3D Systems Achieves Full-Scope EU Medical Device Certification

3D Systems has achieved a significant milestone in the medical 3D printing industry, becoming the first company to receive full-scope certification under the European Union Medical Device Regulation 2017/745.

What This Means

The certification enables 3D Systems to launch its NextDent Jetted Denture Solution in Europe this summer. This is a major regulatory achievement that positions the company ahead of competitors in the medical dental 3D printing space.

Why EU MDR Matters

The EU MDR is one of the most stringent medical device regulatory frameworks globally. Achieving full-scope certification demonstrates that 3D Systems meets the highest standards for quality, safety, and efficacy in medical device manufacturing.

For dental 3D printing, this certification opens doors to the European market for customized dental prosthetics manufactured using additive manufacturing techniques.