{"id":339,"date":"2026-08-10T15:52:55","date_gmt":"2026-08-10T13:52:55","guid":{"rendered":"https:\/\/www.pqra.gr\/the-ivdr-extended-deadlines-but-no-room-for-complacency\/"},"modified":"2026-08-27T11:38:26","modified_gmt":"2026-08-27T09:38:26","slug":"the-ivdr-extended-deadlines-but-no-room-for-complacency","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/the-ivdr-extended-deadlines-but-no-room-for-complacency\/","title":{"rendered":"The IVDR: Extended Deadlines, but No Room for Complacency"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>The In Vitro Diagnostic Regulation reshaped how diagnostics reach the EU market &mdash; and while transition deadlines have been extended, the conditions attached to them have already bitten.<\/strong><\/p>\n<p>Regulation (EU) 2017\/746 (IVDR) became applicable on 26 May 2022, replacing the old IVD Directive. Its central change is scope: under the previous rules only around a fifth of diagnostics needed a notified body, whereas under IVDR the large majority do &mdash; a shift that created a structural capacity bottleneck.<\/p>\n<h2>The transition timeline<\/h2>\n<p>Regulation (EU) 2022\/112 staggered the deadlines for legacy devices by risk class:<\/p>\n<ul>\n<li><strong>31 December 2027<\/strong> &mdash; Class D (highest risk, e.g. blood-screening tests).<\/li>\n<li><strong>31 December 2028<\/strong> &mdash; Class C.<\/li>\n<li><strong>31 December 2029<\/strong> &mdash; Class B and Class A sterile.<\/li>\n<\/ul>\n<p>These extensions are conditional: a fully IVDR-compliant quality management system had to be in place by 26 May 2025, with staggered notified-body application deadlines following. Miss those and the extension does not apply.<\/p>\n<h2>Classification drives everything<\/h2>\n<p>IVDR uses a rule-based A-to-D classification. Because class determines the conformity-assessment route and the evidence required, getting classification right at the outset is the single most important early decision &mdash; and a frequent source of costly rework.<\/p>\n<h2>EUDAMED is now live<\/h2>\n<p>Under Regulation (EU) 2024\/1860, EUDAMED is rolling out module by module. Following a Commission Decision in late 2025, the first four modules &mdash; actor registration, UDI\/device registration, notified bodies and certificates, and market surveillance &mdash; became <strong>mandatory from 28 May 2026<\/strong>, for IVDs as well as medical devices. Actor registration and a Single Registration Number are the gateway.<\/p>\n<h2>Simplification on the way<\/h2>\n<p>In December 2025 the Commission proposed a targeted revision to simplify the MDR and IVDR &mdash; introducing conformity-assessment timelines, harmonising notified-body practice and clarifying rules for AI-enabled devices. It is still a proposal, and adoption is expected only later; treat published timelines with caution.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA supports IVDR classification, technical documentation, notified-body strategy and EUDAMED registration &mdash; so diagnostics stay on the market through the transition and beyond.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Talk to us about your IVD strategy &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>The In Vitro Diagnostic Regulation reshaped how diagnostics reach the EU market &mdash; and while transition deadlines have been extended, the conditions attached to them have already bitten. Regulation (EU) 2017\/746 (IVDR) became applicable on 26 May 2022, replacing the old IVD Directive. Its central change is scope: under the previous rules only around a [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":349,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[9,1],"tags":[],"class_list":["post-339","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-base","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The IVDR: Extended Deadlines, but No Room for Complacency - PQRA<\/title>\n<meta name=\"description\" content=\"The In Vitro Diagnostic Regulation reshaped how diagnostics reach the EU market \u2014 and while transition deadlines have been extended, the conditions\u2026\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pqra.gr\/el\/the-ivdr-extended-deadlines-but-no-room-for-complacency\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The IVDR: Extended Deadlines, but No Room for Complacency - 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