From a regulatory perspective, the introduction of hybrid hydrogels to the market requires navigating a complex framework, informed by guidelines offering "non-binding recommendations." Notably, the FDA has yet to provide specific regulatory definition for key terms such as "nanotechnology," "nanomaterial," or "nanoscale". Depending on their intended use, hydrogels may be classified as drugs or devices, and combination products further complicate the regulatory pathways, increasing costs and time before approval. The material resulting from the incorporation of nano-objects represents a new entity whose properties might surpass the simple sum of its constituents and, as we have seen, the resulting characteristics can point in opposite directions. Therefore, it is crucial to conduct a comprehensive characterization of the nano-objects and develop a thorough understanding of how their properties may impact on the quality, efficacy and safety of the hybrid hydrogel. This includes assessing potential modifications of the nano-objects during the manufacturing process and after in vivo administration, as a result of interactions with biological systems.