{"id":4,"date":"2021-07-18T09:30:00","date_gmt":"2021-07-18T09:30:00","guid":{"rendered":"http:\/\/shirobusiness.com\/?p=1"},"modified":"2023-04-17T09:16:37","modified_gmt":"2023-04-17T09:16:37","slug":"what-is-the-uk-conformity-assessed-mark-ukca","status":"publish","type":"post","link":"https:\/\/shirobusiness.com\/what-is-the-uk-conformity-assessed-mark-ukca\/","title":{"rendered":"What is the UK Conformity Assessed Mark (UKCA)?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4\" class=\"elementor elementor-4\">\n\t\t\t\t\t\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-48f70125 elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"48f70125\" 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=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3fb24b1f ae-bg-gallery-type-default\" data-id=\"3fb24b1f\" 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<div class=\"elementor-element elementor-element-6edf43f8 elementor-widget elementor-widget-text-editor\" data-id=\"6edf43f8\" 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 - v3.12.2 - 23-04-2023 *\/\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<!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\"><strong>What is the UK Conformity Assessed Mark (UKCA)?<\/strong><\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\">The <a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukca-marking#:~:text=The%20UKCA%20(UK%20Conformity%20Assessed,effect%20on%201%20January%202021.\" target=\"_blank\" rel=\"noreferrer noopener\">United Kingdom Conformity Assessed (UKCA) <\/a>mark is replacing the CE mark in Great Britain, as the United Kingdom left the EU single market on 31 December 2020. It is being introduced in a phased approach, with the CE mark remaining acceptable when placing most products on the GB market until 31 December 2022. However, for Medical Devices, the deadline is June 30<sup>th<\/sup> 2023<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\"><strong>What is the UKCA mark?<\/strong><\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\">According to the UK Government, the <a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukca-marking\">UKCA mark<\/a> is &#8220;a new product marking that is being used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required the CE marking known as &#8220;new approach&#8221; goods.&#8221;<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\">It is important to note that the <a href=\"https:\/\/shirobusiness.com\/understanding-ukca-marking-and-labelling-requirements-in-northern-ireland\/\">UKCA mark<\/a> cannot be used for goods in the Northern Ireland market. These goods will still require <a href=\"https:\/\/ec.europa.eu\/growth\/single-market\/ce-marking_en\">CE marking <\/a>for self-assessed goods and those that are conformity assessed by an EU Notified Body. The CE plus UKNI mark is used for goods that are conformity assessed by a UK Notified Body.<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\">The purpose of the UKCA mark is to indicate that the product it is attached to conforms to GB legislation. The manufacturer, or their authorised representative, is responsible for affixing the UKCA mark to their product.<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\"><strong>When does the UKCA mark come into force?<\/strong><\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\">\u00a0The UKCA marking came into effect on 1 January 2021. However, in most cases, CE marking is still acceptable until 1 January 2023 to allow businesses time to adjust.<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\">After 1 January 2021, only products with UKCA marking will be accepted in Great Britain.<\/p>\n<!-- \/wp:paragraph --><!-- wp:image {\"id\":2475,\"sizeSlug\":\"large\",\"linkDestination\":\"none\"} -->\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"499\" class=\"wp-image-2475\" src=\"https:\/\/shirobusiness.com\/wp-content\/uploads\/2022\/07\/ukca-timeline-1024x499.png\" alt=\"Timeline to implement UKCA Marking \" srcset=\"https:\/\/shirobusiness.com\/wp-content\/uploads\/2022\/07\/ukca-timeline-1024x499.png 1024w, https:\/\/shirobusiness.com\/wp-content\/uploads\/2022\/07\/ukca-timeline-300x146.png 300w, https:\/\/shirobusiness.com\/wp-content\/uploads\/2022\/07\/ukca-timeline-768x375.png 768w, https:\/\/shirobusiness.com\/wp-content\/uploads\/2022\/07\/ukca-timeline.png 1058w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<!-- \/wp:image --><!-- wp:paragraph {\"backgroundColor\":\"ast-global-color-4\",\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-ast-global-color-4-background-color has-text-color has-background\">The end date for recognising the CE mark in Great Britain will differ for certain goods, such as medical devices.<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\"><strong>How does the UKCA mark affect medical device manufacturers?<\/strong><\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\"><em>#1 If you are a UK-based manufacturer supplying to the UK market only<\/em><\/p>\n<!-- \/wp:paragraph --><!-- wp:list -->\n<ul><!-- wp:list-item -->\n<li>If it is not already registered, you need to register your device with the MHRA (Medicines and Healthcare Products Regulatory Agency).<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>MDD (Medical Devices Directive) and MHRA certification will be accepted in Great Britain until 30 June 2023. The UKCA mark will be necessary after this date, and MDR will not be mandatory.<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>If you are based in Northern Ireland, the CE mark is required, and MDR has been mandatory from 26 May 2021. Valid MDD certificates will be accepted until their expiry date (and no later than 25 May 2024) as long as there are no substantial changes to the device.<\/li>\n<!-- \/wp:list-item --><\/ul>\n<!-- \/wp:list --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\"><em>#2 If you are a UK-based manufacturer supplying the EU<\/em><\/p>\n<!-- \/wp:paragraph --><!-- wp:list -->\n<ul><!-- wp:list-item -->\n<li>Since 1 January 2021, you must have had an <a href=\"https:\/\/shirobusiness.com\/eu-economic-operator-services\/\">EU or Ni-based authorised representative.<\/a><\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>You must also comply with the CE mark (MDD\/MDR).<\/li>\n<!-- \/wp:list-item --><\/ul>\n<!-- \/wp:list --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\"><em>#3 If you are outside the UK and supplying to the UK market<\/em><\/p>\n<!-- \/wp:paragraph --><!-- wp:list -->\n<ul><!-- wp:list-item -->\n<li>If you supply to Great Britain, the CE mark will be recognised until 30 June 2023, with the UKCA mark required after this. A dual certification, CE + UKCA, will also be accepted.<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>The CE mark and MDR certification will also be required if you supply to the Northern Ireland (NI) market. MDD-certified devices can be placed on the NI market until 24 May 2024 (unless there are substantial changes to the device, which will require MDR certification).<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>You will also have to register with a UK-based responsible person.<\/li>\n<!-- \/wp:list-item --><\/ul>\n<!-- \/wp:list --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\"><strong>Why work with Shiro Business Solutions?<\/strong><\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\">Shiro Business Solutions is highly experienced in ensuring medical devices and medical technology companies are operating as efficiently as possible and are compliant with the rapidly changing regulatory scenarios of the EU. MDR and IVDR.<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"black\"} -->\n<p class=\"has-black-color has-text-color\">Please <a href=\"https:\/\/shirobusiness.com\/contact\/\">contact us<\/a> to get a jargon-free service regarding your UKCA requirements.<\/p>\n<!-- \/wp:paragraph -->\t\t\t\t\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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The United Kingdom Conformity Assessed (UKCA) mark is replacing the CE mark in Great Britain, as the United Kingdom left the EU single market on 31 December 2020. <\/p>\n","protected":false},"author":5,"featured_media":2477,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"categories":[14],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>UK Conformity Assessed Mark (UCA) | Shiro Business Solutions<\/title>\n<meta name=\"description\" content=\"Understand the UKCA marking requirements &amp; more, with regards to Brexit and how it will impact the CE mark.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/shirobusiness.com\/what-is-the-uk-conformity-assessed-mark-ukca\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UK Conformity Assessed Mark (UCA) | Shiro Business Solutions\" \/>\n<meta property=\"og:description\" content=\"Understand the UKCA marking requirements &amp; more, with regards to Brexit and how it will impact the CE mark.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/shirobusiness.com\/what-is-the-uk-conformity-assessed-mark-ukca\/\" \/>\n<meta property=\"og:site_name\" content=\"Shiro\" \/>\n<meta property=\"article:published_time\" content=\"2021-07-18T09:30:00+00:00\" \/>\n<meta property=\"article:modified_time\" 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