title: New risks inadequately managed: the case of smart implants and medical device regulation.
abstract: Many emerging technologies are associated with 'risk'. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of risk, we assess the European medical devices regulatory regime from a risk perspective, focusing on its handling of 'smart' implantable medical devices. In doing so, we discuss the empirical evidence obtained from expert participants in the Implantable Smart Technologies Project, which evidence is framed around three risk typologies: materiality, geography and modality. We conclude that none of these risks are sufficiently addressed within the existing regime, which falls down not just from a standards perspective, but also from the perspective of transparency and balance.
authors.affiliation: School of Law, University of Edinburgh, Scotland, UK.
authors.forename: Shawn H E
authors.initials: SH
authors.lastname: Harmon
authors.affiliation: School of Social and Political Science, University of Edinburgh, Scotland, UK.
authors.forename: Gill
authors.initials: G
authors.lastname: Haddow
authors.affiliation: School of Social and Political Science, University of Edinburgh, Scotland, UK.
authors.forename: Leah
authors.initials: L
authors.lastname: Gilman
keywords: European Union; Implantable Smart Technologies Project; emerging technologies; medical devices; risk