Osstem Implant Gains Crucial EU MDR Certification, Paving Way for Expanded European Market Access – Breaking News
Busan, South Korea – February 16, 2024 – In a significant win for the global dental implant market, Osstem Implant announced today that it has secured EU Medical Device Regulation (MDR) certification for a substantial expansion of its product portfolio. This breaking news confirms certification for 178 species encompassing 4,695 individual products, including its flagship KSIII BA implant line, and positions the company for continued growth in the highly regulated European healthcare landscape. This is a major development for dental professionals and patients alike, signaling a commitment to the highest standards of safety and performance.
What Does EU MDR Certification Mean?
The EU MDR is a rigorous regulatory framework that replaced the previous Medical Device Directive (MDD). Unlike the MDD, the MDR carries legal weight immediately after the grace period, demanding a significantly higher level of clinical evidence, post-market surveillance, and quality management. Passing this certification isn’t just a formality; it’s a testament to a manufacturer’s dedication to patient safety and product efficacy. For Osstem Implant, it means a competitive edge and increased trust from European dentists and patients. This is particularly important in the dental implant sector, where precision and long-term reliability are paramount.
A Broad Spectrum of Certified Products
Osstem Implant’s MDR certification isn’t limited to just implant bodies. The approval extends to a comprehensive range of products crucial for complete implant solutions. This includes orthodontic screws, membranes, and upper structures like KS, TS, and SS implant lines, as well as abutments. Notably, all certified products are designed and manufactured in-house, showcasing Osstem’s vertically integrated approach to quality control. The ‘KS System,’ a cornerstone of the Osstem Implant lineup, is recognized for its user-friendly design and prosthetic ease. The ‘MS SYSTEM,’ known for its initial stability and long-term success rates, also falls under the MDR umbrella. These systems offer customizable surface treatments (SA, CA, BA, SOI, RBM) to cater to diverse patient needs.
Building on Previous Success: A Digital Dentistry Leader
This latest achievement builds upon Osstem Implant’s earlier MDR success. In August of last year, the company secured certification for implant surgery kits and digital guided surgery products, demonstrating its leadership in the rapidly evolving field of digital dentistry. The company has now achieved MDR certification for all products manufactured at its Busan Production Headquarters, with plans underway to extend certification to dental materials and new products produced at other facilities. This proactive approach highlights Osstem’s commitment to maintaining full compliance and expanding its European footprint.
Impact on the European Dental Market & Beyond
Osstem Implant currently operates 11 local subsidiaries across Europe, and reported a remarkable 34% year-over-year sales growth in 2023. The company anticipates that MDR certification will further fuel demand for its products, as European dentists increasingly prioritize regulatory compliance and proven performance. “We expect the demand to expand as the products that are recognized and used by European customers, including implant systems, will be certified as MDR certification,” stated an Osstem Implant official. “We are looking forward to improving brand value.” This isn’t just good news for Osstem; it’s a positive development for the entire dental implant industry, raising the bar for quality and innovation. The MDR certification process, while demanding, ultimately benefits patients by ensuring access to safe and effective dental implant solutions.
As Osstem Implant continues to expand its MDR-certified product range, dental professionals across Europe can confidently integrate these advanced solutions into their practices, knowing they meet the highest regulatory standards. Stay tuned to archyde.com for further updates on this developing story and the latest advancements in dental technology. For more information on Osstem Implant and its product offerings, visit their official website.
