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

IF 26.3 1区医学 Q1 ENGINEERING, BIOMEDICAL

Nature Biomedical Engineering Pub Date : 2026-07-31 DOI:10.1038/s41551-026-01750-3

Muhammad Ibtsaam Qadir, Juliane Wober, Ali McDonnell, Jana Russo, Tom Melvin, Stephen Gilbert, Fiona R. Kolbinger

引用次数: 0

Abstract

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.

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欧盟支离破碎的早期医疗器械研究要求需要改革。

立法改革必须解决欧盟早期医疗器械临床研究要求不协调的问题，即各成员国之间不一致的解释为创新创造了障碍，并延误了患者获得救生技术的时间。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Nature Biomedical Engineering Medicine-Medicine (miscellaneous)

CiteScore

45.30

自引率

1.10%

发文量

138

期刊介绍： Nature Biomedical Engineering is an online-only monthly journal that was launched in January 2017. It aims to publish original research, reviews, and commentary focusing on applied biomedicine and health technology. The journal targets a diverse audience, including life scientists who are involved in developing experimental or computational systems and methods to enhance our understanding of human physiology. It also covers biomedical researchers and engineers who are engaged in designing or optimizing therapies, assays, devices, or procedures for diagnosing or treating diseases. Additionally, clinicians, who make use of research outputs to evaluate patient health or administer therapy in various clinical settings and healthcare contexts, are also part of the target audience.