ArticleNPJ digital medicine2026
Impact of the new European medical device regulation on digital health manufacturers.
Article in NPJ digital medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
Abstract
This study assessed the Medical Device Regulation EU 2017/745 impact on the digital health companies and the industry. An online survey was conducted in April-May 2025, targeting manufacturers registered in the EUDAMED database with a software-type product. 35 responses were received. The survey results empirically confirm the negative effect of the theoretically identified hindering factors. The financial burden was the most common challenge, with 31 respondents (88.6%) reporting a significant or severe impact. The regulation causes delays, the new clinical evidence requirements are challenging, and the process requires more resources. 6 companies (23.1% of those planning a launch) have canceled a new product launch, while 8 (34.8% of companies with 2 or more products) have discontinued an existing product. 6 respondents (17.1%) are exiting the EU market, and 10 companies (28.6%) are considering shutting down their operations. 16 respondents (45.7%) consider certification not worthwhile if the buyers are individual consumers.
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.