Neauvia, a global medical aesthetics business, announced it has attained CE marking under the European Union’s new MDR (Medical Device Regulation) for its range of facial dermal fillers products. According to Neauvia, it becomes the first medical aesthetics business to be granted the certification in Europe.
The new regulation aims to create ‘a robust, transparent, and sustainable regulatory framework, recognized internationally, that improves clinical safety and creates fair market access for manufacturers’ and is widely viewed to be a more thorough and stringent regulation process in comparison to its predecessor, the Medical Device Directive (MDD).
Over the course of the past year, Neauvia compiled and submitted all the required technical and clinical documentation for its facial dermal fillers which was assessed and subsequently approved by a European Union notified body.
Gabriele Drigo, Neauvia’s founder & CEO, said, “The MDR was created with the goal of enhancing overall transparency, creating better access to information on medical products for both the public and healthcare professionals. Due to the dedication and hard work of the team, we are now able to confirm that our facial dermal fillers have successfully passed this rigorous process which should give the medical community and our customers the utmost confidence when using facial dermal fillers products recognized by MDR.”
The news of Neauvia’s CE marking under the EU’s new MDR for its facial dermal fillers comes as the company recently opened a new international training center in Dubai and the unveiling of new clinical research at this year’s IMCAS with further developments expected throughout 2023.