{"id":381,"date":"2026-08-11T10:10:03","date_gmt":"2026-08-11T08:10:03","guid":{"rendered":"https:\/\/www.pqra.gr\/eudamed-and-actor-registration-what-is-now-mandatory\/"},"modified":"2026-08-27T11:37:11","modified_gmt":"2026-08-27T09:37:11","slug":"eudamed-and-actor-registration-what-is-now-mandatory","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/eudamed-and-actor-registration-what-is-now-mandatory\/","title":{"rendered":"EUDAMED and Actor Registration: What Is Now Mandatory"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>The European database on medical devices has moved from &#8220;coming soon&#8221; to &#8220;required now&#8221;. Since May 2026, the first EUDAMED modules are mandatory &mdash; and registration is the gateway to everything else.<\/strong><\/p>\n<p>EUDAMED is the EU&#8217;s central database for medical devices, designed to bring transparency and traceability across the single market. After years of phased development, a Commission Decision of November 2025 declared the first four modules functional, which &mdash; under Regulation (EU) 2024\/1860 &mdash; triggered a six-month transition making them <strong>mandatory from 28 May 2026<\/strong>.<\/p>\n<h2>The four mandatory modules<\/h2>\n<ul>\n<li><strong>Actor registration<\/strong> &mdash; manufacturers, authorised representatives and importers.<\/li>\n<li><strong>UDI \/ device registration<\/strong>.<\/li>\n<li><strong>Notified bodies and certificates<\/strong>.<\/li>\n<li><strong>Market surveillance<\/strong>.<\/li>\n<\/ul>\n<h2>The Single Registration Number<\/h2>\n<p>Actor registration is the foundation. Each economic operator obtains a <strong>Single Registration Number (SRN)<\/strong>, which is then required to register devices and certificates and is used throughout the system. Without an SRN, nothing else can proceed &mdash; so it is the first step for any operator active in the EU.<\/p>\n<h2>Still to come<\/h2>\n<p>Two modules &mdash; vigilance and post-market surveillance, and clinical investigations and performance studies &mdash; remain under development and are not yet mandatory. Current projections point to mandatory use around 2027, but no firm Commission date has been set, so treat those timelines as provisional.<\/p>\n<h2>Simplification in progress<\/h2>\n<p>In December 2025 the Commission proposed a targeted revision of the MDR and IVDR to cut complexity and cost, particularly for smaller companies &mdash; covering revised software rules, wider electronic instructions for use, and new pathways for orphan and breakthrough devices. It is a proposal working its way through the legislative process, not yet law.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA handles actor registration and SRN applications, device and certificate registration, and ongoing EUDAMED obligations.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Get registered in EUDAMED &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>The European database on medical devices has moved from &#8220;coming soon&#8221; to &#8220;required now&#8221;. Since May 2026, the first EUDAMED modules are mandatory &mdash; and registration is the gateway to everything else. EUDAMED is the EU&#8217;s central database for medical devices, designed to bring transparency and traceability across the single market. After years of phased [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":395,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[9,14],"tags":[],"class_list":["post-381","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-base","category-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EUDAMED and Actor Registration: What Is Now Mandatory - PQRA<\/title>\n<meta name=\"description\" content=\"The European database on medical devices has moved from \u201ccoming soon\u201d to \u201crequired now\u201d. 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