{"id":32199,"date":"2024-03-20T10:17:57","date_gmt":"2024-03-20T09:17:57","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=32199"},"modified":"2024-03-20T10:18:10","modified_gmt":"2024-03-20T09:18:10","slug":"europe-harmonised-standards-in-the-medical-devices-industry","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/03\/20\/europe-harmonised-standards-in-the-medical-devices-industry\/","title":{"rendered":"EUROPE: Harmonised Standards in the Medical Devices Industry"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>On <strong>March 6, 2024<\/strong>, the European Commission <strong>amended Implementing Decision (EU) 2021\/1182<\/strong> on <strong>harmonised standards <\/strong>for single-use medical gloves, biological evaluation of medical devices, sterilisation of healthcare products, packaging for terminally sterilised medical devices and packaging for healthcare products.<\/h2>\n<p>By Implementing Decision C (2021) 2406 (5), the European Commission requested the European Committee for Standardisation <strong>(CEN)<\/strong> and the European Committee for Electrotechnical Standardisation <strong>(Cenelec)<\/strong> to <strong>review <\/strong>the existing harmonised standards on medical devices drafted in support of Directives 90\/385\/EEC and 93\/42\/EEC and also requested that new harmonised standards be drafted in support of Regulation (EU) 2017\/745.<\/p>\n<p>As a result, CEN and Cenelec have revised the harmonised standards <strong>EN 455-3:2015<\/strong> on single-use medical gloves, <strong>EN ISO 10993-15:2009<\/strong>, <strong>EN<\/strong> <strong>ISO 10993-17:2009<\/strong> and <strong>EN ISO 10993-18:2020<\/strong> on biological evaluation of medical devices, <strong>EN ISO 11137-2:2015<\/strong> on sterilisation of healthcare products, <strong>EN ISO 11607-1:2020<\/strong> and <strong>EN ISO 11607-2<\/strong>\u00a0 <strong>2020<\/strong> on packaging for terminally sterilised medical devices, and <strong>EN ISO 17664:2017<\/strong> on packaging of health care products, the references of which are not published in the Official Journal of the European Union, to take into account the latest technical and scientific advances and the need to support the requirements of Regulation (EU) 2017\/745.<\/p>\n<p>The alignment by a manufacturer to a harmonised standard, as we know, is a very important aspect because it confers a <strong>presumption of conformity<\/strong> to the essential requirements.<\/p>\n<p>With this initiative, the European Commission once again demonstrates its commitment to ensuring an increasing number of harmonised standards to help manufacturers produce devices that comply with safety and performance requirements to safeguard the health of users and patients.<\/p>\n<p><strong>&gt;&gt;&gt;\u00a0<\/strong>Through the services of<strong>\u00a0<\/strong><a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>strategic-regulatory consulting<\/strong>, support <\/a>to\u00a0<a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/supporto-alla-certificazione-ce-dispositivi-medici-ivd\/\"><strong>EC certification<\/strong><\/a>\u00a0and if necessary, <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/local-representative-mercati-esteri\/servizio-rappresentante-autorizzato-europeo\/\"><strong>a European Authorised Representative<\/strong><\/a>, Thema can help you implement the requirements of the MDR (EU) 2017\/745.<\/p>\n<p><strong>Source<\/strong><\/p>\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=OJ:L_202400815\">COMMISSION IMPLEMENTING DECISION (EU) 2024\/815<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32196,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-32199","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EUROPE: Harmonised Standards in the Medical 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