Bridging clinical integration and regulatory compliance in 3D printing: a hybrid model for university-based manufacturing of custom-made medical devices

Introduction The rapid expansion of 3D printing in healthcare has enabled new paradigms in personalized medicine, particularly in the development of custom-made medical devices. However, in the European context, the integration of point-of-care additive manufacturing into routine clinical practice remains limited by the complexity of the Medical Devices Regulation (EU) 2017/745 (MDR), which poses significant challenges for hospital- and university-based laboratories in achieving regulatory compliance while preserving clinical integration. Materials and methods This study describes a real-world implementation of a hybrid organizational and regulatory model within the 3D Innovation Lab of Humanitas University (Milan, Italy), designed to bridge the gap between clinically embedded 3D printing activities and regulated medical device manufacturing. A top-down, regulatory-driven approach was adopted, based on the interpretation of MDR requirements and the implementation of ISO 13485 and ISO 14971 standards within a fully digital Quality Management System (QMS). The model integrates structured regulatory decision-making, formalized roles and responsibilities, and adapted design control, risk management, validation, and production processes tailored to a clinician-driven, custom-made workflow. Results The implementation resulted in ISO 13485 certification and formal registration as a manufacturer of custom-made medical devices under Annex XIII MDR. Key outcomes include: (i) the implementation of a regulatory decision framework enabling the systematic classification of in-house, custom-made, and CE-marked regulatory pathways within the broader point-of-care manufacturing landscape; (ii) the integration of clinical and manufacturing processes within a unified QMS, ensuring traceability and regulatory compliance across the device lifecycle; (iii) the ability to design, manufacture, and supply Class I and IIa custom-made devices to both internal and external healthcare institutions. Moreover, preliminary observations of this system have demonstrated clinical relevance in complex surgical scenarios, improving preoperative planning accuracy and enabling advanced patient-specific applications with a high precision surgical act, however comparative effectiveness data demonstration is still ongoing. Discussion These findings demonstrate the feasibility of combining clinical integration and regulated manufacturing within a single governance structure. The proposed hybrid model represents a structured and potentially replicable framework for advancing regulatory maturity in university-based 3D printing, supporting the transition from experimental point-of-care activities to sustainable, compliant medical device production.