Teoxane has been granted Medical Device Regulation (MDR) certification, making it the first company to have its entire product portfolio of sterile, injectable, hyaluronic acid-based products recognised for their safety and quality in treating wrinkles.
The CE certification, as part of the MDR implementation, is designed to ensure the safety, efficacy and quality of medical devices marketed in the European Union. Its objectives include improving traceability throughout the supply chain and enhancing the transparency of data relating to these devices.
Teoxane demonstrated the quality and safety of Teosyal Puresense and Teosyal RHA products through 14 clinical studies conducted in Europe and the United States.
“Receiving this approval is a source of great pride for us and a testament to our commitment to safety and clinical excellence, which are central to our product design,” said Valérie Taupin, chief executive and founder of Teoxane, “At Teoxane, our ambition goes beyond mere compliance with standards. We aspire to be pioneers, anticipating regulatory implementation and innovating with solutions that will raise standards in our industry, for the benefit of patients.”
Pascal Brice, chief technical officer, said “Receiving this certification demonstrates Teoxane’s ability to meet the most demanding clinical requirements and ensure a high level of risk prevention and management, consistent with aesthetic benefits. This endorsement rewards the considerable work of Teoxane’s teams and the scale of clinical research conducted over the past six years.”
