Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction

Abstract

Point-of-care (POC) three-dimensional (3D) printing of medical devices presents a paradigm shift in personalized medicine, yet clinical implementation of polyetheretherketone (PEEK) implants remains limited by regulatory, technical, and quality assurance challenges. Traditional external manufacturing timelines of 2–6 weeks constrain immediate reconstruction capabilities, particularly in trauma and oncologic cases requiring rapid intervention. Structured frameworks enabling MDR-compliant hospital-based production of implantable devices remain limited in the literature. We implemented a comprehensive European Union Medical Device Regulation (EU MDR) 2017/745 Article 5(5)-compliant POC manufacturing framework incorporating an electronic quality management system aligned with ISO 13,485, a manufacturing execution system enabling end-to-end device traceability, risk management, process validation, biocompatibility evaluation, and integrated post-market surveillance. Medical-grade PEEK was processed using validated high-temperature specialised material extrusion 3D printers. Representative clinical applications of the EU MDR-compliant point-of-care manufacturing framework are illustrated in two anatomical contexts: (1) a POC 3D-printed PEEK cranial implant and (2) a POC 3D-printed PEEK facial implant. Manufacturing turnaround from image acquisition to sterile delivery was operationally achievable within 3–5 days. The patient-matched implants demonstrated accurate anatomical fit without intraoperative modification, with no major device-related complications observed. The framework has supported the production of over 40 + POC 3D-printed PEEK implants at the index institution and has since been adopted at multiple European centres, demonstrating transferability beyond the index case series. This work describes a validated EU MDR Article 5(5)-compliant framework for hospital-based production of patient-matched 3D-printed PEEK implants, demonstrated across cranial and facial reconstruction. Early clinical results support safety and feasibility, with end-to-end manufacturing achievable within a week, enabling flexible surgical planning. The framework provides a replicable pathway for regulated POC implant production, with multi-centre adoption and long-term outcome surveillance as critical next steps.