{"id":7096,"date":"2022-02-02T17:50:16","date_gmt":"2022-02-02T17:50:16","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7096"},"modified":"2022-06-12T18:00:14","modified_gmt":"2022-06-12T18:00:14","slug":"uk-northern-ireland-marking-guidance-updated","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2022\/02\/02\/uk-northern-ireland-marking-guidance-updated\/","title":{"rendered":"UK Northern Ireland Marking Guidance Updated"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-1024x1024.png\" alt=\"\" class=\"wp-image-7098\" srcset=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-1024x1024.png 1024w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-300x300.png 300w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-100x100.png 100w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-600x600.png 600w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-150x150.png 150w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-768x768.png 768w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-1536x1536.png 1536w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-2048x2048.png 2048w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-270x270.png 270w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-230x230.png 230w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/UKNI_BLK_AW-45x45.png 45w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">2 February 2022&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">On 1 February 2022&nbsp; the <a rel=\"noreferrer noopener\" aria-label=\"Gov.UK (opens in a new tab)\" href=\"https:\/\/www.gov.uk\/\" target=\"_blank\">Gov.UK<\/a> website updated their <a rel=\"noreferrer noopener\" aria-label=\"Guidance on Using the UKNI Marking (opens in a new tab)\" href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukni-marking\" target=\"_blank\">Guidance on Using the UKNI Marking<\/a>. It was originally published on 31 December 2020.  This is guidance for placing goods on the Northern Ireland market.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The UKNI mark applies for Northern Ireland specifically.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><em>Contents of the current UKNI Guidance is<\/em><\/strong><\/h3>\n\n\n\n<ol class=\"wp-block-list\"><li><a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukni-marking?utm_medium=email&amp;utm_campaign=govuk-notifications-topic&amp;utm_source=a070ee8d-139d-49fa-a9d3-6070b6cb2773&amp;utm_content=daily#overview\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Overview (opens in a new tab)\">Overview<\/a><\/li><li><a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukni-marking?utm_medium=email&amp;utm_campaign=govuk-notifications-topic&amp;utm_source=a070ee8d-139d-49fa-a9d3-6070b6cb2773&amp;utm_content=daily#check-whether-you-need-to-use-the-ukni-marking\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Check whether you need to use the UKNI marking<\/a><\/li><li><a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukni-marking?utm_medium=email&amp;utm_campaign=govuk-notifications-topic&amp;utm_source=a070ee8d-139d-49fa-a9d3-6070b6cb2773&amp;utm_content=daily#when-to-use-the-ukni-marking\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">When to use the UKNI marking<\/a><\/li><li><a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukni-marking?utm_medium=email&amp;utm_campaign=govuk-notifications-topic&amp;utm_source=a070ee8d-139d-49fa-a9d3-6070b6cb2773&amp;utm_content=daily#how-to-use-the-ukni-marking\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">How to use the UKNI marking<\/a><\/li><li><a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukni-marking?utm_medium=email&amp;utm_campaign=govuk-notifications-topic&amp;utm_source=a070ee8d-139d-49fa-a9d3-6070b6cb2773&amp;utm_content=daily#technical-documentation\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Technical documentation<\/a><\/li><li><a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukni-marking?utm_medium=email&amp;utm_campaign=govuk-notifications-topic&amp;utm_source=a070ee8d-139d-49fa-a9d3-6070b6cb2773&amp;utm_content=daily#webinars\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Webinars<\/a><\/li><li><a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukni-marking?utm_medium=email&amp;utm_campaign=govuk-notifications-topic&amp;utm_source=a070ee8d-139d-49fa-a9d3-6070b6cb2773&amp;utm_content=daily#more-information\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">More information<\/a><\/li><\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">The Guidance document also points users of the Guidance to the other Marking of concern.  It states &#8220;For similar obligations that apply when using other conformity markings, see&nbsp;<a href=\"https:\/\/www.gov.uk\/guidance\/using-the-ukca-marking\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">how to use the&nbsp;<abbr title=\"UK Conformity Assessed\">UKCA<\/abbr>&nbsp;marking<\/a>.&#8221;  This is for placing goods on the British (UK) market.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Another link in the Guidance that is critical if you need to place a medical product on the UK market is looking at the <a href=\"https:\/\/www.gov.uk\/uk-market-conformity-assessment-bodies\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">UK Market Conformity Assessment Bodies (UKMCAB) database<\/a>.  This db you want to make sure you find a Medical Device Assessment Body that covers your device.  At first glance there now are a lot of bodies (157 currently) in the db but not all of them fall under medical devices.  There are still only 3 of them and they are the usual suspects being BSI, UL and SGS.  Best way to search is under the &#8220;Medical Device&#8221; under the Legislative Search details option.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><em><strong>Need Help?<\/strong><\/em><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Need help with the UK, EU MDR requirements, IEC 60601 (Medical Electrical Equipment), work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, &amp; other country regulatory requirements &amp; standards, laws, directives, and more.&nbsp;<a rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\" href=\"https:\/\/eisnersafety.com\/about_us\/associates\/\" target=\"_blank\">Leo Eisner<\/a>&nbsp;is an expert on standards development and sits on many standards committees.&nbsp;He also has experts on additional standards committees and we all talk to the regulators.  Feel free to <a rel=\"noreferrer noopener\" aria-label=\"schedule a call with Leo (opens in a new tab)\" href=\"http:\/\/www.EisnerSafety.com\/Schedule-Call\/\" target=\"_blank\">schedule a call with Leo<\/a>&nbsp;or contact Leo at&nbsp;Leo@EisnerSafety.com&nbsp;or through our <a href=\"https:\/\/eisnersafety.com\/contact_eisner_safety\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"contact form (opens in a new tab)\">contact form<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>2 February 2022&nbsp; On 1 February 2022&nbsp; the Gov.UK website updated their Guidance on Using the UKNI Marking. It was originally published on 31 December 2020. This is guidance for placing goods on the Northern Ireland market. The UKNI mark<\/p>\n","protected":false},"author":4,"featured_media":7098,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1440,1460,1427,1459,1461,1429,1458,1438,1457,1456],"tags":[],"class_list":["post-7096","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-active-implants","category-feb-2022","category-labeling","category-marking","category-medical-device","category-mhra","category-northern-ireland","category-uk","category-ukca","category-ukni"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7096","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=7096"}],"version-history":[{"count":5,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7096\/revisions"}],"predecessor-version":[{"id":7103,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7096\/revisions\/7103"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/7098"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=7096"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=7096"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=7096"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}