{"id":400,"date":"2022-01-03T08:46:45","date_gmt":"2022-01-03T14:46:45","guid":{"rendered":"https:\/\/casusconsulting.com\/?page_id=400"},"modified":"2024-03-19T15:35:23","modified_gmt":"2024-03-19T20:35:23","slug":"regulatory-updates","status":"publish","type":"page","link":"https:\/\/casusconsulting.com\/regulatory-updates\/","title":{"rendered":"Regulatory Updates"},"content":{"rendered":"<p>[vc_row disable_element=&#8221;yes&#8221;][vc_column][vc_custom_heading text=&#8221;Regulatory Updates&#8221; font_container=&#8221;tag:h2|text_align:center&#8221; use_theme_fonts=&#8221;yes&#8221; css_animation=&#8221;fadeIn&#8221;][\/vc_column][\/vc_row][vc_row disable_element=&#8221;yes&#8221;][vc_column css=&#8221;.vc_custom_1653495707892{background-color: #f7f7f7 !important;}&#8221;][vc_column_text]<form  class=\"is-search-form is-form-style is-form-style-3 is-form-id-791 \" action=\"https:\/\/casusconsulting.com\/\" method=\"get\" role=\"search\" ><label for=\"is-search-input-791\"><span 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!important;padding-bottom: 0px !important;}&#8221;]<script src=\"https:\/\/9931674141ca41baa2023404fd2333a2.js.ubembed.com\" async><\/script><strong>Sort by Market:<\/strong><\/p>\n<h3><!-- Smartsupp Live Chat script -->\r\n\r\n<script type=\"text\/javascript\">\r\n\r\nvar _smartsupp = _smartsupp || {};\r\n\r\n_smartsupp.key = 'aa3132da0431967288b8cf85dfdfa7626d7ecfd3';\r\n\r\nwindow.smartsupp||(function(d) {\r\n\r\n         var s,c,o=smartsupp=function(){ o._.push(arguments)};o._=[];\r\n\r\n         s=d.getElementsByTagName('script')[0];c=d.createElement('script');\r\n\r\n         c.type='text\/javascript';c.charset='utf-8';c.async=true;\r\n\r\n         c.src='https:\/\/www.smartsuppchat.com\/loader.js?';s.parentNode.insertBefore(c,s);\r\n\r\n})(document);\r\n\r\n<\/script><\/h3>\n<p>[\/vc_column_text][vc_column_text]<div class=\"wpcd_dropdown_categories\"<p><select  name='wpcd_parent' id='wpcd_parent' class='663b04eb70e1b'>\n\t<option value=''>Choose Market:<\/option>\n\t<option class=\"level-0\" value=\"6\">European Union<\/option>\n\t<option class=\"level-0\" value=\"4\">Switzerland<\/option>\n\t<option class=\"level-0\" value=\"5\">United Kingdom<\/option>\n<\/select>\n<\/p><div id=\"child_cat_default_text\">Child Category<\/div><div id=\"taxonomy\">category<\/div><div id=\"random_id\">663b04eb70e1b<\/div><div id=\"hide_empty\">1<\/div><div id=\"show_count\">0<\/div><div id=\"exclude\"><\/div><div id=\"include\"><\/div><div id=\"wpcd_child_cat_loader\">Loading....<\/div><div id=\"child_cat_dropdown\" class=\"663b04eb70e1b\"><\/div><\/div>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]<script src=\"https:\/\/9931674141ca41baa2023404fd2333a2.js.ubembed.com\" async><\/script><\/p>\n<p><span style=\"color: #000000;\"><!-- Smartsupp Live Chat script -->\r\n\r\n<script type=\"text\/javascript\">\r\n\r\nvar _smartsupp = _smartsupp || {};\r\n\r\n_smartsupp.key = 'aa3132da0431967288b8cf85dfdfa7626d7ecfd3';\r\n\r\nwindow.smartsupp||(function(d) {\r\n\r\n         var s,c,o=smartsupp=function(){ o._.push(arguments)};o._=[];\r\n\r\n         s=d.getElementsByTagName('script')[0];c=d.createElement('script');\r\n\r\n         c.type='text\/javascript';c.charset='utf-8';c.async=true;\r\n\r\n         c.src='https:\/\/www.smartsuppchat.com\/loader.js?';s.parentNode.insertBefore(c,s);\r\n\r\n})(document);\r\n\r\n<\/script><\/span>[\/vc_column_text][vc_empty_space height=&#8221;32&#8243;]<div  class=\"jblog_postblock_29 jeg_postblock jeg_pagination_loadmore jeg_module___663b04eb72d3d   \" data-unique=\"jeg_module___663b04eb72d3d\"><div class=\"jeg_block_container\"><div class=\"jeg_posts jblog_ajax_flag\">\n                <article class=\"jeg_post post-12113 post type-post status-publish format-standard has-post-thumbnail hentry category-eu category-switzerland category-uk\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/new-imdrf-guidance-labelling-safety-and-performance-regulatory-review\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"New IMDRF Guidance: Labelling, Safety &amp; Performance, Regulatory Review Reports and more\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/05\/shutterstock_230268772-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/05\/shutterstock_230268772-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/05\/shutterstock_230268772-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/new-imdrf-guidance-labelling-safety-and-performance-regulatory-review\/\">New IMDRF Guidance: Labelling, Safety &amp; Performance, Regulatory Review Reports and more<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>The IMDRF released new guidance on labeling, safety & performance requirements, regulatory review reports, and more. Click here for the ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">May 5, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-12028 post type-post status-publish format-standard has-post-thumbnail hentry category-uk tag-mhra tag-uk\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mhra-to-small-to-medium-sized-manufacturers-volunteer-to-help-test-uk-international-recognition-framework\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MHRA to Small-to-Medium Companies: Volunteer to Help Test UK International Recognition Framework\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_1104932450-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_1104932450-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_1104932450-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/uk\/\" class=\"category-uk\">United Kingdom<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mhra-to-small-to-medium-sized-manufacturers-volunteer-to-help-test-uk-international-recognition-framework\/\">MHRA to Small-to-Medium Companies: Volunteer to Help Test UK International Recognition Framework<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>The MHRA is asking small-to-medium sized manufacturers for help testing the new UK International Recognition Framework. The deadline to volunteer ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">April 27, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11988 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-ivdr tag-mdcg-guidance tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdcg-meeting-on-the-may-26-mdr-legacy-device-deadline-and-eu-supply-shortages\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"EU Updates: MDCG Meeting on Device Shortages due to the May MDR Cutoff &amp; New MDR\/IVDR Industry Survey\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_178721420-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_178721420-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_178721420-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdcg-meeting-on-the-may-26-mdr-legacy-device-deadline-and-eu-supply-shortages\/\">EU Updates: MDCG Meeting on Device Shortages due to the May MDR Cutoff &amp; New MDR\/IVDR Industry Survey<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>The MDCG called a special meeting to discuss the May 26, 2024 deadline, including how to handle device shortages. Plus, ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">April 26, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11952 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-eudamed tag-ivdr tag-legacy-devices\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/eu-parliament-votes-to-extend-ivdr-legacy-device-transition-period-and-rollout-eudamed\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"EU Parliament Votes \u201cYes\u201d to Extend IVDR Transition Period &amp; Gradual Rollout of EUDAMED\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_413928301-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_413928301-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_413928301-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/eu-parliament-votes-to-extend-ivdr-legacy-device-transition-period-and-rollout-eudamed\/\">EU Parliament Votes \u201cYes\u201d to Extend IVDR Transition Period &amp; Gradual Rollout of EUDAMED<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>EU Parliament voted to extend the IVDR transition period, rollout EUDAMED in stages, and require reporting of supply disruptions. Find ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">April 25, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11933 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-mdcg-guidance tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdcg-2024-5-clinical-investigation-mdr-investigators-brochure-contents-checklist\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MDCG 2024-5: Guidance on Investigator Brochure Minimum Contents\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_2319949499-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_2319949499-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_2319949499-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdcg-2024-5-clinical-investigation-mdr-investigators-brochure-contents-checklist\/\">MDCG 2024-5: Guidance on Investigator Brochure Minimum Contents<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>New guidance on the Investigator\u2019s Brochure contents, an integral part of clinical investigation documentation. Click here for a summary of ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">April 23, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11873 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-ivdr tag-mdcg-guidance tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdcg-2022-9-rev-1-updates-to-ivdr-summary-of-safety-and-performance-ssp-template\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MDCG 2022-9 Rev.1: Updates to IVDR Summary of Safety and Performance (SSP) Template\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_525226711-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_525226711-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_525226711-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdcg-2022-9-rev-1-updates-to-ivdr-summary-of-safety-and-performance-ssp-template\/\">MDCG 2022-9 Rev.1: Updates to IVDR Summary of Safety and Performance (SSP) Template<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>MDCG 2022-9 on Summary of Safety and Performance requirements under the IVDR has been updated. Find the link to MDCG ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">April 16, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11824 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-ivdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/team-notified-body-ivdr-ce-mark-training-july-2024\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"Team Notified Body: New IVDR Training Session Available for July 2024\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/Team-Notified-Body-IVDR-Training-July-2024-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/Team-Notified-Body-IVDR-Training-July-2024-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/Team-Notified-Body-IVDR-Training-July-2024-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/team-notified-body-ivdr-ce-mark-training-july-2024\/\">Team Notified Body: New IVDR Training Session Available for July 2024<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>Team Notified Body (NB) has scheduled a fourth IVDR training session for Wednesday July 3, 2024. Find out the agenda, ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">April 15, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11786 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/eu-commission-dashboard-reprocessing-single-use-devices-mdr-article-17\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"EU Commission Dashboard: Survey on reprocessing of single-use devices under MDR Article 17\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_347793686-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_347793686-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/04\/shutterstock_347793686-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/eu-commission-dashboard-reprocessing-single-use-devices-mdr-article-17\/\">EU Commission Dashboard: Survey on reprocessing of single-use devices under MDR Article 17<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>New EU Commission dashboard on reprocessing of single-use devices under the MDR 2017\/745. Find out which Competent Authorities allow it, ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">April 12, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11576 post type-post status-publish format-standard has-post-thumbnail hentry category-uk tag-mhra tag-uk tag-ukca tag-united-kingdom\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/update-future-uk-regulation-status-uk-international-recognition-fda-imdrf-meeting\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"Updates: Future UK Regulations, Status of UK International Recognition &#038; IMDRF March Meetings\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/shutterstock_188987774-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/shutterstock_188987774-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/shutterstock_188987774-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/uk\/\" class=\"category-uk\">United Kingdom<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/update-future-uk-regulation-status-uk-international-recognition-fda-imdrf-meeting\/\">Updates: Future UK Regulations, Status of UK International Recognition &#038; IMDRF March Meetings<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>MHRA updates on the International Recognition Framework (testing progress & timing to publish the outline) and the new draft regulation. ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">March 28, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11511 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-mdcg-guidance\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdcg-2024-3-mdr-guidance-clinical-investigation-plan-contents-and-synopsis-template\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MDCG 2024-3: New Guidance on Clinical Investigation Plan Contents &#038; Synopsis Template\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/MDCG-2024-3-Clinical-Investigation-Plan-Guidance-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/MDCG-2024-3-Clinical-Investigation-Plan-Guidance-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/MDCG-2024-3-Clinical-Investigation-Plan-Guidance-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdcg-2024-3-mdr-guidance-clinical-investigation-plan-contents-and-synopsis-template\/\">MDCG 2024-3: New Guidance on Clinical Investigation Plan Contents &#038; Synopsis Template<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>New MDCG guidance Clinical Investigation Plan contents has been issued. Plus, a Word version Clinical Investigation Plan Synopsis Template. Click ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">March 14, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11491 post type-post status-publish format-standard has-post-thumbnail hentry category-switzerland tag-ivdr tag-mdr tag-swissmedic\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/switzerland-eu-mutual-recognition-negotiations-commence\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"Switzerland-EU Mutual Recognition: New Negotiation Discussions Underway\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/Switzerland-EU-Negotiations-Mutual-Recognition-Agreement-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/Switzerland-EU-Negotiations-Mutual-Recognition-Agreement-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/Switzerland-EU-Negotiations-Mutual-Recognition-Agreement-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/switzerland\/\" class=\"category-switzerland\">Switzerland<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/switzerland-eu-mutual-recognition-negotiations-commence\/\">Switzerland-EU Mutual Recognition: New Negotiation Discussions Underway<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>This month the Swiss Federal Council and EU Commission will resume formal negotiations; if successful, this will restore mutual recognition ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">March 13, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11464 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-ivdr tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/new-eu-mdr-ivdr-harmonized-standards-published\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"New EU MDR\/IVDR Harmonized Standards Published\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/Harmonized-Standards_MDR-IVDR_March-2024-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/Harmonized-Standards_MDR-IVDR_March-2024-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/Harmonized-Standards_MDR-IVDR_March-2024-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/new-eu-mdr-ivdr-harmonized-standards-published\/\">New EU MDR\/IVDR Harmonized Standards Published<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>Eight new standards have been harmonized under the EU MDR and three newly harmonized under the EU IVDR. Click here ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">March 11, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11445 post type-post status-publish format-standard has-post-thumbnail hentry category-eu\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/team-notified-body-new-mdr-training-june-and-upcoming-webinar-march\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"Team Notified Body: New MDR Training (June) and Upcoming Webinar (March)\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/Shutterstock_1159623367-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/Shutterstock_1159623367-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/03\/Shutterstock_1159623367-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/team-notified-body-new-mdr-training-june-and-upcoming-webinar-march\/\">Team Notified Body: New MDR Training (June) and Upcoming Webinar (March)<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>Team NB has announced a 6th MDR training session for June 2024. The April 2024 training is now fully booked. ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">March 7, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11405 post type-post status-publish format-standard has-post-thumbnail hentry category-eu\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/team-nb-position-paper-proposal-to-reclassify-sars-cov-2-covid-in-vitro-diagnostic-devices\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"Team NB Position Paper: Proposal to Reclassify SARS-CoV-2 (COVID) in vitro Diagnostic Devices\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/COVID-IVDR-Reclassification-Team-Notified-Body-SARS-CoV-2-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/COVID-IVDR-Reclassification-Team-Notified-Body-SARS-CoV-2-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/COVID-IVDR-Reclassification-Team-Notified-Body-SARS-CoV-2-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/team-nb-position-paper-proposal-to-reclassify-sars-cov-2-covid-in-vitro-diagnostic-devices\/\">Team NB Position Paper: Proposal to Reclassify SARS-CoV-2 (COVID) in vitro Diagnostic Devices<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>Team Notified Body has proposed reclassifying SARS-CoV-2 (COVID) IVD devices. Find out the proposed new classification and consequences for manufacturers.<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">February 22, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11385 post type-post status-publish format-standard has-post-thumbnail hentry category-uk\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/new-uk-association-formed-team-approved-body-ab\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"New Association Formed in the UK: Team Approved Body (\u201cTeam AB\u201d)\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/Team-Approved-Body-AB-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/Team-Approved-Body-AB-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/Team-Approved-Body-AB-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/uk\/\" class=\"category-uk\">United Kingdom<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/new-uk-association-formed-team-approved-body-ab\/\">New Association Formed in the UK: Team Approved Body (\u201cTeam AB\u201d)<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>Like Team Notified Body, there is now an association for UK Approved Bodies (\u201cTeam AB\u201d). Find out their goals, plus ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">February 21, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11307 post type-post status-publish format-standard has-post-thumbnail hentry category-switzerland tag-medical-device-registration tag-swissmedic\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/swissdamed-registration-database-postponed-new-release-date\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"&#8216;swissdamed&#8217; Registration Database: Launch date pushed to 2nd Half 2024\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/Swissdamed-Registration-Database-New-Release-Dates-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/Swissdamed-Registration-Database-New-Release-Dates-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/Swissdamed-Registration-Database-New-Release-Dates-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/switzerland\/\" class=\"category-switzerland\">Switzerland<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/swissdamed-registration-database-postponed-new-release-date\/\">&#8216;swissdamed&#8217; Registration Database: Launch date pushed to 2nd Half 2024<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>Swissdamed is being postponed, due to continued on work on the IT infrastructure. Find out the new 'go-live' dates and ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">February 9, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11269 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-ivdr tag-mdcg-guidance tag-mdr tag-medical-device-registration\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdcg-2024-2-process-to-add-amend-obsolete-new-emdn-codes\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MDCG 2024-2: Process &#038; Timing to Add, Amend, Obsolete New EMDN Codes\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/MDCG-2024-2-EMDN-Code-Process-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/MDCG-2024-2-EMDN-Code-Process-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/MDCG-2024-2-EMDN-Code-Process-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdcg-2024-2-process-to-add-amend-obsolete-new-emdn-codes\/\">MDCG 2024-2: Process &#038; Timing to Add, Amend, Obsolete New EMDN Codes<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>MDCG 2024-2 outlines the process of reviewing new EMDN code requests. Find out how they are processed, the timing, and ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">February 7, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11243 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdr-transition-deadline-26-may-2024-what-is-a-lodged-application-with-a-notified-body\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MDR Transition Deadline of 26 May 2024: What is a \u201clodged\u201d application with the Notified Body?\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/shutterstock_2156400029-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/shutterstock_2156400029-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/shutterstock_2156400029-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdr-transition-deadline-26-may-2024-what-is-a-lodged-application-with-a-notified-body\/\">MDR Transition Deadline of 26 May 2024: What is a \u201clodged\u201d application with the Notified Body?<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>By May 26, 2024 MDD\/AIMDD devices must have \u2018lodged an application\u2019 with a Notified Body, or they lose access to ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">February 6, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11186 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/team-notified-body-nb-new-mdr-training-april-2024\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"Team Notified Body: New MDR Training Session Available for April 2024\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/Team-Notified-Body-MDR-Training-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/Team-Notified-Body-MDR-Training-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/Team-Notified-Body-MDR-Training-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/team-notified-body-nb-new-mdr-training-april-2024\/\">Team Notified Body: New MDR Training Session Available for April 2024<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>Team Notified Body has scheduled another MDR training session for Monday, 29 April 2024. Click here for the agenda, fees, ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">February 2, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11107 post type-post status-publish format-standard has-post-thumbnail hentry category-eu\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdcg-2024-1-device-specific-vigilance-guidance-dsvg-templates\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"New: MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Templates\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_558196114-1-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_558196114-1-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_558196114-1-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdcg-2024-1-device-specific-vigilance-guidance-dsvg-templates\/\">New: MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Templates<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>The MDCG issued guidance harmonizing vigilance reporting for serious incidents, Periodic Summary Reports, and trend reporting. Click here for the ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">January 31, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-11093 post type-post status-publish format-standard has-post-thumbnail hentry category-uk tag-ukca tag-united-kingdom\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mhra-adds-new-uk-approved-bodies-lne-gmed-and-scarlet-nb\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MHRA Adds Two New UK Approved Bodies: LNE-GMED UK Limited &amp; Scarlet NB UK Ltd\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/New-UK-Approved-Bodies-Added-by-MHRA-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/New-UK-Approved-Bodies-Added-by-MHRA-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/New-UK-Approved-Bodies-Added-by-MHRA-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/uk\/\" class=\"category-uk\">United Kingdom<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mhra-adds-new-uk-approved-bodies-lne-gmed-and-scarlet-nb\/\">MHRA Adds Two New UK Approved Bodies: LNE-GMED UK Limited &amp; Scarlet NB UK Ltd<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>The MHRA newly designated LNE-GMED & Scarlet NB as UK Approved Bodies. Find the list of all Approved Bodies, their ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">January 30, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-10842 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-ivdr tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/new-eu-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"New Commission Proposal: Further Delay to IVDR, New Reporting Obligation &#038; New EUDAMED Deadline\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_1508994980-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_1508994980-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_1508994980-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/new-eu-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout\/\">New Commission Proposal: Further Delay to IVDR, New Reporting Obligation &#038; New EUDAMED Deadline<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>New Commission Proposal to 1) further the delay the IVDR for 'legacy' devices 2) require manufacturers to report disruption to ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">January 23, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-10781 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-ivdr tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/eu-commission-language-translation-requirements-mdr-ivdr-software-interface\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"EU Commission Publishes Language Translation Requirements under the MDR &#038; IVDR\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/EU-Commission-Language-Requirements-under-MDR-and-IVDR-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/EU-Commission-Language-Requirements-under-MDR-and-IVDR-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/EU-Commission-Language-Requirements-under-MDR-and-IVDR-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/eu-commission-language-translation-requirements-mdr-ivdr-software-interface\/\">EU Commission Publishes Language Translation Requirements under the MDR &#038; IVDR<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>New EU Commission resource: consolidated Language Translation Requirements under the MDR\/IVDR. Find out what\u2019s included, what\u2019s excluded, and get the ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">January 18, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-10657 post type-post status-publish format-standard has-post-thumbnail hentry category-uk tag-mhra tag-uk tag-ukca\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/uk-mhra-2024-2025-roadmap-of-medical-device-regulation\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"UK MHRA: 2024-2025 Roadmap of Future Regulatory Framework\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_2367897851-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_2367897851-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_2367897851-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/uk\/\" class=\"category-uk\">United Kingdom<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/uk-mhra-2024-2025-roadmap-of-medical-device-regulation\/\">UK MHRA: 2024-2025 Roadmap of Future Regulatory Framework<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>The UK MHRA updated the timing and planning for the new medical device and IVD regulation. Click here for the ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">January 9, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-10626 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-ivdr tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/eu-commission-dashboard-monitoring-availability-medical-devices-ivds-oneu-market\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"EU Commission: New Dashboard Monitoring Availability of Medical Devices on the EU Market\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_2285412735-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_2285412735-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/shutterstock_2285412735-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/eu-commission-dashboard-monitoring-availability-medical-devices-ivds-oneu-market\/\">EU Commission: New Dashboard Monitoring Availability of Medical Devices on the EU Market<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>The European Commission created a new dashboard, providing an overview of the availability of medical devices & IVDs on the ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">January 9, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-10555 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-mdcg-guidance\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdcg-2023-7-clinical-investigation-exemptions-claiming-equivalence\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MDCG 2023-7: Clinical Investigation Exemptions &amp; Claiming Equivalence\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/MDCG-2023-7-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/MDCG-2023-7-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/MDCG-2023-7-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdcg-2023-7-clinical-investigation-exemptions-claiming-equivalence\/\">MDCG 2023-7: Clinical Investigation Exemptions &amp; Claiming Equivalence<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>MDCG 2023-7 on clinical investigation exemptions & level of data needed to claim equivalence, was newly published in December 2023. ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">January 4, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-10513 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-ivdr tag-mdcg-guidance tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdcg-2019-07-rev-1-mdr-ivdr-article-15-prrc\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MDCG 2019-07 Updated: MDR\/IVDR Art. 15, Person Responsible for Regulatory Compliance (PRRC)\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/PRRC-MDCG-2019-7-rev1-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/PRRC-MDCG-2019-7-rev1-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/01\/PRRC-MDCG-2019-7-rev1-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdcg-2019-07-rev-1-mdr-ivdr-article-15-prrc\/\">MDCG 2019-07 Updated: MDR\/IVDR Art. 15, Person Responsible for Regulatory Compliance (PRRC)<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>MDCG 2019-07, on the Person Responsible for Regulatory Compliance (PRRC), was originally published in June 2019. It has now been ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">January 3, 2024<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-10365 post type-post status-publish format-standard has-post-thumbnail hentry category-eu tag-ivdr tag-mdcg-guidance tag-mdr\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdcg-2021-27-rev-1-updated-mdr-ivdr-article-13-importers-14-distributors\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MDCG 2021-27 Updated: Q&amp;A on MDR\/IVDR Articles 13 (Importers) &amp; 14 (Distributors)\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/MDCG-2021-7-rev.1-Importers-Distributors-MDR-IVDR-Article-13-14-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/MDCG-2021-7-rev.1-Importers-Distributors-MDR-IVDR-Article-13-14-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/MDCG-2021-7-rev.1-Importers-Distributors-MDR-IVDR-Article-13-14-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdcg-2021-27-rev-1-updated-mdr-ivdr-article-13-importers-14-distributors\/\">MDCG 2021-27 Updated: Q&amp;A on MDR\/IVDR Articles 13 (Importers) &amp; 14 (Distributors)<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>MDCG 2021-27 has been revised to add six new Q&As and update three existing Q&As. For the link and what's ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">December 20, 2023<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-10263 post type-post status-publish format-standard has-post-thumbnail hentry category-eu\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/team-notified-body-nb-position-paper-medical-device-lifetime\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"Team Notified Body (NB) Position Paper: Medical Device Lifetime\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Team-Notified-Body-NB_Medical-Device-Lifetime-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Team-Notified-Body-NB_Medical-Device-Lifetime-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/Team-Notified-Body-NB_Medical-Device-Lifetime-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/team-notified-body-nb-position-paper-medical-device-lifetime\/\">Team Notified Body (NB) Position Paper: Medical Device Lifetime<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>Team NB released a new position paper on medical device lifetime: common understanding of the term, how to determine lifetime ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">December 18, 2023<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article><article class=\"jeg_post post-10054 post type-post status-publish format-standard has-post-thumbnail hentry category-eu\">\n\t\t\t\t<div class=\"jeg_post_wrapper\">\n\t\t\t\t\t<div class=\"jeg_thumb\">\n\t                    \n\t                    <a href=\"https:\/\/casusconsulting.com\/mdcg-2021-6-updated-mdr-qa-regarding-clinical-investigations\/\"><div class=\"thumbnail-container animate-lazy  size-800\"><img loading=\"lazy\" decoding=\"async\" width=\"370\" height=\"296\" src=\"https:\/\/casusconsulting.com\/wp-content\/plugins\/jblog-elements\/lib\/jeg-element\/assets\/img\/jeg-empty.png\" class=\"attachment-jeg-370x296 size-jeg-370x296 lazyload wp-post-image\" alt=\"MDCG 2021-6 Updated: MDR Q&#038;A Regarding Clinical Investigations\" data-src=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/shutterstock_394273012-scaled-370x296.jpg\" data-sizes=\"auto\" data-srcset=\"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/shutterstock_394273012-scaled-370x296.jpg 370w, https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/shutterstock_394273012-scaled-120x96.jpg 120w\" data-expand=\"700\" \/><\/div><\/a>\n\t                <\/div>\n\t                <div class=\"jeg_postblock_content\">\n\t                    <div class=\"jeg_post_category\">\n\t                        <span><a href=\"https:\/\/casusconsulting.com\/category\/regulatory-updates\/eu\/\" class=\"category-eu\">European Union<\/a><\/span>\n\t                    <\/div>\n\t                    <h3 class=\"jeg_post_title\">\n\t                        <a href=\"https:\/\/casusconsulting.com\/mdcg-2021-6-updated-mdr-qa-regarding-clinical-investigations\/\">MDCG 2021-6 Updated: MDR Q&#038;A Regarding Clinical Investigations<\/a>\n\t                    <\/h3>\n\t                    <div class=\"jeg_post_excerpt\">\n\t\t\t                <p>A revision to MDCG 2021-6, MDR Q&A regarding clinical investigations, has been released. Click here to access the link and ...<\/p>\n\t\t\t            <\/div>\n\t                    <div class=\"jeg_post_meta\"><div class=\"jeg_meta_date\">December 13, 2023<\/div><\/div>\n\t                <\/div>\n\t\t\t\t<\/div>\n            <\/article>\n            <\/div><\/div>\n\t\t\t\t<div class=\"jeg_block_pagination jeg_align\"><div class=\"jeg_block_loadmore\"><a href=\"#\" data-load=\"Load More\" data-loading=\"Loading...\"> Load More<\/a><\/div><\/div><script>var jeg_module___663b04eb72d3d = {\"compatible_column_notice\":\"\",\"post_type\":\"post\",\"number_post\":\"30\",\"post_offset\":\"0\",\"unique_content\":\"disable\",\"include_post\":\"\",\"exclude_post\":\"\",\"include_category\":\"6,4,5\",\"exclude_category\":\"1\",\"include_author\":\"\",\"include_tag\":\"\",\"exclude_tag\":\"\",\"ctl-stories\":\"\",\"portfolio-types\":\"\",\"sort_by\":\"latest\",\"date_type\":\"published\",\"date_format\":\"default\",\"date_format_custom\":\"F j, Y\",\"pagination_mode\":\"loadmore\",\"pagination_number_post\":\"30\",\"pagination_scroll_limit\":0,\"el_id\":\"\",\"el_class\":\"\",\"css\":\"\",\"paged\":1,\"class\":\"jblog_block_29\"};<\/script><\/div>[\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[vc_row disable_element=&#8221;yes&#8221;][vc_column][vc_custom_heading text=&#8221;Regulatory Updates&#8221; font_container=&#8221;tag:h2|text_align:center&#8221; use_theme_fonts=&#8221;yes&#8221; css_animation=&#8221;fadeIn&#8221;][\/vc_column][\/vc_row][vc_row disable_element=&#8221;yes&#8221;][vc_column css=&#8221;.vc_custom_1653495707892{background-color: #f7f7f7 !important;}&#8221;][vc_column_text][\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1668120557697{margin-bottom: 0px !important;padding-bottom: 0px !important;}&#8221;]Sort by Market: [\/vc_column_text][vc_column_text][\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text] [\/vc_column_text][vc_empty_space height=&#8221;32&#8243;][\/vc_column][\/vc_row]<\/p>\n","protected":false},"author":2,"featured_media":6173,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ub_ctt_via":"","footnotes":""},"featured_image_src":"https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/12\/shutterstock_660340387-scaled.jpg","_links":{"self":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/400"}],"collection":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/comments?post=400"}],"version-history":[{"count":88,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/400\/revisions"}],"predecessor-version":[{"id":11543,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/400\/revisions\/11543"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media\/6173"}],"wp:attachment":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media?parent=400"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}