TÜV Rheinland Issues MDR Notified Body Certificate for De Corematrix Zirconia Blocks

On August 15, 2025 – TÜV Rheinland Greater China, a leading international independent testing, inspection, and certification organization, has issued a Notified Body certificate under the European Medical Device Regulation (Regulation (EU) 2017/745, MDR) to De Corematrix Co., Ltd for two of its Zirconia Dental Ceramics Model CMW and CMC. With this certification, De Corematrix becomes one of the few domestic manufacturers of zirconia dental materials to meet the stringent market access requirements of the European Union.

The certificate awarding ceremony was attended by Liu Hui, Vice Chairman of De Corematrix, Zhou Pingping, General Manager, and Chen Yuxing, Regional Manager at TÜV Rheinland Greater China Medical, along with representatives from both organizations.

De Corematrix has worked closely with TÜV Rheinland for nearly a decade, successfully completing a wide range of projects including annual surveillance audits, ISO standard upgrades, CE directive and regulation conformity assessments, as well as a factory relocation audit in 2023. This long-term cooperation has built a strong foundation of trust and collaboration between the two parties.

Liu Hui commented: “Since our first cooperation in 2016, De Corematrix and TÜV Rheinland have walked side by side for nearly ten years. Every stringent audit, every standard upgrade has strengthened our product quality and management system. The successful MDR conformity assessment for our zirconia blocks is not only a milestone of our win–win cooperation, but also sets a new benchmark for Chinese high-end dental materials entering international markets. We will continue to work with TÜV Rheinland to drive the global development of China’s dental materials industry and provide better oral restoration solutions to patients worldwide.”

Chen Yuxing congratulated De Corematrix, noted “The MDR regulation imposes strict requirements covering product safety and performance, pre-market clinical evaluation and data collection, as well as post-market surveillance and vigilance. De Corematrix achievement of MDR certification demonstrates its compliance in technical innovation, production management, and quality control, meeting EU market access standards. TÜV Rheinland is proud to be a trusted partner in this journey and will continue to support De Corematrix with our global network and local expertise, enabling compliance and value creation in the EU and beyond.”

With strong testing capabilities and extensive international certification experience, TÜV Rheinland provides comprehensive market access support to medical device manufacturers worldwide. As a designated Notified Body for both the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), TÜV Rheinland offers conformity assessments under MDR and IVDR, ISO 13485 certification, Medical Device Single Audit Program (MDSAP) certification, INMETRO certification for Brazil, and a broad range of medical device testing services.