Endomag Magtrace device gains EU MDR approval

The Magtrace lymphatic tracer has become the latest Endomag device 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.

EU MDR certification is widely recognised 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.

Achieving EU MDR approval across the board shows Endomag’s continued drive to advancing breast cancer care, and reflects the company’s ongoing investment in research, engineering and regulatory excellence – ensuring that its wire-free surgical solutions continue to set the standard for breast cancer localisation and lymphatic mapping.

Endomag regulatory director, Mehryar Behizad, said: “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 reliability.”

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.