3D Systems Unlocks European Denture Market With Full EU MDR Clearance

• U.S.-based 3D printer manufacturer 3D Systems has been fully certified under the European Union Medical Device Regulation (EU MDR) 2017/745, clearing the bloc’s most demanding standard for quality systems, technical documentation, and clinical evidence. Rather than a blanket rollout, the company will introduce compliant versions of its dental product lines in stages across European markets […]

U.S.-based 3D printer manufacturer 3D Systems has been fully certified under the European Union Medical Device Regulation (EU MDR) 2017/745, clearing the bloc’s most demanding standard for quality systems, technical documentation, and clinical evidence. Rather than a blanket rollout, the company will introduce compliant versions of its dental product lines in stages across European markets to keep supply uninterrupted. The certification also unlocks the immediate introduction of new materials, feeding directly into the company’s next commercial move in Europe. “Receiving full-scope EU MDR certification validates our commitment to the highest standards of quality and patient safety while unlocking significant new growth opportunities across the European dental market,” said Jeffrey Graves