{"id":22670,"date":"2025-06-11T14:58:19","date_gmt":"2025-06-11T11:58:19","guid":{"rendered":"https:\/\/uni-cert.ua\/?p=22670"},"modified":"2025-06-11T15:13:11","modified_gmt":"2025-06-11T12:13:11","slug":"22670","status":"publish","type":"post","link":"https:\/\/uni-cert.ua\/en\/2025\/06\/11\/22670\/","title":{"rendered":"Practical guide for the use of European Medical Device Nomenclature"},"content":{"rendered":"<div class=\"xdj266r x14z9mp xat24cr x1lziwak x1vvkbs x126k92a\">\n<div dir=\"auto\" style=\"text-align: justify;\">Manufacturers operating under the (EU) 2017\/745 Medical Device Regulation (MDR) and (EU) 2017\/746 In Vitro Diagnostic Regulation (IVDR) are required to utilise the European Medical Device Nomenclature (EMDN) for regulatory submissions, device registration in EUDAMED, and sampling.<\/div>\n<div dir=\"auto\" style=\"text-align: justify;\">\u00a0<\/div>\n<div dir=\"auto\" style=\"text-align: justify;\">To support consistent and compliant application, MedTech Europe released a practical guide for the use of the EMDN to:<\/div>\n<\/div>\n<div dir=\"auto\">\u00a0<\/div>\n<div class=\"x14z9mp xat24cr x1lziwak x1vvkbs xtlvy1s x126k92a\" style=\"text-align: justify;\">\n<ul>\n<li>Assist in the identification and assignment of appropriate EMDN codes<\/li>\n<li>Clarify the structure, categories, and hierarchy of the EMDN<\/li>\n<li dir=\"auto\">Explain how EMDN relates to GMDN and GIVD<\/li>\n<li dir=\"auto\">Guide users in cases where no appropriate code exists, including how to propose new EMDN entries<\/li>\n<li dir=\"auto\">Promote alignment in device categorization across certificates, EUDAMED entries, and notified body documentation<\/li>\n<\/ul>\n<\/div>\n<div class=\"x14z9mp xat24cr x1lziwak x1vvkbs xtlvy1s x126k92a\">\n<div dir=\"auto\" style=\"text-align: justify;\">This reference is particularly relevant for regulatory, quality, and technical teams seeking a robust understanding of EMDN requirements and practical implementation strategies: <a href=\"https:\/\/www.medtecheurope.org\/wp-content\/uploads\/2025\/05\/250522_medtech-europe_emdn-booklet_final-dp.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.medtecheurope.org\/wp-content\/uploads\/2025\/05\/250522_medtech-europe_emdn-booklet_final-dp.pdf<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Manufacturers operating under the (EU) 2017\/745 Medical Device Regulation (MDR) and (EU) 2017\/746 In Vitro Diagnostic Regulation (IVDR) are required to utilise the European Medical Device Nomenclature (EMDN) for regulatory submissions, device registration in EUDAMED, and sampling. \u00a0 To support consistent and compliant application, MedTech Europe released a practical guide for the use of the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":22671,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1,4],"tags":[],"class_list":["post-22670","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-publikaczii"],"acf":[],"_links":{"self":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/22670","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/comments?post=22670"}],"version-history":[{"count":7,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/22670\/revisions"}],"predecessor-version":[{"id":22678,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/22670\/revisions\/22678"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media\/22671"}],"wp:attachment":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media?parent=22670"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/categories?post=22670"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/tags?post=22670"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}