{"id":2389,"date":"2020-01-31T19:29:22","date_gmt":"2020-01-31T19:29:22","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=2389"},"modified":"2023-07-17T05:26:50","modified_gmt":"2023-07-17T05:26:50","slug":"uk-brexit-next-steps","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/uk-brexit-next-steps\/","title":{"rendered":"Now That Brexit Has Happened, What&#8217;s Next for Medical Device Manufacturers?"},"content":{"rendered":"<p style=\"text-align: left;\"><img decoding=\"async\" loading=\"lazy\" class=\" wp-image-256 alignleft\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/02\/brexit-300x169.jpg\" alt=\"Brexit-RA\/QA\" width=\"240\" height=\"135\" \/><em>UPDATED SEPTEMBER 2, 2020<\/em><\/p>\n<h4 style=\"text-align: left;\">It was supposed to happen on March 29, 2019, then October 31, 2019. It finally did happen on January 31, 2020. Brexit is done.<\/h4>\n<p>&nbsp;<\/p>\n<p><strong>NOTE: The UK MHRA released new guidance in September 2020. The information below is updated but <a href=\"https:\/\/www.orielstat.com\/blog\/uk-mhra-medical-device-registration\/\">this blog post has more complete information<\/a>.<\/strong><\/p>\n<p><em>Heres what you need to know as a medical device manufacturer:<\/em><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-listid=\"49\" data-font=\"Symbol\" data-leveltext=\"'\"><span data-contrast=\"auto\">The UK <\/span><span data-contrast=\"auto\">is<\/span> <span data-contrast=\"auto\">no longer a member of the European Union. FYI the UK includes England, Wales, Scotland and Northern Ireland but not Ireland which is part of the EU. <\/span><span data-ccp-props=\"{&quot;134233279&quot;:true}\"><\/span><\/li>\n<li aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"2\" data-listid=\"49\" data-font=\"Symbol\" data-leveltext=\"'\"><span data-contrast=\"auto\">The<\/span><span data-contrast=\"auto\"> UK<\/span><span data-contrast=\"auto\"> MHRA has decided that it will implement its own regulatory scheme for medical devices and will not follow the <\/span><span data-contrast=\"auto\">EU <\/span><span data-contrast=\"auto\">Medical Device Regulation (EU MDR). The MDR takes effect in May 2021. <\/span><span data-contrast=\"auto\"><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true}\"><\/span><\/li>\n<li aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"2\" data-listid=\"49\" data-font=\"Symbol\" data-leveltext=\"'\">Medical device manufacturers that want to pace devices on the UK market after January 1, 2021 will need to register with the MHRA.<\/li>\n<li aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"2\" data-listid=\"49\" data-font=\"Symbol\" data-leveltext=\"'\">Existing CE Marking certificates issued by Notified Bodies will continue to be recognized until June 30, 2023.<\/li>\n<li aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"2\" data-listid=\"49\" data-font=\"Symbol\" data-leveltext=\"'\">The UK will be issuing its own UKCA (UK Conformity Assessed) mark to replace CE Marking. CE will not be recognized in the EU after June 2023.<\/li>\n<li aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"4\" data-listid=\"49\" data-font=\"Symbol\" data-leveltext=\"'\"><span data-contrast=\"auto\">If your company does not have a presence in the UK and you sell products there, you will need to appoint <\/span><span data-contrast=\"auto\">a<\/span> <span data-contrast=\"auto\"><a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-from-1-january-2021#responsible\">UK <\/a><\/span><span data-contrast=\"auto\">R<\/span><span data-contrast=\"auto\">esponsible Person<\/span><span data-contrast=\"auto\"> based in the UK. <\/span><span data-contrast=\"auto\">Despite the name, <\/span><span data-contrast=\"auto\">its more like a hybrid Importer\/EC REP role and can be filled by<\/span><span data-contrast=\"auto\"> a person or company<\/span><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true}\"><\/span><\/li>\n<li aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"4\" data-listid=\"49\" data-font=\"Symbol\" data-leveltext=\"'\"><span data-contrast=\"auto\">Your UK <\/span><span data-contrast=\"auto\">Responsible Person must<\/span> <span data-contrast=\"auto\">be the one to <\/span><span data-contrast=\"auto\">register your <\/span><span data-contrast=\"auto\">devices with the MHRA but <\/span><a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-event-of-a-no-deal-scenario#registrations\"><span data-contrast=\"none\">you will only have <\/span><span data-contrast=\"none\">4-12 months<\/span> <span data-contrast=\"none\">to <\/span><span data-contrast=\"none\">register<\/span><\/a> <span data-contrast=\"auto\">(depends on device classification).<\/span> <span data-contrast=\"auto\">You will not need a separate UK Authorized Representative as required under the EU MDR. <\/span><span data-contrast=\"auto\">I<\/span><span data-contrast=\"auto\">f you have not already done so, get busy finding your UK Responsible Person<\/span><span data-contrast=\"auto\"> as they will also be responsible for registering your devices with the MHRA.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true}\"><\/span><\/li>\n<li aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"4\" data-listid=\"49\" data-font=\"Symbol\" data-leveltext=\"'\"><span data-contrast=\"auto\">If you are shipping goods from the UK to the EU by boat, consider making contingency plans as border controls will go into effect on January 1, 2021 if all goes as planned. That could slow<\/span> <span data-contrast=\"auto\">down <\/span><span data-contrast=\"auto\">shipping <\/span><span data-contrast=\"auto\">until the kinks get worked out. Note that this issue has nothing to do with the EU MDR. <\/span><span data-ccp-props=\"{&quot;134233279&quot;:true}\"><\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Of course, as with everything related to Brexit, things may have changed since the publishing of this article. We advise checking the <\/span><a href=\"https:\/\/www.gov.uk\/topic\/medicines-medical-devices-blood\/medical-devices-regulation-safety\"><span data-contrast=\"none\">MHRA website<\/span><\/a><span data-contrast=\"auto\"> for the latest information. <\/span><span data-contrast=\"auto\">Of course, our<\/span><span data-contrast=\"auto\"> team of EU MDR compliance experts is <\/span><span data-contrast=\"auto\">always <\/span><span data-contrast=\"auto\">ready to help<\/span><span data-contrast=\"auto\"> you make sense of the changes, ready to help with <\/span><a href=\"https:\/\/www.orielstat.com\/courses\/eu-mdr-auditor-training-2017-745\"><span data-contrast=\"none\">MDR audit training<\/span><\/a><span data-contrast=\"auto\">, or specific <\/span><a href=\"https:\/\/www.orielstat.com\/consulting\/New-EU-Medical-Device-Regulation\"><span data-contrast=\"none\">MDR consulting<\/span><\/a> <span data-contrast=\"auto\">solutions<\/span><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{}\"><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>UPDATED SEPTEMBER 2, 2020 It was supposed to happen on March 29, 2019, then October 31, 2019. It finally did happen on January 31, 2020. Brexit is done. &nbsp; NOTE: The UK MHRA released new guidance in September 2020. The information below is updated but this blog post has more complete information. Heres what you [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[12,16],"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=\"description\" content=\"Now that the UK is no longer part of the EU, Oriel STAT A MATRIX explains what comes next for medical device manufacturers who still want access to the UK market.\" \/>\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-brexit-next-steps\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Now that the UK is no longer part of the EU, Oriel STAT A MATRIX explains what comes next for medical device manufacturers who still want access to the UK market.\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/uk-brexit-next-steps\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2020-01-31T19:29:22+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2023-07-17T05:26:50+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/02\/brexit-300x169.jpg\" \/>\r\n<meta name=\"author\" content=\"Oriel STAT A MATRIX\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Oriel STAT A MATRIX\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","description":"Now that the UK is no longer part of the EU, Oriel STAT A MATRIX explains what comes next for medical device manufacturers who still want access to the UK market.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orielstat.com\/blog\/uk-brexit-next-steps\/","og_locale":"en_US","og_type":"article","og_description":"Now that the UK is no longer part of the EU, Oriel STAT A MATRIX explains what comes next for medical device manufacturers who still want access to the UK market.","og_url":"https:\/\/www.orielstat.com\/blog\/uk-brexit-next-steps\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2020-01-31T19:29:22+00:00","article_modified_time":"2023-07-17T05:26:50+00:00","og_image":[{"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/02\/brexit-300x169.jpg"}],"author":"Oriel STAT A MATRIX","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Oriel STAT A MATRIX","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.orielstat.com\/blog\/uk-brexit-next-steps\/#article","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/uk-brexit-next-steps\/"},"author":{"name":"Oriel STAT A MATRIX","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/c137edf93eeddb244b6098bf8d2e09ed"},"headline":"Now That Brexit Has Happened, What&#8217;s Next for Medical Device Manufacturers?","datePublished":"2020-01-31T19:29:22+00:00","dateModified":"2023-07-17T05:26:50+00:00","mainEntityOfPage":{"@id":"https:\/\/www.orielstat.com\/blog\/uk-brexit-next-steps\/"},"wordCount":426,"publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"articleSection":["All Category","EU MDR (2017\/745)"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.orielstat.com\/blog\/uk-brexit-next-steps\/","url":"https:\/\/www.orielstat.com\/blog\/uk-brexit-next-steps\/","name":"","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/#website"},"datePublished":"2020-01-31T19:29:22+00:00","dateModified":"2023-07-17T05:26:50+00:00","description":"Now that the UK is no longer part of the EU, Oriel STAT A MATRIX explains what comes next for medical device manufacturers who still want access to the UK market.","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.orielstat.com\/blog\/uk-brexit-next-steps\/"]}]},{"@type":"WebSite","@id":"https:\/\/www.orielstat.com\/blog\/#website","url":"https:\/\/www.orielstat.com\/blog\/","name":"Oriel STAT A MATRIX Blog","description":"","publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.orielstat.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.orielstat.com\/blog\/#organization","name":"Oriel STAT A MATRIX Blog","url":"https:\/\/www.orielstat.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","contentUrl":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","width":1458,"height":1042,"caption":"Oriel STAT A MATRIX Blog"},"image":{"@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/c137edf93eeddb244b6098bf8d2e09ed","name":"Oriel STAT A MATRIX","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/5362548f38f456fa69cbc3bb0c9f1a96?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/5362548f38f456fa69cbc3bb0c9f1a96?s=96&d=mm&r=g","caption":"Oriel STAT A MATRIX"},"url":"https:\/\/www.orielstat.com\/blog\/author\/orielstat\/"}]}},"_links":{"self":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/2389"}],"collection":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/comments?post=2389"}],"version-history":[{"count":21,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/2389\/revisions"}],"predecessor-version":[{"id":6244,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/2389\/revisions\/6244"}],"wp:attachment":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media?parent=2389"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/categories?post=2389"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/tags?post=2389"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}