{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T12:50:52Z","timestamp":1788439852660,"version":"build-2803163510"},"reference-count":30,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,5,6]],"date-time":"2021-05-06T00:00:00Z","timestamp":1620259200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>In recent years, skin reactions secondary to the use of medical devices (MD), such as allergic contact dermatitis have increasingly been observed (e.g. to continuous blood sugar monitoring systems, insulin pumps, wound dressings, medical gloves, etc.): this is regarded as a developing epidemic. Lack of labelling of the composition of MD, as well as frequent lack of cooperation of manufacturers to disclose this relevant information, even when contacted by the clinician for the individual case of an established adverse reaction, significantly impede patient care.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To advocate for full ingredient labelling in the implementation of EU regulation for MD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This position paper reviews the scientific literature, the current regulatory framework adopted for MD to date, and the likely impact, including some costs data in case of the absence of such labelling.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Efforts made by several scientific teams, who are trying to identify the culprit of such adverse effects, either via asking for cooperation from companies, or using costly chemical analyses of MD, can only partly, and with considerable delay, compensate for the absence of meaningful information on the composition of MD; hence, patient management is compromised. Indeed, without knowing the chemical substances present, physicians are unable to inform patients about which substances they should avoid, and which alternative MD may be suitable\/tolerated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>There is an urgent need for full and accurate labelling of the chemical composition of MD in contact with the human body.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.17238","type":"journal-article","created":{"date-parts":[[2021,5,6]],"date-time":"2021-05-06T22:50:23Z","timestamp":1620341423000},"page":"1444-1448","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":45,"title":["Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices"],"prefix":"10.1111","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7000-1672","authenticated-orcid":false,"given":"A.","family":"Herman","sequence":"first","affiliation":[{"name":"Department of Dermatology Cliniques universitaires Saint\u2010Luc Universit\u00e9 catholique de Louvain (UCLouvain) Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.","family":"Uter","sequence":"additional","affiliation":[{"name":"Department of Medical Informatics, Biometry and Epidemiology Univ. Erlangen\/N\u00fcrnberg Erlangen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7580-0684","authenticated-orcid":false,"given":"T.","family":"Rustemeyer","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology Amsterdam University Medical Centres Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Matura","sequence":"additional","affiliation":[{"name":"Dermatology Unit Skaraborgs Hospital Sk\u00f6vde Sk\u00f6vde Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Aalto\u2010Korte","sequence":"additional","affiliation":[{"name":"Occupational Health Unit Finnish Institute of Occupational Heath Helsinki Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Duus Johansen","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergy National Allergy Research Centre Herlev\u2010Gentofte Hospital University of Copenhagen Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Gon\u00e7alo","sequence":"additional","affiliation":[{"name":"Department of Dermatology Coimbra University Hospital and Faculty of Medicine University of Coimbra Coimbra Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I.R.","family":"White","sequence":"additional","affiliation":[{"name":"Cutaneous Allergy Team St. John's Institute of Dermatology Guy's Hospital London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5485-0172","authenticated-orcid":false,"given":"A.","family":"Balato","sequence":"additional","affiliation":[{"name":"Department of Advanced Biomedical Sciences University of Naples Federico II Napoli Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5434-7753","authenticated-orcid":false,"given":"A.M.","family":"Gim\u00e9nez Arnau","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital del Mar. Universitat Aut\u00f2noma de Barcelona Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2775-3681","authenticated-orcid":false,"given":"K.","family":"Brockow","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergy Biederstein School of Medicine Technical University of Munich Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.G.","family":"Mortz","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergy Center Odense Research Center for Anaphylaxis (ORCA) Odense University Hospital Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Mahler","sequence":"additional","affiliation":[{"name":"Med. Faculty Univ. 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