MOYOM Secures EU MDR Certification and Partners with Expert2Expert

The certification, issued by BSI UK on July 7 under Regulation (EU) 2017/745, validates that APHRANEL® meets the region’s stringent requirements for clinical performance and safety. While the regulatory milestone provides the legal framework for the product's European launch, MOYOM leadership emphasizes that physician adoption depends primarily on long-term clinical data and education rather than administrative approval alone.

To bridge this gap, the collaboration with Expert2Expert will focus on independent research, including cadaver-based anatomical studies and clinical evidence generation. Dr. Patrick Trévidic, who brings over 35 years of surgical and academic experience to the partnership, will lead efforts to develop scientific programs and medical education initiatives. Patrice Delobel, European Medical and Marketing Director at MOYOM, noted that the initiative aims to build a sustainable scientific platform for practitioners. The partnership maintains scientific independence for Trévidic’s team, focusing on evidence-based innovation to support the integration of calcium hydroxyapatite technology into European clinical practice.