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First Dermal Filler CE-marked Under Annex XVI Of The EU's Medical Device Regulation

 
• By Amanda Maxwell

Austrian company Croma-Pharma is the trailblazer with its newly certified dermal filler.

A gloved hand injects a dermal filler into the cheek of an Asian woman.

A dermal filler is the first non-medical, Annex XVI, device to be CE-marked under the Medical Device Regulation (MDR). Intended for cosmetic use, it has no clinical purpose.

The Austria-based manufacturer of minimally invasive aesthetics products, Croma-Pharma, says it submitted all the necessary technical and clinical documentation over the course of the past year, which was reviewedas a...

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