Reforming medical device regulation in Europe: centralization, governance, and the case for an EU medical device agency

Abstract

Summary Innovation in medical technologies, especially AI-enabled tools, is exposing the limits of Europe’s current medical device regulatory dogma. Existing rules treat devices as isolated products rather than integrated systems shaping care. Any region that wants to be home to the most innovative businesses and technologies must have a regulatory system fit for adopting state-of-the-art technologies and making fast, effective decisions. While US and UK frameworks innovate, Europe’s model stifles medical-technology innovation and the exploration of new regulatory paradigms through ineffective multi-level governance and uncoordinated, decentralized decision-making. In response, MedTech stakeholders, including industry, professional associations, patient representatives, hospitals, politicians, national authorities, and regulatory scientists, have recently called for a centralised EU-level “single-authority” (for strategy-setting, coordination, and regulatory support) to take accountable ownership of the regulatory system and its strategic development for all medical technologies in Europe. We describe the benefits and drawbacks of this approach and contend how centralization in the complex MedTech system could actually work.