ArticleNPJ digital medicine2025
Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape.
Article in NPJ digital medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed.
- Value in app store metadata and user reviews: A dual perspective on quality of Parkinson's and dementia apps.PLOS digital health · 2026Article
- An Ontology for the Adoption of Medical Devices in Health Care Organizations: Design and Development Study.Journal of medical Internet research · 2026Article
- Co-Develop-IT! Unifying Methodological Guideline for the Co-Design, Development, and Evaluation of Individually Tailored Technology-Enhanced Training and Rehabilitation Concepts: Consensus Development Study and Tutorial.Journal of medical Internet research · 2026Article
- The future digital outpatient clinic for movement disorders: from technological innovation to ethical and systemic implementation-a position paper.Journal of neural transmission (Vienna, Austria : 1996) · 2026Review
- A dataset of digital therapeutic device approvals to support regulatory decisions and industry research.Scientific data · 2026Article
- A scoping review on using real-world data to evaluate the effectiveness of mHealth applications.NPJ digital medicine · 2026Article
- Clinical utility of digital technologies in Parkinson's disease.Journal of neural transmission (Vienna, Austria : 1996) · 2026Review
- Engagement with the national electronic health records by people with Parkinson's disease.Frontiers in aging neuroscience · 2026Article
- Health economic evaluations of digital health technologies-a rapid review of applied methods.Frontiers in digital health · 2026Review
- Consensus on the clinical utility of digital mobility outcomes for personalized clinical decision support in parkinson's disease.Neurological research and practice · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
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.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.