Medytox Obtains European MDR CE Certification for Two Hyaluronic Acid Fillers

'Neuramis' Expected to Expand Distribution Network in the European Market

Medytox announced on April 10 that it has obtained MDR CE certification under the new European Medical Device Regulation for two types of its hyaluronic acid (HA) filler, 'Neuramis.'

Medytox Hyaluronic Acid (HA) Fillers Neuramis Deep and Volum Lido. Medytox

The European MDR CE certification is a regulation that significantly strengthens standards compared to the previous Medical Device Directive (MDD), including the reliability of clinical data, safety verification procedures, quality management, and post-market surveillance systems, and is applied uniformly across Europe. In particular, hyaluronic acid fillers are classified as high-risk Class III medical devices, requiring even more rigorous verification in quality management system assessments, technical documentation reviews, and drug evaluations.

The certification covers two products: 'Neuramis Deep Lido' and 'Neuramis Volume Lido.' With this certification, the company expects not only to expand its distribution network in the European market but also to accelerate entry into key countries in Asia, the Middle East, and Africa, where MDR CE certification is recognized as a reference standard for medical device approval.

A Medytox official stated, "We will solidify our position as a global premium filler brand based on the product quality verified by Europe's highest-level medical device regulations."

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