{"id":5488,"date":"2025-05-09T08:00:00","date_gmt":"2025-05-09T07:00:00","guid":{"rendered":"https:\/\/www.v-apps.cloud\/?p=5488"},"modified":"2025-05-03T00:37:56","modified_gmt":"2025-05-02T23:37:56","slug":"indagini-cliniche-il-belgio-introduce-nuove-regole","status":"publish","type":"post","link":"https:\/\/www.v-apps.cloud\/en\/indagini-cliniche-il-belgio-introduce-nuove-regole\/","title":{"rendered":"FAMHP Issues New MDR Guidance"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong>Belgian Federal Agency Updates Clinical Investigation Submission Process<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The Belgian Federal Agency for Medicines and Health Products (FAMHP) has released new guidance outlining the submission process for clinical investigations aligned with the Medical Device Regulation (MDR). The guidelines offer essential clarity on the national perspective for submitting clinical investigation documents in Belgium.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Highlights of the New Guidelines:<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The guidance is specifically tailored to ensure alignment with the requirements of the MDR.<\/li>\n\n\n\n<li>It provides detailed instructions and processes for clinical investigation submissions to better serve medical device companies, regulatory affairs professionals, and clinical researchers.<\/li>\n\n\n\n<li>The document addresses Belgium&#8217;s national submission requirements within the framework of the MDR.<\/li>\n\n\n\n<li>The guidelines are set to become effective starting <strong>January 2025<\/strong>, giving stakeholders ample time to familiarize themselves with the updated procedures.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Download the new guidelines<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Medical device companies and clinical researchers conducting investigations in Belgium are encouraged to review the document thoroughly to ensure compliance and streamlined processing of future submissions.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For more information, visit FAMHP&#8217;s official website or consult with a regulatory expert to align your processes with the upcoming changes.<\/p>\n\n\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\/H0jQj5V0\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>DOWNLOAD THE GUIDELINES<\/strong><\/a><\/div>\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong><strong>Book a demo<\/strong><\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">With features like real-time data insights, AI-based alerts, and an intuitive design, <strong>V-Apps.cloud<\/strong> is the ideal solution for efficient compliance management.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Schedule a demo today<\/strong> to discover how it can revolutionize your business.<\/p>\n\n\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\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The guidelines offer essential clarity on the national perspective for submitting clinical investigation documents in Belgium.<\/p>\n","protected":false},"author":2,"featured_media":5482,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[78],"tags":[],"class_list":["post-5488","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FAMHP Issues New MDR Guidance<\/title>\n<meta name=\"description\" content=\"The guidelines offer essential clarity on the national perspective for submitting clinical investigation documents in Belgium.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.v-apps.cloud\/en\/indagini-cliniche-il-belgio-introduce-nuove-regole\/\" \/>\n<meta property=\"og:locale\" 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