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EU’s fragmented early-stage medical device study requirements need reform

delete2026-07-31
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PRE
AI
M
Muhammad Ibtsaam Qadir
J
Juliane Wober
A
Ali McDonnell
J
Jana Russo
T
Tom Melvin
S
Stephen Gilbert
F
Fiona R. Kolbinger *
DOI：10.1038/s41551-026-01750-3delete
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Abstract

Abstract

En 中文
Legislative change must fix the European Union’s disharmonized map of early-stage medical device clinical study requirements, whereby fragmented interpretations across Member States create barriers to innovation and delay patient access to life-saving technologies.

Journal

Nature Biomedical Engineering cover
Nature Biomedical Engineering
IF:
26.6
Papers:
1.7K
Citations:
2.0W

Organization

M
medtech europe
Scholars:
2
Papers: 1
Citations: 0
T
TUD Dresden University of Technology
Scholars:
575
Papers: 197
Citations: 0
P
Purdue University
Scholars:
2.6W
Papers: 2.0W
Citations: 147
U
university of galway
Scholars:
1.4K
Papers: 701
Citations: 1
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