Pursuing Legal Certainty within Multilevel Regulation: An Empirical Investigation of Manufacturer Perceptions of Medical Device Regulation in Europe
Nupur Chowdhury, University of Twente
As a regulatory space, the marketing authorization regulation of medical devices in Europe, is characterised by dispersion of regulatory authority amongst public regulators and private actors. These actors are involved in the regulatory lifecycle, that involves rule making, rule enforcement and rule adjudication activities at multiple administrative levels. Multilevel regulation as a framework is characterised by hetarchy rather than hierarchical relationships that Weber argued served as a structural imperative in ensuring legal certainty. Therefore, does multilevel regulation undermine legal certainty? This is the primary research question, that I investigate in this paper through a qualitative case study of marketing authorization of medical device regulation in Europe. Legal certainty is a concern not only for regulators trying to ensure applicability, coherence, continuity and predictability of the regulatory regime; but also for regulatees who demand clarity in their legal obligations and predictability in regulatory decision-making. This paper explores legal certainty through the perception of manufacturers. Do they experience legal uncertainty in this regulatory space? How do they pursue and secure legal certainty in such a multilevel regulatory framework? The study finds that this regulatory space is indeed characterised by multilevel regulation. The dispersion of regulatory authority has undermined the strict functional relationship between regulators and regulatees. The regulator’s legal authority to regulate is now increasingly challenged by private actors that have claims to superior technical knowledge (and therefore better equipped to regulate). Increased spaces for regulatory conversations that manufacturers can access as “substantially equal parties” have emerged and have led to the growth of a positional identity for manufacturers. And, it is this growing positional identity that has helped manufacturers secure legal certainty in the context of marketing authorization of medical devices in Europe.