Evidence map›Paper›PMID 41459722›Full record

ReviewNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2026

Medical device regulation and dialysis practice-impact on patients, doctors and manufacturers.

Björn Meijers, Rukshana Shroff, Yuri Battaglia, Rumeyza Kazancioglu, Gaetano Alfano, Casper Franssen, Manfred Hecking, Valerie Luyckx, Christian Combe

Abstract readReview
In one paragraph

Review in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. Over 500 000 people on kidney replacement therapy in the European Union.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Björn MeijersLaboratory of Nephrology and Renal Transplantation, Department of Microbiology, Immunology and Transplantation, KU Leuven, Belgium.ORCID 0000-0002-2846-2026
Rukshana ShroffPaediatric Nephrology Unit, University College London Great Ormond Street Hospital and Institute of Child Health, London, UK.ORCID 0000-0001-8501-1072
Yuri BattagliaUniversity of Verona, Department of Medicine, Verona, Italy.ORCID 0000-0003-3947-1814
Rumeyza KazanciogluDivision of Nephrology School of Medicine, Bezmialem Vakif University, Istanbul, Türkiye.
Gaetano AlfanoNephrology Dialysis and Kidney Transplant Unit, Azienda Ospedaliero Universitaria di Modena, Modena, Italy.ORCID 0000-0003-0591-8622
Casper FranssenDepartment of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Manfred HeckingMedical University of Vienna, Department of Internal Medicine III, Clinical Division of Nephrology & Dialysis, Vienna, Austria.ORCID 0000-0002-8047-2395
Valerie LuyckxUniversity Children's Hospital, University of Zurich, Zurich, Switzerland.
Christian CombeUniv. Bordeaux, INSERM, Bordeaux Public Health, U1219, CIC 1401, Bordeaux, France.ORCID 0000-0002-0360-573X

Funding

European Renal Association
6 · The paper itself

Abstract

The Medical Device Regulation (MDR) was adopted in 2017 to replace the Medical Device Directive. Key changes included more rigorous clinical evidence requirements, increased scrutiny of notified bodies and improved traceability of medical devices, with the overarching aim to improve their safety and quality. For chronic haemodialysis, the impact of the MDR on devices has been substantial, resulting in niche devices being no longer available, and critical shortages, especially in paediatric nephrology. The EuDial board discussed these developments and concluded that the MDR has had a clear negative impact on innovation. In conjunction with other emerging economic macro-trends, this development heightens the potential for disruptions within critical supply chains. We offer actionable recommendations to optimize the benefits of the MDR and to minimize unintended consequences.

Indexed as

Equipment and SuppliesKidney Failure, ChronicMedical Device LegislationPhysiciansRenal DialysisHumanschronic hemodialysisdialysisguidelineshaemodiafiltrationhaemodialysis

Identifiers

PMID41459722
PMCPMC13130945

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.