[NA Eun-kyung, Edaily Reporter] Graphy is nearing European Union Medical Device Regulation (EU MDR) certification for five dental 3D printing materials after completing the final conformity assessment process. This milestone is expected to support the company’s efforts to expand its material supply and establish local partnerships in Europe, particularly for its shape memory aligner (SMA) technology.

Graphy announced Tuesday that it had completed conformity assessments and final reviews for all five materials under the EU MDR framework. Certification will be finalized once the designated notified body issues the certificates.

The products include three materials from the TeraHarz Clear lineup—TC-85DAC, TA-28, and TR-07—and two from the TeraHarz lineup—TC-80DC and BR-23. Graphy plans to leverage this certification milestone to expand its dental 3D printing materials business across Europe.

The EU MDR replaced the bloc’s previous Medical Devices Directive (MDD), introducing stricter requirements for clinical evidence, technical documentation, risk management, quality management systems, and post-market surveillance.

The regulation also requires manufacturers to demonstrate their ability to monitor product safety and performance throughout a device’s life cycle. Depending on a product’s risk classification and certification pathway, the new framework may involve more extensive documentation and assessment procedures.

Graphy stated that completing the final review for five core materials—rather than a single product—represents a significant step in its European expansion strategy. Once the certificates are issued, the company expects to accelerate material supply through local distribution networks and pursue new customers.

Graphy’s flagship SMA technology combines shape memory materials with direct 3D printing to produce orthodontic aligners. Conventional clear aligners are manufactured by thermoforming plastic sheets over dental models, whereas Graphy’s technology prints aligners directly from digital designs.

The company’s proprietary materials are designed to utilize shape memory properties to apply orthodontic forces to teeth. Graphy has been expanding its presence in the global clear aligner market through this combination of materials technology and manufacturing processes.

In Europe, Graphy is also pursuing partnerships with local manufacturers and distributors. One example is its recent collaboration with Smilers, the clear aligner brand of the French dental company Biotech Dental.

Under this model, local partners use Graphy’s materials and manufacturing solutions to produce and distribute dental products under their own brands or the Graphy brand.

This approach allows Graphy to leverage existing production facilities and sales networks without making substantial investments in overseas manufacturing plants. The company also expects recurring revenue from material supplies to increase as production volumes grow.

Graphy has previously secured U.S. Food and Drug Administration (FDA) 510(k) clearance and registration with Brazil’s health regulatory agency, ANVISA, thereby strengthening its international business foundation.

With EU MDR certification nearing completion, Graphy plans to expand its materials business and local partnerships in Europe, building on its presence in North America, other markets in the Americas, and Asia.

“Completing the final EU MDR review is significant because our five core dental 3D printing materials have passed the rigorous assessment process under Europe’s strengthened medical device regulations,” said Graphy Chairman Shim Woon-seop.

“Once the final certificates are issued, we will expand local manufacturing and distribution partnerships in Europe and translate our proprietary materials technology into tangible orders and sales,” he added.