitive tests can be conducted at home remotely and the doctor can see the results and provide recommendations based on this results.

Thus,we are even questioning if the product itself can be categorized as a Medical Device Software (MDSW) since, in principle, it is just presenting some already validated tests in digital version, compiling the results and presenting the results remotely to the doctor who takes the desicion.

So, it is a little bit strange because we're dealing with a SW that can be a) even NOT be considered a Medical Device or b) if it is considered a MD, it is very likely to be positioned as a Class IIa MDSW and not Class I... So, it seems to be: Non-MD vs Class IIa MDSW

Thus, we're trying to understand if there is a way to position the product as a Class I. For instance, do you think the product could be consider a Class I a if it is stated that the SW "monitors the progress of congnitive impairement"? We're avoiding to state that it has a "therapeutic purpouse" and we're also avoiding to state that it is "monitoring a physiological parameter" (rule 11b)

thanks again!
J
 

dgrainger

Trusted Information Resource
#5
If it's just digitising a paper 'test' and any analysis is validated by the clinician then you could argue it isn't a device.

However.... if it is a device, the fact that the results are used by the clinician to make recommendations will place it in IIa or above.
 

Raisin picker

Quite Involved in Discussions
#6
"the cognitive tests can be conducted at home remotely and the doctor can see the results and provide recommendations based on this results":
This still sounds like "Software intended to provide information which is used to take decisions ..."

If you provide a piece of paper and a pencil to the patient, ist this a medical device? Yes, if you sell it as such, it could be considered as a medical device. The important part of the MD definition (Article 2 (1)) is here " intended by the manufacturer ". So, if you sell it to practitioners, it is most likely a medical device. If you don't claim some benefit, noone will buy it. You can try to find an intended use wording that fits under class I, but I honestly doubt that you then find suitable marketing claims to sell it.
 

mihzago

Trusted Information Resource
#7
Paper and pencil tests are generally not considered to be medical devices. A software however that administers a cognitive tests most likely will be considered a medical device. I'm saying most likely because it depends a little on what does the software do.
Does it simply ask questions and maybe present letters/words/graphics/images or does it also measure reaction time and response accuracy (e.g., did the person select or tapped on a correct stimulus). In the former case, you could argue the software simply digitizes a standard questionnaire, and I would determine that software to be not a medical device, or maybe a Class I, if there were some aggressive claims.
In the latter case, the software would be at least a Class IIa.
 
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