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Microneedle length vs skin penetration and EU legislation
My question is concerned with microneedle penetration and classification of these devices as cosmetic vs medical in the EU. I am only interested in manual roller or patch microneedle applications. Not microneedle pens on which the penetration depth can be set to a certain um depth.
I am wondering if these have different names in the US as I could not find anything using the search function.
Below is an excerpt from the EU Borderline Manual
It seems to me that there are two fundamental questions to answer
1. how thick is facial epidermis
2 what is the penetration depth of the needleI have seen 0.1mm/100um used as epidermis depth for facial skin. From research, this varies by region as in the citation below.
A Comprehensive Examination of Topographic Thickness of Skin in the Human Face
Aesthetic Surgery Journal, Volume 35, Issue 8, November/December 2015, Pages 1007–1013, https://doi.org/10.1093/asj/sjv079values in Table 1are in um
Key for microneedles being “cosmetic” is penetration depth. Some papers have demonstrated that with the roller microneedles and patches, the depth of penetration is not the same as needle length.
Does anyone in the EU have experience with microneedles?
I am looking for a citation that describes which needle lengths only penetrate the epidermis and therefore are cosmetic. Is 250um is the shortest needle length?
Is there a consensus about epidermis thickness of facial skin?
Sorry for the length of this post. I hope someone can provide some insight.
Thank you @drsara -
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