{"id":13124,"date":"2026-03-23T16:34:50","date_gmt":"2026-03-23T15:34:50","guid":{"rendered":"https:\/\/www.entecerma.it\/eudamed-avoiding-basic-udi-di-upload-errors\/"},"modified":"2026-03-23T17:13:28","modified_gmt":"2026-03-23T16:13:28","slug":"eudamed-avoiding-basic-udi-di-upload-errors","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/eudamed-avoiding-basic-udi-di-upload-errors\/","title":{"rendered":"EUDAMED: Avoiding Basic UDI-DI upload errors"},"content":{"rendered":"\n<p>The correct registration of medical devices within the European EUDAMED database is a mandatory step for regulatory compliance. Recently, we have observed that many manufacturers incorrectly register <b data-path-to-node=\"2,0\" data-index-in-node=\"201\">Annex X<\/b> of Regulation (EU) 2017\/745 (MDR) as the conformity assessment procedure. This error, while seemingly formal, creates significant operational blockages within the system.<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-20149f9ef9d3bec378198926fb6ee74d\"><strong>THE IMPACT ON BASIC UDI-DI CONFIRMATION<\/strong><\/h3>\n\n<p>The technical complications stem from the very nature of <b data-path-to-node=\"2,0\" data-index-in-node=\"58\">Annex X<\/b>. This procedure is applicable exclusively to <b data-path-to-node=\"2,0\" data-index-in-node=\"111\">Class III<\/b> or <b data-path-to-node=\"2,0\" data-index-in-node=\"124\">Class IIb implantable devices<\/b>, in combination with the procedure set out in <b data-path-to-node=\"2,0\" data-index-in-node=\"200\">Annex IX<\/b>. For these categories, Article 29 of the MDR stipulates that the <b data-path-to-node=\"2,0\" data-index-in-node=\"274\">Basic UDI-DI<\/b> must be confirmed by the <b data-path-to-node=\"2,0\" data-index-in-node=\"312\">Notified Body (NB)<\/b> at the time the certificate is uploaded to the portal. If a manufacturer selects Annex X for a device that does not fall into these classes, or which belongs to these classes but is certified under a different procedure, EUDAMED will automatically trigger a validation request to the NB.<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-862b984b33907d61ffb5358e2f0c2165\"><strong>THE ROLE AND LIMITATIONS OF THE NOTIFIED BODY<\/strong><\/h3>\n\n<p>It is essential to clarify that <b data-path-to-node=\"2,0\" data-index-in-node=\"33\">ECM \u2013 Ente Certificazione Macchine<\/b> cannot proceed with the Basic UDI-DI confirmation if the registration is incorrect. The reason is straightforward: Annex X does not fall within our current <b data-path-to-node=\"2,0\" data-index-in-node=\"224\">scope of designation<\/b>; therefore, no Annex X certificates issued by ECM can exist. Without an exact match between the issued certificate and the procedure declared in the system, the Notified Body is unable to validate the data, and the Basic UDI-DI will never be confirmed.<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-a7475c263ccaae008f2bd00e80d1ddc2\"><strong>HOW TO PROCEED CORRECTLY<\/strong><\/h3>\n\n<p>For a compliant assessment, the procedures actually provided and managed by <b data-path-to-node=\"2,0\" data-index-in-node=\"77\">ECM<\/b> are those related to <b data-path-to-node=\"2,0\" data-index-in-node=\"102\">Annex IX<\/b> or <b data-path-to-node=\"2,0\" data-index-in-node=\"114\">Annex XI<\/b>. We urge all manufacturers to carefully verify their technical documentation before registration. Correcting the certificate type associated with the device is the only way to unblock the process: once the correct Annex is set, EUDAMED will no longer require Basic UDI-DI approval, thus ensuring a smooth market entry.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The correct registration of medical devices within the European EUDAMED database is a mandatory step&#8230;<\/p>\n","protected":false},"author":2,"featured_media":13115,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-13124","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EUDAMED: Avoiding Basic UDI-DI upload errors - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"The correct registration of medical devices within the European database EUDAMED is a necessary step for regulatory compliance.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.entecerma.it\/en\/eudamed-avoiding-basic-udi-di-upload-errors\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EUDAMED: Avoiding Basic UDI-DI upload errors - 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