3D Systems Achieves Full EU MDR Certification — NextDent Denture Launching in Europe This Summer

3D Systems Secures EU MDR Certification

3D Systems (NYSE: DDD) has achieved a significant regulatory milestone, receiving full-scope certification under the European Union Medical Device Regulation (EU MDR) 2017/745. The certification was attained on Monday, March 17, 2026.

This certification confirms that the company's quality system, technical documentation, and clinical evidence meet the stringent requirements for medical devices in the European Union. It's a crucial step for any medical device manufacturer looking to sell products in European markets.

Clearing the Path for NextDent Launch

With the MDR certificate in hand, 3D Systems will now accelerate the European launch of its NextDent Jetted Denture Solution, which is targeted for summer 2026. The NextDent Jetted Denture Solution represents the company's entry into the dental prosthetics market using additive manufacturing.

The certification is particularly significant given the complexity of EU MDR compliance, which has proven challenging for many medical device companies. The regulation, which replaced the previous Medical Devices Directive, imposes more rigorous requirements for clinical evidence and post-market surveillance.

A Boost for Dental 3D Printing

3D Systems has been positioning itself as a key player in the dental 3D printing space. The company's NextDent brand offers a range of photopolymer resins specifically designed for dental applications. The jetted denture solution represents a natural expansion of this portfolio.

Dental 3D printing has been one of the fastest-growing segments in additive manufacturing, with applications ranging from surgical guides to orthodontic appliances. The ability to 3D print dentures directly represents a significant advancement in personalized healthcare.