One of the points of focus of our centre is the clinical translation of our research. Because the medical industry is a highly regulated sector, translational research does not happen outside of regulatory and legal structures. It has been well established that 3D printing technologies and additive manufacturing (AM) in the health sector may pose regulatory and legal issues of various sorts. In our recent publication, PhD candidate Antonia Horst argued that if AM products in the health sector are to be regulated in the near future, stakeholders involved in translational research need to understand the challenges faced by both regulators and industry. The language used – in scientific, regulatory and industry contexts alike – must be defined clearly and used consistently. We portray different points of possible dissonance for AM medical products with existing regulatory frameworks and advocate for stakeholders to proactively provide regulatory-rooted risk profiles for regulatory processes for products emerging from AM in the health sector
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