Regulatory aspects of 3D printing systems in healthcare

New technologies, like 3D printing, are revolutionizing the R&D and manufacturing of medicinal products (MPs) and medical device (MDs). This is pushing competent Authorities to update the relevant regulatory framework to overcome barriers that may hinder the development of high-innovation products, on the one hand, and to ensure proper quality standards for the protection of publich health, on the other. To this end the correct qualification of a healthcare product and the proper definition of its target profile are essential. If a 3D-printed product has an intended medical prupose, it falls under the regulatory framework of either MPs or MDs, depending on the primary mode of action. For this innovative products, existing regulatory MP/MD pathways may be effectively applicable in some cases, complemented by a case-by-case benefit/risk assessment. In other cases, particulary when scientific innovation brings product production closer to the patient's beside or in a point-of-care setting, the existing MP/MD regulatory frameworks may represent a barrier.