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3D printing has been adopted into routine use for certain medical applications, but more widespread usage has been hindered by, among other things, unclear legislation. We performed an analysis, using legal doctrinal study and legal informatics, of relevant EU legislation and case law in four issues relevant to medical 3D printing (excluding bioprinting or pharmacoprinting): pre-market approval, post-market liability, intellectual property rights, and data protection. Several gaps and uncertainties in the current legislation and interpretations were identified. In particular, we regard the current EU regulatory framework to be quite limiting and inflexible, exemplifying a cautionary approach common in EU law. Though the need to establish high safety standards in order to protect patients as a disadvantaged population is understood, both legal uncertainties and overregulation are seen as harmful to innovation. Hence, more adaptive legislation is called for to ensure continuous innovation efforts and enhanced patient outcomes. [ABSTRACT FROM AUTHOR]

The methods of additive manufacturing of anatomical models are widely used in medical practice, including physician support, education and planning of treatment procedures. The aim of the review was to identify the area of additive manufacturing and the application of anatomical models, imitating both soft and hard tissue. The paper outlines the most commonly used methodologies, from medical imaging to obtaining a functional physical model. The materials used to imitate specific organs and tissues, and the related technologies used to produce, them are included. The study covers publications in English, published by the end of 2022 and included in the Scopus. The obtained results emphasise the growing popularity of the issue, especially in the areas related to the attempt to imitate soft tissues with the use of low-cost 3D printing and plastic casting techniques. [ABSTRACT FROM AUTHOR]

Three-dimensionally printed metals and polymers have been widely used and studied in medical applications, yet ceramics also require attention. Ceramics are versatile materials thanks to their excellent properties including high mechanical properties and hardness, good thermal and chemical behavior, and appropriate, electrical, and magnetic properties, as well as good biocompatibility. Manufacturing complex ceramic structures employing conventional methods, such as ceramic injection molding, die pressing or machining is extremely challenging. Thus, 3D printing breaks in as an appropriate solution for complex shapes. Amongst the different ceramics, bioinert ceramics appear to be promising because of their physical properties, which, for example, are similar to those of a replaced tissue, with minimal toxic response. In this way, this review focuses on the different medical applications that can be achieved by 3D printing of bioinert ceramics, as well as on the latest advances in the 3D printing of bioinert ceramics. Moreover, an in-depth comparison of the different AM technologies used in ceramics is presented to help choose the appropriate methods depending on the part geometry. [ABSTRACT FROM AUTHOR]

This paper presents the results of an experimental study to evaluate the possibility of using SLM additive technology to produce structures with specific surface morphological features. Qualitative and quantitative tests were conducted on samples fabricated by 3D printing from titanium (Ti6Al4V)-powder-based material and analysed in direct relation to the possibility of their use in medicine for the construction of femoral stem and models with a specific degree of porosity predicted by process-control in the self-decision-making 3D printing machine. This paper presents the results of the study, limitations of the method, recommendations that should be used in the design of finished products, and design proposals to support the fabrication process of 3D printers. Furthermore, the study contains an evaluation of how the printing direction affects the formation of certain structures on the printed surface. The research can be used in the development of 3D printing standardization, particularly in the consideration of process control and surface control. [ABSTRACT FROM AUTHOR]