Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation.

Abstract

Substance-based medical devices (SBMDs) are increasingly used in wound care due to their favorable safety profile, physicochemical mechanisms of action, and therapeutic effectiveness. These products often incorporate biopolymers such as hyaluronic acid or chitosan, alone or in combination with antimicrobial agents like silver nanoparticles (AgNPs) or silver sulfadiazine (SSD), offering hydration, tissue protection, and control of microbial burden in both acute and chronic wounds. Despite their w