{"id":33706,"date":"2025-03-19T16:16:34","date_gmt":"2025-03-19T15:16:34","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=33706"},"modified":"2025-12-23T15:53:37","modified_gmt":"2025-12-23T14:53:37","slug":"eudamed-deadlines-and-obligations-for-economic-operators","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/03\/19\/eudamed-deadlines-and-obligations-for-economic-operators\/","title":{"rendered":"EUDAMED: Deadlines and Obligations for Economic Operators"},"content":{"rendered":"<p><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>EUDAMED is the database developed by the European Commission to centralise and make easily accessible information on <strong>Medical Devices <\/strong>and <strong>In Vitro Diagnostic Devices (IVDs)<\/strong>, as required by the MDR (EU) Regulations 2017\/745 and IVDR (EU) 2017\/746.<\/p>\n<p>After years of postponement, <strong>EUDAMED<\/strong> is finally taking shape, and with it new timelines and obligations for medical device manufacturers. <strong>Regulation (EU) 2024\/1860<\/strong> updated the roadmap for the gradual roll-out of EUDAMED, and the completion of the system is estimated by 2027.<\/p>\n<p>The EUDAMED platform consists of <strong>six interconnected modules<\/strong>. Currently, <strong>three modules (ACTOR, UDI\/Devices, Notified Bodies, and Certificates) are active and usable on a voluntary basis to allow manufacturers<\/strong> to adapt in advance and reduce the risk of future delays.<\/p>\n<p>It should also be considered that in<b> 2026<\/b>, the first modules of EUDAMED are expected to be <b>mandatory<\/b>: the <b>\u201cActor\u201d module (ACT)<\/b> and the <b>\u201cUDI\/Device\u201d module (UDI\/DEV), the Notified Bodies and Certificates module (NB\/CRF) and the Vigilance and Post-Market Surveillance module (VGL). <\/b><span style=\"background-color: rgba(0, 0, 0, 0);\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/17\/eudamed-obligation-starts-may-28-2026-what-to-do-now\/\"><b>See the update of November 27, 2025.<\/b><\/a><\/span><\/p>\n<p>What are the changes and implications for economic operators about each module?<br \/>\nWe will analyse these aspects in the course of the article.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.25; --minfontsize: 24; --fontSize: 24; --minFontSize: 24;\" data-fontsize=\"24\" data-lineheight=\"30px\">Phased implementation of EUDAMED: what changes?<\/h2>\n<p><strong>Article 34<\/strong> <strong>MDR<\/strong>, as amended by <strong>Regulation 2024\/1860<\/strong>, stipulates that EUDAMED forms become mandatory <strong>six months<\/strong> <strong>after the publication of the notice of full functionality in the Official Journal of the European Union (OJEU)<\/strong>. An independent third-party audit will verify the compliance of the module, following which the <strong>official activation notice <\/strong>will be published.<\/p>\n<p>However, there are <strong>additional timeframes<\/strong> for <strong>registering<\/strong> certain devices and their certificates in <strong>EUDAMED<\/strong>. In particular, <strong>for legacy devices<\/strong> and those <strong>compliant with the MDR <\/strong>and <strong>IVDR <\/strong>that continue to be placed on the market after the date of mandatory use of device registration and certificate forms, Regulation (EU) 2024\/1860 introduced additional<\/p>\n<ul>\n<li><strong>6 months<\/strong> extra time for <strong>manufacturers<\/strong>.<\/li>\n<li><strong>12 months<\/strong> extra time for <strong>notified bodies<\/strong> which, for these devices, will <strong>only<\/strong> be required to <strong>register the latest version of the relevant certificate<\/strong> and, if applicable, the relevant decision.<\/li>\n<\/ul>\n<p>The additional timeframes provided for the registration of devices <strong>do not apply<\/strong> if, once the use of the <strong>vigilance <\/strong>module has also been made compulsory, the devices are subject to:<\/p>\n<ul>\n<li>PSUR &#8211; Periodic Safety Update Report<\/li>\n<li>Serious accident<\/li>\n<li>Security Corrective Action<\/li>\n<li>Trend Report<\/li>\n<\/ul>\n<p>In these cases, the registration of devices is a necessary and preliminary action to the possibility of using the functionalities of the vigilance module.<br \/>\nIn other words, if in the extra period, the <strong>vigilance <\/strong>module also becomes mandatory, then the manufacturer <strong>cannot wait<\/strong> <strong>6 or 12 months to register the devices<\/strong>: he must register them now before the vigilance module can be used.<\/p>\n<p>The guideline of November 21, 2024 <em>&#8216;Gradual roll-out of EUDAMED &#8211; Q&amp;As on practical aspects related to the implementation of Regulation (EU) 2024\/1860&#8217;<\/em> provided important clarifications.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.25; --minfontsize: 24; --fontSize: 24; --minFontSize: 24;\" data-fontsize=\"24\" data-lineheight=\"30px\">EUDAMED Modules: Features and Timing<\/h2>\n<ol>\n<li><strong>Actor Registration Module (ACT)<\/strong><br \/>\nAllows manufacturers (including those of procedural systems and kits), agents, and importers to register for a <strong>Single Registration Number<\/strong> <strong>(SRN).<\/strong> Competent Authorities validate the data of economic operators before assigning the SRN number.<\/li>\n<\/ol>\n<ul>\n<li>Active voluntarily from December 1, 2020. <a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/17\/eudamed-obligation-starts-may-28-2026-what-to-do-now\/\"><b>See the update of November 27, 2025.<\/b><\/a><\/li>\n<li>Mandatory six months after publication of the official notice in the OJEU. Obligation is expected in<b> 2026<\/b>.<\/li>\n<li>Registration in ACT is <strong>also<\/strong> required <strong>for<\/strong> <strong>operators with legacy devices<\/strong> on the market.<\/li>\n<\/ul>\n<ol start=\"2\">\n<li><strong>UDI\/device registration module (UDI\/DEV)<\/strong><br \/>\nManages the registration and management of UDI identifiers of devices<\/li>\n<\/ol>\n<ul>\n<li>Active voluntarily from October 4, 2021.<\/li>\n<li>Manufacturers can still register devices in national databases, but the UDI\/DEV form, already available voluntarily, will completely replace them six months after the publication of the notice in the Official Journal. Obligation is expected in <b>2026<\/b>. <a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/17\/eudamed-obligation-starts-may-28-2026-what-to-do-now\/\"><b>See the update of November 27, 2025.<\/b><\/a><\/li>\n<li>For devices placed on the market after the date on which the module becomes mandatory: mandatory registration before first placing on the market.<\/li>\n<li>For devices placed on the market before the date on which the form becomes mandatory: registration within <strong>twelve months<\/strong> of publication of the notice in the Official Journal.<\/li>\n<li><strong>Legacy devices and regulated devices<\/strong> for which individual (sales) units are no longer placed on the market as of the date on which the UDI\/DEV form becomes mandatory, only need to be registered in the UDI\/DEV form when accidents or corrective safety actions are involved. The same applies to custom-made devices.<\/li>\n<\/ul>\n<p><strong>Example:<\/strong> A device placed on the market between May 2021 and November 2025 does not need to be registered in EUDAMED if the UDI\/DEV module becomes mandatory in 2026. However, if the Vigilance and Post-Market Surveillance (VGL) Module becomes mandatory in July 2026 and the device is subject to supervision in September 2026, registration will be required.<\/p>\n<p>If a vigilance action concerns a legacy device that is not registered as a <strong>&#8216;same<\/strong> <strong>device&#8217;<\/strong> that already complies with regulations, it will exceptionally have to be registered in the UDI\/DEV module to allow reporting in the Vigilance and Post-Market Surveillance (VGL) module.<\/p>\n<p>The general rule remains: legacy devices do not require registration if &#8216;the same device&#8217; is already registered.<\/p>\n<p>It is important to note that <strong>legacy devices<\/strong> are not subject to the UDI obligations under MDR. However, to enable their registration in EUDAMED, specific unique identifiers, called EUDAMED DI and EUDAMED ID, will be assigned to replace the Basic UDI-DI and the UDI-DI.<\/p>\n<ol start=\"3\">\n<li><strong>Notified and Certified Bodies Form (NB\/CRF)<\/strong><\/li>\n<\/ol>\n<p>It allows Notified Bodies (NBs) to register and manage certificates issued for MDR and IVDR-compliant devices. In addition, NBs must upload the Summary of Safety and Clinical Performance (SSCP) for higher-risk devices.<\/p>\n<ul>\n<li>Active voluntarily from October 4, 2021, except for the functionality of the examination mechanism and the Clinical Evaluation Consultation Procedure (CECP). <a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/17\/eudamed-obligation-starts-may-28-2026-what-to-do-now\/\"><b>See the update of November 27, 2025.<\/b><\/a><\/li>\n<li>Certificates issued after the mandatory date: <strong>immediate registration.<\/strong><\/li>\n<li>Certificates issued before compulsoriness: registration <strong>within 18 months <\/strong>of publication in the Official Journal, only if associated with devices registered in the UDI\/DEV form.<\/li>\n<\/ul>\n<ol start=\"4\">\n<li><strong> Vigilance and Post-Market Surveillance (VGL) Module<br \/>\n<\/strong>Manages reports of adverse events, incidents and Field Safety Corrective Actions (FSCA).<\/li>\n<\/ol>\n<ul>\n<li>Manufacturers and agents: obligation to report adverse events and FSCA.<\/li>\n<li>The competent authorities monitor and evaluate corrective actions.<\/li>\n<li>Not operational; it will become mandatory six months after the publication of the notice of full functionality.<\/li>\n<\/ul>\n<ol start=\"5\">\n<li><strong> Clinical Investigations and Performance Studies Module (CIP)<br \/>\n<\/strong>Allows the registration and monitoring of clinical studies on Medical Devices and IVDs.<\/li>\n<\/ol>\n<ul>\n<li>Competent authorities: approve and monitor studies.<\/li>\n<li>Not operational; it will become mandatory <strong>six months<\/strong> after the publication of the notice of full functionality.<\/li>\n<\/ul>\n<ol start=\"6\">\n<li><strong> Market Surveillance Module (MSM)<br \/>\n<\/strong>Reserved for Competent Authorities to manage inspections and non-conformities.<\/li>\n<\/ol>\n<ul>\n<li>Access is limited to Authorities and, in some cases, Notified Bodies.<\/li>\n<li>Not operational; it will become mandatory six months after the publication of the official notice of full functionality. <a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/17\/eudamed-obligation-starts-may-28-2026-what-to-do-now\/\"><b>See the update of November 27, 2025.<\/b><\/a><\/li>\n<\/ul>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24; --fontSize: 24; --minFontSize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">Summary Table<\/h2>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background 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-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1024\" height=\"768\" title=\"ITA (3)\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/03\/ITA-3.png\" alt class=\"img-responsive wp-image-33770\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/03\/ITA-3-200x150.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/03\/ITA-3-400x300.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/03\/ITA-3-600x450.png 600w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/03\/ITA-3-800x600.png 800w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/03\/ITA-3.png 1024w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 1024px\" \/><\/span><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container has-pattern-background has-mask-background 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-2 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.25; --minfontsize: 24; --fontSize: 24; --minFontSize: 24;\" data-fontsize=\"24\" data-lineheight=\"30px\">How to Prepare for EUDAMED<\/h2>\n<p>For manufacturers, the phased implementation of EUDAMED represents a significant challenge, but also an opportunity to adapt to a more efficient and centralised European system for managing medical device information. Manufacturers need to adopt a strategy of adaptation to EUDAMED, starting with <strong>the use of the modules available voluntarily <\/strong>and <strong>staying up-to-date<\/strong> <strong>on the developments in the database<\/strong>, given the compulsory adoption of the modules.<\/p>\n<p>With the <b>compulsory ACTOR and UDI<\/b> Form expected in<b> 2026<\/b>, there is no time to lose. It is essential to take action as soon as possible. <a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/17\/eudamed-obligation-starts-may-28-2026-what-to-do-now\/\"><b>See the update of November 27, 2025.<\/b><\/a><\/p>\n<p>&gt;&gt;&gt; Thema follows the developments of EUDAMED and is at the side of manufacturers and other economic operators for <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">strategic-regulatory<\/a> <\/strong>consultancy and support activities in the use of already active EUDAMED modules.<\/p>\n<h2>Update of November 27, 2025<\/h2>\n<p>On November 27, 2025, the European Commission announced the <b>full functionality of four of the six EUDAMED<\/b> modules through <b>Decision (EU) 2025\/2371<\/b> published in the Official Journal. See the<b> <a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/17\/eudamed-obligation-starts-may-28-2026-what-to-do-now\/\">full article<\/a><\/b>.<\/p>\n<p><strong>USEFUL SOURCES AND RESOURCES<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/gradual-roll-out-eudamed-qas-practical-aspects-related-implementation-regulation-eu-20241860-2024-11-21_en\">\u201cGradual roll-out of EUDAMED &#8211; Q&amp;As on practical aspects related to the implementation of Regulation (EU) 2024\/1860\u201d<\/a><\/li>\n<li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_sector\/docs\/md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf\">MDCG 2021-13 rev.1 Questions and answers<\/a>.<\/li>\n<li><a href=\"https:\/\/health.ec.europa.eu\/medical-devices-eudamed\/overview_en\">https:\/\/health.ec.europa.eu\/medical-devices-eudamed\/overview_en<\/a><\/li>\n<li><a href=\"https:\/\/webgate.ec.europa.eu\/eudamed-help\/en\/files\/Legacy%20Devices%20-%20user%20guide.pdf\">EUDAMED user guide Legacy Devices<\/a><\/li>\n<li><a href=\"https:\/\/www.salute.gov.it\/portale\/dispositiviMedici\/dettaglioContenutiDispositiviMedici.jsp?lingua=italiano&amp;id=5610&amp;area=dispositivi-medici&amp;menu=eudamed\">https:\/\/www.salute.gov.it\/portale\/dispositiviMedici\/dettaglioContenutiDispositiviMedici.jsp?lingua=italiano&amp;id=5610&amp;area=dispositivi-medici&amp;menu=eudamed<\/a><\/li>\n<li><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/fb6f6ec5-d0eb-4edc-b168-8e74cfa0c89e_en?filename=md_eudamed_20250521_co1\">https:\/\/health.ec.europa.eu\/document\/download\/fb6f6ec5-d0eb-4edc-b168-8e74cfa0c89e_en?filename=md_eudamed_20250521_co1<\/a><\/li>\n<\/ul>\n<p><em>03\/19\/2025<\/em><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":33720,"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":[13],"tags":[],"class_list":["post-33706","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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