This editorial argues that the European Union must pivot from fragmented, late-stage engagement to a harmonized framework for early regulatory advice, mirroring successful aspects of the U.S. FDA’s EFS program, to foster the EU competitiveness and attractiveness.
From fragmentation to framework: why early regulatory advice is critical for European medical device innovation
Callea, Giuditta;
2026
Abstract
This editorial argues that the European Union must pivot from fragmented, late-stage engagement to a harmonized framework for early regulatory advice, mirroring successful aspects of the U.S. FDA’s EFS program, to foster the EU competitiveness and attractiveness.
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