Five materials pass final review
Seoul-based Graphy Inc. (KOSDAQ: 318060) has completed the final conformity assessment review for five dental 3D printing materials under the EU Medical Device Regulation, the company said, and is awaiting issuance of the certificates. The five are TC-85DAC, TA-28 and TR-07 from the TeraHarz Clear series, and TC-80DC and BR-23 from the TeraHarz series. The certification process will conclude once the certificates are issued, Graphy said.
What the EU review covers
Graphy said the EU Medical Device Regulation (Regulation (EU) 2017/745) imposes stricter requirements than the previous Medical Devices Directive, particularly for clinical evidence, technical documentation, risk management, quality management systems and post-market surveillance. The assessment covers device safety and performance as well as manufacturers' quality management systems and their ability to manage safety throughout the product lifecycle, according to the company. It said the scope and complexity of the review can vary with a product's characteristics and the applicable conformity assessment procedure. Completion of the final review shows that Graphy's materials technology and quality management capabilities passed the assessment process, the company said.
European partnerships planned
Once the certificates are issued, Graphy plans to accelerate supply of its materials in Europe and pursue new commercial opportunities, the company said. It has been expanding its local distribution network and partnerships in key European markets, including Germany. Graphy is pursuing a model that combines local manufacturing and distribution partnerships with recurring materials supply. A recent example is its partnership with Smilers, the clear aligner brand of France-based Biotech Dental, which aims to explore product validation and commercialization using Graphy's materials and manufacturing technologies. Under the model, local partners would manufacture and supply dental products using Graphy's materials and solutions under their own brands or the Graphy brand. Graphy said the approach is intended to expand market reach while reducing the need for direct investment in local manufacturing facilities, and that ongoing materials supply is intended to generate recurring revenue. Chairman Un seob Sim said the company would expand local manufacturing and distribution partnerships in Europe once the certificates are issued and seek to turn its materials technology into orders and revenue.
