EUROSPINE has published a position paper outlining key considerations regarding the implementation of the EU Medical Device Regulation (MDR). While supporting the regulation’s goal of enhancing patient safety, EUROSPINE highlights important areas where improved clarity and practical solutions are urgently needed to maintain access to critical spinal care, support innovation, and ensure long-term research viability in Europe.
The position paper addresses core challenges, including clinical evidence requirements, the impact on research and small enterprises, and the current capacity of notified bodies. It also presents EUROSPINE’s ongoing efforts to contribute through high-quality data collection, international collaboration, and the Spine Tango registry.
We invite stakeholders across the spine care ecosystem — including clinicians, researchers, manufacturers, and regulators — to review the full document.
