Global aesthetic manufacturer Teoxane has been granted Medical Device Regulation (MDR) certification for two of its injectable products.
The company has become the first to manufacture sterile, injectable, hyaluronic acid-based products specifically to treat wrinkles and to have its entire product portfolio (Teosyal PureSense and Teosyal RHA) recognised for the safety and quality of its therapeutic and aesthetic properties, notes the company.
Introduced in May 2017 and in effect since May 2021, the MDR imposed stricter requirements for performance and safety assessments, technical documentation, post-marketing monitoring and regarding responsibilities of medical device manufacturers, distributors and importers.
The company has demonstrated the quality and safety of Teosyal PureSense and Teosyal RHA products through 14 clinical studies conducted in Europe and the US, showcasing the clinical performance of the products, Teoxane says. Valérie Taupin, CEO and founder of Teoxane, said, “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. 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.”
