Abstract
ABSTRACTMany 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.
Highlights
All manner of risks to human well-being have been identified, including injury, invasive pathogens, genetic inheritance and the acquired and chronic diseases associated with aging, to name but a few
In an attempt to isolate and avoid these risks, and mitigate their deleterious consequences, we invent health technologies aimed at preventing, diagnosing and treating a wide range of conditions. Many of these health technologies are medical devices, a field which employs over 500,000 people in about 25,000 companies in Europe alone, and which generates annual sales of around €95 billion from some 500,000 products
After unpacking the concept of risk, we discuss evidence generated in relation to risks, smart implanted medical devices (IMDs) and the fitness of the European Union (EU) regulatory framework, which informs United Kingdom (UK) approaches to device testing and market authorisation
Summary
All manner of risks to human well-being have been identified, including injury, invasive pathogens, genetic inheritance and the acquired and chronic diseases associated with aging, to name but a few. In an attempt to isolate and avoid these risks, and mitigate their deleterious consequences, we invent health technologies aimed at preventing, diagnosing and treating a wide range of conditions Many of these health technologies are medical devices, a field which employs over 500,000 people in about 25,000 companies in Europe alone, and which generates annual sales of around €95 billion from some 500,000 products.. After unpacking the concept of risk, we discuss evidence generated in relation to risks, smart IMDs and the fitness of the European Union (EU) regulatory framework, which informs United Kingdom (UK) approaches to device testing and market authorisation.. LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF 7Council Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices, [1998] 41 OJ L331. We argue that smart IMDs have features that challenge regulatory frameworks beyond the devices regime, and we make some modest suggestions for reform
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