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Accountability of Certification – Consequences of the PIP crisis and the European New Approach

Democracy
Governance
International Relations
Regulation
Christian Ewert
University of Zurich
Christian Ewert
University of Zurich

Abstract

The European New Approach is a complex regulatory regime that, in particular, is responsible for the certification and approval of medical devices. So-called Notified Bodies conduct this certification, and hence “escort” regulators of the European common market. However, the democratic accountability of the New Approach and Notified Bodies to citizens, or to actors speaking on citizens' behalf, is questionable. Hence, this paper analyzes how accountability unfolded in response to the “PIP crisis,” during which the Notified Body TÜV Rheinland certified implants for cosmetic surgery that were, in fact, dangerous. Results of this paper indicate that mostly the producer was blamed for the crisis. However, proposals have been made to increase supervision and accountability of Notified Bodies, and to make it easier for citizens to obtain compensation for received damages. It is of concern, however, that at least some actors equal certification with safety, when in fact it only signifies conformity. Those actors, thus, might develop exaggerated expectations about the New Approach's performance