Korea's Osstem Implant gains EU MDR certifications

Osstem Implant

Mon. 14. October 2024

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SEOUL, South Korea: Osstem Implant recently announced that it has been awarded certification under Regulation (EU) 2017/745 (MDR) for 156 of its products, including implant surgical kits and tools. On 30 August, Frank Juettner, CEO of TÜV Rheinland Korea, a global testing and certification organisation, visited Osstem’s headquarters and presented the certificate to the CEO, Kim Hae-Sung, in person.

Osstem has made a successful transition from certification under the previous Council Directive (EEC) 93/42 (MDD) to MDR certification for its 122 Taper KIT, 123 Straight KIT, OneGuide KIT and OneCAS KIT and secured MDR certification for its new products, including OneGuide KIT (Short) and One485 KIT. The company shared that it had made significant improvements to its production and quality management processes to achieve MDR certification.

From left: OneCAS KIT, OneGuide KIT and 122 Taper KIT, all certified under the new EU medical device regulations.

Commenting on the achievement, a spokesperson for Osstem said: “With the acquisition of the EU MDR certification, we expect to see growth in trust among local dental professionals in our company, which operates ten overseas subsidiaries in Europe.”

“Our surgical kits, which incorporate our unique technologies, such as the 122 Taper KIT and OneGuide KIT, are our flagship products, and local customers are encouraged to familiarise themselves with the kits through master courses and hands-on lectures provided at our subsidiaries in Europe,” the representative continued.

On 24 October, Osstem will be offering six hands-on sessions focusing on implant placement utilising the 122 Taper KIT at the 2024 annual scientific meeting of the European Association for Osseointegration, the largest dental congress in Europe, to be held in Milan in Italy. In addition, Osstem will share clinical expertise on the use of OneGuide and the 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, came into effect in May 2021. According to a survey conducted by the trade association MedTech Europe in April 2022, of 475 medical device manufacturers operating in EU countries, over 50% planned to reduce their product portfolios. Among them, 33% indicated that they intended to discontinue their products rather than pursue MDR certification. The survey also indicated that, as of 2022, more than 85% of over 500,000 medical device manufacturers worldwide that had received certification under the MDD or the older Council Directive (EEC) 90/385 regarding active implantable medical devices had not obtained MDR certification.

According to a recent survey by the European Association of Medical Devices Notified Bodies, composed of 35 European certification bodies, including TÜV Rheinland, only 33.5% of the applications submitted last year had received MDR certification 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 companies that lack the necessary human and material infrastructure.

Osstem invests 11% of its revenue in research and development. The company has 22 research institutes and around 1,000 research personnel in the areas of implants, orthodontics, materials and equipment. Osstem produces 18.3 million sets of implants annually at a single factory and holds the leading market position in terms of implant sales. It plans to complete MDR certification for its main implant products by the first half of 2025 and to obtain MDR certification for its dental materials, including bone grafting materials, by 2026.