European regulatory framework for the clinical translation of bioprinted scaffolds and tissues

Tissue Engineering and Regenerative medicine, empowered by Biofabrication technologies, hold the premises to provide solutions to unmet clinical needs, such as organ donor shortage or genetic diseases. These huge advancements are determining a changing scenario, with a quite confusing understanding about the steps toward the clinical translation of new researches and products, giving as result an overestimation or an underestimation of the required in vitro and in vivo tests for their validation. The proper definition and classification of the research products can be considered an action toward the refinement of animal experiments. An appropriate classification is crucial because the complications due to the combination of biological and non-biological materials need the application of specific rules. This paper aims at helping the academic and industrial community to clarify the identification and classification of their research products.