{"id":35601,"date":"2026-05-11T11:15:51","date_gmt":"2026-05-11T09:15:51","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35601"},"modified":"2026-05-12T14:45:13","modified_gmt":"2026-05-12T12:45:13","slug":"eudamed-registration-act-udi-modules","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2026\/05\/11\/eudamed-registration-act-udi-modules\/","title":{"rendered":"EUDAMED Registration: ACT, UDI Modules and Frequently Asked Questions"},"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-blend:overlay;--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\"><p><strong>EUDAMED<\/strong> is the European Union&#8217;s online database for Medical Devices. It serves as a centralized system where:<\/p>\n<ul>\n<li><strong>Manufacturers<\/strong> register their organizations.<\/li>\n<li><strong>Devices<\/strong> are registered before being placed on the EU market.<\/li>\n<li><strong>Notified Bodies<\/strong> upload certificate information.<\/li>\n<li><strong>Authorities<\/strong> monitor safety and compliance.<\/li>\n<\/ul>\n<p>The use of EUDAMED becomes mandatory on <strong>May 28, 2026<\/strong>, for fully functional modules. From this date, any manufacturer introducing new Medical Devices or in vitro diagnostic Medical Devices to the EU market must use the following two modules:<\/p>\n<ul>\n<li><strong>Actor Registration Module (ACT):<\/strong> for the registration of economic operators.<\/li>\n<li><strong>UDI &amp; Device Registration Module:<\/strong> for the registration of Medical Devices and their identification codes.<\/li>\n<\/ul>\n<p>For products already on the market (including <strong>legacy devices<\/strong>) before <strong>May 28, 2026<\/strong>, registration must be completed by <strong>November 27, 2026<\/strong>. However, this derogation does not apply if devices are subject to vigilance actions, incidents, or FSCA; therefore, immediate action is strongly recommended.<\/p>\n<p>The other two operational modules, <strong>Notified Bodies and Certificates (NB\/CRF)<\/strong> and <strong>Market Surveillance (MSU)<\/strong>, are used by Notified Bodies and Competent Authorities, respectively.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\"><strong>Annex VI and Regulatory Framework: MDR (EU) 2017\/745 and IVDR (EU) 2017\/746<\/strong><\/h3>\n<p>The technical structure of EUDAMED is based on <strong>Annex VI<\/strong> of Regulations MDR (EU) 2017\/745 and IVDR (EU) 2017\/746. While specific articles establish the legal mandate, Annex VI provides the operational details of the information to be transmitted.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\"><strong>Actor Module: Registration and SRN Issuance (Art. 30 MDR \/ Art. 27 IVDR)<\/strong><\/h3>\n<p>The <strong>Actor Registration module<\/strong> uniquely identifies economic operators by issuing a <strong>Single Registration Number (SRN)<\/strong>. Obtaining the SRN is an essential preliminary step: without a number validated by the Competent Authority, manufacturers cannot register products or interact with Notified Bodies.<\/p>\n<p>Operationally, access management can be delegated by the <strong>Local Actor Administrator (LAA)<\/strong> to <strong>Local User Administrator (LUA)<\/strong> profiles. LUAs must request access via their own EU Login account to be authorized by the LAA for granular user and permission management.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\"><strong>UDI\/Device Module and Registration in EUDAMED<\/strong><\/h3>\n<p>Under <strong>Articles 28-29 (MDR)<\/strong> and <strong>25-26 (IVDR),<\/strong> manufacturers must populate the database following the technical specifications in <strong>Annex VI (Parts B and C)<\/strong>:<\/p>\n<ul>\n<li><strong>Basic UDI-DI and UDI-DI:<\/strong> the primary identifier for a group of devices with the same intended use, class, and essential characteristics. It is the cornerstone of technical documentation and CE certificates. The system requires the manufacturer to register it before the Notified Body can upload related certificates. The system allows Basic UDI-DI entry even if the certification process is ongoing.<\/li>\n<li><strong>Data Set Elements:<\/strong> per <strong>Annex VI (Part B),<\/strong> manufacturers must enter specific attributes such as <strong>risk class<\/strong>, <strong>intended use<\/strong>, and <strong>technical features<\/strong>, following the language specifications required by EUDAMED.<\/li>\n<li><strong>UDI-DI Hierarchy:<\/strong> every packaging level and specific variant (UDI-DI) must be registered to ensure full traceability. For legacy devices, the system allows a direct link between the old identifier and the new regulation-compliant code.<\/li>\n<\/ul>\n<p>The manufacturer bears sole responsibility for consistency between EUDAMED data and the labelling\/Instructions for Use (IFU).<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\"><strong>FAQ: UDI and EUDAMED Obligations<\/strong><\/h3>\n<p><strong>1. Can I register for the Basic UDI-DI before the certificate is ready?<\/strong><br \/>\nYes. The system allows registration during the conformity assessment process.<\/p>\n<p><strong>2. How should legacy and MDR\/IVDR devices with linked codes be managed?<\/strong><br \/>\nThe registration deadline for legacy devices is November 27, 2026. The database allows linking an MDR\/IVDR compliant device to its corresponding legacy device. If a UDI-DI has already been assigned to the legacy device, it must be entered.<\/p>\n<p><strong>3. What happens when expanding distribution to new EU Countries?<\/strong><br \/>\nAt the time of registration, the European countries in which it has been decided to market the device must be entered into Eudamed. Subsequently, if it is decided to expand the market, other European countries may be added to the Eudamed database. Similarly, if it is decided to cease marketing in a European country, that country must be removed from the Eudamed database.<\/p>\n<p><strong>4. Is it necessary to register ISO 13485:2016 certificates in EUDAMED?<\/strong><br \/>\nNo. The registration of certificates related to the Quality Management System (such as ISO 13485:2016) is not required. Only certificates of conformity issued under the MDR\/IVDR Regulations must be uploaded to EUDAMED.<\/p>\n<p><strong>5. How are Systems and Procedure Packs (SPP) managed?<\/strong><br \/>\nIf the manufacturer makes an error (typos, incorrect versions, etc.) when uploading certificate-related data, can the Notified Body correct them? No. The Notified Body (NB) cannot correct this data during the registration of the actual certificate in EUDAMED. Such rectification is the sole responsibility of the manufacturer, who must provide the correction. By logging in with the role of \u2018System\/procedure pack producer&#8217;, it is possible to register systems and procedure packs. A procedure pack producer who is also a manufacturer of other devices must have two different SRNs.<\/p>\n<p><b>6. If the manufacturer makes an error (typos, incorrect versions, etc.) when uploading certificate-related data, can the Notified Body correct them?<br \/>\n<\/b>No. The Notified Body (NB) cannot correct this data during the registration of the actual certificate in EUDAMED. Such rectification is the sole responsibility of the manufacturer, who must provide the correction.<\/p>\n<p><strong>7. What is the role of the Local Actor Administrator (LAA)?<\/strong> Economic operators registered on EUDAMED are required to confirm the accuracy of their data every 2 years. The economic operator must perform this confirmation or update through their LAA profile. Although it is possible to operate with a single LAA, it is strongly recommended to have at least two registered Local Actor Administrators to ensure operational continuity and the management of registrations even in the absence of one of the two users.<\/p>\n<p><strong>8. How do I configure a LUA profile to manage users?<\/strong> To create a LUA profile, it is not possible to proceed directly from the LAA&#8217;s account. The interested user must log in with their own personal account (EU Login) and send an access request to the actor (the company) already registered. Only at that point will the LAA be able to view the request, confirm it, and enable the user to manage other profiles and authorizations.<\/p>\n<p><strong>9. In which language should information be entered?<\/strong> It is possible to use the official language of the Member State where the devices will be placed on the market and the language of technical documentation. It is necessary to remember, where required by the system, to select the specific language in which the information is being entered.<\/p>\n<p><strong>10. How are &#8220;critical warnings&#8221; and their translations handled?<\/strong> Critical warnings must be selected from a drop-down menu within the system, and the options are provided exclusively in English. It is possible to add a further description, but this is not a mandatory field.<\/p>\n<p><strong>&gt;&gt;&gt; Complife Team<\/strong> supports economic operators in ensuring EUDAMED compliance through strategic regulatory consultancy and dedicated training.<\/p>\n<p><strong>SOURCES:<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/health.ec.europa.eu\/medical-devices-eudamed\/udidevice-registration_it\">EUDAMED (UDI\/Device)<\/a><\/li>\n<li><a href=\"https:\/\/webgate.ec.europa.eu\/eudamed-static\/documents\/assets\/guides\/user_guide_eo_en.pdf\">User Guide Actor module for Economic Operators<\/a><\/li>\n<li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/IT\/TXT\/?uri=CELEX:32017R0745\">MDR (UE) 2017\/745<\/a><\/li>\n<li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/IT\/TXT\/?uri=CELEX:32017R0746\">IVDR (UE) 2017\/746<\/a><\/li>\n<li><a href=\"https:\/\/www.complifegroup.com\/academy-course\/eudamed-mandatory-use\/\">Complife Academy Webinar <\/a>.<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":35610,"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":[679],"tags":[],"class_list":["post-35601","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EUDAMED Registration: ACT and UDI Modules (FAQ)<\/title>\n<meta name=\"description\" content=\"EUDAMED 2026 obligations: How to manage ACT and UDI modules. 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