MDR: Active medical device or not?

#1
Hi,
I am currently trying to classify my device via MDCG2020-24.
I am wondering whether my device is active or not.

The device is a gas pressurised can that sprays a (non medicinal) substance into the vagina to alter the ph of the vaginal environment.
The substance sprayed in the vagina is considered non-medicinal and has no active substance.
Leaving the discussing on whether or not the substance is medicinal or not aside, is this device an active medical device under rule 12?
Or does an active device always need to administer substance with a medicinal effect?

Thanks in advance for your input.
Danny
 
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Raisin picker

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#2
Hi,

For me, Rule 12 reads: "All active devices intended to administer and/or remove medicinal products, body liquids or other substances ...". MDCG 2021-24 says "This rule is intended to primarily cover drug delivery systems and anaesthesia equipment", so I see no reason not to apply rule 12 for your active device that administers other substances.
 
#3
thanks raisin picker!
I have a follow up question. My device fits both under Rule 5 (short term invasive) and Rule 12(active device to administer substance). Both leading to a class 2a classification. Which rule should one "choose"? I understand that if multiple rules apply, the one with the highest classification is applicable. But what about this case?
 

Raisin picker

Quite Involved in Discussions
#4
When both rules lead to the same class, just name both rules. I don't think you are required to choose only one rule, you just have to settle on one class.
This is different for the device code, where you have to define only one MDA /MDN code (maybe MDA 0306 in your case).

Regarding the "other substance", take a close look on rule 21 ;-)
 
#5
Hi raisin picker,
You have a valid comment about rule 21. However, I want to argue that our product is more than the "substance" sprayed into the vagina. The pressurized cannister is not intended to be introduced into the human body for absorption or locally dispersion (only the substance)
But I want to look at our product as more than just the substance as the substance only has clinical value in combination with the delivery mechanism
If that makes sense?
 

Junn1992

Quite Involved in Discussions
#6
Hi Danny, what's the intended use of the device? Once that is settled, and the intended medical purpose is clear, the rest of the classification rules should be easy to apply.
 
#7
Hi Danny, what's the intended use of the device? Once that is settled, and the intended medical purpose is clear, the rest of the classification rules should be easy to apply.
Hi Junn, thanks for your input! The intended use is clear. However, since our product is in a grey zone (delivery method of a non medical substance (-->not a combination device) contributes to the treatment of the end user), many rules can be answered with "maybe" :)
I do believe we have a good reasoning to state that our device fits under both rule 5 and 12,
thanks again!
 
#9
My device fits both under Rule 5 (short term invasive) and Rule 12(active device to administer substance). Both leading to a class 2a classification. Which rule should one "choose"? I understand that if multiple rules apply, the one with the highest classification is applicable. But what about this case?
Would you say that your device fits Rule 5 but intended for transient use ? ... in which case the Rule 12 applies better.
From the view point of the intended use, it is more closer to Rule 12. In your case this is a better fit >> Class 2A per Rule 12.
Note that Class 2A in your device case can't be per Rule 21
 
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