{"id":11426,"date":"2024-01-09T12:40:13","date_gmt":"2024-01-09T11:40:13","guid":{"rendered":"https:\/\/biopmed.eu\/evento\/mdr-ivdr-certification-where-are-we\/"},"modified":"2024-02-14T15:33:30","modified_gmt":"2024-02-14T14:33:30","slug":"mdr-ivdr-certification-where-are-we","status":"publish","type":"tribe_events","link":"https:\/\/biopmed.eu\/en\/evento-en\/mdr-ivdr-certification-where-are-we\/","title":{"rendered":"MDR &amp; IVDR certification: where are we?"},"content":{"rendered":"<h6><em>During the meeting we will discuss regulatory updates regarding the registration process of medical devices (MDR) and in particular in vitro medical devices (IVDR). We will discover the necessary steps to submit certification requests to notified bodies (NB) proposing winning strategies to keep up with the deadlines set by Regulation 2023\/607. Finally, we will provide an overview of the current European situation.<\/em><\/h6>\n<p><button id=\"rtec-form-toggle-button\" class=\"rtec-register-button rtec-form-toggle-button rtec-js-show\" style=\"display: inline-block;\" type=\"button\"><a class=\"link_register_eventi_esternamente\" href=\"https:\/\/www.eventbrite.it\/e\/biglietti-certificazione-mdr-e-ivdr-a-che-punto-siamo-795128088517?aff=oddtdtcreator\" target=\"_blank\" rel=\"noopener\">Register<\/a><\/button><\/p>\n<h3>Target group<\/h3>\n<ul>\n<li>Quality and RA Manager<\/li>\n<li>R&amp;D<\/li>\n<li>Company managers<\/li>\n<\/ul>\n<h3>What we learn from the webinar<\/h3>\n<ul>\n<li>IVDR \u2013 current situation Italian market and NB<\/li>\n<li>MDR focus on Regulation 2023\/607 &#8211; MDD extension mode<\/li>\n<li>Testing active medical devices &#8211; activity promotion IMQ laboratories<\/li>\n<li>How IMQ wants to support companies in keeping up with the times: IMQ MED UP<\/li>\n<\/ul>\n<h3>Program<\/h3>\n<p>We will talk about the current regulatory situation at the beginning of 2024 on the subject of IVDR and MDR to understand the critical issues and necessary actions to be taken to comply with the deadlines dictated by Regulation 2023\/607. It is essential to understand the stages within which manufacturers must send applications to the NB and the European situation.<br \/>\nSpecifically we will talk about the Active medical device world to treat the continuous regulatory update of the standards for electrical safety and electromagnetic compatibility and what IMQ laboratories can offer.<br \/>\nThis is linked to the new format launched by IMQ (IMQ MED UP) with the aim of offering a tool to companies to stay up to date in the regulatory field.<\/p>\n<h3>Lecturer<\/h3>\n<p><strong>Andrea Santoleri<\/strong>. Andrea Santoleri is the current Sales Manager of the Medical Devices Division of IMQ Spa.<br \/>\nBiomedical engineer, he graduated from Politecnico di Milano with a specialization in Cells, Tissues and Biotechnology and a thesis at the University of Arizona in the field of microfluidics.<\/p>\n<p><button id=\"rtec-form-toggle-button\" class=\"rtec-register-button rtec-form-toggle-button rtec-js-show\" style=\"display: inline-block;\" type=\"button\"><a class=\"link_register_eventi_esternamente\" href=\"https:\/\/www.eventbrite.it\/e\/biglietti-certificazione-mdr-e-ivdr-a-che-punto-siamo-795128088517?aff=oddtdtcreator\" target=\"_blank\" rel=\"noopener\">Register<\/a><\/button><\/p>\n","protected":false},"excerpt":{"rendered":"<p>During the meeting we will discuss regulatory updates regarding the registration process of medical devices (MDR) and in particular in vitro medical devices (IVDR). We will discover the necessary steps &hellip; <a href=\"https:\/\/biopmed.eu\/en\/evento-en\/mdr-ivdr-certification-where-are-we\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">MDR &amp; IVDR certification: where are we?<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":11145,"template":"","meta":{"content-type":"","cybocfi_hide_featured_image":"","_tribe_events_status":"","_tribe_events_status_reason":"","footnotes":""},"tags":[],"tribe_events_cat":[141],"class_list":["post-11426","tribe_events","type-tribe_events","status-publish","has-post-thumbnail","hentry","tribe_events_cat-biopmed-events","cat_biopmed-events"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR &amp; IVDR certification: where are we? - bioPmed<\/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:\/\/biopmed.eu\/en\/evento-en\/mdr-ivdr-certification-where-are-we\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR &amp; IVDR certification: where are we? - bioPmed\" \/>\n<meta property=\"og:description\" content=\"During the meeting we will discuss regulatory updates regarding the registration process of medical devices (MDR) and in particular in vitro medical devices (IVDR). We will discover the necessary steps &hellip; Continue reading MDR &amp; IVDR certification: where are we?\" \/>\n<meta property=\"og:url\" content=\"https:\/\/biopmed.eu\/en\/evento-en\/mdr-ivdr-certification-where-are-we\/\" \/>\n<meta property=\"og:site_name\" content=\"bioPmed\" \/>\n<meta property=\"article:modified_time\" content=\"2024-02-14T14:33:30+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/biopmed.eu\/wp-content\/uploads\/2024\/01\/MDRIVDR.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/evento-en\\\/mdr-ivdr-certification-where-are-we\\\/\",\"url\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/evento-en\\\/mdr-ivdr-certification-where-are-we\\\/\",\"name\":\"MDR &amp; IVDR certification: where are we? - bioPmed\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/evento-en\\\/mdr-ivdr-certification-where-are-we\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/evento-en\\\/mdr-ivdr-certification-where-are-we\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/biopmed.eu\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/MDRIVDR.png\",\"datePublished\":\"2024-01-09T11:40:13+00:00\",\"dateModified\":\"2024-02-14T14:33:30+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/evento-en\\\/mdr-ivdr-certification-where-are-we\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/biopmed.eu\\\/en\\\/evento-en\\\/mdr-ivdr-certification-where-are-we\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/evento-en\\\/mdr-ivdr-certification-where-are-we\\\/#primaryimage\",\"url\":\"https:\\\/\\\/biopmed.eu\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/MDRIVDR.png\",\"contentUrl\":\"https:\\\/\\\/biopmed.eu\\\/wp-content\\\/uploads\\\/2024\\\/01\\\/MDRIVDR.png\",\"width\":1920,\"height\":1080},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/evento-en\\\/mdr-ivdr-certification-where-are-we\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Events\",\"item\":\"https:\\\/\\\/biopmed.eu\\\/events\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"MDR &amp; IVDR certification: where are we?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/\",\"name\":\"bioPmed\",\"description\":\"Piemonte Innovation Cluster\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/biopmed.eu\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"MDR &amp; IVDR certification: where are we? - bioPmed","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/biopmed.eu\/en\/evento-en\/mdr-ivdr-certification-where-are-we\/","og_locale":"en_US","og_type":"article","og_title":"MDR &amp; IVDR certification: where are we? - bioPmed","og_description":"During the meeting we will discuss regulatory updates regarding the registration process of medical devices (MDR) and in particular in vitro medical devices (IVDR). 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