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Although topically applied MDs in the form of gels and creams might be used on damaged skin, their composition is often similar to that of cosmetic products applicable to intact skin, especially in terms of preservatives and fragrances. However, unlike cosmetics, these products are not subject to compound\u2010specific restrictions when used in MDs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>This study aimed to identify and quantify preservatives and fragrances in topically applied MDs and assess their safety towards the Cosmetic Regulation (EC) 1223\/2009.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>Sixty\u2010nine MDs available on the EU market were subjected to previously validated liquid chromatography tandem mass spectrometry (LC\u2013MS\/MS) and gas chromatography\u2013mass spectrometry (GC\u2013MS) methods to identify and quantify occurring preservatives and fragrances.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Findings revealed that 32% of the examined MDs did not provide comprehensive ingredient lists, leaving users uninformed about potential risks associated with product use. Furthermore, 30% of these MDs would not meet safety standards for cosmetic products and, most significantly, 13% of the analysed samples contained ingredients that are prohibited in leave\u2010on cosmetics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Results highlight the pressing demand for more stringent requirements regarding the labelling and composition of MDs to enhance patient safety. Improved regulation and transparency can mitigate potential risks associated with the use of topically applied MDs.<\/jats:p><\/jats:sec>","DOI":"10.1111\/cod.14533","type":"journal-article","created":{"date-parts":[[2024,3,13]],"date-time":"2024-03-13T01:39:35Z","timestamp":1710293975000},"page":"594-606","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Analysis of preservatives and fragrances in topical medical devices: The need for more stringent regulation"],"prefix":"10.1111","volume":"90","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-4216-5109","authenticated-orcid":false,"given":"Ania","family":"Stras","sequence":"first","affiliation":[{"name":"Medicines and Health Products Sciensano  Elsene Belgium"},{"name":"Department In Vitro Toxicology and Dermato\u2010Cosmetology (IVTD) Vrije Universiteit Brussel  Jette Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aleksandra","family":"Grassmann","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Catholique de Louvain  Wolluwe\u2010Saint\u2010Lambert Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Van Campenhout","sequence":"additional","affiliation":[{"name":"Medicines and Health Products Sciensano  Elsene Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Deconinck","sequence":"additional","affiliation":[{"name":"Medicines and Health Products Sciensano  Elsene Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tamara","family":"Vanhaecke","sequence":"additional","affiliation":[{"name":"Department In Vitro Toxicology and Dermato\u2010Cosmetology (IVTD) Vrije Universiteit Brussel  Jette Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7388-2281","authenticated-orcid":false,"given":"Bart","family":"Desmedt","sequence":"additional","affiliation":[{"name":"Medicines and Health Products Sciensano  Elsene Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,3,12]]},"reference":[{"key":"e_1_2_9_2_1","first-page":"1","article-title":"EU regulation 745\/2017 on medical devices","volume":"117","year":"2017","journal-title":"Off J Eur Union"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010019\u201000878\u20103"},{"key":"e_1_2_9_4_1","first-page":"1","article-title":"EU regulation 1223\/2009 on cosmetic products","volume":"342","year":"2009","journal-title":"Off J Eur Union"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clindermatol.2008.04.002"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/978\u20103\u2010642\u201027606\u20104_1"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11845\u2010018\u20101880\u20104"},{"key":"e_1_2_9_8_1","unstructured":"Lautenschl\u00e4gerH.Keeping an overview\u2014what distinguishes topical medical devices from cosmetic products.Dermaviduals. 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