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

The medical device regulation (MDR) was adopted in 2017 to replace the medical device directive (MDD). 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 optimise the benefits of the MDR and to minimise unintended consequences.

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Publication Details

Journal
Nephrology Dialysis Transplantation
Published
2025-12-27
DOI
https://doi.org/10.1093/ndt/gfaf269
Citations
1
Primary Topic
Pharmaceutical Economics and Policy
Type
article
Field-Weighted Citation Impact
3.13
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article

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

Rümeyza Kazancioğlu, Yuri Battaglia, Rukshana Shroff, M. Hecking et al.
1 citations
Nephrology Dialysis Transplantation
Pharmaceutical Economics and Policy
3.13
article

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

Rümeyza Kazancioğlu, Yuri Battaglia, Rukshana Shroff, M. Hecking, Casper F. M. Franssen, Valérie A. Luyckx, Chantal Combe, Gaetano Alfano, Björn Meijers
article en
1 citations

Abstract

The medical device regulation (MDR) was adopted in 2017 to replace the medical device directive (MDD). 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 optimise the benefits of the MDR and to minimise unintended consequences.

Nephrology Dialysis Transplantation
University of Verona (IT), Cambridge Health Alliance (US), Brigham and Women's Hospital (US), University Medical Center Groningen (NL), Université de Bordeaux (FR), Inserm (FR), University of Cape Town (ZA), University of Zurich (CH), Great Ormond Street Hospital (GB), Renal Association (GB), Prevention Institute (US), Bezmiâlem Vakıf Üniversitesi (TR), Hospices Civils de Lyon (FR), Bordeaux Population Health (FR), Casa di Cura Villa Garda (IT), Azienda Ospedaliero-Universitaria di Modena (IT), Metabolism and Renal Physiology (FR), University Children's Hospital Zurich (CH), Centre Hospitalier Départemental Vendée (FR), University College London (GB), Medical University of Vienna (AT), KU Leuven (BE)
Industry, innovation and infrastructure
Openalex Percentile: Top 5%
Pharmaceutical Economics and Policy
3.13
DOIOpen Access PDFOpenAlex
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