{"id":4555,"date":"2025-04-16T10:00:00","date_gmt":"2025-04-16T09:00:00","guid":{"rendered":"https:\/\/www.v-apps.cloud\/?p=4555"},"modified":"2025-04-17T21:56:48","modified_gmt":"2025-04-17T20:56:48","slug":"updated-mhra-guide-on-device-registration","status":"publish","type":"post","link":"https:\/\/www.v-apps.cloud\/en\/updated-mhra-guide-on-device-registration\/","title":{"rendered":"Updated MHRA Guide on Device Registration"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on the registration of medical devices, specific to the UK market. This crucial update is designed to help manufacturers, importers and distributors navigate the post-Brexit regulatory landscape. <\/p>\n\n<h2 class=\"wp-block-heading\"><strong>Key details of the guide<\/strong><\/h2>\n\n<h3 class=\"wp-block-heading\"><strong>Who must register:<\/strong><\/h3>\n\n<ul class=\"wp-block-list\">\n<li><strong>UK-based manufacturers<\/strong> of medical devices, in vitro diagnostics (IVDs) and custom-made devices must register.<\/li>\n\n\n\n<li><strong>Non-UK resident manufacturers <\/strong>must appoint a UK Responsible Person (UKRP) to manage the registration process on their behalf.<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\"><strong>Device classifications and deadlines:<\/strong><\/h3>\n\n<ul class=\"wp-block-list\">\n<li>The guidance specifies different timelines based on the risk classification of devices (Classes I, IIa, IIb, III, IVD).<\/li>\n\n\n\n<li>Transition periods are still in place for compliance with <strong>UKCA<\/strong> marking requirements and EU MDR\/IVDR standards.<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\"><strong>Registration process:<\/strong><\/h3>\n\n<ul class=\"wp-block-list\">\n<li>Device details must be submitted via the MHRA Online Device Registration System (DORS).<\/li>\n\n\n\n<li>The necessary documentation includes CE or UKCA certificates, conformity assessments and details of the UKRP (if applicable).<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\"><strong>Marking requirements:<\/strong><\/h3>\n\n<ul class=\"wp-block-list\">\n<li>The <strong>UKCA<\/strong> marking is mandatory for placing devices on the market in Great Britain, including England, Scotland and Wales.<\/li>\n\n\n\n<li>The <strong>CE<\/strong> marking will still be accepted during the transition period under certain conditions.<\/li>\n\n\n\n<li><strong>Northern Ireland<\/strong> is aligned with EU MDR\/IVDR regulations, requiring CE marking and a designated UKRP.<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\"><strong>Strengthened enforcement measures:<\/strong><\/h3>\n\n<ul class=\"wp-block-list\">\n<li>The MHRA has announced stricter control on unregistered devices and expects full compliance.<\/li>\n\n\n\n<li>The updated guide clarifies which changes to recordings require re-registration and how to make these changes.<\/li>\n<\/ul>\n\n<h2 class=\"wp-block-heading\"><strong>Why this update is important<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">This guide highlights the UK&#8217;s commitment to greater regulatory scrutiny of medical devices. It highlights the importance of compliance with the UK&#8217;s specific requirements to avoid enforcement actions and maintain market access.<br\/>For manufacturers, the transition to UKCA marking is crucial for placing devices in Britain. At the same time, companies focusing on Northern Ireland must adhere to the EU MDR\/IVDR regulations, which are subject to parallel requirements for CE marking and a UKRP.  <\/p>\n\n<h2 class=\"wp-block-heading\"><strong>Next steps for manufacturers and distributors<\/strong><\/h2>\n\n<ul class=\"wp-block-list\">\n<li><strong>Review all device registrations<\/strong> in light of the new guidance and ensure compliance.<\/li>\n\n\n\n<li><strong>Update and confirm the UKRP information <\/strong>for an accurate representation.<\/li>\n\n\n\n<li><strong>Plan transitions to UKCA marking<\/strong>, especially for CE marked devices that are still in use.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">Acting proactively and ensuring full compliance is critical as the MHRA continues to strengthen its oversight. Organizations that act now will be well positioned to maintain market access and meet regulatory expectations. <\/p>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/eu1.hubs.ly\/H0jdtff0\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>DOWNLOAD THE MHRA GUIDE<\/strong><\/a><\/div>\n<\/div>\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n<h2 class=\"wp-block-heading\"><strong><strong>Find out how V-Apps.cloud can help you<\/strong><\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Want to know how V-Apps.cloud can support your business in achieving greater security and compliance?<\/p>\n\n<p class=\"wp-block-paragraph\"><strong>Book a demo today<\/strong> and discover the benefits of our innovative solutions.<br\/>Transform the way you work with advanced tools and personalized support.<\/p>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/www.v-apps.cloud\/book-a-demo\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>BOOK A DEMO<\/strong><\/a><\/div>\n<\/div>\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>MHRA has published updated guidance on medical device registration, specific to the UK market.<\/p>\n","protected":false},"author":2,"featured_media":4657,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[78],"tags":[],"class_list":["post-4555","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"yoast_head":"<!-- This site is optimized 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