Triggering authored paradox in medical device governance: notified bodies, regulatory change and artificial intelligence

Vollständiger Abstract

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Purpose This study examines how paradoxical tensions are institutionally embedded within EU Medical Device Regulation (MDR) and why they become salient when regulatory and technological changes converge. Design/methodology/approach The study analyses the adoption of artificial intelligence (AI) in European conformity assessment, focussing on notified bodies operating under the MDR, In Vitro Device Regulation and AI Act. It draws on 17 semi-structured interviews with regulatory professionals, analysis of EU legal texts and observations of regulatory practice, following an abductive analytical approach. Findings Five paradoxical tensions are codified within EU legal texts as parallel obligations rather than hierarchically ordered priorities. These tensions remain latent as long as regulatory work proceeds within established routines. Four governance-induced triggers (regulatory reform, workload pressure, institutional scrutiny and intensified procedural demands) collapse the arrangements that maintain latency, rendering tensions salient. AI functions as a cross-cutting amplifier across the system. Research limitations/implications The study is limited to EU medical device governance and draws on 17 interviews with conformity assessment professionals. The concept of authored paradox and the trigger mechanisms identified may operate differently in other regulatory regimes. Future research could examine how different legal traditions author paradox differently, and whether the same triggers produce different patterns of salience depending on enforcement intensity or organisational position. Practical implications Introducing AI into conformity assessment requires governance arrangements that explicitly acknowledge the contradictions AI will activate. Regulatory guidance clarifying acceptable use and accountability would reduce informal workarounds. Notified bodies would benefit from structured experimentation spaces insulated from immediate accreditation scrutiny, enabling learning without triggering the full weight of accountability arrangements. Social implications Regulatory systems designed to protect patient safety and public health govern through sustained contradiction rather than despite it. When these contradictions become simultaneously salient, the resulting hesitation and deferral can delay access to technologies that may benefit patients. Making deferral dynamics more transparent may support more accountable governance of emerging technologies in healthcare. Originality/value The study contributes to paradox theory by showing how latency is institutionally designed, by identifying the mechanisms through which governance-induced triggers activate latent paradoxical tensions and by introducing the concept of authored paradox to capture how regulatory systems deliberately embed and preserve contradiction through institutional design.