Regulatory aspects for emerging technologies in healthcare

Synopsis

The R&D and manufacturing of healthcare products have been strongly affected by new scientific and technologicaldiscoveries and applications, such as 3D printing, combination products and digitals therapeutics. As ever, those technologicaladvances require an update of the regulatory framework, to overcome the current regulatory obstacles for high-innovationproducts and to ensure quality standards adequate for the protection of public health. In this context, although existingregulatory pathways can be used effectively for the marketing of high-innovation products , benefit/risk assessment mayrequire additional data to be defined case-by-case, based on the specific features of the innovative products. It is necessary todiscuss the critical issues in the marketing of products and devices produced bydifferent emerging technologies fortherapeutic purposes, with a particular focus on point-of-care settings.