{"id":1263,"date":"2020-09-05T09:33:59","date_gmt":"2020-09-05T13:33:59","guid":{"rendered":"https:\/\/f2labs.com\/technotes\/?p=1263"},"modified":"2025-04-02T22:19:22","modified_gmt":"2025-04-03T02:19:22","slug":"ukca-mark-and-ce-marking-september-2020-update-from-f2-labs","status":"publish","type":"post","link":"https:\/\/f2labs.com\/technotes\/2020\/09\/05\/ukca-mark-and-ce-marking-september-2020-update-from-f2-labs\/","title":{"rendered":"Great Britain&#8217;s UKCA mark \u2013 September 2020 Update"},"content":{"rendered":"\n<p>We published an article about Brexit and its implications for CE marking back in February of this year. A link to that article is <a href=\"https:\/\/f2labs.com\/technotes\/2020\/02\/06\/brexit-happened-does-ce-still-cover-the-uk\/\">here<\/a>. The UK government posted new guidance about this on September 1, 2020. The link to that information is <a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukca-mark-from-1-january-2021\">here<\/a>.<\/p>\n\n\n\n<p>You do not need to go to those links and sift through the information.  We have summarized the main points below.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>CE marking will apply to most products until January 1, 2022. These product area categories are:<ul><li>Toys<\/li><\/ul><ul><li>Recreational and personal watercraft<\/li><\/ul><ul><li>Simple Pressure Vessels<\/li><\/ul><ul><li>EMC<\/li><\/ul><ul><li>Non-automatic Weighing Instruments<\/li><\/ul><ul><li>Measuring Instruments<\/li><\/ul><ul><li>Lifts<\/li><\/ul><ul><li>Radio Equipment<\/li><\/ul><ul><li>Pressure Equipment<\/li><\/ul><ul><li>Personal Protective Equipment<\/li><\/ul><ul><li>Gas Appliances<\/li><\/ul><ul><li>Machinery<\/li><\/ul><ul><li>Outdoor Noise<\/li><\/ul><ul><li>Ecodesign<\/li><\/ul><ul><li>Aerosols<\/li><\/ul><\/li><\/ul>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<ul class=\"wp-block-list\"><li>CE marking will apply to medical devices until June 30, 2023.<ul><li>Note that beginning January 1, 2021 all medical devices and in vitro diagnostic medical devices imported into the UK must be registered with the <a href=\"https:\/\/www.gov.uk\/government\/publications\/report-a-non-compliant-medical-device-enforcement-process\/how-mhra-ensures-the-safety-and-quality-of-medical-devices\">Medicines &amp; Healthcare Products Regulatory Agency<\/a>.<\/li><li>There is a 4-month grace period for Class IIIs, Class IIb implantable products, and active implantable medical devices<\/li><li>There is an 8-month grace period for registering for Class IIb and Class IIa devices.<\/li><li>All manufacturers based outside the UK will need to establish a <a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-from-1-january-2021#responsible\">UK Responsible Person<\/a>.<\/li><li>There is a 12-month grace period for Class I devices.<\/li><li>You can start using the UKCA mark (if your product complies) as soon as January 1, 2021 but if it is a medical device the CE marking will suffice until June 30, 2023.<\/li><\/ul><\/li><\/ul>\n<\/div><\/div>\n\n\n\n<p>You will need to apply the UKCA mark to your product beginning January 1, 2021 if all of the following apply to the product:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>it is for the market in Great Britain, and<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>it is covered by legislation which requires the\u00a0UKCA\u00a0marking, and<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>it requires mandatory third-party conformity assessment, and<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>conformity assessment has been carried out by a\u00a0<a href=\"https:\/\/www.gov.uk\/guidance\/conformity-assessment-bodies-change-of-status-from-1-january-2021\">UK conformity assessment body<\/a>\u00a0and you haven\u2019t transferred your conformity assessment files from your UK body to an\u00a0EU\u00a0recognised body before 1 January 2021. *Note that most UK bodies have opened offices in the EU.<\/li><\/ul>\n\n\n\n<p>The above means that if your product is a medical device you will need to register it in the UK at the end of this year or sometime in 2021 based on device category. You will also need a UK Responsible Person. Regarding other product categories you have some time (another year) as long as your product does not meet all four bulleted points immediately above.<\/p>\n\n\n\n<p>We can be contacted via this&nbsp;<a href=\"http:\/\/f2labs.com\/contactx\">link<\/a>.&nbsp;<\/p>\n\n\n\n<p>We can be reached by phone at&nbsp;<a href=\"tel:+18774051580\">877-405-1580<\/a>&nbsp;and are here to help you.&nbsp;<\/p>\n\n\n\n<p><a href=\"http:\/\/www.f2labs.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">F2 Labs&nbsp;is here to help.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>We published an article about Brexit and its implications for CE marking back in February of this year. A link to that article is here. The UK government posted new guidance about this on September 1, 2020. The link to &hellip; <a href=\"https:\/\/f2labs.com\/technotes\/2020\/09\/05\/ukca-mark-and-ce-marking-september-2020-update-from-f2-labs\/\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,1,5,305,295,296,2,3,288,97,7,94,6,263],"tags":[],"class_list":["post-1263","post","type-post","status-publish","format-standard","hentry","category-atex-directive-201434eu","category-ce-marking","category-emc-directive-201430eu","category-emc-testing","category-general-product-safety-regulation-eu-2023-988","category-gpsr","category-low-voltage-directive-201435eu","category-machinery-directive-200642ec","category-machinery-regulation-eu2023-1230","category-medical-devices-directive-9342eec","category-pressure-equipment-directive-201468eu","category-radio-equipment-directive-201453eu","category-rohs-directive-201165eu","category-ukca"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/f2labs.com\/technotes\/wp-json\/wp\/v2\/posts\/1263","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/f2labs.com\/technotes\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/f2labs.com\/technotes\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/f2labs.com\/technotes\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/f2labs.com\/technotes\/wp-json\/wp\/v2\/comments?post=1263"}],"version-history":[{"count":2,"href":"https:\/\/f2labs.com\/technotes\/wp-json\/wp\/v2\/posts\/1263\/revisions"}],"predecessor-version":[{"id":2083,"href":"https:\/\/f2labs.com\/technotes\/wp-json\/wp\/v2\/posts\/1263\/revisions\/2083"}],"wp:attachment":[{"href":"https:\/\/f2labs.com\/technotes\/wp-json\/wp\/v2\/media?parent=1263"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/f2labs.com\/technotes\/wp-json\/wp\/v2\/categories?post=1263"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/f2labs.com\/technotes\/wp-json\/wp\/v2\/tags?post=1263"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}