First prototyping results with the open-source library of tissue engineering scaffolds have led to the validation of printability by applying a wide set of additive manufacturing technologies and printable materials. Depending on the actual technology and material, different geometries may be printable or not, as has been documented elsewhere (check INKplant's project website and related information in Zenodo and forthcoming open-source publications by our team).
As already mentioned in the product specification section:
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 forin vitrotesting, they could be considered in vitro testing medical devices, which would be marketed under EU IVDR 2017/746.