{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T04:43:04Z","timestamp":1777869784257,"version":"3.51.4"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2025,12,29]],"date-time":"2025-12-29T00:00:00Z","timestamp":1766966400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"European Renal Association"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,4,30]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>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.<\/jats:p>","DOI":"10.1093\/ndt\/gfaf269","type":"journal-article","created":{"date-parts":[[2025,12,27]],"date-time":"2025-12-27T12:41:52Z","timestamp":1766839312000},"page":"969-977","source":"Crossref","is-referenced-by-count":2,"title":["Medical device regulation and dialysis practice\u2014impact on patients, doctors and manufacturers"],"prefix":"10.1093","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2846-2026","authenticated-orcid":false,"given":"Bj\u00f6rn","family":"Meijers","sequence":"first","affiliation":[{"name":"Laboratory of Nephrology and Renal Transplantation , Department of Microbiology, Immunology and Transplantation, KU Leuven ,","place":["Belgium"]},{"name":"Nephrology Unit Department of Internal Medicine, , UZ Leuven ,","place":["Belgium"]},{"name":"EuDial Working Group, European Renal Association"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8501-1072","authenticated-orcid":false,"given":"Rukshana","family":"Shroff","sequence":"additional","affiliation":[{"name":"Paediatric Nephrology Unit, University College London Great Ormond Street Hospital and Institute of Child Health , London ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3947-1814","authenticated-orcid":false,"given":"Yuri","family":"Battaglia","sequence":"additional","affiliation":[{"name":"University of Verona , Department of Medicine, Verona ,","place":["Italy"]},{"name":"Pederzoli Hospital, Nephrology and Dialysis Unit , Peschiera del Garda ,","place":["Italy"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rumeyza","family":"Kazancioglu","sequence":"additional","affiliation":[{"name":"Division of Nephrology School of Medicine, Bezmialem Vakif University , Istanbul ,","place":["T\u00fcrkiye"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0591-8622","authenticated-orcid":false,"given":"Gaetano","family":"Alfano","sequence":"additional","affiliation":[{"name":"Nephrology Dialysis and Kidney Transplant Unit, Azienda Ospedaliero Universitaria di Modena , Modena ,","place":["Italy"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Casper","family":"Franssen","sequence":"additional","affiliation":[{"name":"Division of Nephrology, University Medical Center Groningen, University of Groningen Department of Internal Medicine, , Groningen ,","place":["The Netherlands"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8047-2395","authenticated-orcid":false,"given":"Manfred","family":"Hecking","sequence":"additional","affiliation":[{"name":"Medical University of Vienna , Department of Internal Medicine III, Clinical Division of Nephrology & Dialysis, Vienna ,","place":["Austria"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valerie","family":"Luyckx","sequence":"additional","affiliation":[{"name":"University Children\u2019s Hospital, University of Zurich , Zurich ,","place":["Switzerland"]},{"name":"Epidemiology, Biostatistics and Prevention Institute, University of Zurich Department of Public and Global Health, , Zurich ,","place":["Switzerland"]},{"name":"Renal Division, Brigham and Women\u2019s Hospital, Harvard Medical School , Boston, MA ,","place":["USA"]},{"name":"University of Cape Town Department of Paediatrics and Child Health, , Cape Town ,","place":["South Africa"]},{"name":"President European Kidney Health Alliance , Brussels ,","place":["Belgium"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0360-573X","authenticated-orcid":false,"given":"Christian","family":"Combe","sequence":"additional","affiliation":[{"name":"Univ. 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