Biological equivalency - Dermal filler

#1
Hi everyone,

I would like to ask you about a dermal filler consist of hyaluronic acid. if additives /preservatives are different from the device presumed to be equivalent although the main substances are the same, is it possible to claim equivalency?
 
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shimonv

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#2
You cannot claim equivalency without evidence or evaluation. I suggest you turn to consultancy firm that is able to do a biological evaluation report.
 
#3
Thanks for your comment.
Both devices shall use the same material and substances according to the guideline; we got confused.
If we prove that this change does not pose a risk, can we claim biological equivalency? Or is it impossible concerning the'' same '' wording in the article?
 

Raisin picker

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#4
You have to demonstrate (not just claim) that the differences do not influence the performance and safety of the device. Especially under MDR (Annex XIV, 3, emphasis by me):
The characteristics listed in the first paragraph shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device. Considerations of equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.
That means, you have to show where you found the exact formula of the equivalent device (can be e.g. IFU od own lab analysis). You have to name the differences and provide evidence that these do not affect the clinical properties.
So, in my opinion, I think you can go that path, but provide a good reasoning. Best check with your NB as soon as possible, since this is most likely a class III device.
 
#5
Thank you very much for your comment.
''Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;''
Although the second paragraph lets to justify the differences without any expectation for any characteristic( biological, technical, and clinical) considering performance and safety, in the first paragraph it has been stated that both devices shall use the same material/substances. On the other hand, it has been stated that some issues may be similar rather than same, related to technical and clinical characteristics. We understood that although the manufacturer demonstrates that the differences do not influence the performance and safety of the device, it is not allowed to use another substance/material those different from the device presumed to be equivalent, biologically they must be the same, so biological differences are not allowed to justify.
However, the second paragraph has in contradiction with the third indent of the first paragraph, as you mentioned.

Thanks a lot for your help.
 
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