3D Systems announces first MDR-compliance 3D-printed PEEK facial implant

3D Systems (DDD) announced that in collaboration with the University Hospital Basel the Company’s point-of-care additive manufacturing solution has been used to design and produce the world’s first Medical Device Regulation, MDR-compliant 3D-printed PEEK facial implant. Prof. Florian Thieringer and Dr. Neha Sharma, together with their team of biomedical engineers, successfully designed and manufactured a custom device to address a patient’s unique need using 3D Systems technology and product manufacturing expertise. They used this implant as part of a successful surgery completed at the hospital on March 18, 2025. Production of the first MDR-compliant facial implant was completed using VESTAKEEP i4 3DF PEEK by Evonik on 3D Systems’ EXT 220 MED. The cleanroom-based architecture of the printer and simplified post-processing workflows enable the efficient production of patient-specific medical devices directly at the hospital.