---
title: "3D Systems secures EU MDR certification"
url: https://www.voxelmatters.com/3d-systems-secures-eu-mdr-certification/
date: 2026-03-27
modified: 2026-03-27
lang: en
author: "Joseph Caron-Dawe"
description: "3D Systems has received full-scope certification under the European Union Medical Device Regulation (EU MDR) 2017/745, which now clears the path for the European commercial launch of its NextDent Jetted..."
categories:
  - "Dental AM"
  - "Medical AM"
  - "Personalized Medicine"
tags:
  - "insights"
image: https://www.voxelmatters.com/wp-content/uploads/2026/03/3D-Systems-EU-MDR-Certification-01-640x400.jpg
word_count: 379
---

# 3D Systems secures EU MDR certification

[3D Systems](https://www.voxelmatters.directory/company/3d-systems/) has received full-scope certification under the European Union Medical Device Regulation (EU MDR) 2017/745, which now clears the path for the European commercial launch of its [NextDent Jetted Denture Solution](https://www.voxelmatters.com/3d-systems-fda-cleared-nextdent-jetted-denture-solution/), targeted for summer 2026.

The Rock Hill, South Carolina-based company will now introduce MDR-compliant product versions through a phased rollout across its dental product families and European markets, a process it described as designed to maintain uninterrupted product availability during the transition.

## European denture market in focus

[The NextDent Jetted Denture Solution, which completed its US commercial launch in 2025](https://www.voxelmatters.com/3d-systems-debuts-new-dental-3d-printing-technology/), sits at the center of 3D Systems' digital dentistry strategy — a portfolio spanning applications for the straightening, protection, repair, and replacement of teeth.

![3D Systems secures EU MDR certification](https://www.voxelmatters.com/wp-content/uploads/2026/03/3D-Systems-EU-MDR-Certification-02-340x340.jpg)The 3D Systems 3D Sprint software

The company's internal estimates place the addressable US market for the replacement segment at approximately $600 million by 2029, and the EU market as comparable or slightly larger than the US, based on the company's analysis of demographic trends. 

Powered by the NextDent 300 MultiJet 3D printer alongside NextDent Jet Base and Teeth materials, the solution [enables dental labs to produce one-piece dentures faster and at lower cost than traditional analog methods](https://www.voxelmatters.com/dental-lab-halves-removable-partial-denture-production-times-3d-systems/).

“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,” stated Jeffrey Graves, President and Chief Executive Officer of 3D Systems.

“Building on our established dominance in high-volume aligner production and the industry-leading NextDent materials portfolio from our Vertex acquisition, the NextDent Jetted Denture Solution represents a transformative advancement in delivering monolithic, multi-material prosthetics with superior aesthetics, durability, and production efficiency using our MultiJet Printing technology.

“With strong early traction in the US and the substantial addressable market we outlined in our recent earnings call, this launch accelerates momentum in our dental business, one of our most significant growth initiatives, and reinforces its role as a key driver of long-term shareholder value. We are excited about these accomplishments and the substantial business opportunities they generate.”

## Leadership update

Separately, 3D Systems also named Phyllis Nordstrom as Executive Vice President and Chief Financial Officer. Nordstrom has been serving as Interim CFO since August 2025 and continues to hold her concurrent role as Chief Administrative Officer.