Teoxane Receives the Medical Device Regulation Certification

Teoxane has announced that it has been granted with the Medical Device Regulation (MDR) certification. Teoxane has thus become the first company that manufactures sterile, injectable, hyaluronic acid-based products specifically to treat wrinkles to have its entire product portfolio (TEOSYAL PureSense and TEOSYAL RHA) recognised for the safety and quality of its therapeutic and aesthetic properties.

The CE certification, as part of the Medical Device Regulation (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.

Introduced in May 2017 and in effect since May 2021, the MDR imposes stricter requirements for performance and safety assessments, technical documentation, post-market monitoring and regarding responsibilities of medical device manufacturers, distributors, and importers.

Teoxane has demonstrated the quality and safety of TEOSYAL PureSense and TEOSYAL RHA products through 14 clinical studies conducted in Europe and the United States. These studies notably showcase the clinical performance of the products.

The MDR certification is further proof of Teoxane’s robust standards in terms of product design, production and post-market monitoring. The company is also distinguished by its speed of execution in demonstrating the compliance of its products towards these new requirements to the accredited body, the British Standard Institute (BSI), recognised for its stringent evaluation process.

“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.” comments Valérie Taupin, CEO and Founder of Teoxane

“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.” shares Pascal Brice, Chief Technical Officer

In 2017, Teoxane received FDA approval for the RHA range, the first and only hyaluronic acid-based fillers for correcting moderate to severe dynamic facial wrinkles and folds.

This recognition, a guarantee of quality and safety, supports Teoxane’s expertise in the science of facial aesthetics.