{"id":3584,"date":"2022-05-05T15:50:10","date_gmt":"2022-05-05T14:50:10","guid":{"rendered":"https:\/\/www.bdrdiagnostics.com\/?p=3584"},"modified":"2024-06-13T10:21:00","modified_gmt":"2024-06-13T09:21:00","slug":"new-european-in-vitro-diagnostic-medical-devices-regulation","status":"publish","type":"post","link":"https:\/\/www.bdrdiagnostics.com\/es\/new-european-in-vitro-diagnostic-medical-devices-regulation\/","title":{"rendered":"New European In Vitro Diagnostic Medical Devices Regulation"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3584\" class=\"elementor elementor-3584 elementor-3583\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6046257 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6046257\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;_id&quot;:&quot;a01c5fd&quot;,&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:&quot;1&quot;,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-fa37a8e\" data-id=\"fa37a8e\" 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-476f76f6 elementor-widget elementor-widget-text-editor\" data-id=\"476f76f6\" 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 data-contrast=\"auto\">There are only 3 weeks left until the implementation of the new European Regulation on\u00a0<\/span><i><span data-contrast=\"auto\">In Vitro<\/span><\/i><span data-contrast=\"auto\">\u00a0Diagnostic Medical Devices, which aims to create a safer, more transparent, reliable and predictable environment for these products.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For us as manufacturers, this new regulation is good news as, for the first time, the requirements for all diagnostic solutions in a laboratory will have to comply with the same regulation, meeting rigorous quality and safety standards.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">At the level of regulators, notified bodies and reference laboratories, stricter controls are established, both for their designation and for the evaluation of products and their access to the market, as well as reinforcements in the surveillance system.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Although the implementation date of the new regulation is 26 May 2022, a few months ago Regulation 2022\/112 of 25 January was published, amending Regulation (EU) 2017\/746, providing an additional period for certifying products: higher risk products will see their deadline extended until 2025; high risk products until 2026; and low risk products until 2027.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">However, this extension may not be enough, given that 53% of manufacturers still do not have a notified body, according to sources from the Spanish Federation of Healthcare Technology Companies (Fenin). Therefore, taking into account that IVD products requiring external certification have increased by 70% (from 15% to 85%), it seems necessary to increase the capacity of these bodies to cover this demand.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Given the current situation, we at BDR consider ourselves fortunate. Over the last two years we have been preparing, together with our Notified Body (BSI), how to comply with the new Regulation. Our management system has already been audited, with good results, and the technical files of our products have been submitted. We expect to be certified under CE-IVDR during this month of May.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n\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>There are only 3 weeks left until the implementation of the new European Regulation on\u00a0In Vitro\u00a0Diagnostic Medical Devices, which aims to create a safer, more transparent, reliable and predictable environment for these products.\u00a0 For us as manufacturers, this new regulation is good news as, for the first time, the requirements for all diagnostic solutions in [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3587,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,27],"tags":[],"class_list":["post-3584","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-sin-categorizar"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - 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