Evidence map›Paper›PMID 42527494›Full record

Reviewnpj health systems2026

Data-driven medical devices and the EU MDR: mapping gaps in standards for regulatory compliance.

Ugur Ilker Atmaca, Saif Ul Islam, Gregory Epiphaniou, Anita Khadka, Stuart Harrison, Nikolaos Matragkas, Scott Hansen, Rance DeLong, Carsten Maple

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in npj health systems, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ugur Ilker AtmacaWMG, University of Warwick, Coventry, UK. ugur-ilker.atmaca@warwick.ac.uk.
Saif Ul IslamWMG, University of Warwick, Coventry, UK.
Gregory EpiphaniouWMG, University of Warwick, Coventry, UK.
Anita KhadkaWMG, University of Warwick, Coventry, UK.
Stuart HarrisonWMG, University of Warwick, Coventry, UK.
Nikolaos MatragkasCEA, List, Université Paris-Saclay, 2 Bd Thomas Gobert, Palaiseau, France.
Scott HansenThe Open Group, Brussels, Belgium.
Rance DeLongThe Open Group, Brussels, Belgium.
Carsten MapleWMG, University of Warwick, Coventry, UK.

Funding

the European Commission 101095661
6 · The paper itself

Abstract

Data-driven medical devices promise significant enhancements to diagnostic accuracy, personalised treatments, real-time patient monitoring, and clinical decision support. However, these innovations present regulatory challenges. This study maps the current European Union Medical Device Regulation requirements against international data safety and quality assurance standards, identifying critical gaps. It highlights challenges in data quality, algorithm transparency, risk management, continuous validation, and synthetic data use. Recommendations are proposed to support regulatory adaptation.

Identifiers

PMID42527494
PMCPMC13354248

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.