Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table.
PMID: 39977258 ·
Stephan Windecker, Alan G Fraser, Piotr Szymanski, Martine Gilard, Thomas F Lüscher, Leila Abid, John Brennan, Robert Byrne, Lia Crotti, Inga Drossart, Jennifer Franke, Mario Gabrielli Cossellu, Ajay J Kirtane, Jana Kurucova, Mitchell Krucoff, Gearóid McGauran, Patrick O Myers, Donal B O'Connor, Radosław Parma, Paul Piscoi, Archana Rao, Andrea Rappagliosi, Giulio Stefanini, Eigil Samset, Alphons Vincent, Ralph Stephan von Bardeleben, Franz Weidinger
Abstract
The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European Society of Cardiology strongly advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) medical devices in EU countries. Although devi
Official Source
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