{"id":13193,"date":"2026-06-16T11:43:09","date_gmt":"2026-06-16T14:43:09","guid":{"rendered":"https:\/\/passarini.com.br\/siud-anvisa-udi-medical-devices-brazil-2026-deadlines-2\/"},"modified":"2026-06-16T16:52:20","modified_gmt":"2026-06-16T19:52:20","slug":"eudamed-mandatory-medical-device-compliance-eu","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/eudamed-mandatory-medical-device-compliance-eu\/","title":{"rendered":"EUDAMED Enforcement: Essential Requirements for Medical Device Operators"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left center;--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-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-margin-top:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.webp\" alt=\"newsletter passarini\" width=\"1920\" height=\"500\" class=\"wp-image-7421\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 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-padding-top:10px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h1 data-path-to-node=\"3\">EUDAMED Is Now Mandatory: What Changes for Medical Device Manufacturers and Importers?<\/h1>\n<p data-path-to-node=\"4\"><b data-path-to-node=\"4\" data-index-in-node=\"0\">Published by Passarini Group | Regulatory Affairs &amp; International Market<\/b><\/p>\n<p data-path-to-node=\"6\">As of <b data-path-to-node=\"6\" data-index-in-node=\"6\">May 28, 2026<\/b>, the European medical device sector has undergone a significant structural transformation: four modules of <b data-path-to-node=\"6\" data-index-in-node=\"126\">EUDAMED<\/b>\u2014the European Database on Medical Devices\u2014have become mandatory across the <a href=\"https:\/\/en.wikipedia.org\/wiki\/European_Union\">European Union<\/a>. If your company manufactures, imports, or distributes medical devices within the European market, this article is essential for maintaining regulatory compliance.<\/p>\n<h2 data-path-to-node=\"8\">What Is EUDAMED?<\/h2>\n<p data-path-to-node=\"9\">EUDAMED is the information system developed by the European Commission to implement Regulations <b data-path-to-node=\"9\" data-index-in-node=\"96\">(EU) 2017\/745<\/b> (MDR\u2014<i data-path-to-node=\"9\" data-index-in-node=\"115\">Medical Device Regulation<\/i>) and <b data-path-to-node=\"9\" data-index-in-node=\"146\">(EU) 2017\/746<\/b> (IVDR\u2014<i data-path-to-node=\"9\" data-index-in-node=\"166\">In Vitro Diagnostic Regulation<\/i>). It functions as a large, centralized database designed to bring greater transparency, traceability, and safety to the lifecycle of medical devices available in the European market.<\/p>\n<p data-path-to-node=\"10\">In practical terms, EUDAMED centralizes information within a single European system regarding who manufactures and imports devices, which products are on the market, which certificates have been issued, and what actions are being taken by surveillance authorities. Once fully operational, the platform will also include data on clinical investigations and post-market surveillance.<\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-2\"><h2 data-path-to-node=\"12\">The Regulatory Landmark: How Did We Get Here?<\/h2>\n<p data-path-to-node=\"13\">The mandatory enforcement of the first four modules was triggered by the publication of the European Commission\u2019s <b data-path-to-node=\"13\" data-index-in-node=\"114\">Decision (EU) 2025\/2371<\/b> in the Official Journal of the European Union on November 27, 2025. This decision confirmed that these modules had successfully passed an independent audit and were technically ready for operation.<\/p>\n<p data-path-to-node=\"14\">Based on <b data-path-to-node=\"14\" data-index-in-node=\"9\">Regulation (EU) 2024\/1860<\/b>, this publication initiated a six-month transitional period\u2014which expired on May 28, 2026, the date from which their use became strictly mandatory.<\/p>\n<h2 data-path-to-node=\"16\">Which Modules Are Now Mandatory?<\/h2>\n<p data-path-to-node=\"17\">EUDAMED is structured into <b data-path-to-node=\"17\" data-index-in-node=\"27\">six interconnected modules<\/b>. The first four are now mandatory:<\/p>\n<ol start=\"1\" data-path-to-node=\"18\">\n<li>\n<p data-path-to-node=\"18,0,0\"><b data-path-to-node=\"18,0,0\" data-index-in-node=\"0\">Actor Registration (Economic Operators)<\/b> \u2014 Mandatory since 05\/28\/2026 Manufacturers, authorized representatives, importers, and producers of systems or procedure packs must be registered in this module.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"18,1,0\"><b data-path-to-node=\"18,1,0\" data-index-in-node=\"0\">UDI \/ Device Registration<\/b> \u2014 Mandatory since 05\/28\/2026 For new devices placed on the European market under the MDR\/IVDR, registration in the UDI\/Device module must be considered an essential step prior to making the product available on the market, as applicable.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"18,2,0\"><b data-path-to-node=\"18,2,0\" data-index-in-node=\"0\">Notified Bodies and Certificates<\/b> \u2014 Mandatory since 05\/28\/2026 Centralizes information regarding certifications issued by responsible notified bodies across the EU.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"18,3,0\"><b data-path-to-node=\"18,3,0\" data-index-in-node=\"0\">Market Surveillance<\/b> \u2014 Mandatory since 05\/28\/2026 (for Competent Authorities and the European Commission)<\/p>\n<\/li>\n<\/ol>\n<p data-path-to-node=\"19\">The remaining two modules\u2014<i data-path-to-node=\"19\" data-index-in-node=\"26\"><a href=\"https:\/\/grinn.co\/#clinical\">Clinical<\/a> Investigations and Performance Studies<\/i> and <i data-path-to-node=\"19\" data-index-in-node=\"78\">Post-Market Surveillance<\/i>\u2014are still under development. A critical feature to note: <b data-path-to-node=\"19\" data-index-in-node=\"160\">there will be no voluntary period before they become mandatory.<\/b><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-image-element fusion-image-align-center in-legacy-container\" style=\"text-align:center;--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);\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"400\" height=\"500\" alt=\"EUDAMED Is Now Mandatory: What Changes for the Medical Device Sector?\" title=\"feed BLOG Passarini-EN_EUDAMED_\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-400x500.webp\" class=\"img-responsive wp-image-13198\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-768x960.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/06\/feed-BLOG-Passarini-EN_EUDAMED_.webp 1080w\" sizes=\"(max-width: 800px) 100vw, 400px\" \/><\/span><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-margin-top:10px;\"><h2 data-path-to-node=\"21\">What Changes in Portugal: Integration with the SIDM<\/h2>\n<p data-path-to-node=\"22\">For companies operating in the Portuguese market, the operationalization of EUDAMED is accompanied by an important update to the <b data-path-to-node=\"22\" data-index-in-node=\"129\">SIDM<\/b>\u2014the Medical Device Information System (<i data-path-to-node=\"22\" data-index-in-node=\"173\">Sistema de Informa\u00e7\u00e3o para Dispositivos M\u00e9dicos<\/i>), managed by INFARMED.<\/p>\n<p data-path-to-node=\"23\">The SIDM has been adapted to link directly with the European database, aiming to achieve clear goals: streamline processes, prevent duplicate registrations, and reduce the administrative burden on companies.<\/p>\n<h3 data-path-to-node=\"24\">What changes in practice?<\/h3>\n<ul data-path-to-node=\"25\">\n<li>\n<p data-path-to-node=\"25,0,0\"><b data-path-to-node=\"25,0,0\" data-index-in-node=\"0\">Existing registrations in the SIDM must be updated<\/b> to align with the information made available in EUDAMED. The system will provide functionalities to speed up this update, allowing the mapping between the device&#8217;s <b data-path-to-node=\"25,0,0\" data-index-in-node=\"215\">CDM (Medical Device Code)<\/b> and its respective <b data-path-to-node=\"25,0,0\" data-index-in-node=\"260\">UDI-DI<\/b> registered in EUDAMED\u2014thereby preserving the documentation already residing in the system.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"25,1,0\"><b data-path-to-node=\"25,1,0\" data-index-in-node=\"0\">Adoption of the EMDN (European Medical Device Nomenclature)<\/b>: EUDAMED utilizes a standardized European nomenclature. The SIDM will transition to it gradually, <b data-path-to-node=\"25,1,0\" data-index-in-node=\"158\">phasing out the NPDM<\/b> (Portuguese Medical Device Nomenclature) for new registrations and updates to existing entries. Consequently, the respective CDMs will be created or updated.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"25,2,0\"><b data-path-to-node=\"25,2,0\" data-index-in-node=\"0\">A faster, more transparent notification process<\/b>: Reusing information across systems eliminates red tape and creates a more efficient regulatory flow.<\/p>\n<\/li>\n<\/ul>\n<h3 data-path-to-node=\"26\">The SIDM Is Not Disappearing<\/h3>\n<p data-path-to-node=\"27\">It is crucial to clarify: <b data-path-to-node=\"27\" data-index-in-node=\"26\">the SIDM maintains its relevant role at the national level<\/b>, addressing specific requirements that extend beyond EUDAMED\u2019s European scope, such as:<\/p>\n<ul data-path-to-node=\"28\">\n<li>\n<p data-path-to-node=\"28,0,0\">Supporting national market surveillance;<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"28,1,0\">Procurement within the scope of the <b data-path-to-node=\"28,1,0\" data-index-in-node=\"36\">SNS (National Health Service)<\/b>;<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"28,2,0\">Issuing <b data-path-to-node=\"28,2,0\" data-index-in-node=\"8\">Free Sale Certificates (FSC)<\/b>.<\/p>\n<\/li>\n<\/ul>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-4\" style=\"--awb-margin-top:10px;\"><div class=\"x_elementToProof\" data-olk-copy-source=\"MessageBody\">\n<h2 data-path-to-node=\"30\">Why Does This Matter to Brazilian Companies?<\/h2>\n<p data-path-to-node=\"31\">For Brazilian companies that already export or intend to export medical devices to Europe, the operationalization of EUDAMED represents a concrete shift in regulatory obligations. The European Authorized Representative (EC Rep)\u2014a mandatory figure for manufacturers outside the EU\u2014now holds direct responsibilities within the platform, particularly regarding the Actor Registration module.<\/p>\n<p data-path-to-node=\"32\"><b data-path-to-node=\"32\" data-index-in-node=\"0\">Passarini Group<\/b>, with an established presence in Sintra (Portugal), is fully prepared to guide Brazilian companies through this journey, from understanding the core requirements to achieving full compliance with European regulatory mandates.<\/p>\n<h2 data-path-to-node=\"34\">Sources and Supplementary Resources<\/h2>\n<ul data-path-to-node=\"35\">\n<li>\n<p data-path-to-node=\"35,0,0\"><a class=\"ng-star-inserted\" href=\"https:\/\/health.ec.europa.eu\/medical-devices-eudamed\/overview_en\" target=\"_blank\" rel=\"noopener\" data-hveid=\"0\" data-ved=\"0CAAQ_4QMahgKEwj44s2l-4uVAxUAAAAAHQAAAAAQ2QI\">EUDAMED Overview \u2013 European Commission<\/a><\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"35,1,0\"><a class=\"ng-star-inserted\" href=\"https:\/\/extranet.infarmed.pt\/SIDM-fo\/\" target=\"_blank\" rel=\"noopener\" data-hveid=\"0\" data-ved=\"0CAAQ_4QMahgKEwj44s2l-4uVAxUAAAAAHQAAAAAQ2gI\">SIDM \u2013 INFARMED<\/a><\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"35,2,0\"><a class=\"ng-star-inserted\" href=\"https:\/\/www.infarmed.pt\/web\/infarmed\/perguntas-frequentes-area-transversal\/dm\/eudamed-e-obrigacoes-de-registro\/eudamed\" target=\"_blank\" rel=\"noopener\" data-hveid=\"0\" data-ved=\"0CAAQ_4QMahgKEwj44s2l-4uVAxUAAAAAHQAAAAAQ2wI\">EUDAMED\/SIDM Frequently Asked Questions \u2013 INFARMED<\/a><\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"35,3,0\"><a class=\"ng-star-inserted\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ:L_202502371\" target=\"_blank\" rel=\"noopener\" data-hveid=\"0\" data-ved=\"0CAAQ_4QMahgKEwj44s2l-4uVAxUAAAAAHQAAAAAQ3AI\">Decision (EU) 2025\/2371 \u2013 Official Journal of the EU<\/a><\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"35,4,0\"><a class=\"ng-star-inserted\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32024R1860\" target=\"_blank\" rel=\"noopener\" data-hveid=\"0\" data-ved=\"0CAAQ_4QMahgKEwj44s2l-4uVAxUAAAAAHQAAAAAQ3QI\">Regulation (EU) 2024\/1860<\/a><\/p>\n<\/li>\n<\/ul>\n<p data-path-to-node=\"37\"><i data-path-to-node=\"37\" data-index-in-node=\"0\">Passarini Group specializes in healthcare product regulation both in Brazil and the international market. With offices in Ribeir\u00e3o Preto, S\u00e3o Paulo, Joinville, Curitiba, Orlando, and Sintra (Portugal), we are the ONE-STOP-SHOP regulatory partner for companies looking to grow safely and compliantly.<\/i><\/p>\n<p data-path-to-node=\"38\"><i data-path-to-node=\"38\" data-index-in-node=\"0\">Need support to align your company with EUDAMED? Email -&gt; <\/i><strong><a href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/strong><\/p>\n<\/div>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-stacked\" style=\"background-color:#f6f6f6;--awb-separator-border-sizes:0px;--awb-layout:row;--awb-alignment-small:space-between;--awb-stacked-align-small:center;\" data-title=\"EUDAMED Enforcement: Essential Requirements for Medical Device Operators\" data-description=\"EUDAMED Is Now Mandatory: What Changes for Medical Device Manufacturers and Importers?\r\nPublished by Passarini Group | Regulatory Affairs &amp; International Market\r\nAs of May 28, 2026, the European medical device sector has undergone a significant structural transformation: four modules of EUDAMED\u2014the European Database\" data-link=\"https:\/\/passarini.com.br\/en\/eudamed-mandatory-medical-device-compliance-eu\"><h4 class=\"tagline\" style=\"color:#333333;\">Share<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fpassarini.com.br%2Fen%2Feudamed-mandatory-medical-device-compliance-eu&amp;t=EUDAMED%20Enforcement%3A%20Essential%20Requirements%20for%20Medical%20Device%20Operators\" target=\"_blank\" rel=\"noreferrer\" title=\"Facebook\" aria-label=\"Facebook\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Facebook\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" style=\"color:#ffffff;background-color:#3b5998;border-color:#3b5998;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a 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style=\"color:#ffffff;background-color:#0077b5;border-color:#0077b5;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a href=\"mailto:?subject=EUDAMED%20Enforcement%3A%20Essential%20Requirements%20for%20Medical%20Device%20Operators&amp;body=https%3A%2F%2Fpassarini.com.br%2Fen%2Feudamed-mandatory-medical-device-compliance-eu\" target=\"_self\" title=\"Email\" aria-label=\"Email\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Email\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-mail awb-icon-mail\" style=\"color:#ffffff;background-color:#000000;border-color:#000000;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_4 1_4 fusion-one-fourth fusion-column-last\" style=\"--awb-bg-size:cover;width:25%;width:calc(25% - ( ( 4% ) * 0.25 ) );\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-5\"><h3 data-fontsize=\"22\" data-lineheight=\"48\"><strong>Mais not\u00edcias:<\/strong><\/h3>\n<\/div><div class=\"fusion-recent-posts fusion-recent-posts-1 avada-container layout-default layout-columns-1\"><section class=\"fusion-columns columns fusion-columns-1 columns-1\"><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-06-16T16:52:20-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/eudamed-mandatory-medical-device-compliance-eu\/\">EUDAMED Enforcement: Essential Requirements for Medical Device Operators<\/a><\/h4><\/div><\/article><article class=\"post 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":13198,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67],"tags":[353,354,69,355,356,357,358,359,360,361,362,363,364,203,365,366],"class_list":["post-13193","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","tag-ae","tag-afe","tag-anvisa-en","tag-anvisa-automation","tag-company-operating-authorization","tag-debureaucratization","tag-digital-transformation","tag-health-surveillance","tag-legal-security","tag-passarini-group","tag-regulatory-compliance","tag-regulatory-consulting","tag-regulatory-process-brazil","tag-solicita-system","tag-special-authorization","tag-time-to-market"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/13193","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/comments?post=13193"}],"version-history":[{"count":4,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/13193\/revisions"}],"predecessor-version":[{"id":13207,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/13193\/revisions\/13207"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/13198"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=13193"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=13193"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=13193"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}