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Here, xenotransplantation offers a suitable option since the genetic modification of animals has become an established method that allows the generation of animals as donors of cells, tissues, and organs with reduced antigenicity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Focus is given on the generation of decellularized matrix scaffolds, for example, for valve transplantation and\/or repair, that have the potential being fully assimilated by the recipient as they are no longer a mechanical implant with risk of calcification and related failure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>This new class of products is transplants that will be regulated either as medical devices or as cell\u2010based medicinal products, that is, advanced therapy medicinal products, according to the regulations in the European Union.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In this review, we compile relevant regulatory aspects and point out the possibilities of how these products for human use may be regulated in the future.<\/jats:p><\/jats:sec>","DOI":"10.1111\/xen.12609","type":"journal-article","created":{"date-parts":[[2020,5,25]],"date-time":"2020-05-25T08:35:26Z","timestamp":1590395726000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Xenotransplantation of decellularized pig heart valves\u2014Regulatory aspects in Europe"],"prefix":"10.1111","volume":"27","author":[{"given":"Antonia W.","family":"Godehardt","sequence":"first","affiliation":[{"name":"Division of Medical Biotechnology Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralf R.","family":"T\u00f6njes","sequence":"additional","affiliation":[{"name":"Division of Medical Biotechnology Paul\u2010Ehrlich\u2010Institut Langen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,5,25]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/TP.0000000000002226"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00108-015-3803-z"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/af\/vfz014"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/ctr.12522"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.burns.2018.02.029"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2019.02.058"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/ejcts\/ezw050"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.burns.2013.08.020"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.68.7.1590"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trim.2003.12.016"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/0142-9612(96)82721-9"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.5051\/jpis.2017.47.6.388"},{"key":"e_1_2_8_14_1","unstructured":"EUR\u2010Lex \u2010 02001L0083\u201020190726 \u2010 EN \u2010 EUR\u2010Lex.https:\/\/eur\u2010lex.europa.eu\/legal\u2010content\/EN\/TXT\/?uri=CELEX:02001L0083\u201020190726&qid=1584011974355. 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