(the photo at the bottom) Son Hee-kwon, Director of the Regulatory Affairs Department at Osstem Implant; Kim Hae-sung, CEO of Osstem Implant; Frank Juettner, CEO of TÜV Rheinland Korea; Nah Hana, Team Leader of the Medical Devices Team at TÜV Rheinland Korea.
Excitement Builds for Hands-On Session on Certified Items at EAO 2024
Osstem Implant announced that it secured EU Medical Device Regulation (MDR) certification for 156 items of implant surgical kits and tools. On August 30, Frank Juettner, CEO of TÜV Rheinland Korea, a global testing and certification organization visited Osstem Implant Headquarters and presented the certificate to CEO Haesung Kim in person.
Osstem Implant has made a successful transition from MDD certification to MDR certification for its 122 Taper KIT, 123 Straight KIT, OneGuide KIT, One CAS KIT and secured MDR certification for its new products including OneGuide KIT(short) and One485 KIT. The company explained that it made a significant improvement in its production and quality management processes to achieve MDR certification.
“Our surgical kits, which incorporate our unique technologies, such as the 122 Taper KIT and OneGuide KIT, are our flagship products. Therefore, local customers are encouraged to familiarize themselves with the kits through master courses and hands-on lectures provided at our subsidiaries in Europe,” Osstem Implant stated. “With the acquisition of the EU MDR certification, we expect to see a growth in trust among local dental professionals in our company, which operates 10 overseas subsidiaries in Europe,” Osstem Implant added. Osstem Implant plans to offer six hands-on sessions focusing on implant placement utilizing the 122 Taper KIT on the first day of EAO 2024, the largest dental congress in Europe, to be held in Milan, Italy, in October this year. In addition, Osstem Implant will share clinical know-how on the use of OneGuide and OneGuide KIT with European dentists through large-scale forums and hands-on sessions over two consecutive days during the three-day event.
MDR, which is a strengthened certification system replacing the MDD (Medical Device Directive), came into effect in May 2021. According to a survey on 475 medical device manufacturers operating in EU countries conducted by MedTech Europe, a non-profit organization, in April 2022, over 50% of respondents planned to reduce their product portfolios. Among them, 33% indicated that they intended to give up securing MDR certification and discontinue their products. MedTech Europe also analyzed that, as of 2022, more than 85% of over 500,000 medical device manufacturers worldwide that had received MDD or AIMDD certification had not obtained MDR certification.
According to a recent survey by The European Association of Medical Devices Notified Bodies (TEAM NB) composed of 35 European medical devices certification bodies including TÜV Rheinland, the share of MDR certification issued among the applications submitted last year was only 33.5% as of the end of 2023. As significant investment in research, production, and quality management is required to meet the strict and rigorous MDR review standards, MDR certification serves as a high entry barrier for small companies that lack the necessary human and material infrastructure.
Osstem Implant, which marked annual revenue of 902 million USD(based on the exchange rate as of March 21, 2024), invests 11% of its revenue in R&D. The company has 22 research institutes and around 1,000 research personnel in the areas of implant, orthodontics, materials, and equipment. Osstem Implant produces 18.3 million sets of implants annually at a single factory, holding the No. 1 position in terms of implant sales. It plans to complete the MDR certification for its main implant products by the first half of 2025 and aims to obtain MDR certification for dental materials, including bone graft materials, by 2026.■
Osstem Implant, South Korea
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