This open-source library of tissue engineering scaffolds is mainly developed and shared for researchers in the field of tissue engineering and for developers of biomedical additive manufacturing technologies and related biomaterials, with the intention of providing a comprehensive set of test geometries for evaluating the precision, repeatability and performance of mentioned technologies and biomaterials. The collection is also aimed at making research in the field more comparable and may lead, in the future, to an open standard on tissue engineering scaffolds.
Considering the research orientation of this collection, it is expected that trials for evaluating these printed scaffolds will be performed in vitro. Through UBORA, as a result from design tasks within INKplant EU project, only CAD geometries and related characterization data are shared, but it is necessary to note that the final performance of these structures is completely dependent on the actual printing technology and employed materials.
Besides, it is the responsibility of eventual users and manufacturers to strictly follow the applicable regulations, standards and ethical, social and environmental considerations required for the safe and sustainable in vitro testing of these geometries.
It is important to highlight that the shared geometries (scaffolding geometries for being printed without involving cells in the fabrication process) have been designed considering that the final products, once CE-marked as mass-fabricated products, would be Class III implantable medical devices according to the EU MDR 2017/745. Variations of these geometries and their mapping upon CAD models obtained from medical images (i.e. employing conformal lattice design methods or topology optimization approaches) could eventually lead to patient-specific medical devices, which could only be applied with the prescription and supervision of a medical professional under EU MDR 2017/745. Finally, if these geometries are just used for in vitro testing, they could be considered in vitro testing medical devices, which would be marketed under EU IVDR 2017/746.