{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T19:30:09Z","timestamp":1783020609593,"version":"3.54.6"},"reference-count":59,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T00:00:00Z","timestamp":1782950400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The EU Medical Device Regulation (MDR), effective since May 25, 2017, aims to enhance the safety and quality of medical devices within the EU. This study models the potential net mortality implications of the MDR in Germany under explicit assumptions about safety improvements, market withdrawals, and certification delays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A combined top-down and bottom-up approach was employed to evaluate the impact of the EU MDR on mortality in Germany. The top-down approach estimated avoided deaths using the Keyfitz\u2013Vaupel life-table elasticity, while the bottom-up approach quantified mortality reductions attributable to individual MDR-regulated medical devices. Based on the results of both approaches, the analysis also estimated the number of deaths potentially resulting from market withdrawals and certification delays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Official German reports attribute an average of 17 device-related deaths annually, whereas international estimates suggest the true figure may reach up to 2,500 per year. Market withdrawals and certification delays associated with MDR implementation were modelled as potentially contributing an estimated 163\u20131,884 additional annual deaths and a one-time mortality burden of 700\u20134,200 deaths.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Under central assumptions, the MDR is consistent with long-term reductions in device-related mortality, but transition-period certification bottlenecks and withdrawals\u2014especially for niche\/pediatric devices\u2014can offset gains in the short to medium term. Targeted mitigation is warranted to secure benefits and limit unintended harms.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0350175","type":"journal-article","created":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T18:06:44Z","timestamp":1783015604000},"page":"e0350175","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluating the impact of the EU Medical Device Regulation (MDR) on mortality and device availability in Germany"],"prefix":"10.1371","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4262-8344","authenticated-orcid":true,"given":"Afschin","family":"Gandjour","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2026,7,2]]},"reference":[{"key":"pone.0350175.ref001","author":"European Medicines Agency","year":"2021"},{"key":"pone.0350175.ref002","author":"European Commission","year":"2012"},{"key":"pone.0350175.ref003","author":"Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte","year":"2016"},{"key":"pone.0350175.ref004","volume-title":"Die Implant Files: das gef\u00e4hrliche Gesch\u00e4ft mit der Gesundheit","author":"S\u00fcddeutsche Zeitung","year":"2018"},{"key":"pone.0350175.ref005","author":"P Wien","year":"2023"},{"key":"pone.0350175.ref006","author":"Bundesverband Medizintechnologie","year":"2023"},{"key":"pone.0350175.ref007","author":"Deutsches \u00c4rzteblatt","year":"2022"},{"key":"pone.0350175.ref008","author":"RegDesk","year":"2023"},{"issue":"2","key":"pone.0350175.ref009","doi-asserted-by":"crossref","first-page":"201","DOI":"10.1353\/dem.2003.0018","article-title":"Decomposing change in life expectancy: a bouquet of formulas in honor of Nathan Keyfitz\u2019s 90th birthday","volume":"40","author":"JW Vaupel","year":"2003","journal-title":"Demography"},{"issue":"1","key":"pone.0350175.ref010","first-page":"66","article-title":"The effect of medical technology innovations on patient outcomes, 1990-2015: results of a physician survey","volume":"25","author":"DE Wamble","year":"2019","journal-title":"J Manag Care Spec Pharm"},{"issue":"9","key":"pone.0350175.ref011","doi-asserted-by":"crossref","first-page":"1546","DOI":"10.1377\/hlthaff.2020.00284","article-title":"Contributions of public health, pharmaceuticals, and other medical care to US life expectancy changes, 1990-2015","volume":"39","author":"JD Buxbaum","year":"2020","journal-title":"Health Affairs"},{"issue":"1","key":"pone.0350175.ref012","first-page":"56","article-title":"Regulation of medical devices in Australia","volume":"3","author":"A Craig","year":"2019","journal-title":"EMJ Innov"},{"key":"pone.0350175.ref013","author":"International Consortium of Investigative Journalists","year":"2018"},{"issue":"9","key":"pone.0350175.ref014","doi-asserted-by":"crossref","first-page":"1217","DOI":"10.1001\/jamainternmed.2021.3942","article-title":"Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death","volume":"181","author":"C Lalani","year":"2021","journal-title":"JAMA Internal Medicine"},{"issue":"5","key":"pone.0350175.ref015","doi-asserted-by":"crossref","first-page":"399","DOI":"10.1016\/j.jacbts.2016.06.003","article-title":"Drugs and Devices: Comparison of European and U.S. Approval Processes","volume":"1","author":"GA Van Norman","year":"2016","journal-title":"JACC Basic Transl Sci"},{"key":"pone.0350175.ref016","article-title":"Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study","volume":"353","author":"TJ Hwang","year":"2016","journal-title":"BMJ"},{"key":"pone.0350175.ref017","unstructured":"The Guardian. 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