The Magseed® Marker achieves EU MDR certification
In October 2025, the Magseed® marker achieved EU Medical Device Regulation (MDR) certification, confirming it meets the most rigorous European standards for medical devices.
Obtaining MDR certification provides clinicians and their patients with even greater reassurance in the safety, quality, and reliability of the world’s most-studied localization marker¹, used for the detection and removal of breast cancer.
This latest milestone reflects our ongoing commitment to raising the bar in product quality, previously acknowledged through recognition from the National Institute for Health and Care Excellence (NICE) and years of proven clinical studies supporting the reliability and effectiveness of our technology.
A Mark of Quality
Widely regarded as one of the world's most difficult regulatory processes, EU MDR is a badge of trust, earned through robust evidence of clinical effectiveness, ongoing surveillance, and a highly effective quality management system. Only devices meeting these exceptional standards are granted this certification.
From 2027, MDR is set to completely replace the previous European standards set by the Medical Device Directive (MDD). With this latest approval secured, we’re now in an even stronger position to continue innovating unique technologies that improve patient outcomes.
Achieving EU MDR certification for the Magseed marker is testament to the importance we place on product quality, rigorous evidence of clinical effectiveness and engineering expertise. Navigating one of the toughest regulatory processes means clinicians can have even greater assurance in the safety and reliability of the technology they depend on to support their patients every day.Mehryar Behizad, Regulatory Director
With over 500,000 patients already treated with the Magseed® marker, the wire-free revolution is already underway. Now with MDR certification in place, the future for breast cancer treatment looks brighter than ever.
→ Find out more about the Magseed marker
¹ Data on file at Endomag. Data correct as of November 2025