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Medical Device Classification under MDR - Rule 21

#1
Hello everyone!

I have been reviewing the new MDR for medical devices and I have a question related to classification due to the amended rules in Annex VII of the MDR. Currently all emollient products fit in the MDD as class I device under Rule 1 in Annex IX as they are non-invasive, non-sterile, non-measuring devices. This rule remains unchanged so I believe that emollients would still be classified as Class I under Rule 1:
All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies.”

However the new newly introduced MDR Rule 21 should be considered:
"Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as..."

Is this rule applicable to emollient products where the intended use is moisturising the skin surface and there is no intended systemic absorption? I personally read this rule as seperate dependent clauses. And that a device would need to be intended for application to the skin and absorbed by or locally dispersed in the human body (systemic absorbed) in order to meet this rule.

Has anyone else considered this classification? And do you agree with my interpretation?

Thank you in advance!
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
a device would need to be intended for application to the skin and absorbed by or locally dispersed in the human body (systemic absorbed) in order to meet this rule.
I don't understand your interpretation which I emphasised above.

I see 2 conditions in the rule which seem applicable to your case:
- [applied to the skin], AND
- [absorbed by the human body] OR [locally dispersed in the human body]

So an emollient applied to the skin and absorbed by the body seems to come under this category (alternatively I could argue that it's locally dispersed in the human body). It says nowhere that it has to be absorbed by, or throughout, "the entire body". The only mention of systemic absorption is in the class III categories, and given your statement these seem N/A in your case.

Not every emollient product where the intended use is moisturising the skin surface is a medical device though. Is there a medical purpose (acc. to the MDR's MD definition)?
 
#3
We sell class I medical device (gloves) under EU MDD, some products are coated with aloe vera on the inside surface of the glove. Will the new rule 21 apply to our product? If its taken as an independent clause, we believe it should not because the emollient does not necessarily affect the intended use of the glove.

Any help will be appreciated
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
We sell class I medical device (gloves) under EU MDD, some products are coated with aloe vera on the inside surface of the glove. Will the new rule 21 apply to our product? If its taken as an independent clause, we believe it should not because the emollient does not necessarily affect the intended use of the glove.

Any help will be appreciated
I think it's N/A. The intended use of the gloves is to provide protection (a barrier); people don't wear them, in the first place, to get their hands treated!
To be on the safe side though, consider not mentioning (or downplaying) the Aloe Vera in your labeling, so it's not perceived as a claim.
 
#5
I think it's N/A. The intended use of the gloves is to provide protection (a barrier); people don't wear them, in the first place, to get their hands treated!
To be on the safe side though, consider not mentioning (or downplaying) the Aloe Vera in your labeling, so it's not perceived as a claim.
Thank you!!
 
#6
There are ongoing discussions about this and Rule 21 as a whole as I know that different NBs are interpreting it differently. For example one of our NBs is taking the stance that ALL substance-based devices should be Rule 21 as even if they are not absorbed, because they will be dispersed ON the skin. Their interpretation as the translation from English into their language apparently is different to our English version.

So, if you go Class I then do you need to state why Rule 21 does not apply and why you chose Rule 1? If so how do you prove it without doing some sort of test / assessment to prove there is no absorption?

Interestingly a German working group has drafted a new MEDDEV (2.4 /1) which includes moisturising products specifically under Rule 4 making them IIa - so up-classification would be required even if Rule 21 is not applied. Although this will be dependent on your intended use. Of course that may not make it through to the final version so who knows?!
 

Ronen E

Problem Solver
Staff member
Super Moderator
#7
For example one of our NBs is taking the stance that ALL substance-based devices should be Rule 21 as even if they are not absorbed, because they will be dispersed ON the skin. Their interpretation as the translation from English into their language apparently is different to our English version.
This doesn't make sense to me. The first part of the sentence already includes "applied to the skin" (unless this is also twisted in translation), so the result would be "applied to the skin and [also] locally dispersed ON the human body..." - this looks like wording excess.
So, if you go Class I then do you need to state why Rule 21 does not apply and why you chose Rule 1? If so how do you prove it without doing some sort of test / assessment to prove there is no absorption?
If you go class I and your cream is benign, your classification decision is likely to stay unchallenged (maybe even unnoticed), so more likely most manufacturers in that position will suffice with claiming that it's not absorbed or dispersed in the body (perhaps with some documented theoretical rationale), and won't bother proving it beyond doubt.
 
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#8
This doesn't make sense to me. The first part of the sentence already includes "applied to the skin" (unless this is also twisted in translation), so the result would be "applied to the skin and [also] locally dispersed ON the human body..." - this looks like wording excess.

If you go class I and your cream is benign, your classification decision is likely to stay unchallenged (maybe even unnoticed), so more likely most manufacturers in that position will suffice with claiming that it's not absorbed or dispersed in the body (perhaps with some documented theoretical rationale), and won't bother proving it beyond doubt.
Agree on both counts. Re: the NB - I got nowhere in a discussion with them. We are now hoping some guidance is issued that clarifies it so that we can force the issue (not keen to do that yet as we don't need to up-classify yet and want to keep them onside for now!)
 
#9
So, if you go Class I then do you need to state why Rule 21 does not apply and why you chose Rule 1? If so how do you prove it without doing some sort of test / assessment to prove there is no absorption?
I'm also facing the same rule 21 issue as i'm working on a Class I mouth wash (MDD rule 5) and trying to avoid the up classification. As the product is being spitted out after 30 seconds we want to claim there's not absorption (easier to claim) and it is not being dispersed (harder to claim)

interesting thing that i've found during my searches is in the attached presentation (dated 2013) by B.A.H on IMDRF , rule 21 discussion is starting on page 6. Their proposal was to amend the text to "..that are absorbed by or and dispersed in the human body to achieve their intended purpose".
I assume it wasn't accepted. :-(
 

Ronen E

Problem Solver
Staff member
Super Moderator
#10
the product is being spitted out after 30 seconds
I understand that this is the intended use, but there's a high probability (IMO) that it will be exceeded - misuse - so I wouldn't use this as the basis of the classification argument unless the 30 seconds already include a big safety factor (e.g. the IFU says something like 5 s. or wash briefly and spit out immediately). With a mouthwash there's also the additional risk of swallowing small amounts, and of residues - how can you guarantee complete removal?...
 
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