MDR: Active medical device or not?

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Junn1992

Quite Involved in Discussions
#12
Hmm I see now.

I think Rule 5 definitely applies, and also Rule 12, because:

"‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity,"

Therefore, your device is an active device.
 
#13
It looks like two devices in combination. An active substance (primary action) and a delivery system.
I understand your point of view, however, our substance is not an active substance. The substance itself has no medical or pharmaceutical effect. Only in combination with the the delivery method, it can alter the ph of the vagina --> which has positive effects on user
When interpreting the MDR or MDCG2022-05, the MD is only a combinational device when it delivers an active substance or medicine
 

dgrainger

Trusted Information Resource
#14
our substance is not an active substance
Sorry, by 'in combination' I wasn't referring to drug-device but device-device combination.

Just wondering how it alters pH? Is it chemically?

You appear to have a substance based device ('...which does not achieve its principal intended action by pharmacological, immunological or metabolic means...') and a delivery system in combination.

Rule 21 would apply to the substance component. See MDCG 2021- 24 - Gel for vaginal moisturizing / vaginal lubricants are class IIb
 

Junn1992

Quite Involved in Discussions
#15
I was abit hesitant to call our Rule 21, as it specifies " absorbed by or locally dispersed in the human body " But as @dgrainger pointed it out, I had to do my due diligence and double check. And viola, what do you know:

According to MDCG 2021-24:
"Local dispersion: The condition by which substances remain in a specific site without being distributed into the body via the blood and/or lymphatic system."

THEREFORE, Rule 21 applies. AND:

Classification becomes IIb.

I believe the key is the MDCG 2021-24 definition of local dispersion as pointed out by @dgrainger

What do you know, learn something new each day!

@DannyVerbiest Time to get "promoted" to IIb =)
 
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