Home Medical 3D Systems and University Hospital Basel Produce First MDR-Compliant PEEK Facial Implant...

3D Systems and University Hospital Basel Produce First MDR-Compliant PEEK Facial Implant On-Site

Picture: 3D Systems

In March 2025, University Hospital Basel and 3D Systems successfully produced and implanted a patient-specific facial implant directly at the hospital site. The project utilized an additive manufacturing solution that enables the entire workflow—from design to production—within a point-of-care setting. The implant was made using the biocompatible high-performance polymer VESTAKEEP i4 3DF PEEK from Evonik, processed on the EXT 220 MED 3D printer, which was specifically developed for medical applications.

What makes this case noteworthy is its full compliance with the European Medical Device Regulation (MDR), a requirement that has so far been difficult to meet in near-patient additive manufacturing environments.

Professor Florian Thieringer, head of the interdisciplinary team at University Hospital Basel, emphasized the clinical relevance: “Our goal is always to provide our patients with the best possible care. By integrating both the design and production of patient-specific implants directly into the hospital, we can tailor treatments more precisely, respond faster, and improve surgical outcomes. The ability to produce implants on demand and on-site marks the beginning of a new era in personalized medicine.”

The technology used combines cleanroom-compatible machine architecture with standardized post-processing protocols, enabling the production of custom implants in a controlled environment directly at the treatment location.

“The rapid adoption of the EXT 220 MED by leading healthcare institutions, along with the growing number of clinical applications, highlights the transformative potential of 3D printing in the medical field,” said Dr. Stefan Leonhardt, Director of Medical Devices at 3D Systems. Since its market launch in August 2023, the system has already been used in over 80 successful cranial surgeries at partner hospitals. According to Leonhardt, the recent use of the system for maxillofacial implants demonstrates its growing clinical relevance and underscores the company’s commitment to ongoing innovation and the development of personalized healthcare solutions.

The global market for maxillofacial 3D-printed implants is steadily expanding. According to forecasts, the market volume is expected to more than double by 2034, exceeding USD 4 billion. The implementation of additive manufacturing directly within hospital environments is likely to accelerate this trend by advancing both the personalization and cost-effectiveness of medical care.


Metal Binder Jetting: The Key to Efficient Tool Manufacturing? - Exclusive Insights from INDO-MIM

Fill out the form and get instant access to an exclusive webinar on HP's Metal Binder Jetting 3D printing technology with exciting insights from INDO-MIM.
Please enable JavaScript in your browser to complete this form.
By filling this form, HP may contact you to keep you updated on offers, updates and events. Please, select your preferences.
You can find out more about 3Printr.com's privacy policy here.

Subscribe to our Newsletter

3DPresso is a weekly newsletter that links to the most exciting global stories from the 3D printing and additive manufacturing industry.

Privacy Policy*
 

You can find the privacy policy for the newsletter here. You can unsubscribe from the newsletter at any time. For further questions, you can contact us here.