{"id":69634,"date":"2023-09-28T03:00:39","date_gmt":"2023-09-28T10:00:39","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?p=69634"},"modified":"2023-10-25T11:16:09","modified_gmt":"2023-10-25T18:16:09","slug":"uk-regulators-name-3-approved-bodies-to-ease-device-certification-bottleneck","status":"publish","type":"post","link":"https:\/\/www.jamasoftware.com\/legacy\/blog\/uk-regulators-name-3-approved-bodies-to-ease-device-certification-bottleneck\/","title":{"rendered":"UK Regulators Name 3 Approved Bodies to Ease Device Certification Bottleneck"},"content":{"rendered":"<div id=\"attachment_69635\" style=\"width: 1034px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" aria-describedby=\"caption-attachment-69635\" class=\"size-full wp-image-69635\" src=\"https:\/\/www.jamasoftware.com\/media\/2023\/09\/UK-regulators-name-3-approved-bodies-to-ease-device-certification-bottleneck-1.jpg\" alt=\"\" width=\"1024\" height=\"512\" srcset=\"https:\/\/www.jamasoftware.com\/legacy\/media\/2023\/09\/UK-regulators-name-3-approved-bodies-to-ease-device-certification-bottleneck-1.jpg 1024w, https:\/\/www.jamasoftware.com\/legacy\/media\/2023\/09\/UK-regulators-name-3-approved-bodies-to-ease-device-certification-bottleneck-1-300x150.jpg 300w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><p id=\"caption-attachment-69635\" class=\"wp-caption-text\">Jama Software is always looking for news that would benefit and inform our industry partners. As such, we\u2019ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share excerpts from an article, sourced from MedTech Dive, titled <a href=\"https:\/\/www.medtechdive.com\/news\/mhra-approved-bodies-uk-device-certification\/692412\/\" target=\"_blank\" rel=\"noopener\">\u201cUK regulators name 3 approved bodies to ease device certification bottleneck\u201d<\/a> \u2013 originally written by <a href=\"https:\/\/www.medtechdive.com\/editors\/ntaylor\/\" target=\"_blank\" rel=\"noopener\">Nick Paul Taylor<\/a> and published on August 31, 2023.<\/p><\/div>\n<hr \/>\n<h2>UK regulators name 3 approved bodies to ease device certification bottleneck<\/h2>\n<p><em>A MHRA leader hailed the action as \u201calmost doubling capacity for medical device assessment in the U.K.\u201d<\/em><\/p>\n<h3>Dive Brief:<\/h3>\n<ul>\n<li>The Medicines and Healthcare Products Regulatory Agency (MHRA) <a href=\"https:\/\/www.gov.uk\/government\/news\/three-new-uk-approved-bodies-to-certify-medical-devices-announced-by-the-mhra\" target=\"_blank\" rel=\"noopener\">has designated<\/a> three more bodies to certify medical devices in the U.K.<\/li>\n<li>As a result of Brexit, the U.K. is requiring manufacturers of all except the lowest-risk devices to apply for UK Conformity Assessment (UKCA) certification from an approved body. The approved bodies perform the same role as the notified bodies that issue CE marks to devices sold in the European Union.<\/li>\n<li>MHRA\u2019s designation of three approved bodies helps address <a href=\"https:\/\/www.gov.uk\/government\/publications\/government-response-to-the-rhc-report-on-medical-devices\/regulatory-horizons-council-report-on-medical-devices-government-response\" target=\"_blank\" rel=\"noopener\">a capacity shortage<\/a> that led the government to stagger the transition from CE marks to UKCA certification.<\/li>\n<\/ul>\n<hr \/>\n<h4><span style=\"color: #ff6600;\"><strong>RELATED: <\/strong><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/resources.jamasoftware.com\/blog\/failure-modes-effects-and-diagnostic-analysis-fmeda-for-medical-devices-what-you-need-to-know\" target=\"_blank\" rel=\"\u201cnoopener noopener\">Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know<\/a><\/span><\/span><\/h4>\n<hr \/>\n<h3>Dive Insight:<\/h3>\n<p>MHRA automatically moved the U.K.\u2019s three existing notified bodies, BSI, SGS and UL, to the approved body scheme when the country split from the European Union. Since then, efforts to add capacity have proceeded slowly. The U.K. affiliate of DEKRA, a notified body in the EU, became the first new approved body for medical devices <a href=\"https:\/\/www.gov.uk\/government\/news\/mhra-appoints-first-new-uk-approved-body-to-certify-medical-devices-since-brexit\" target=\"_blank\" rel=\"noopener\">11 months ago<\/a>.<\/p>\n<p>Now, MHRA has designated T\u00dcV S\u00dcD, Intertek, and T\u00dcV Rheinland UK. The designation clears the three bodies to certify general medical devices and empowers T\u00dcV Rheinland UK to assess in vitro diagnostic (IVD) products. IVD capacity is lagging behind, with MHRA <a href=\"https:\/\/www.gov.uk\/government\/publications\/medical-devices-uk-approved-bodies\/uk-approved-bodies-for-medical-devices\" target=\"_blank\" rel=\"noopener\">having designated<\/a> four bodies in total.<\/p>\n<p>In a statement, Laura Squire, chief healthcare quality and access officer at MHRA, hailed the addition of the three approved bodies as \u201calmost doubling capacity for medical device assessment in the U.K.\u201d It is unclear how many applications each approved body is capable of handling.<\/p>\n<hr \/>\n<h4><span style=\"color: #ff6600;\"><strong>RELATED: <\/strong><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/resources.jamasoftware.com\/webinar\/elevating-your-medical-device-and-life-sciences-product-development-processes-with-jama-connect\" target=\"_blank\" rel=\"\u201cnoopener noopener\">Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect<sup>\u00ae<\/sup><\/a><\/span><\/span><\/h4>\n<hr \/>\n<p>Even so, the designations go at least some way toward addressing a long-standing concern. The Regulatory Horizons Council identified the \u201clack of capacity in approved bodies within the U.K.\u201d as a risk to patient safety and access to devices in <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1012043\/rhc-medical-report.pdf\" target=\"_blank\" rel=\"noopener\">a report<\/a> two years ago.<\/p>\n<p>Responding to the report early this year, the government <a href=\"https:\/\/www.gov.uk\/government\/publications\/government-response-to-the-rhc-report-on-medical-devices\/regulatory-horizons-council-report-on-medical-devices-government-response\" target=\"_blank\" rel=\"noopener\">accepted recommendations<\/a> about addressing bottlenecks in device approval, notably the shortage of approved bodies, and taking mitigating steps to ensure the supply of products after the transition to UKCA. The concerns informed the decision to <a href=\"https:\/\/www.gov.uk\/government\/news\/ce-marking-recognition-for-medical-devices-and-in-vitro-diagnostics\" target=\"_blank\" rel=\"noopener\">keep accepting devices<\/a> with CE marks through 2028 or 2030, depending on the regulation.<\/p>\n<hr \/>\n<p><!-- Uberflip Embedded Hub Widget --><\/p>\n<div id=\"UfEmbeddedHub1694114093739\"><\/div>\n<p><script>\n  window._ufHubConfig = window._ufHubConfig || [];\n  window._ufHubConfig.push({\n    'containers':{'app':'#UfEmbeddedHub1694114093739'},\n    'collection': '4131730',\n    'openLink':function(url){\n      window.open(url);\n    },\n    'lazyloader':{\n      'itemDisplayLimit':20,\n      'maxTilesPerRow':3,\n      'maxItemsTotal': 3\n    },\n    'tileSize': 'small',\n    'enablePageTracking':false,\n    'baseUrl': 'https:\/\/resources.jamasoftware.com\/',\n    'filesUrl': 'https:\/\/resources.jamasoftware.com\/',\n    'generatedAtUTC': '2023-09-07 19:14:36',\n  });\n  <\/script><\/p>\n<p><script>(function(d,t,u) {\n    function load(){\n      var s=d.createElement(t);s.src=u;d.body.appendChild(s);\n    }\n    if (window.addEventListener) {\n      window.addEventListener('load',load,false);\n    }\n    else if (window.attachEvent) {\n      window.attachEvent('onload',load);\n    }\n    else{\n      window.onload=load;\n    }\n  }(document,'script','https:\/\/resources.jamasoftware.com\/hubsFront\/embed_collection'));\n  <\/script><br \/>\n<!-- \/End Uberflip Embedded Hub Widget --><\/p>\n<input class=\"fooboxshare_post_id\" type=\"hidden\" value=\"69634\"\/>","protected":false},"excerpt":{"rendered":"<p>UK regulators name 3 approved bodies to ease device certification bottleneck A MHRA leader hailed the action as \u201calmost doubling capacity for medical device assessment in the U.K.\u201d Dive Brief: The Medicines and Healthcare Products Regulatory Agency (MHRA) has designated three more bodies to certify medical devices in the U.K. As a result of Brexit, [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":69635,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[846],"tags":[841,840,838],"industry":[574],"class_list":["post-69634","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-regulation","tag-compliance-regulation","tag-product-development-management","tag-requirements-requirements-management","industry-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.1 (Yoast SEO v28.1) - 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As such, we\u2019ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share excerpts from an article, sourced from MedTech Dive, titled \u201cQ&A: How Monogram\u2019s CEO Plans to Disrupt Robotic Joint Replacement Surgery\u201d \u2013 originally written by Susan Kelly and published on August 4, 2023."},{"@type":"BreadcrumbList","@id":"https:\/\/www.medtechdive.com\/news\/mhra-approved-bodies-uk-device-certification\/692412\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.jamasoftware.com\/"},{"@type":"ListItem","position":2,"name":"UK Regulators Name 3 Approved Bodies to Ease Device Certification Bottleneck"}]},{"@type":"WebSite","@id":"https:\/\/www.jamasoftware.com\/#website","url":"https:\/\/www.jamasoftware.com\/","name":"Jama Software","description":"Jama Connect\u00ae #1 in Requirements Management","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.jamasoftware.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.jamasoftware.com\/#\/schema\/person\/59a942565a528aa5f56b240c9342fc7f","name":"Jama Software","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/6e1172c5d380b2a20a9e5b5a4c0fb4e38bc497dc27ce100567da29abe37001af?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/6e1172c5d380b2a20a9e5b5a4c0fb4e38bc497dc27ce100567da29abe37001af?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/6e1172c5d380b2a20a9e5b5a4c0fb4e38bc497dc27ce100567da29abe37001af?s=96&d=mm&r=g","caption":"Jama Software"},"description":"Subject matter experts from Jama Software provide guidance and best practices on requirements management, test management, compliance and regulation, risk management, and complex product and software development.","url":"https:\/\/www.jamasoftware.com\/blog\/author\/jama-software\/"}]}},"_links":{"self":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/posts\/69634","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/comments?post=69634"}],"version-history":[{"count":0,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/posts\/69634\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/media\/69635"}],"wp:attachment":[{"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/media?parent=69634"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/categories?post=69634"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/tags?post=69634"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.jamasoftware.com\/legacy\/wp-json\/wp\/v2\/industry?post=69634"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}