European Union Regulations on Nanomedicine

Abstract

Rapidly emerging technologies, such as nanotechnologies, constitute significant challenges to the EU regulatory framework due to the uncertainties of development trajectories, product properties, and potential risk problems. This article analyses the emerging regulatory activities in relation to nanomedicine, in the context of an increased awareness about particular regulatory questions and problems that have emerged over the last few years, in exploring the particularities of the EU medical technology regulatory framework. The main conclusion of this article is that all the deficiencies that could be identified in the EU nanomedicine regulation framework led to the lack of legal certainty, a principle that has high priority in EU medical regulation policy.