{"id":3922,"date":"2025-07-18T10:09:15","date_gmt":"2025-07-18T10:09:15","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3922"},"modified":"2025-07-18T10:09:15","modified_gmt":"2025-07-18T10:09:15","slug":"why-the-uk-is-moving-toward-eu-aligned-standards-for-ivds","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/why-the-uk-is-moving-toward-eu-aligned-standards-for-ivds\/","title":{"rendered":"Why the UK is moving toward EU-aligned standards for IVDs"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 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:1248px;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-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--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-1\"><p><strong>The UK\u2019s decision to adopt EU Common Specifications for high-risk in vitro diagnostic (IVD) devices<\/strong> reflects a regulatory shift toward performance-based requirements and alignment with internationally recognised standards. This approach supports public health objectives, replaces legacy mechanisms such as the CTDA, and sets the foundation for a more consistent regulatory framework.<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/why-the-uk-is-moving-toward-eu-aligned-standards-for-ivds\/#What_are_Common_Specifications_under_EU_IVDR\" >What are Common Specifications under EU IVDR?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/why-the-uk-is-moving-toward-eu-aligned-standards-for-ivds\/#Why_is_the_UK_adopting_these_standards_now\" >Why is the UK adopting these standards now?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/why-the-uk-is-moving-toward-eu-aligned-standards-for-ivds\/#What_is_changing_for_COVID-19_test_regulation\" >What is changing for COVID-19 test regulation?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/why-the-uk-is-moving-toward-eu-aligned-standards-for-ivds\/#When_will_these_changes_take_effect\" >When will these changes take effect?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/why-the-uk-is-moving-toward-eu-aligned-standards-for-ivds\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 id=\"common-specs\" class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"What_are_Common_Specifications_under_EU_IVDR\"><\/span>What are Common Specifications under EU IVDR?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>Common Specifications (CS)<\/b> are legally binding sets of technical and performance requirements adopted at the EU level. Under the <strong>In Vitro Diagnostic Medical Devices Regulation (IVDR)<\/strong>, they apply to specific high-risk devices when harmonised standards are not available or additional regulatory clarity is required.<\/p>\n<p>The scope of these specifications includes IVDs intended for detecting serious infectious diseases such as <strong>HIV<\/strong>, <strong>hepatitis B, C and D<\/strong>, and <strong>syphilis<\/strong>, as well as devices used for <strong>blood grouping<\/strong> and <strong>tissue typing<\/strong>. These diagnostics are critical for patient management, clinical decision-making, and public health surveillance.<\/p>\n<h2 id=\"why-now\" class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Why_is_the_UK_adopting_these_standards_now\"><\/span>Why is the UK adopting these standards now?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>As stated by the <strong>UK government<\/strong>, the aim is to establish <b>a performance-driven regulatory model that ensures IVDs meet stringent safety and efficacy thresholds<\/b>. This move also reflects the outcome of a public consultation in which stakeholders expressed overwhelming support for the repeal of the <strong>Coronavirus Test Device Approvals (CTDA)<\/strong> and the adoption of Common Specifications as a replacement.<\/p>\n<p>The government\u2019s position is that aligning with European-level requirements will not only reinforce the scientific rigour of the UK framework but also facilitate operational consistency for manufacturers placing products on both UK and EU markets.<\/p>\n<p>According to <strong>Rob Reid<\/strong>, Deputy Director of Innovative Devices at the MHRA:<br \/>\n<em>\u201cBy aligning with standards already in place across Europe, we\u2019re not only enhancing patient safety but also making it easier for manufacturers to navigate regulatory requirements across different markets.\u201d<\/em><\/p>\n<h2 id=\"covid19\" class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"What_is_changing_for_COVID-19_test_regulation\"><\/span>What is changing for COVID-19 test regulation?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The existing <strong>CTDA process<\/strong>, implemented during the pandemic to control the quality of COVID-19 tests sold in Great Britain, will be formally repealed. In its place, an <strong>interim accelerated CTDA pathway<\/strong> will remain available for COVID-19 tests that:<\/p>\n<ul>\n<li>Are CE marked under the EU IVDR<\/li>\n<li>Comply with the relevant EU Common Specifications<\/li>\n<\/ul>\n<p>This transitional measure is intended to ensure continued access to high-quality COVID-19 diagnostics while the UK prepares for full integration of Common Specifications into its domestic law.<\/p>\n<h2 id=\"timeline\" class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"When_will_these_changes_take_effect\"><\/span>When will these changes take effect?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color: rgba(0, 0, 0, 0);\"><b>The government has stated that the new specifications will be introduced in regulations expected to be published later this year<\/b><\/span>. The reforms form part of a broader program to modernise the regulation of medical devices and diagnostics in Great Britain, as outlined by the <strong>Medicines and Healthcare products Regulatory Agency (MHRA)<\/strong>.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>The UK is aligning with the EU\u2019s Common Specifications for high-risk IVDs<\/b>. This change will replace the CTDA framework, raise performance expectations, and create greater regulatory coherence across UK and EU markets.<\/p>\n<p>At <strong>CMC Medical Devices<\/strong>, we support IVD manufacturers in adapting to evolving regulatory frameworks, from CE marking under IVDR to aligning with new UK, specific requirements.<\/p>\n<p><b style=\"background-color: rgba(0, 0, 0, 0);\"><a style=\"color: #062b21;\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\">Contact us<\/a> to schedule a consultation and prepare your documentation for the next phase of UK market access.<\/b><\/p>\n<p>These changes were officially announced by the UK government in July 2025 as part of its ongoing regulatory reform programme:<br \/>\n<b><a href=\"https:\/\/www.gov.uk\/government\/news\/government-to-align-with-european-specifications-on-high-risk-in-vitro-diagnostic-devices-to-reduce-regulatory-burden?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener noreferrer\">Government to align with European specifications on high-risk in vitro diagnostic devices<\/a><\/b><\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us for more information<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-max-width:600px;--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=\"1640\" height=\"924\" alt=\"UK aligns with EU Common Specifications for high-risk IVD devices\" title=\"UK aligns with EU Common Specifications for high-risk IVD devices\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/UK-aligns-with-EU-Common-Specifications-for-high-risk-IVD-devices.jpg\" class=\"img-responsive wp-image-3899\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/UK-aligns-with-EU-Common-Specifications-for-high-risk-IVD-devices-200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/UK-aligns-with-EU-Common-Specifications-for-high-risk-IVD-devices-400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/UK-aligns-with-EU-Common-Specifications-for-high-risk-IVD-devices-600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/UK-aligns-with-EU-Common-Specifications-for-high-risk-IVD-devices-800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/UK-aligns-with-EU-Common-Specifications-for-high-risk-IVD-devices-1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/UK-aligns-with-EU-Common-Specifications-for-high-risk-IVD-devices.jpg 1640w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;center&quot;,&quot;id&quot;:&quot;3922&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;5&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this&quot;,&quot;legend&quot;:&quot;5\\\/5 - (5 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;Why the UK is moving toward EU-aligned standards for IVDs&quot;,&quot;width&quot;:&quot;142.5&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 142.5px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (5 votos)    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3922","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Master UDI-DI deadlines for contact lenses and spectacle frames<\/title>\n<meta name=\"description\" content=\"Learn when the Master UDI-DI becomes mandatory for contact lenses and spectacle frames under MDR. 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