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欧盟环境下评估数字医疗设备的分类网格和证据矩阵。

Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape.

作者信息

Boers Magali, Rochereau Aude, Stuwe Louisa, Miguel Lorena San, Klucken Jochen, Mezei Fruzsina, Fabiano Jérôme, Boulet Sandrine, Perchant Aymeric, Tarricone Rosanna, Petracca Francesco, Hoefgen Barbara, Collignon Corinne, Zohar Sarah

机构信息

Luxembourg Ministry of Health and Social Security, Luxembourg, Luxembourg.

Mission numérique en santé, Haute Autorité de Santé, Saint-Denis, France.

出版信息

NPJ Digit Med. 2025 May 24;8(1):304. doi: 10.1038/s41746-025-01697-w.


DOI:10.1038/s41746-025-01697-w
PMID:40413360
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12103570/
Abstract

A uniform and harmonised taxonomy of Digital Medical Devices (DMDs) and their evidence-based evaluation are essential to ensure their integration into healthcare systems across the European Union (EU). As part of the Taskforce for Harmonised Evaluation of DMDs, a Common European Classification Grid for DMDs (CEUGrid-DMD) associated with an Evidence Matrix is developed. These tools are based on the mapping of existing frameworks, a survey of Health Technology Assessment (HTA) practices, consensus meetings and workshop. The survey was sent to 32 national representatives of HTA bodies from 18 EU countries. Ten HTA bodies from nine countries completed the survey while others could not, in the absence of the effective implementation of a DMD evaluation framework. This work results in the CEUGrid-DMD including four taxonomy categories, associated with an evidence-based matrix. Overall, this first version should help to converge scientific assessments of DMDs in the context of HTA Regulations across the EU.

摘要

数字医疗设备(DMD)的统一和协调分类法及其基于证据的评估对于确保其融入欧盟(EU)各地的医疗保健系统至关重要。作为DMD协调评估特别工作组的一部分,开发了与证据矩阵相关联的数字医疗设备通用欧洲分类网格(CEUGrid-DMD)。这些工具基于对现有框架的映射、卫生技术评估(HTA)实践调查、共识会议和研讨会。该调查发送给了来自18个欧盟国家的32个HTA机构的国家代表。来自9个国家的10个HTA机构完成了调查,而其他机构由于缺乏DMD评估框架的有效实施而未能完成。这项工作产生了包括四个分类类别的CEUGrid-DMD,并与一个基于证据的矩阵相关联。总体而言,这个第一版应有助于在欧盟HTA法规的背景下统一对DMD的科学评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/facc/12103570/452aab5617e4/41746_2025_1697_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/facc/12103570/452aab5617e4/41746_2025_1697_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/facc/12103570/452aab5617e4/41746_2025_1697_Fig1_HTML.jpg

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[1]
Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape.

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本文引用的文献

[1]
International Market Access Strategies for Artificial Intelligence-Based Medical Devices: Can We Standardize the Process to Faster Patient Access?

Mayo Clin Proc Digit Health. 2023-8-8

[2]
"Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning".

NPJ Digit Med. 2024-10-1

[3]
Skating the line between general wellness products and regulated devices: strategies and implications.

J Law Biosci. 2022-7-14

[4]
Success Factors for Scaling Up the Adoption of Digital Therapeutics Towards the Realization of P5 Medicine.

Front Med (Lausanne). 2022-4-12

[5]
Medical Mobile App Classification Using the National Institute for Health and Care Excellence Evidence Standards Framework for Digital Health Technologies: Interrater Reliability Study.

J Med Internet Res. 2020-6-5

[6]
The HTA Core Model-10 Years of Developing an International Framework to Share Multidimensional Value Assessment.

Value Health. 2017-2

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