{"id":3737,"date":"2026-03-27T10:19:02","date_gmt":"2026-03-27T08:19:02","guid":{"rendered":"https:\/\/biophot.lv\/?p=3737"},"modified":"2026-03-27T10:19:34","modified_gmt":"2026-03-27T08:19:34","slug":"video-webinars-eu-regulations-for-medical-devices-and-in-vitro-diagnostics","status":"publish","type":"post","link":"https:\/\/biophot.lv\/en\/video-vebinars-eu-regulations-for-medical-devices-and-in-vitro-diagnostics\/","title":{"rendered":"VIDEO: Webinar \u201cEU Regulations for Medical Devices and In Vitro Diagnostics\u201d"},"content":{"rendered":"<p><strong>A webinar on the European Union framework for medical devices and in vitro diagnostics introduced participants to the significant changes within the MDR and IVDR.<\/strong><\/p>\n\n\n\n<p>Given that regulatory requirements have changed significantly in recent years, particular attention has been paid to the importance of early understanding for innovation projects moving from the research environment to the market.<\/p>\n\n\n\n<p>The webinar was moderated by Stefan Bolleininger, CEO of Consultys Medical and Senior Regulatory Affairs Consultant, 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>The webinar covered:<\/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<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-4-3 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<iframe loading=\"lazy\" title=\"Webinar &quot;EU Regulations for Medical Devices and In Vitro Diagnostics&quot;\" width=\"640\" height=\"480\" src=\"https:\/\/www.youtube.com\/embed\/U2xZ5C4J7mQ?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe>\n<\/div><\/figure>","protected":false},"excerpt":{"rendered":"<p>Vebin\u0101r\u0101 par Eiropas Savien\u012bbas regul\u0113jumu medic\u012bniskaj\u0101m ier\u012bc\u0113m un in vitro diagnostikudal\u012bbnieki tika iepaz\u012bstin\u0101ti ar b\u016btiskaj\u0101m izmai\u0146\u0101m MDR un IVDR ietvaros. \u0145emot v\u0113r\u0101, ka p\u0113d\u0113jos gados regulat\u012bv\u0101s pras\u012bbas ir b\u016btiski main\u012bju\u0161\u0101s, \u012bpa\u0161a uzman\u012bba tika piev\u0113rsta agr\u012bnas izpratnes noz\u012bmei inov\u0101ciju projektiem, kas no p\u0113tniec\u012bbas vides virz\u0101s uz tirgu. Vebin\u0101ru vad\u012bja Stefan Bolleininger, Consultys Medical vad\u012bt\u0101js un vec\u0101kais [&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":[8,5,13],"tags":[],"class_list":["post-3737","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pasakums","category-pazinojums","category-video"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>VIDEO: Vebin\u0101rs &quot;EU Regulations for Medical Devices and In Vitro Diagnostics&quot; - 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\/video-webinars-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=\"VIDEO: Vebin\u0101rs &quot;EU Regulations for Medical Devices and In Vitro Diagnostics&quot; - BioPhoT\" \/>\n<meta property=\"og:description\" content=\"Vebin\u0101r\u0101 par Eiropas Savien\u012bbas regul\u0113jumu medic\u012bniskaj\u0101m ier\u012bc\u0113m un in vitro diagnostikudal\u012bbnieki tika iepaz\u012bstin\u0101ti ar b\u016btiskaj\u0101m izmai\u0146\u0101m MDR un IVDR ietvaros. \u0145emot v\u0113r\u0101, ka p\u0113d\u0113jos gados regulat\u012bv\u0101s pras\u012bbas ir b\u016btiski main\u012bju\u0161\u0101s, \u012bpa\u0161a uzman\u012bba tika piev\u0113rsta agr\u012bnas izpratnes noz\u012bmei inov\u0101ciju projektiem, kas no p\u0113tniec\u012bbas vides virz\u0101s uz tirgu. Vebin\u0101ru vad\u012bja Stefan Bolleininger, Consultys Medical vad\u012bt\u0101js un vec\u0101kais [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/biophot.lv\/en\/video-webinars-eu-regulations-for-medical-devices-and-in-vitro-diagnostics\/\" \/>\n<meta property=\"og:site_name\" content=\"BioPhoT\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-27T08:19:02+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-27T08:19:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/biophot.lv\/wp-content\/uploads\/2026\/02\/Copy-of-1080-x-1080px-1-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ilze\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ilze\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/biophot.lv\\\/video-vebinars-eu-regulations-for-medical-devices-and-in-vitro-diagnostics\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/biophot.lv\\\/video-vebinars-eu-regulations-for-medical-devices-and-in-vitro-diagnostics\\\/\"},\"author\":{\"name\":\"Ilze\",\"@id\":\"https:\\\/\\\/biophot.lv\\\/#\\\/schema\\\/person\\\/b6835496fc3e60bba9412a8a135755f1\"},\"headline\":\"VIDEO: Vebin\u0101rs &#8220;EU Regulations for Medical Devices and In Vitro Diagnostics&#8221;\",\"datePublished\":\"2026-03-27T08:19:02+00:00\",\"dateModified\":\"2026-03-27T08:19:34+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/biophot.lv\\\/video-vebinars-eu-regulations-for-medical-devices-and-in-vitro-diagnostics\\\/\"},\"wordCount\":227,\"publisher\":{\"@id\":\"https:\\\/\\\/biophot.lv\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/biophot.lv\\\/video-vebinars-eu-regulations-for-medical-devices-and-in-vitro-diagnostics\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/biophot.lv\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/Copy-of-1080-x-1080px-1-1.jpg\",\"articleSection\":[\"Pas\u0101kums\",\"Pazi\u0146ojums\",\"Video\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/biophot.lv\\\/video-vebinars-eu-regulations-for-medical-devices-and-in-vitro-diagnostics\\\/\",\"url\":\"https:\\\/\\\/biophot.lv\\\/video-vebinars-eu-regulations-for-medical-devices-and-in-vitro-diagnostics\\\/\",\"name\":\"VIDEO: Vebin\u0101rs \\\"EU Regulations for Medical Devices and In Vitro Diagnostics\\\" - 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