Abstract: Silk fibroin (SF) is the primary component of silk, and currently, clinically used medical devices based on SF materials mainly include hemostatic dressings, biological patches, etc. As SF is being applied in nerve vascular tissue engineering scaffolds, oral and bone tissue defect repair devices, flexible bioelectrodes, among others, these products demand higher mechanical and biological properties of the materials. These products require a better match between the mechanical properties of the materials and the tissue, as well as improved biocompatibility, in order to achieve therapeutic goals that promote tissue repair and regeneration. This has led to the emergence of SF-based composite materials, which have become a hot topic in the cardiovascular and orthopedic fields. This article summarizes the research progress and key technological development trends of medical devices based on SF composite materials, providing a reference for R&D and regulatory personnel in the medical device field. It aims to ensure product quality while achieving innovation, meet clinical needs, and ultimately benefit more patients.