{"id":13274,"date":"2019-10-23T17:10:12","date_gmt":"2019-10-23T15:10:12","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=13274"},"modified":"2023-01-24T14:59:17","modified_gmt":"2023-01-24T13:59:17","slug":"european-union-uncertainty-and-tension-rise-as-the-eu-and-uk-strike-new-brexit-deal","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2019\/10\/23\/european-union-uncertainty-and-tension-rise-as-the-eu-and-uk-strike-new-brexit-deal\/","title":{"rendered":"EUROPEAN UNION: uncertainty and tension rise as the EU and UK strike new Brexit deal"},"content":{"rendered":"\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/10\/brexit-3575383_1920-1024x683.jpg\" alt=\"\" class=\"wp-image-13553\"\/><\/figure>\n\n\n\n<p>On October 17, 2019, the EU and UK announced\nthat a Brexit deal has been agreed upon, but needs to be ratified. The outcome\nis still uncertain as the British parliament is in gridlock. <strong>The UK could\nstill leave the EU with no deal on 31 October 2019<\/strong> if the parties involved\ndo not approve and sign the withdrawal agreement until such date.<\/p>\n\n\n\n<p>In case of \u201cno-deal\u201d Brexit, <strong>all medical devices<\/strong> placed on the UK market <a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-event-of-a-no-deal-scenario\"><strong>will have to be registered with MHRA<\/strong><\/a>, the competent Regulatory Authority. Only a UK-based manufacturer or a UK Responsible Person (UK RP), meaning an entity with a registered place of business in the UK, can do this. Therefore, starting November 1<sup>st<\/sup>, 2019, foreign manufacturers must designate a UK RP to act on their behalf. <\/p>\n\n\n\n<p>The requirement to appoint a UK RP is in line\nwith the <strong>grace period<\/strong> for registering the medical devices with MHRA, as\nfollows: <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>4\nmonths (by the end of February 2020) for class III medical devices, class IIb\nimplantable medical devices, active implantable medical devices and IVD List A;\n<\/li><li>8\nmonths (by the end of June 2020) for class IIb non-implantable medical devices,\nclass IIa medical devices, IVD List B and Self-test IVDs;<\/li><li>12\nmonths (by the end of October 2020) for class I medical devices, general IVDs\nand class A IVDs (if complying with the EU IVDR 2017\/746).<\/li><\/ul>\n\n\n\n<p>Foreign Manufacturers are urged to appoint a UK\nRP <strong>before the end of the grace period<\/strong> for post-market surveillance\npurposes. A\nmanufacturer may sell directly to the end user in the UK provided that they\nhave appointed a UK RP to register them with MHRA before they can be placed on\nthe UK market. Furthermore, a single manufacturer may have several designated UK RPs.<\/p>\n\n\n\n<p>No immediate labelling changes will be required to reflect the role of the \u2018UK RP\u2019. However, <strong><a rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\" href=\"http:\/\/www.legislation.gov.uk\/ukdsi\/2019\/9780111179260\/pdfs\/ukdsi_9780111179260_en.pdf#page=123\" target=\"_blank\">changes to the labelling requirements<\/a><\/strong> for medical devices will come into force in May 2020. The UK MDR will mirror the (UE) 2017\/745. As such, the name and address of the UK RP will be required to appear on the label, similar to what is expected for the EU REP, in compliance with <a rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\" href=\"\" target=\"_blank\">Schedule 3 (Part 3) of the UK MDR 2002<\/a>&nbsp;(as amended by the&nbsp;<a href=\"http:\/\/www.legislation.gov.uk\/ukdsi\/2019\/9780111179260\/contents\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">UK MDR 2019)<\/a>.<\/p>\n\n\n\n<p><em>Please bear in mind that, considering the\ndegree of uncertainty associated with Brexit, any views provided on the\ninterpretation of the legislation represent our best judgement at the time,\nbased on the available information.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On October 17, 2019, the EU and UK announced that a Brexit deal has been agreed upon, but needs to be  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-13274","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EUROPEAN UNION: uncertainty and tension rise as the EU and UK strike new Brexit deal - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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