Neo Medical SA, a Swiss company specializing in spine surgery technology, has announced that its entire product portfolio has received approval under the European Union’s Medical Device Regulation (MDR) EU 2017/745. This certification confirms that Neo Medical’s products meet the highest global quality standards for medical devices.
“Achieving full MDR certification is a significant milestone in Neo’s journey. From the beginning, we committed to long-term clinical evaluation, and MDR certification validates our approach to safety, which relies on data-driven decision-making,” said Vincent Lefauconnier, Neo Medical’s co-founder and CEO. “The new MDR standards are more stringent than ever, resulting in some manufacturers reconsidering their presence in the EU. However, Neo Medical’s portfolio remains unaffected, and this achievement opens up exciting opportunities for us to expand and demonstrate our dedication to both the European and global markets.”
Introduced in 2017, the MDR was designed to create a more transparent, sustainable, and modern regulatory framework for medical devices. This updated regulation is intended to better address market needs and account for the increased capabilities of modern technologies. MDR places a stronger emphasis on safety, risk management, and comprehensive life-cycle oversight of medical devices compared to its predecessor, the Medical Device Directive (MDD).
For Class III and Class IIb implantable devices, MDD certification will be replaced by MDR by the end of December 2027, with the transition for all other devices completed by December 2028. With MDR certification now in place, Neo Medical ensures that its products will remain available to customers beyond these deadlines, reinforcing the company’s commitment to patient safety and product quality.
“MDR certification not only secures our continued access to the European and global markets, but it also provides a stable foundation for our ongoing commercial growth and technological innovation,” Lefauconnier added. “This milestone reaffirms our unwavering commitment to delivering safe, high-quality spine surgery products.”
To achieve MDR compliance, manufacturers must meet three key requirements:
- Quality Management System (QMS): Devices must be developed with a rigorous QMS in place, ensuring quality throughout design, manufacturing, and post-market oversight.
- Clinical Evidence: MDR demands more stringent clinical evidence to demonstrate the safety and efficacy of devices, requiring a thorough risk/benefit analysis based on clinical data.
- Regulatory Systems and Processes: The MDR involves more detailed quality control and extensive scrutiny of technical documentation, including post-market clinical performance reports, risk management, and regulatory processes.
Neo Medical, based in Lausanne, Switzerland, is a leader in spine surgery innovation, combining biomechanics with augmented reality to set new standards in spine fusion surgery. The company’s portfolio integrates proprietary force control technologies with AI-driven intraoperative augmented reality, improving patient outcomes, reducing environmental impact, and lowering healthcare costs. Neo Medical is rapidly expanding its presence in the U.S. and globally, with subsidiaries in Spain, France, Germany, and the U.S.
