ArticleEuro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin2026
Despite good intentions, the regulation on in vitro diagnostic medical devices (IVDR) in Europe could impact negatively on preparedness and response for the next pandemic.
Article in Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 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
3 citing papers in PubMed.
- Improving public health laboratory preparedness at European Union level: learning points from experiences during the COVID-19 pandemic.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2026Article
- Perspective on human diagnostic and national reference laboratory preparedness for zoonotic influenza in Europe.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2026Article
- Beyond static biomarkers: systems biology and AI for decoding cancer dynamics.Frontiers in systems biology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Currently, there is concern and uncertainty in the European and North American markets for in vitro diagnostics regarding the regulation of in vitro diagnostic tests. In the European Union, starting from May 2022, the regulation on vitro diagnostic medical devices (IVDR) has replaced the directive on in vitro diagnostic medical devices (IVDD). The IVDR, while written with the good intentions to ensure patient safety and health while supporting innovation and transparency, has resulted in uncertainty, instances of disruption of diagnostic development, and concerns related to pandemic preparedness and response. We here outline the history, current situation and concerns regarding pandemic preparedness in Europe. Finally, we make recommendations that could improve the IVDR while supporting pandemic preparedness.
Indexed as
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.