- MDR certification received from notified body BSI (CE 2797), covering TBS Osteo™ and Medimaps' full product portfolio
- Upgrades the company's prior certification under the 93/42/EEC directive
- TBS Osteo™ is CE marked and FDA approved, with commercial availability in 60 countries worldwide
Geneva, Switzerland — September 4, 2023
Medimaps — the creator of TBS® (Trabecular Bone Score®), the global standard in bone microarchitecture assessment — today announced it has received Medical Device Regulation (MDR) certification from its notified body BSI (CE 2797) for its management system and product portfolio.
"We are very proud to be one of the earliest AI companies to achieve MDR certification. By successfully navigating the rigorous requirements of the Medical Device Regulation, our company proves its ability to deliver innovative and reliable solutions that meet the highest regulatory standards for the benefit of patients, healthcare professionals, and medical business partners."
said Univ.-Prof. Dr. Didier Hans, Co-founder and CEO of Medimaps.
"The MDR framework is of utmost importance, as it governs our processes to develop, manufacture, market, and monitor the safety of our products. This is the result of a two-year effort to execute this complex regulatory process, which guarantees the highest manufacturing standards and traceability for our medical software."
added Meinhard F. Schmidt, Chairman of the Board of Directors of Medimaps.
The new MDR came into effect in Europe in May 2021 and represents the most significant change to the European healthcare regulatory framework in decades. The certification ensures that medical device manufacturers meet the most stringent quality requirements in order to commercialize their products in Europe. It upgrades the 93/42/EEC directive certification the company had held for years, confirming its solidity and reliability in delivering high-quality products. Through the MDR, Medimaps was able to increase the robustness of its clinical evaluation, technical design, and post-market surveillance.
With this certification, Medimaps can continue to supply certified TBS Osteo™ software, without interruption, at the highest standard to its valued customers in Europe and beyond. TBS Osteo™ is a medical image-processing device seamlessly integrated into dual-energy X-ray absorptiometry (DXA) scanners, and/or X-ray and CT PACS systems, used to measure BMD to detect bone fragility in osteoporosis patients. The software provides deep-tech bone texture analysis related to bone microarchitecture and complements BMD measurement and clinical risk factors to refine the management of osteoporosis, without further examination or radiation.
TBS Osteo™ is recommended in over 30 medical guidelines worldwide and published in over 1,000 peer-reviewed scientific articles. It is CE marked and FDA approved, enabling commercial availability in 60 countries worldwide. It benefits from reimbursement in certain countries, including dedicated CPT codes in the US.