{"id":3352,"date":"2025-03-06T14:01:00","date_gmt":"2025-03-06T14:01:00","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3352"},"modified":"2025-03-06T14:01:00","modified_gmt":"2025-03-06T14:01:00","slug":"uk-ivd-registration-key-updates-for-manufacturers-with-expiring-ce-certificates","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/uk-ivd-registration-key-updates-for-manufacturers-with-expiring-ce-certificates\/","title":{"rendered":"UK IVD Registration: Key Updates for Manufacturers with Expiring CE Certificates"},"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\"><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-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/uk-ivd-registration-key-updates-for-manufacturers-with-expiring-ce-certificates\/#New_MHRA_guidance_on_in_vitro_diagnostic_IVD_device_registration_in_the_UK\" >New MHRA guidance on in vitro diagnostic (IVD) device registration in the UK<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/uk-ivd-registration-key-updates-for-manufacturers-with-expiring-ce-certificates\/#What_has_changed\" >What has changed?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/uk-ivd-registration-key-updates-for-manufacturers-with-expiring-ce-certificates\/#Key_points_for_manufacturers\" >Key points for manufacturers<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/uk-ivd-registration-key-updates-for-manufacturers-with-expiring-ce-certificates\/#Need_a_UK_Responsible_Person_UK_RP_We_can_help\" >Need a UK Responsible Person (UK RP)? We can help!<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/uk-ivd-registration-key-updates-for-manufacturers-with-expiring-ce-certificates\/#How_to_stay_compliant\" >How to stay compliant<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/cmcmedicaldevices.com\/es\/uk-ivd-registration-key-updates-for-manufacturers-with-expiring-ce-certificates\/#Need_Help_with_UK_IVD_registration\" >Need Help with UK IVD registration?<\/a><\/li><\/ul><\/nav><\/div>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"New_MHRA_guidance_on_in_vitro_diagnostic_IVD_device_registration_in_the_UK\"><\/span>New MHRA guidance on in vitro diagnostic (IVD) device registration in the UK<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The <b><u><a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\" target=\"_blank\" rel=\"noopener noreferrer\">UK Medicines and Healthcare products Regulatory Agency (MHRA)<\/a><\/u> <\/b>has issued updated guidance on the<b> registration of in vitro diagnostic (IVD) devices<\/b> with <b>expiring CE certificates<\/b>. These new measures outline how manufacturers can maintain <b>market access in the UK<\/b> while ensuring compliance with evolving regulatory requirements.<br \/>\nIf your IVD devices are affected by these changes, it\u2019s crucial to take action <b>before your CE certificate expires<\/b> to avoid disruptions in distribution.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"What_has_changed\"><\/span>What has changed?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The UK government has introduced specific conditions for<b> IVDs benefiting from the EU IVDR transitional extension<\/b>. If your IVDs fall under this category, you may still be able to <b>register and market them in the UK<\/b>, but compliance with updated regulations is essential.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"Key_points_for_manufacturers\"><\/span>Key points for manufacturers<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>1\ufe0f\u20e3 <b>IVDs with extended CE certificates may remain on the UK market<\/b><\/p>\n<ul>\n<li>Devices covered by the<b> EU IVDR transition period<\/b> can continue to be marketed in the UK under specific conditions.<\/li>\n<li>The full <b><u><a href=\"https:\/\/www.gov.uk\/government\/publications\/registration-of-in-vitro-diagnostic-devices-with-expiring-ce-certificates\/registration-of-certain-in-vitro-diagnostic-devices\" target=\"_blank\" rel=\"noopener noreferrer\">MHRA guidance on IVD registration<\/a><\/u><\/b> provides detailed instructions.<\/li>\n<\/ul>\n<p>2\ufe0f\u20e3<b> Compliance with new UK regulations is mandatory<\/b><\/p>\n<ul>\n<li>Manufacturers must ensure their devices meet the <b>UK regulatory framework<\/b> to maintain validity.<\/li>\n<li>The MHRA has introduced specific registration and compliance conditions for affected devices.<\/li>\n<\/ul>\n<p>3\ufe0f\u20e3 <b>Deadlines matter: Certificates expiring on or after July 9, 2024, require action<\/b><\/p>\n<ul>\n<li>Manufacturers must <b>update their registration<\/b> with MHRA before their certificate expires.<\/li>\n<li>Registrations must be submitted through <b>DORS (Device Online Registration System)<\/b> to ensure continued market access.<\/li>\n<\/ul>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"Need_a_UK_Responsible_Person_UK_RP_We_can_help\"><\/span>Need a UK Responsible Person (UK RP)? We can help!<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Non-UK manufacturers are required to appoint a <b><a href=\"https:\/\/cmcmedicaldevices.com\/services\/representation-uk\/\"><u>UK Responsible Person (UK RP)<\/u><\/a> <\/b>to register and maintain compliance for their devices in the UK market.<\/p>\n<p>As your <b>trusted UK RP<\/b>, we provide:<\/p>\n<p>\u2714 <b>Complete MHRA registration services<\/b> for medical devices and IVDs<br \/>\n\u2714 <b>Ongoing regulatory compliance support<\/b> to ensure seamless market access<br \/>\n\u2714<b> Expert guidance on UK MDR and IVDR requirements<\/b><\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"How_to_stay_compliant\"><\/span>How to stay compliant<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>To maintain your presence in the UK market, take these proactive steps:<\/p>\n<p>\u2714<b> Identify affected devices:<\/b> Review your IVD portfolio to determine which products require registration updates.<br \/>\n\u2714<b> Register or update your devices in MHRA\u2019s system:<\/b> Ensure all required documentation is submitted through DORS before deadlines.<br \/>\n\u2714<b> Appoint a UK Responsible Person (UK RP):<\/b> If you are a non-UK manufacturer, you must have a designated UK RP to handle compliance.<br \/>\n\u2714 <b>Monitor regulatory changes:<\/b> Stay informed on updates from the MHRA to avoid compliance risks.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"Need_Help_with_UK_IVD_registration\"><\/span>Need Help with UK IVD registration?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Ensuring compliance with <b>MHRA\u2019s evolving regulations<\/b> is crucial for manufacturers looking to maintain access to the UK market. If you need support with <b>IVD registration<\/b>, UK RP services, or guidance on compliance strategies, our regulatory experts are here to help.<\/p>\n<p><b>Contact us today<\/b> to ensure your IVD devices remain compliant and available in the UK.<\/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:10px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us<\/span><\/a><\/div><div class=\"fusion-image-element \" 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