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