{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T17:28:20Z","timestamp":1777915700000,"version":"3.51.4"},"reference-count":20,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2018,5,24]],"date-time":"2018-05-24T00:00:00Z","timestamp":1527120000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Perfusion"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:p>This review summarizes the European rules to control the market when introducing new products. In particular, it shows all the steps to achieve the European Conformity (CE Mark), a certification that all new medical products must achieve before being used in Europe. Extracorporeal membrane oxygenation (ECMO) devices are exposed to the same procedures. Hereby, we present some regulatory issues regarding pumps and oxygenators, providing technical details as released by the manufacturers on their websites and information charts.<\/jats:p>","DOI":"10.1177\/0267659118772452","type":"journal-article","created":{"date-parts":[[2018,5,24]],"date-time":"2018-05-24T12:00:36Z","timestamp":1527163236000},"page":"553-561","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe"],"prefix":"10.1177","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0051-8080","authenticated-orcid":false,"given":"Matteo","family":"Di Nardo","sequence":"first","affiliation":[{"name":"Pediatric Intensive Care Unit, Children\u2019s Hospital Bambino Ges\u00f9, IRCCS, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leen","family":"Vercaemst","sequence":"additional","affiliation":[{"name":"Department of Perfusion, University Hospital Gasthuisberg, Louvain, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2903-092X","authenticated-orcid":false,"given":"Justyna","family":"Swol","sequence":"additional","affiliation":[{"name":"Department of Pulmonology, Intensive Care Medicine, Paracelsus Medical University, Nuremberg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicholas","family":"Barret","sequence":"additional","affiliation":[{"name":"Department of Critical Care, Guy\u2019s and St. Thomas\u2019 NHS Foundation Trust, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabio S.","family":"Taccone","sequence":"additional","affiliation":[{"name":"Department of Intensive Care, Erasme Hospital, Universit\u00e9 Libre de Bruxelles (ULB), Brussels, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maximilian V.","family":"Malfertheiner","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4124-4581","authenticated-orcid":false,"given":"Lars M.","family":"Broman","sequence":"additional","affiliation":[{"name":"ECMO Centre Karolinska, Department of Pediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Federico","family":"Pappalardo","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Anesthesia and Intensive Care, San Raffaele Hospital, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan","family":"Belohlavek","sequence":"additional","affiliation":[{"name":"Second Department of Medicine, Cardiovascular Medicine, General University Hospital in Prague, First Faculty of Medicine, Charles University in Prague, Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Mueller","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberto","family":"Lorusso","sequence":"additional","affiliation":[{"name":"Department of Cardio-Thoracic Surgery, Heart & Vascular Centre, Maastricht University Medical Hospital, Maastricht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margherita","family":"Lonero","sequence":"additional","affiliation":[{"name":"Pediatric Intensive Care Unit, Children\u2019s Hospital Bambino Ges\u00f9, IRCCS, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mirko","family":"Belliato","sequence":"additional","affiliation":[{"name":"U.O.C. Anestesia e Rianimazione 1, IRCCS, Policlinico San Matteo Foundation, Pavia, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2018,5,24]]},"reference":[{"key":"bibr1-0267659118772452","unstructured":"Changes to EU Medical Device Legislation\u2013What you need to know\u2013White paper Cromsource Regulatory Services. https:\/\/www.cromsource.com\/download\/changes-eu-medical-device-legislation-need-know-white-paper-june-2016\/ (June 2016; accessed 29th January 2018)."},{"key":"bibr2-0267659118772452","unstructured":"Understanding Europe\u2019s New Medical Devices Regulation (MDR 2017\/745) \u2013 E.Loh \u2013 Emergo. https:\/\/www.emergogroup.com\/resources\/articles\/whitepaper-understanding-europes-medical-devices-regulation (2017; accessed 29th January 2018)."},{"key":"bibr3-0267659118772452","unstructured":"ISO 13485 2016 and how it impacts medical devices companies. https:\/\/www.iso.org\/standard\/59752.html (2016; accessed 29th January 2018)."},{"key":"bibr4-0267659118772452","unstructured":"Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EE. http:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32017R0745. (2017; accessed 29th January 2018)"},{"key":"bibr5-0267659118772452","unstructured":"The Official Journal of the European Union. http:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ%3AL%3A2017%3A117%3ATOC. (April 2017; accessed 29th January 2018)."},{"key":"bibr6-0267659118772452","unstructured":"ISO 18242 Cardiovascular implants and extracorporeal systems \u2013 Centrifugal pumps. https:\/\/www.iso.org\/standard\/61855.html (2016; accessed 29th January 2018)."},{"key":"bibr7-0267659118772452","unstructured":"Centrimag\n                      TM\n                      & PediVas\n                      TM\n                      ; https:\/\/www.sjmglobal.com\/en-int\/professionals\/featured-products\/heart-failure-management\/mechanical-circulatory-support\/acute-circulatory-support-system\/centrimag-acute-circulatory-support-system (accessed 29th January 2018)."},{"key":"bibr8-0267659118772452","doi-asserted-by":"publisher","DOI":"10.1093\/icvts\/ivt320"},{"key":"bibr9-0267659118772452","doi-asserted-by":"publisher","DOI":"10.1177\/2150135114526760"},{"key":"bibr10-0267659118772452","unstructured":"Maquet Rotaflow; https:\/\/www.maquet.com\/int\/products\/rotaflow-centrifugal-pump\/ (accessed 29th January 2018)."},{"key":"bibr11-0267659118772452","doi-asserted-by":"publisher","DOI":"10.1177\/0267659106074003"},{"key":"bibr12-0267659118772452","unstructured":"Medtronic ECLS pumps; http:\/\/www.medtronic.com\/us-en\/healthcare-professionals\/therapies-procedures\/cardiovascular\/perfusion.html (accessed 29th January 2018)."},{"key":"bibr13-0267659118772452","unstructured":"Revolution Livanova; http:\/\/www.livanova.sorin.com\/products\/cardiac-surgery\/perfusion\/centrifugal-blood-pump\/revolution (accessed 29th January 2018)."},{"key":"bibr14-0267659118772452","unstructured":"ISO 7199 Cardiovascular implants and extracorporeal systems \u2013 Blood gas exchangers (oxygenators); https:\/\/www.iso.org\/standard\/67607.html; (2016; accessed 29th January 2018)."},{"key":"bibr15-0267659118772452","unstructured":"PLS System oxygenators Maquet Getinge Group; https:\/\/www.maquet.com\/int\/products\/pls-system\/ (accessed 29th January 2018)."},{"key":"bibr16-0267659118772452","unstructured":"Medos Hilite, Xenios AG; https:\/\/www.xenios-ag.com\/medos-products\/hilite-oxygenators (accessed 29th January 2018)."},{"key":"bibr17-0267659118772452","unstructured":"Novalung oxygenators Xenios AG; https:\/\/www.xenios-ag.com\/novalung-products (accessed 29th January 2018)."},{"key":"bibr18-0267659118772452","unstructured":"LivaNova oxygenators; http:\/\/www.livanova.sorin.com\/products\/cardiac-surgery\/perfusion\/long-term-use (accessed 29th January 2018)."},{"key":"bibr19-0267659118772452","unstructured":"Eurosets oxygenators; https:\/\/www.eurosets.com\/ecls\/ (accessed 29th January 2018)."},{"key":"bibr20-0267659118772452","unstructured":"Paragon oxygenators; https:\/\/www.chalicemedical.com\/index.php\/product\/paragon-oxygenators (accessed 29th January 2018)."}],"container-title":["Perfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0267659118772452","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0267659118772452","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0267659118772452","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T17:27:21Z","timestamp":1777656441000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/0267659118772452"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,5,24]]},"references-count":20,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2018,10]]}},"alternative-id":["10.1177\/0267659118772452"],"URL":"https:\/\/doi.org\/10.1177\/0267659118772452","relation":{},"ISSN":["0267-6591","1477-111X"],"issn-type":[{"value":"0267-6591","type":"print"},{"value":"1477-111X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,5,24]]}}}