Full Sentimag® platform now EU MDR approved with latest Magtrace® certification
The Magtrace® lymphatic tracer has become the latest of our devices to receive EU Medical Device Regulation (EU MDR) certification, marking the final step in securing approval across the full Endomag surgical platform.
This announcement follows the approval of the Magseed® marker in October 2025, meaning that all technologies across the Sentimag® portfolio have now been confirmed as meeting the most demanding European standards for medical devices.
Why does EU MDR matter?
EU MDR certification is widely recognized as one of the world’s most comprehensive and stringent regulatory processes for medical devices. It demands robust clinical evidence, ongoing safety monitoring, demonstrable clinical effectiveness and exceptional manufacturing standards.
Securing EU MDR approval across the board shows our continued drive to advancing breast cancer care, and reflects our ongoing investment in research, engineering, and regulatory excellence - ensuring that our wire-free surgical solutions continue to set the standard for breast cancer localisation and lymphatic mapping.
Securing EU MDR approval for Magtrace® completes our journey to full regulatory compliance for our whole Sentimag® platform in Europe. Completing this process comfortably ahead of the 2027 deadline shows physicians they can be confident that every element of our technology is held to the highest standards of safety and reliabilityMehryar Behizad, Regulatory Director
With MDR fully replacing the Medical Device Directive (MDD) by 2027, the platform is now fully future-proofed to support healthcare teams across Europe and paves the way for continued innovation.
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