Neauvia becomes first medical aesthetics business to attain new MDR certification

Neauvia, the global medical aesthetics business, has attained CE marking under the European Union’s new Medical Device Regulation (MDR) for its range of facial dermal filler products.

In the process, Neauvia has become the first medical aesthetics business to be granted the certification in Europe.

CE marking certifies that a product has met EU health, safety and environmental requirements. The new regulation aims to create ‘a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers'. It is considered to be a more thorough and stringent regulatory process in comparison to its predecessor, the Medical Device Directive (MDD).

To achieve the certification, over the past year, the team at Neauvia submitted technical and clinical documentation which was assessed and subsequently approved by a European Union notified body.

The news comes at an exciting time for Neauvia, following the opening of a new international training centre in Dubai and the unveiling of new clinical research at this year’s IMCAS. Further developments are expected throughout 2023, which the company hopes will cement Neauvia’s position as one of the world’s fastest-growing medical aesthetic businesses.

“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,” explains the founder and chief executive of Neauvia, Gabriele Drigo.

“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.”