{"id":376828,"date":"2025-11-27T21:27:49","date_gmt":"2025-11-27T21:27:49","guid":{"rendered":"https:\/\/all4compliance.pt\/?p=376828"},"modified":"2025-11-27T21:27:51","modified_gmt":"2025-11-27T21:27:51","slug":"eudamed-mandatory-from-28-may-2026","status":"publish","type":"post","link":"https:\/\/all4compliance.pt\/en\/eudamed-mandatory-from-28-may-2026\/","title":{"rendered":"EUDAMED mandatory from 28 May 2026"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; background_image=&#8221;https:\/\/all4compliance.pt\/wp-content\/uploads\/2022\/12\/backestatisticas.jpg&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_post_title meta=&#8221;off&#8221; featured_image=&#8221;off&#8221; _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; title_font=&#8221;Poppins||||||||&#8221; title_text_align=&#8221;center&#8221; title_text_color=&#8221;#FFFFFF&#8221; title_font_size=&#8221;49px&#8221; title_font_size_tablet=&#8221;49px&#8221; title_font_size_phone=&#8221;28px&#8221; title_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_post_title][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;40px|||||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row use_custom_gutter=&#8221;on&#8221; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.19.2&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;50%&#8221; width_phone=&#8221;90%&#8221; width_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_post_title title=&#8221;off&#8221; meta=&#8221;off&#8221; _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;||50px|||&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_post_title][et_pb_text _builder_version=&#8221;4.27.4&#8243; text_font=&#8221;Poppins|300|||||||&#8221; text_font_size=&#8221;16px&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>\u200b<strong>EUDAMED will finally become mandatory as of 28 May 2026!<\/strong><\/p>\n<p>The official notice was published by the European Commission in the Official Journal of the European Union on <strong>27 November 2025<\/strong>, initiating a six-month transition period that ends on <strong>28 May 2026<\/strong>.<br \/>From this date onwards, the first <strong>four EUDAMED modules<\/strong> will become mandatory, marking a decisive step for manufacturers, authorised representatives, importers, and notified bodies operating in the European Union.<\/p>\n<ul>\n<li><strong><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ:L_202502371\">Decision &#8211; 2025\/2371 &#8211; EN &#8211; EUR-Lex<\/a><\/strong><\/li>\n<\/ul>\n<p><strong>WHICH MODULES BECOME MANDATORY<\/strong><\/p>\n<p>As of 28 May 2026, the following modules are required:<\/p>\n<ol>\n<li><strong>Actor Registration<\/strong> \u2013 registration of economic operators (manufacturers, authorised representatives, importers, etc.)<\/li>\n<li><strong>UDI\/Devices Registration<\/strong> \u2013 registration of devices and UDI data<\/li>\n<li><strong>Notified Bodies &amp; Certificates<\/strong> \u2013 registration of notified bodies and certificates<\/li>\n<li><strong>Market Surveillance<\/strong> \u2013 tool supporting market surveillance and coordination between Competent Authorities<\/li>\n<\/ol>\n<p><strong>KEY DATES TO REMEMBER<\/strong><\/p>\n<table style=\"border-style: double; border-color: #588dbf; background-color: #f2f2f2;\">\n<thead>\n<tr>\n<td><strong>Milestone<\/strong><\/td>\n<td><strong>Date<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Publication of OJEU notice<\/td>\n<td>27 November 2025<\/td>\n<\/tr>\n<tr>\n<td>EUDAMED mandatory (4 modules)<\/td>\n<td>28 May 2026<\/td>\n<\/tr>\n<tr>\n<td>OJEU notice for the Vigilance Module<\/td>\n<td>Q4 2026<\/td>\n<\/tr>\n<tr>\n<td>Vigilance Module becomes mandatory<\/td>\n<td>Q2 2027<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>WHAT CHANGES AND WHY IT MATTERS<\/strong><\/p>\n<ul>\n<li>Registration of economic operators becomes mandatory <strong>before placing devices on the market<\/strong>; without this registration, other modules cannot be used.<\/li>\n<li>Registration of <strong>new medical devices\/UDI<\/strong> becomes strategic for market placement.<\/li>\n<li><strong>Notified Bodies<\/strong> must upload new certificates from <strong>28\/05\/2026<\/strong>, and upload existing certificates by <strong>27\/05\/2027<\/strong>.<\/li>\n<li>Competent Authorities across EU Member States will have a harmonised tool for <strong>market surveillance and coordination<\/strong>.<\/li>\n<\/ul>\n<p>The mandatory use of these modules represents a major step towards improving transparency, safety, and traceability of medical devices within the European Union. Early preparation is essential to avoid delays, data submission backlogs, and compliance issues!<\/p>\n<p><strong>HOW ALL4COMPLIANCE CAN SUPPORT YOU<\/strong><\/p>\n<p>All4Compliance supports manufacturers, authorised representatives, and importers in ensuring that their companies and products are fully compliant with the new EUDAMED deadlines. We can help you plan and manage the entire process &#8211; from readiness assessment and registration strategy to device data preparation and submission, as well as regulatory consulting and EUDAMED training.<\/p>\n<p>Our goal is to make the implementation of EUDAMED as simple and efficient as possible, reducing the risk of errors, delays, and compliance-related challenges.<br \/>Contact us for a fit-to-need proposal, suited to your company\u2019s needs, your products, and to ensure you meet the new mandatory deadlines!<\/p>\n<p><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdf\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-376819 aligncenter size-full\" src=\"https:\/\/all4compliance.pt\/wp-content\/uploads\/2025\/11\/eudamed-rollout1.jpg\" alt=\"\" width=\"1919\" height=\"1079\" srcset=\"https:\/\/all4compliance.pt\/wp-content\/uploads\/2025\/11\/eudamed-rollout1.jpg 1919w, https:\/\/all4compliance.pt\/wp-content\/uploads\/2025\/11\/eudamed-rollout1-1280x720.jpg 1280w, https:\/\/all4compliance.pt\/wp-content\/uploads\/2025\/11\/eudamed-rollout1-980x551.jpg 980w, https:\/\/all4compliance.pt\/wp-content\/uploads\/2025\/11\/eudamed-rollout1-480x270.jpg 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 1919px, 100vw\" \/><\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; 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Developed by  <a href=\"https:\/\/bestsites.pt\/\" target=\"_blank\" rel=\"noopener noreferrer\">Bestsites.pt<\/a>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u200bEUDAMED will finally become mandatory as of 28 May 2026! The official notice was published by the European Commission in the Official Journal of the European Union on 27 November 2025, initiating a six-month transition period that ends on 28 May 2026.From this date onwards, the first four EUDAMED modules will become mandatory, marking a [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":376807,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"<!-- wp:paragraph -->\r\n<p>Welcome to WordPress. This is your first post. 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