Beyond 2027 “only MDR-approved fillers will remain”: Teoxane CTO on MDR approval

According to chief technical officer at Teoxane, Pascal Brice, Teoxane is the first company that manufactures injectable, hyaluronic acid-based products to have its whole product portfolio – TEOSYAL PureSense and TEOSYAL RHA – recognised for the safety and quality of both its therapeutic and aesthetic properties, for all indications. 

“Before Teosyal approvals, only two dermal fillers were delivered a very restricted MDR for one indication (either a therapeutic or an aesthetic one),” explained Brice.

This CE certification – which is part of the Medical Device Regulation (MDR) implementation – is designed to ensure the safety, efficacy and quality of medical devices sold in the EU. Its purposes include improving traceability throughout the supply chain and enhancing the transparency of data relating to these devices.

The MDR has imposed stricter requirements​

This came into effect since May 2021 and since the MDR has imposed stricter requirements for performance and safety assessments, technical documentation, post-market monitoring and regarding responsibilities of medical device manufacturers, distributors, and importers.

Brice noted that Teoxane’s teams have conducted extensive clinical research over the past six years. Clinical evidence specific to each product was required, covering all indications to get MDR approved. He said that Teoxane provided 12 clinical studies (five in the US and seven in Europe) to support its filing.

“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,” Brice continued.

He explained that its Preserved Network Technology has been patented for 10 years, but this has not come without its challenges, which have included “to determine the optimal parameters to preserve the HA chains so that they create very effective rheology and duration.”

“The research team has also performed a very strong characterisation of the cross-linked HA molecule to understand what drives the excellent safety profile of this technology,” he shared.

Increased requirements for more qualitative, efficient, safer products​

Brice raised that with the new required MDR certification, the whole beauty industry faces increased requirements to guarantee more qualitative, efficient, and safer products. “The MDR implementation should have an impact on both the number of products available on the market and the indications the manufacturers can promote,” he explained.  

“We don’t expect every dermal filler currently on the market in EU to comply in the end with these new requirements. The whole industry is currently in a transition period with product on the market from their initial approval (therefore not MDR compliant) and the newly MDR-approved fillers,”

He expected that this period would last up until around 2027, beyond which “only MDR approved fillers will remain and manufacturers will promote them in their approved indications,” he concluded.