Neo Medical SA (Neo), a Swiss technology company specializing in spine surgery, today announced the approval of its entire product portfolio under the European Union’s (EU) Medical Device Regulation (MDR) EU 2017/745, confirming compliance with the world’s highest quality control standards for medical devices.
“Full MDR certification is an important milestone in Neo’s history. From the outset, we committed to a program of long-term clinical evaluation. MDR certification acknowledges the strength and validity of our life-cycle approach to safety, using data to evaluate and guide every step we take”
Certification allows Neo to continue supporting customers across all markets, delivering and innovating solutions that seek to improve the long-term outcomes of surgical spine care without interruption.
“Full MDR certification is an important milestone in Neo’s history. From the outset, we committed to a program of long-term clinical evaluation. MDR certification acknowledges the strength and validity of our life-cycle approach to safety, using data to evaluate and guide every step we take,” said Vincent Lefauconnier, Neo’s co-founder and CEO. “The new standards represent a huge step up in stringency for EU medical device certification processes. The tighter oversight has led some manufacturers to reconsider their commercialization strategy in Europe, with 70% of companies manufacturing surgical instruments withdrawing individual products from the EU market.1 There will be no such impact on our portfolio, and this moment represents a huge opportunity to expand and accelerate our market reach and show our full commitment to our home market.”
Introduced in 2017, MDR aims to create a transparent and sustainable regulatory framework, modernizing the EU regulatory system to better address current market needs and reflect the improved capabilities and potential of new technologies.
The new regulation places even greater emphasis on safety, risk management, and whole-lifecycle oversight for medical devices than the Medical Device Directive (MDD) it replaces. For Class III and Class IIb implantable devices, MDD certification is set to be replaced by MDR at the end of December 2027, and by the end of December 2028 for all other devices.
“MDR approval secures Neo’s ongoing European and global market access, providing a stable foundation for commercial growth and our exciting program of technological development. Ensuring that each and every one of our spine surgery products will be available to all users beyond the 2027 and 2028 deadlines, certification reaffirms our absolute commitment to patient safety and product quality,” added Mr. Lefauconnier.
Compliance with the MDR requires manufacturers to focus on three overall components to market a medical device in the EU.
- Quality management system (QMS): Medical devices must be developed with an appropriate QMS in place, ensuring the device meets its stated purpose through strict controls around design, manufacturing, and post-market, life-cycle oversight.
- Clinical evidence: Clinical evidence requirements are higher for MDR approval than they were in the MDD. Manufacturers must demonstrate the safety and efficacy of their devices with a risk/benefit analysis based on clinical evidence gathered on the devices under approval.
- Regulatory systems and process: Compared to the MDD, the MDR requires more extensive quality control processes and in-depth scrutiny of the technical documentation supporting a full, new conformity assessment process from MDR Notified Bodies, including post-market clinical performance reports, regulated risk management processes, technical documentation, and more.
