Neo Medical SA, a pioneering Swiss firm in spinal surgery technology, has proudly announced that its full suite of products has gained approval under the European Union’s updated Medical Device Regulation (MDR) EU 2017/745. This accomplishment underscores the company’s adherence to the highest global standards in medical device quality.
With this certification, Neo Medical is positioned to continually assist clients in all markets, maintaining its dedication to delivering and innovating groundbreaking solutions that enhance the long-term success of spinal surgeries without disruption.
“Acquiring full MDR certification represents a pivotal achievement for us,” stated Vincent Lefauconnier, co-founder and CEO of Neo. “From the beginning, our focus was firmly on a program of enduring clinical evaluation. MDR certification not only validates but also strengthens our comprehensive life-cycle approach to safety, integrating data-driven evaluations at every step. These new regulations bring a heightened level of rigor to EU medical device certification processes, which has even led some companies to reconsider their presence in the EU market, with 70% withdrawing specific surgical products. However, our portfolio will remain intact, turning this moment into a significant opportunity to enhance our market influence and reinforce our commitment to our core region.”
Originally unveiled in 2017, MDR was designed to establish a clear and enduring regulatory framework, modernizing the EU’s regulatory system to better cater to current demands while incorporating the enhanced capabilities of emerging technologies.
This revised regulation places greater importance on safety, risk control, and the complete life-cycle monitoring of medical devices than its predecessor, the Medical Device Directive (MDD). For Class III and Class IIb implantable devices, transitioning from MDD to MDR is required by December 2027, extending until December 2028 for all other device categories.
Lefauconnier added, “Achieving MDR approval ensures that Neo will retain European and global market access, creating a robust basis for commercial development and technological advancement. This certification guarantees that our entire line of spine surgery products will remain accessible to users beyond the 2027 and 2028 cutoff dates, reaffirming our steadfast dedication to patient safety and product quality.”
Conformance with MDR necessitates that manufacturers concentrate on three primary elements to market a medical device within the EU:
1. **Quality Management System (QMS):** Devices must be developed under a rigorous QMS, ensuring they fulfill their intended purpose through meticulous design, production, and life-cycle oversight.
2. **Clinical Evidence:** The MDR necessitates more substantial clinical evidence than the MDD, mandating manufacturers to showcase device safety and efficacy via a risk/benefit analysis of the clinical data collected.
3. **Regulatory Systems and Processes:** Compared to the MDD, it’s essential to have more comprehensive quality checks and detailed assessment of the technical paperwork, which involves a thorough new conformity evaluation process by MDR Notified Bodies, including post-market reports, managed risk processes, technical files, and more.
Neo Medical leverages cutting-edge biomechanics and augmented reality technologies to redefine standards in spinal fusion surgery.