Nanomaterials-Enabled Electrochemical Biosensors: From Enhanced Performance to Regulatory Readiness

Electrochemical biosensors represent mature platforms for point-of-need analysis due to their high sensitivity, intrinsic selectivity, low cost, and facile miniaturization. In the last decade, nanomaterials have become integral to advanced biosensor architectures, acting as high-surface-area supports, electron-transfer mediators, and signal-amplifying elements. This review critically examines the most represented nanomaterial classes in mature electrochemical biosensors—carbon nanostructures, gold nanoparticles, and iron-based magnetic nanoparticles—highlighting how morphology, electronic structure, and surface chemistry influence key performance metrics such as limit of detection, linear range, and assay time. Despite a strong technology push and numerous proof-of-concept demonstrations, the translation of nanomaterial-enabled electrochemical biosensors into commercial devices remains limited. This gap arises from the intrinsic physicochemical complexity of nanomaterials, which hampers standardization, reproducibility, and long-term safety assessment. Accordingly, this review integrates performance analysis with a systematic overview of the European regulatory framework, including the Medical Device Regulation (MDR) (EU) 2017/745, the In Vitro Diagnostic Regulation (IVR) (EU) 2017/746, EFSA guidance for food and water applications, and relevant ISO standards, outlining key translational bottlenecks and design principles for deployable biosensing technologies.