{"id":3425,"date":"2026-02-24T11:10:40","date_gmt":"2026-02-24T09:10:40","guid":{"rendered":"https:\/\/biophot.lv\/?p=3425"},"modified":"2026-02-24T11:12:51","modified_gmt":"2026-02-24T09:12:51","slug":"eu-regulations-for-medical-devices-and-in-vitro-diagnostics","status":"publish","type":"post","link":"https:\/\/biophot.lv\/en\/aicinam-uz-vebinaru-eu-regulations-for-medical-devices-and-in-vitro-diagnostics\/","title":{"rendered":"Welcome to the webinar \u201cEU Regulations for Medical Devices and In Vitro Diagnostics\u201d"},"content":{"rendered":"<p><strong>Join us for a webinar on the European Union framework for medical devices and in vitro diagnostics. The requirements for MDR and IVDR have changed significantly in recent years and an early understanding of the regulatory conditions is crucial for innovation projects moving from the research environment to the market.<\/strong><\/p>\n\n\n\n<p><strong>The webinar will take place on 6 March at 10.00.<\/strong><\/p>\n\n\n\n<p>The webinar will be moderated by Stefan Bolleininger, CEO of Consultys Medical and Senior Regulatory Advisor, who specialises in supporting early stage innovation projects and helping to navigate the EU regulatory environment when preparing products for CE marking.<\/p>\n\n\n\n<p><strong>Topics covered in the webinar:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EU regulatory framework for MDR and IVDR, role of notified bodies and CE marking requirements<\/li>\n\n\n\n<li>Classification of medical devices and IVDs and its role in the choice of regulatory pathway<\/li>\n\n\n\n<li>Conformity assessment procedures and required documentation<\/li>\n\n\n\n<li>Harmonised standards, common specifications and guidelines<\/li>\n\n\n\n<li>Integrating regulatory planning at an early stage<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<p>Norise: Zoom platform<\/p>\n\n\n\n<p>Working language: english<\/p>\n\n\n\n<p><strong>Registration:<\/strong>&nbsp;<a href=\"https:\/\/luma.com\/48rvig6y\">https:\/\/luma.com\/48rvig6y<\/a><\/p>\n\n\n\n<p>Participants are invited to send their questions by 9 February by e-mail:&nbsp;<a>alise.ose@osi.lv<\/a><\/p>\n\n\n\n<p>Please note that the webinar will be recorded.<\/p>","protected":false},"excerpt":{"rendered":"<p>Aicin\u0101m pievienoties vebin\u0101ram par Eiropas Savien\u012bbas regul\u0113jumu medic\u012bniskaj\u0101m ier\u012bc\u0113m un in vitro diagnostiku. P\u0113d\u0113jos gados pras\u012bbas MDR un IVDR ietvaros ir b\u016btiski main\u012bju\u0161\u0101s, un agr\u012bna izpratne par regulat\u012bvajiem nosac\u012bjumiem ir iz\u0161\u0137iro\u0161a inov\u0101ciju projektiem, kas no p\u0113tniec\u012bbas vides virz\u0101s uz tirgu. Vebin\u0101rs norisin\u0101sies 6. mart\u0101, plkst. 10.00. Vebin\u0101ru vad\u012bs Stefans Boleiningers (Stefan Bolleininger), Consultys Medical vad\u012bt\u0101js [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3422,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[8,5],"tags":[],"class_list":["post-3425","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pasakums","category-pazinojums"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Aicin\u0101m uz vebin\u0101ru \u201cEU Regulations for Medical Devices and In Vitro Diagnostics\u201d - BioPhoT<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biophot.lv\/en\/eu-regulations-for-medical-devices-and-in-vitro-diagnostics\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Aicin\u0101m uz vebin\u0101ru \u201cEU Regulations for Medical Devices and In Vitro Diagnostics\u201d - BioPhoT\" \/>\n<meta property=\"og:description\" content=\"Aicin\u0101m pievienoties vebin\u0101ram par Eiropas Savien\u012bbas regul\u0113jumu medic\u012bniskaj\u0101m ier\u012bc\u0113m un in vitro diagnostiku. P\u0113d\u0113jos gados pras\u012bbas MDR un IVDR ietvaros ir b\u016btiski main\u012bju\u0161\u0101s, un agr\u012bna izpratne par regulat\u012bvajiem nosac\u012bjumiem ir iz\u0161\u0137iro\u0161a inov\u0101ciju projektiem, kas no p\u0113tniec\u012bbas vides virz\u0101s uz tirgu. Vebin\u0101rs norisin\u0101sies 6. mart\u0101, plkst. 10.00. 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