{"id":7999,"date":"2024-01-11T17:08:48","date_gmt":"2024-01-11T17:08:48","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7999"},"modified":"2024-01-12T19:28:07","modified_gmt":"2024-01-12T19:28:07","slug":"uk-mhra-medical-device-registration","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/uk-mhra-medical-device-registration\/","title":{"rendered":"Medical Device Registration under UK MHRA: UKCA Marking Requirements, UK Responsible Person, and More"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7999\" class=\"elementor elementor-7999\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/11\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 11, 2024\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Medical Device Registration under UK MHRA: UKCA Marking Requirements, UK Responsible Person, and More<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"900\" height=\"575\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/brexit-uk-web-e1601067002259.png\" class=\"attachment-full size-full wp-image-3432\" alt=\"Brexit UKCA medical device\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/brexit-uk-web-e1601067002259.png 900w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/brexit-uk-web-e1601067002259-300x192.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/brexit-uk-web-e1601067002259-768x491.png 768w\" sizes=\"(max-width: 900px) 100vw, 900px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>If you have worked in European regulatory affairs for some time, it\u2019s hard to wrap your brain around the fact that the United Kingdom is no longer part of the European Union. The UK will once again forge its own path, interacting with its continental neighbors in a manner similar to Norway. Yet the key difference is that Norway has chosen to emulate the EU Medical Device Regulation (2017\/745) as national law and require CE Marking.<\/p><p>In late 2020 the UK MHRA further ensured job security among medical device regulatory professionals by\u00a0<a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-from-1-january-2021\" target=\"_blank\" rel=\"nofollow noopener\">moving<\/a>\u00a0to implement their own registration and marking scheme.<\/p><h3>\u00a0<\/h3><h3>Overview of the New UK Registration &amp; Marking Scheme<\/h3><p>An understanding of the new UK MHRA medical device registration requirements starts with a basic UK geography lesson. Brexit created many logistical and political headaches, one of which is what to do about cross-border trade between Northern Ireland (part of the UK) and the country of Ireland (an EU member). As such, a scheme was created that treats Northern Ireland and Great Britain (England, Wales, Scotland) differently from a regulatory perspective, even though all four regions are part of the UK. This is the side effect of an effort to prevent a \u201chard border\u201d between Ireland and Northern Ireland.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"lazy loaded\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_GB_MAP-e1601093484893.png\" sizes=\"(max-width: 522px) 100vw, 522px\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_GB_MAP-e1601093484893.png 953w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_GB_MAP-e1601093484893-300x86.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_GB_MAP-e1601093484893-768x219.png 768w\" alt=\"\" width=\"522\" height=\"149\" data-src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_GB_MAP-e1601093484893.png\" data-sizes=\"(max-width: 522px) 100vw, 522px\" data-srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_GB_MAP-e1601093484893.png 953w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_GB_MAP-e1601093484893-300x86.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_GB_MAP-e1601093484893-768x219.png 768w\" data-was-processed=\"true\" \/><\/p><h3>\u00a0<\/h3><h3>The MDD Will Remain in Effect\u2026For Now<\/h3><p>Now, device manufacturers selling in the UK must follow the UK Medicines and Medical Devices Act of 2021 (MMDA). Valid CE Marking certificates issued by EU Notified Bodies will continue to be recognized in the UK until June 30, 2023.<\/p><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"lazy loaded\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_Transition_Timeline-e1601093534976.png\" sizes=\"(max-width: 1044px) 100vw, 1044px\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_Transition_Timeline-e1601093534976.png 1044w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_Transition_Timeline-e1601093534976-300x134.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_Transition_Timeline-e1601093534976-1024x459.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_Transition_Timeline-e1601093534976-768x344.png 768w\" alt=\"\" width=\"1044\" height=\"468\" data-src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_Transition_Timeline-e1601093534976.png\" data-sizes=\"(max-width: 1044px) 100vw, 1044px\" data-srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_Transition_Timeline-e1601093534976.png 1044w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_Transition_Timeline-e1601093534976-300x134.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_Transition_Timeline-e1601093534976-1024x459.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_Transition_Timeline-e1601093534976-768x344.png 768w\" data-was-processed=\"true\" \/><\/p><p>\u00a0<\/p><p><strong><a href=\"https:\/\/www.gov.uk\/guidance\/register-medical-devices-to-place-on-the-market-from-1-january-2021\" target=\"_blank\" rel=\"nofollow noopener\">See this new MHRA guidance document on the UK medical device and IVD registration process published in December 2020<\/a>.<\/strong><\/p><h3>\u00a0<\/h3><h3>The New UKCA and UKNI Marks<\/h3><p>Medical device manufacturers must apply a new UK Conformity Assessed (UKCA) Mark to their device labeling for products sold in England, Wales, and Scotland. This means that if you have a current, valid Declaration of Conformity or CE Marking certificate, you automatically meet UKCA mark requirements. However, you will not need to modify your existing labeling to add the UKCA mark until July 1, 2023. After this date UKCA it will be mandatory, but dual labels with the CE and UKCA Marks will be acceptable.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"lazy loaded\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/CE-Mark-UKCA-Mark-e1601067208108.jpg\" sizes=\"(max-width: 224px) 100vw, 224px\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/CE-Mark-UKCA-Mark-e1601067208108.jpg 400w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/CE-Mark-UKCA-Mark-e1601067208108-300x119.jpg 300w\" alt=\"UKCA Mark\" width=\"224\" height=\"89\" data-src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/CE-Mark-UKCA-Mark-e1601067208108.jpg\" data-sizes=\"(max-width: 224px) 100vw, 224px\" data-srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/CE-Mark-UKCA-Mark-e1601067208108.jpg 400w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/CE-Mark-UKCA-Mark-e1601067208108-300x119.jpg 300w\" data-was-processed=\"true\" \/><\/p><p>As for new devices, a UK Conformity Assessment Body will need to a conduct an assessment for compliance with the UKCA mark requirements. Existing UK Notified Bodies under the European MDD most likely will continue to be designated for UKCA conformity assessment according to CE Marking. However, note the conformity assessment will be against the UK medical device regulations, which follow the MDD.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"lazy loaded\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-150x150.png\" sizes=\"(max-width: 150px) 100vw, 150px\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-150x150.png 150w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-300x300.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-1024x1024.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-768x768.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-1536x1536.png 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-2048x2048.png 2048w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-90x90.png 90w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-75x75.png 75w\" alt=\"UKNI Mark\" width=\"150\" height=\"150\" data-src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-150x150.png\" data-sizes=\"(max-width: 150px) 100vw, 150px\" data-srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-150x150.png 150w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-300x300.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-1024x1024.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-768x768.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-1536x1536.png 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-2048x2048.png 2048w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-90x90.png 90w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/UKNI_BLK_AW-75x75.png 75w\" data-was-processed=\"true\" \/><\/p><p>As if Brexit wasn\u2019t confusing enough, the UKCA mark will not be recognized in Northern Ireland which will have its own UKNI mark! If you want to make your head hurt even more than it already does, you can read about that\u00a0<a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukni-marking-from-1-january-2021\" target=\"_blank\" rel=\"nofollow noopener\">know more<\/a>. You better design larger labels to account for all these new marks!<\/p><h3>\u00a0<\/h3><h3>Appointing a UK Responsible Person<\/h3><p>In addition to the new UKCA mark, manufacturers located outside of the UK will need to appoint a UK Responsible Person prior to registration. This applies to products sold in England, Scotland and Wales (collectively Great Britain). Similar to the EU Authorized Representative, the UK Responsible Person will be responsible for registering devices with the MHRA, ensuring that a Declaration of Conformity has been drawn up and that technical documentation exists. Various other responsibilities apply as well.<\/p><p>For devices sold in Northern Ireland, things get really tricky. If the manufacturer is located in Great Britain, an EU Authorized Representative is required, not a UK Responsible Person. If the company is located outside the UK, a UK Responsible Person will be required, along with a UK importer.<\/p><h4>\u00a0<\/h4><h3>UK and EU Representation Requirements<\/h3><h4><img decoding=\"async\" loading=\"lazy\" class=\"lazy loaded\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_and_EU_representation_requirements-e1601067259669.png\" sizes=\"(max-width: 900px) 100vw, 900px\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_and_EU_representation_requirements-e1601067259669.png 900w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_and_EU_representation_requirements-e1601067259669-300x141.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_and_EU_representation_requirements-e1601067259669-768x360.png 768w\" alt=\"\" width=\"900\" height=\"422\" data-src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_and_EU_representation_requirements-e1601067259669.png\" data-sizes=\"(max-width: 900px) 100vw, 900px\" data-srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_and_EU_representation_requirements-e1601067259669.png 900w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_and_EU_representation_requirements-e1601067259669-300x141.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/09\/UK_and_EU_representation_requirements-e1601067259669-768x360.png 768w\" data-was-processed=\"true\" \/><\/h4><h3>\u00a0<\/h3><h3>The Legislative Process Is Still at Work<\/h3><p>The process of untangling nearly 50 years of political, trade, and legal integration with the EU is messy and ongoing. There is plenty more to do, and the MHRA is surely working hard to establish a new framework for regulation of medical devices in the UK. As things evolve, Oriel STAT A MATRIX will keep you updated.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3400fd elementor-widget elementor-widget-shortcode\" data-id=\"a3400fd\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. 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Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li 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href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical Device Registration under UK MHRA: UKCA Marking Requirements, UK Responsible Person, and More If you have worked in European regulatory affairs for some time, it\u2019s hard to wrap your brain around the fact that the United Kingdom is no longer part of the European Union. The UK will once again forge its own path, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3432,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[34,16],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/uk-mhra-medical-device-registration\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Medical Device Registration under UK MHRA: UKCA Marking Requirements, UK Responsible Person, and More If you have worked in European regulatory affairs for some time, it\u2019s hard to wrap your brain around the fact that the United Kingdom is no longer part of the European Union. 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