MDR is widely viewed to be a more thorough and stringent regulation process than MDD.

Neauvia scored CE marking under the European Union’s new MDR (Medical Device Regulation) for its range of facial dermal fillers products, making it the first medical aesthetics business to receive such certification in Europe. 

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’ and is widely viewed to be a more thorough and stringent regulation process in comparison to its predecessor, the Medical Device Directive (MDD).  

Neauvia compiled and submitted all the required technical and clinical documentation which was meticulously assessed and subsequently approved by a European Union notified body. 

The company just opened an international training centre in Dubai and presented new clinical research at this year’s IMCAS.

“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,” says Gabriele Drigo, Neauvia’s Founder & CEO, in a news release.

“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 upmost confidence when using facial dermal fillers products recognized by MDR.”