Labelling requirements for a medical device containing fragrance allergens

Frypot

Starting to get Involved
#1
We are currently developing a medical device (Class I or class I sterile), it is a wet wipe sachet to deliver a water-based resin dispersion that dries to leave a barrier film on the skin to protect from bodily waste (either from incontinence or stoma related).
Our sales team have suggested the inclusion of a low level fragrance. We have one in mind and it seems that if this product were a cosmetic, various components would need to be declared as fragrance allergens (as they will be above 0.001% w/w in the fluid applied).

My question is, for a Medical device, does this need to be declared on the label?
We haven't got to the stage of test biocompatibility yet, but felt we may need to consider this.
 
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planB

Trusted Information Resource
#2
Frypot,

your question comes down to (biological) risk management:

From your description, your device seems to have intact (mucosal?) skin contact for at least prolonged period of times according to ISO 10993-1. Such devices are expected to be non-sensitizing. In case adding your quantity of fragrance might trigger a sensitizing host response, this would have to be addressed in your risk management process, including any risk control measures such as potentially disclosing the fragrance in the labelling.

HTH,
 
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