Digital medical devices (DMDs) present unique opportunities in their regulation and reimbursement. A dynamic landscape of DMD assessment frameworks is emerging within the European Union, with five clusters of prevailing approaches identified. Despite notable gaps in maturity levels, cross-country learning effects are becoming prevalent. We expect more countries, both within the EU and beyond, to follow the steps of current frontrunners, hence expediting the harmonization process.

中文翻译：

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“通过相互学习，协调欧盟数字医疗器械的评估和报销”

数字医疗设备 （DMD） 在监管和报销方面提供了独特的机会。欧盟内部正在形成 DMD 评估框架的动态格局，确定了五组流行的方法。尽管成熟度水平存在显著差距，但跨国学习效应正变得越来越普遍。我们预计欧盟内外会有更多国家效仿当前领跑者的步伐，从而加快协调进程。