{"id":9967,"date":"2023-09-15T12:17:13","date_gmt":"2023-09-15T12:17:13","guid":{"rendered":"https:\/\/accellerate.co.uk\/?p=9967"},"modified":"2023-11-15T12:19:06","modified_gmt":"2023-11-15T12:19:06","slug":"scope-of-regulatroy-changes-for-2023","status":"publish","type":"post","link":"https:\/\/accellerate.co.uk\/?p=9967","title":{"rendered":"Scope of Regulatroy changes for 2023"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"9967\" class=\"elementor elementor-9967\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5198439 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"5198439\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ed46480\" data-id=\"ed46480\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c151654 elementor-widget elementor-widget-text-editor\" data-id=\"c151654\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Regulatory compliance in the UK medical market has undergone significant changes in 2023, primarily driven by the post-Brexit transition away from the European Union&#8217;s legal and regulatory systems. Here&#8217;s a comprehensive overview for a blog post on this topic:<\/span><\/p><h3><b>Introduction<\/b><\/h3><p><span style=\"font-weight: 400;\">In 2023, the UK&#8217;s Medicines &amp; Healthcare Products Regulatory Agency (MHRA) has been the cornerstone of major regulatory shifts in the medical devices market. This transformation is part of a broader move to establish an independent regulatory framework following Brexit.<\/span><\/p><h3><b>Key Regulatory Changes<\/b><\/h3><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">MHRA&#8217;s Central Role: The MHRA is responsible for regulating the UK medical devices market, emphasising patient safety and supporting industry and patients within the operating environment\u200b\u200b\u200b\u200b.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Legislation Amendments: The UK government amended The Medical Device Regulations 2002 to extend the acceptance of CE-marked medical devices on the Great Britain market\u200b\u200b.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CE Mark Transition: A significant change is the phasing out of CE marks, which, until June 30, 2023, were recognised in England, Scotland, and Wales. Post this date, CE-marked medical devices no longer apply in Great Britain\u200b\u200b.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">UKCA Compliance: Manufacturers are now required to comply with UK Conformity Assessed (UKCA) marking requirements, a critical step for market access in the UK\u200b\u200b.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Draft Post-Market Surveillance Regulations: Proposed regulations for post-market surveillance are expected to be effective from 2024, impacting devices sold in England, Wales, Scotland, and Northern Ireland\u200b\u200b.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Upcoming Statutory Instruments: Three key statutory instruments are anticipated &#8211; Transitional arrangements, Post-market Surveillance (PMS), and Future MDR. These will introduce new requirements and adjust existing ones for medical devices in the UK market\u200b\u200b.<\/span><\/li><\/ul><h3><b>Regulatory Framework for 2023<\/b><\/h3><p><span style=\"font-weight: 400;\">The MHRA&#8217;s 2023 framework includes:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">New Market Access Pathways: Designed to facilitate faster patient access to innovative medical devices.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Software and AI Oversight: A framework for managing software as a medical device (SaMD) and artificial intelligence in medical devices.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Amended IVD Regulations: Updated in vitro diagnostic regulations, including new device classification schemes and patient risk review processes.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sustainability in Device Manufacturing: Enhanced processes for re-using and re-manufacturing medical devices to reduce reliance on single-use devices\u200b\u200b.<\/span><\/li><\/ul><h3><b>Conclusion<\/b><\/h3><p><span style=\"font-weight: 400;\">The UK&#8217;s medical device regulatory landscape in 2023 marks a significant shift towards a more independent and localised framework, primarily influenced by the post-Brexit context. This includes the introduction of UKCA marking, revised regulations for medical devices, and a focus on innovative and sustainable medical technologies. Manufacturers and stakeholders in the UK medical market must be cognizant of these changes to ensure compliance and successful market access.<\/span><\/p><p><span style=\"font-weight: 400;\">This overview provides a foundation for a blog post on UK medical market regulatory compliance in 2023, highlighting the key changes and their implications for manufacturers and other stakeholders.<\/span><\/p><p><br \/><br \/><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Medicines and Healthcare products Regulatory Agency (MHRA). &#8220;Regulating medical devices in the UK.&#8221; GOV.UK. [Online] Available:<\/span><a href=\"http:\/\/www.gov.uk\/\"> <span style=\"font-weight: 400;\">www.gov.uk<\/span><\/a><span style=\"font-weight: 400;\">. &#8220;Implementation of the Future Regulations.&#8221; GOV.UK. [Online] Available:<\/span><a href=\"http:\/\/www.gov.uk\/\"> <span style=\"font-weight: 400;\">www.gov.uk<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">&#8220;UKCA Compliance for Medical Devices: What You Need to Do by June 2023.&#8221; MDDI Online. [Online] Available:<\/span><a href=\"http:\/\/www.mddionline.com\/\"> <span style=\"font-weight: 400;\">www.mddionline.com<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">&#8220;Countdown to June 2023 for UKCA compliance.&#8221; MedTech Intelligence. [Online] Available: medtechintelligence.com.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">&#8220;UK Releases Draft Post Market Surveillance Requirements for Medical Devices.&#8221; MedTech Intelligence. [Online] Available: medtechintelligence.com.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\">\u00a0<\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">&#8220;UK MHRA outlines key dates in 2023 for medical device regulatory changes.&#8221; Emergo by UL. [Online] Available:<\/span><a href=\"http:\/\/www.emergobyul.com\/\"> <span style=\"font-weight: 400;\">www.emergobyul.com<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">&#8220;Latest updates from UK regulators on post-Brexit changes to medical device and IVD regulatory requirements.&#8221; Emergo by UL. [Online] Available:<\/span><a href=\"http:\/\/www.emergobyul.com\/\"> <span style=\"font-weight: 400;\">www.emergobyul.com<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Regulatory compliance in the UK medical market has undergone significant changes in 2023, primarily driven by the post-Brexit transition away from the European Union&#8217;s legal and regulatory systems. Here&#8217;s a comprehensive overview for a blog post on this topic: Introduction In 2023, the UK&#8217;s Medicines &amp; Healthcare Products Regulatory Agency (MHRA) has been the cornerstone [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":9933,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"categories":[18],"tags":[67],"class_list":["post-9967","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-market-access-uk"],"_links":{"self":[{"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/9967","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=9967"}],"version-history":[{"count":4,"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/9967\/revisions"}],"predecessor-version":[{"id":9971,"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/9967\/revisions\/9971"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=\/wp\/v2\/media\/9933"}],"wp:attachment":[{"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=9967"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=9967"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/accellerate.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=9967"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}