The human hand is the most precise and versatile tool that nature has given man, and any deficits in this area affect the functional capabilities and quality of human life. Scientists, engineers and clinicians are constantly looking for solutions in the field of diagnosis, treatment, rehabilitation and care of patients with hand function deficits. One such solution is a hand exoskeleton. In the process of designing and testing the hand exoskeleton, emphasis should be placed on the full usability and comfort of the system; hence, the issues of personalization, matching and testing are crucial for the development of the discussed group of solutions. The aim of this paper is to present the possibilities of personalizing 3D-printed medical devicesbased on our own experience in functional user assessment andthe material selection, design, optimization using artificial intelligence and production and testing of several generations of different upper limb exoskeletons, incorporatingthe considerations of the Medical Device Regulation (MDR), ISO 13485 and ISO 10993 standards.The novelty and possible contribution of the proposed approach consist of the possibilities and limitations of the personalization of the upper limb exoskeleton discussed in the article as well as the directions of further development of significant scientific, technical and clinical importance.