{"id":14810,"date":"2026-08-27T16:19:22","date_gmt":"2026-08-27T14:19:22","guid":{"rendered":"https:\/\/www.entecerma.it\/eudamed-and-udi-di-registration-a-practical-guide-to-avoiding-data-upload-errors\/"},"modified":"2026-08-27T16:26:08","modified_gmt":"2026-08-27T14:26:08","slug":"eudamed-and-udi-di-registration-a-practical-guide-to-avoiding-data-upload-errors","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/eudamed-and-udi-di-registration-a-practical-guide-to-avoiding-data-upload-errors\/","title":{"rendered":"EUDAMED and UDI-DI Registration: A Practical Guide to Avoiding Data Upload Errors"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The correct registration of medical devices in the European EUDAMED database is a necessary step for regulatory compliance. Recently, we have noticed that many manufacturers incorrectly register Annex X of Regulation (EU) 2017\/745 (MDR) as their conformity assessment procedure. This seemingly formal error creates significant operational bottlenecks 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-5756292a7892b9eca06238451cc9673f\"><div class=\"attachment-container unknown\">&#13;\n<div class=\"text-box-container ng-star-inserted\" data-test-id=\"text-box-container\">&#13;\n<div class=\"text-box-content\">&#13;\n<div class=\"text-box-text gds-headline-s\" dir=\"auto\" data-test-id=\"text-box-text\"><strong>THE IMPACT ON BASIC UDI-DI CONFIRMATION<\/strong><\/div><br\/><\/div><br\/><\/div><br\/><\/div><\/h3>\n\n<p class=\"wp-block-paragraph\">The origin of these technical complications lies in the very nature of Annex X. Indeed, this procedure applies exclusively to class III or class IIb implantable devices, in combination with the procedure set out in Annex IX. For these categories, Article 29 of the MDR stipulates that the Basic UDI-DI must be confirmed by the Notified Body (NB) 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 that\u2014even if belonging to these classes\u2014is 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-91301150084f02dacdfae375f2b29eba\"><div class=\"attachment-container unknown\">&#13;\n<div class=\"text-box-container ng-star-inserted\" data-test-id=\"text-box-container\">&#13;\n<div class=\"text-box-content\">&#13;\n<div class=\"text-box-text gds-headline-s\" dir=\"auto\" data-test-id=\"text-box-text\"><strong>THE ROLE AND LIMITATIONS OF THE NOTIFIED BODY<\/strong><\/div><br\/><\/div><br\/><\/div><br\/><\/div><\/h3>\n\n<p class=\"wp-block-paragraph\">It is essential to clarify that ECM \u2013 Ente Certificazione Macchine cannot proceed with the confirmation of the Basic UDI-DI if the registration is incorrect. The reason is simple: Annex X does not fall within our current scope of designation, and therefore no Annex X certificates issued by ECM can exist. Without proper matching 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 class=\"wp-block-paragraph\">For a compliant assessment, the procedures actually covered and managed by ECM are those relating to Annex IX or Annex XI. We invite all manufacturers to carefully review the technical documentation prior to registration. Correcting the certificate type associated with the device is the only way to unblock the procedure: once the correct Annex is selected, EUDAMED will no longer require Basic UDI-DI approval, thus ensuring a smooth placement on the market.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The correct registration of medical devices in the European EUDAMED database is a necessary step&#8230;<\/p>\n","protected":false},"author":2,"featured_media":14808,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-14810","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 v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EUDAMED and UDI-DI Registration: A Practical Guide to Avoiding Data Upload Errors - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"We invite all manufacturers to carefully review the technical documentation prior to registration.\" \/>\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-and-udi-di-registration-a-practical-guide-to-avoiding-data-upload-errors\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EUDAMED and UDI-DI Registration: A Practical Guide to Avoiding Data Upload Errors - 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