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Anett Schönfelder

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Review Open access Oct 2026

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

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 techn...

Anett Schönfelder, Tom Melvin, Timo Minssen et al. · 0 citations

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