{"id":9082,"date":"2023-10-31T07:09:21","date_gmt":"2023-10-31T12:09:21","guid":{"rendered":"https:\/\/casusconsulting.com\/?page_id=9082"},"modified":"2024-04-08T10:11:56","modified_gmt":"2024-04-08T15:11:56","slug":"mdr-ivdr-legacy-medical-device-2020-3-ivd-2022-6-mdcg-significant-change-guidance","status":"publish","type":"page","link":"https:\/\/casusconsulting.com\/mdr-ivdr-legacy-medical-device-2020-3-ivd-2022-6-mdcg-significant-change-guidance\/","title":{"rendered":"MDR\/IVDR Legacy Devices: Significant Change Assessment Tool"},"content":{"rendered":"\n<div class=\"wp-block-themepunch-revslider revslider\" data-modal=\"false\" data-slidertitle=\"Legacy Device Change Assessment\" style=\"\">\n\t\t\t<!-- START Legacy Device Change Assessment REVOLUTION SLIDER 6.7.1 --><p class=\"rs-p-wp-fix\"><\/p>\n\t\t\t<rs-module-wrap id=\"rev_slider_182_1_wrapper\" data-source=\"gallery\" style=\"visibility:hidden;background:#ffffff;padding:0;margin:0px auto;margin-top:0;margin-bottom:0;\">\n\t\t\t\t<rs-module id=\"rev_slider_182_1\" style=\"\" data-version=\"6.7.1\">\n\t\t\t\t\t<rs-slides style=\"overflow: hidden; position: absolute;\">\n\t\t\t\t\t\t<rs-slide style=\"position: absolute;\" data-key=\"rs-401\" data-title=\"Slide\" data-in=\"o:0;\" data-out=\"a:false;\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/\/casusconsulting.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/dummy.png\" alt=\"\" title=\"Question,Mark,Design,With,Copy,Space,On,White,Background\" width=\"2560\" height=\"1158\" class=\"rev-slidebg tp-rs-img rs-lazyload\" data-lazyload=\"\/\/casusconsulting.com\/wp-content\/uploads\/2023\/11\/Tools-and-Templates-scaled.jpg\" data-no-retina>\n<!--\t\t\t\t\t\t--><rs-zone id=\"rrzt_401\" class=\"rev_row_zone_top\" style=\"z-index: 6;\"><!--\n\n\t\t\t\t\t\t\t\t--><rs-row\n\t\t\t\t\t\t\t\t\tid=\"slider-182-slide-401-layer-0\" \n\t\t\t\t\t\t\t\t\tdata-type=\"row\"\n\t\t\t\t\t\t\t\t\tdata-xy=\"xo:50px;yo:50px;\"\n\t\t\t\t\t\t\t\t\tdata-rsp_o=\"off\"\n\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\tdata-margin=\"t:150,150,100,100;b:150,150,100,100;\"\n\t\t\t\t\t\t\t\t\tdata-padding=\"r:100,50,30,30;l:100,50,30,30;\"\n\t\t\t\t\t\t\t\t\tdata-frame_0=\"y:50;\"\n\t\t\t\t\t\t\t\t\tdata-frame_1=\"sp:1000;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8000;sA:9000;\"\n\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;\"\n\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-182-slide-401-layer-1\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:50px;yo:50px;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_o=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:50%;\"\n\t\t\t\t\t\t\t\t\t\tdata-padding=\"r:30,30,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_0=\"o:1;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8700;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-182-slide-401-layer-4\" \n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-color=\"#000000\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal,normal,normal,normal;s:35,35,30,30;l:45,45,35,35;fw:600;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:468px,auto,auto,auto;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_o=\"off\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8700;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;font-family:'Poppins';\"\n\t\t\t\t\t\t\t\t\t\t>MDR\/IVDR Legacy Device<br \/>\nChange Assessment Tool \n\t\t\t\t\t\t\t\t\t\t<\/rs-layer><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-182-slide-401-layer-2\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:50px;yo:50px;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_o=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:50%;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:0,0,20,20;\"\n\t\t\t\t\t\t\t\t\t\tdata-padding=\"l:30,30,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_0=\"o:1;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8700;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-182-slide-401-layer-5\" \n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-color=\"#000000\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:18,18,18,14;l:30,30,30,25;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_o=\"off\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8700;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;font-family:'Roboto';\"\n\t\t\t\t\t\t\t\t\t\t>Assess if your device change is non-significant, allowing it to maintain its legacy status. Or if the change is significant, requiring MDR\/IVDR CE Marking. \n\t\t\t\t\t\t\t\t\t\t<\/rs-layer><!--\n\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-182-slide-401-layer-22\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer rev-btn\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/contact-casus\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"button\"\n\t\t\t\t\t\t\t\t\t\t\tdata-bsh=\"v:20px;b:60px;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"yo:0,100px,100px,100px;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"l:60,60,60,50;fw:600;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"minh:0px,none,none,none;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_o=\"off\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:50;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"r:50;l:50;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:10px,10px,10px,10px;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8700;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"bgc:#21232d;bor:10px,10px,10px,10px;sp:300ms;e:power1.inOut;bri:120%;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;background-color:#000000;font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Need Help? \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\t\t\t\t\t\t\t\t--><\/rs-row><!--\n\t\t\t\t\t\t\t--><\/rs-zone><!--\n-->\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t<\/rs-slides>\n\t\t\t\t<\/rs-module>\n\t\t\t\t<script>\n\t\t\t\t\tsetREVStartSize({c: 'rev_slider_182_1',rl:[1240,1024,778,480],el:[500,530,520,515],gw:[1240,1024,778,480],gh:[400,300,400,400],type:'standard',justify:'',layout:'fullwidth',mh:\"0\"});if (window.RS_MODULES!==undefined && window.RS_MODULES.modules!==undefined && window.RS_MODULES.modules[\"revslider1821\"]!==undefined) {window.RS_MODULES.modules[\"revslider1821\"].once = false;window.revapi182 = undefined;if (window.RS_MODULES.checkMinimal!==undefined) window.RS_MODULES.checkMinimal()}\n\t\t\t\t<\/script>\n\t\t\t<\/rs-module-wrap>\n\t\t\t<!-- END REVOLUTION SLIDER -->\n<\/div>\n\n\n\n<div style=\"height:44px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-5 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:90%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div style=\"height:5px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><p><\/p><script src=\"https:\/\/9931674141ca41baa2023404fd2333a2.js.ubembed.com\" async=\"\"><\/script><\/p>\n\n\n<div class=\"wp-block-ub-table-of-contents-block ub_table-of-contents\" data-showtext=\"show\" data-hidetext=\"hide\" data-scrolltype=\"auto\" id=\"ub_table-of-contents-8047c1da-c7a6-4186-a562-13a4a73f4eeb\" data-initiallyhideonmobile=\"false\"\n                    data-initiallyshow=\"true\"><div class=\"ub_table-of-contents-header-container\"><div class=\"ub_table-of-contents-header\">\n                    <div class=\"ub_table-of-contents-title\">Table of Contents<\/div><\/div><\/div><div class=\"ub_table-of-contents-extra-container\"><div class=\"ub_table-of-contents-container ub_table-of-contents-1-column \"><ul><li><a href=https:\/\/casusconsulting.com\/mdr-ivdr-legacy-medical-device-2020-3-ivd-2022-6-mdcg-significant-change-guidance\/#0-background->Background<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/mdr-ivdr-legacy-medical-device-2020-3-ivd-2022-6-mdcg-significant-change-guidance\/#1-mdcg-guidance-for-legacy-device-changes->MDCG Guidance for Legacy Device Changes<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/mdr-ivdr-legacy-medical-device-2020-3-ivd-2022-6-mdcg-significant-change-guidance\/#2-notifying-your-notified-body->Notifying your Notified Body<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/mdr-ivdr-legacy-medical-device-2020-3-ivd-2022-6-mdcg-significant-change-guidance\/#3-disclaimer->Disclaimer<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/mdr-ivdr-legacy-medical-device-2020-3-ivd-2022-6-mdcg-significant-change-guidance\/#4-legacy-devices-change-assessment-tool->Legacy Devices: Change Assessment Tool<\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n<p>&nbsp;Prior to making a change to your <strong><a href=\"https:\/\/casusconsulting.com\/what-are-legacy-devices\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u2018legacy\u2019 device<\/a><\/strong>, you must determine if it is considered \u2018significant\u2019 or not. <!-- 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><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-b00d0bf099b0449f8f5a069708da7434\">Our tool helps assess if the change is non-significant, allowing it to remain a legacy device. Or if the change is considered significant, and therefore pushes the device into MDR\/IVDR designation.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-2c51984453ccf24225bc068cb0885204\">The tool incorporates decision trees from the MDCG guidance documents, along with additional examples of significant and non-significant changes. It should allow you to easily understand if a change is considered significant or not.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-dc38c5fe4b82731ee9a3ba5214d58b43\">NOTE: please refer to the MDCG guidances (linked below) for additional examples; and as the fundamental resource for change assessment under the MDR\/IVDR\u2019s transition provisions.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-4d18caa4f7819ac8c5eff2ed3d77828a\" id=\"0-background-\"><strong>Background<\/strong><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-586f177206712b683a1499f2a3c9ca7c\">Legacy devices are those that hold valid CE Marking under the MDD\/AIMDD\/IVDD and may continue to be placed onto the market.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-43f5469206dece2cfefd59c7b5e49517\">For devices to maintain legacy status, no significant changes to the design or intended purpose can occur after the MDR and IVDR Dates of Application:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul class=\"has-black-color has-text-color has-link-color wp-elements-eee12058b4132ac876398268d06cf1cd\">\n<li>26 May 2021 (medical devices)<\/li>\n\n\n\n<li>26 May 2022 (IVDs)<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-26d1460ef55256fdfef6178203d7cb70\">This is per the legacy device transition articles:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-2 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul class=\"has-black-color has-text-color has-link-color wp-elements-af50cec1af54fd10ab9133003eb6546d\">\n<li>MDR Art. 120(3c), point (b)<\/li>\n\n\n\n<li>IVDR Art. 110(3)<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-spacer\" style=\"height: 20px;\" aria-hidden=\"true\">\u00a0<\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-fca7562c45c5b3b9433d464092feb421\" id=\"1-mdcg-guidance-for-legacy-device-changes-\"><strong>MDCG Guidance for Legacy Device Changes<\/strong><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-bb16298f78e24e6f5dd92e3d0b1048f6\">If a significant change is made, the product must be certified to the MDR of IVDR before the change can be incorporated. However, the regulations do not identify what constitutes a significant change to the intended purpose or design.&nbsp;<\/p>\n\n\n\n<p>Instead, industry should refer to the MDCG guidance documents:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-3 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li><strong><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-09\/mdcg_2020-3_en_1.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">MDCG 2020-3 Rev.1<\/a><\/strong> &#8211; Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD<\/li>\n\n\n\n<li><strong><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-05\/mdcg_2022-6.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">MDCG 2022-6<\/a><\/strong> &#8211; Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-f3386bd5a21940388e9f8c31862ea727\">The MDCG guidances cover:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-4 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul class=\"has-black-color has-text-color has-link-color wp-elements-e8c381c5d9babe94b467bf6ce7c72e12\">\n<li>Further explanation as to what constitutes a \u2018significant\u2019 change to the intended purpose or design<\/li>\n\n\n\n<li>Examples of changes that are, and are not, considered significant<\/li>\n\n\n\n<li>Decision trees to help determine if a change is considered significant or not, i.e., to determine if a specific change allows a device to maintain legacy status or requires the device to be certified to the MDR\/IVDR<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-spacer\" style=\"height: 20px;\" aria-hidden=\"true\">\u00a0<\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-be9f96b0ca8e8715edec4cc88f222674\" id=\"2-notifying-your-notified-body-\"><strong>Notifying your Notified Body<\/strong><\/h2>\n\n\n\n<p>There is a difference between a significant change that pushes a device out of its legacy device status, and changes significant enough to inform your Notified Body, <strong><a href=\"https:\/\/casusconsulting.com\/services\/europe\/authorized-representative\/\" target=\"_blank\" rel=\"noreferrer noopener\" data-type=\"link\" data-id=\"https:\/\/casusconsulting.com\/services\/europe\/authorized-representative\/\">Authorized Representative<\/a><\/strong> and\/or Competent Authority.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-118f9e046426ef88c0a7ff03f7ef941a\">A change that is considered non-significant per MDCG 2020-3 and MDCG 2022-6 may still need to be notified to the Notified Body, Authorized Representative or Competent Authority. Manufacturers should follow their change procedure to ensure the proper entities are notified.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-426926e8dc8bb2343959f80ab63bc583\">In some situations, you may wish to request that your Notified Body issue written confirmation that the change is not considered \u2018significant\u2019. For example, changes that result in your product label no longer matching the information on your CE Marking certificate or Declaration of Conformity, neither of which should be reissued after the MDR\/IVDR&#8217;s date of application.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-d3f3d2d0b917453323761cd0665178c1\">Further, manufacturers should document the rationale as to why the change is not considered \u2018significant\u2019 under the MDR\/IVDR transitional provisions.<\/p>\n\n\n\n<div class=\"wp-block-spacer\" style=\"height: 20px;\" aria-hidden=\"true\">\u00a0<\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-6b52dbef8babab0485fc0325ca63ae33\" id=\"3-disclaimer-\"><strong>Disclaimer<\/strong><\/h2>\n\n\n\n<p>The change assessments provided below are for reference only. Casus Consulting does not take responsibility for the accuracy of this information. Casus Consulting has taken due care in preparing the legacy device change assessment tool, but we do not guarantee, nor do we assume legal liability or responsibility for, the accuracy or completeness of the information contained in these materials.<\/p>\n\n\n\n<p>The legacy device change assessments outlined in the MDCG documents are publicly available on the EU Commission website. Links are provided on this page and individuals should verify the information as published by the EU Commission before taking any action. Further, if there is a question on a specific requirement, users should contact their Notified Body or Competent Authority to confirm.<\/p>\n\n\n\n<div class=\"wp-block-spacer\" style=\"height: 20px;\" aria-hidden=\"true\">\u00a0<\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-89240a63505932b57c7ffbe1f31aa0c7\" id=\"4-legacy-devices-change-assessment-tool-\"><strong>Legacy Devices: Change Assessment Tool<\/strong><\/h2>\n\n\n\n<div class=\"wp-block-spacer\" style=\"height: 30px;\" aria-hidden=\"true\">\u00a0<\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>[vc_row][vc_column]<script type=\"text\/javascript\">var gform;gform||(document.addEventListener(\"gform_main_scripts_loaded\",function(){gform.scriptsLoaded=!0}),window.addEventListener(\"DOMContentLoaded\",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,initializeOnLoaded:function(o){gform.domLoaded&&gform.scriptsLoaded?o():!gform.domLoaded&&gform.scriptsLoaded?window.addEventListener(\"DOMContentLoaded\",o):document.addEventListener(\"gform_main_scripts_loaded\",o)},hooks:{action:{},filter:{}},addAction:function(o,n,r,t){gform.addHook(\"action\",o,n,r,t)},addFilter:function(o,n,r,t){gform.addHook(\"filter\",o,n,r,t)},doAction:function(o){gform.doHook(\"action\",o,arguments)},applyFilters:function(o){return gform.doHook(\"filter\",o,arguments)},removeAction:function(o,n){gform.removeHook(\"action\",o,n)},removeFilter:function(o,n,r){gform.removeHook(\"filter\",o,n,r)},addHook:function(o,n,r,t,i){null==gform.hooks[o][n]&&(gform.hooks[o][n]=[]);var e=gform.hooks[o][n];null==i&&(i=n+\"_\"+e.length),gform.hooks[o][n].push({tag:i,callable:r,priority:t=null==t?10:t})},doHook:function(n,o,r){var t;if(r=Array.prototype.slice.call(r,1),null!=gform.hooks[n][o]&&((o=gform.hooks[n][o]).sort(function(o,n){return o.priority-n.priority}),o.forEach(function(o){\"function\"!=typeof(t=o.callable)&&(t=window[t]),\"action\"==n?t.apply(null,r):r[0]=t.apply(null,r)})),\"filter\"==n)return r[0]},removeHook:function(o,n,t,i){var r;null!=gform.hooks[o][n]&&(r=(r=gform.hooks[o][n]).filter(function(o,n,r){return!!(null!=i&&i!=o.tag||null!=t&&t!=o.priority)}),gform.hooks[o][n]=r)}});<\/script>\n                <div class='gf_browser_unknown gform_wrapper gravity-theme gform-theme--no-framework' data-form-theme='gravity-theme' data-form-index='0' id='gform_wrapper_12' style='display:none'><form method='post' enctype='multipart\/form-data'  id='gform_12'  action='\/wp-json\/wp\/v2\/pages\/9082' data-formid='12' novalidate>\n                        <div class='gform-body gform_body'><div id='gform_fields_12' class='gform_fields top_label form_sublabel_below description_above validation_below'><div id=\"field_12_17\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_17\" ><label class='gfield_label gform-field-label' for='input_12_17'>What type of change is occuring?<\/label><div class='ginput_container ginput_container_select'><select name='input_17' id='input_12_17' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Administrative changes (e.g., change in EU AR, changes to manufacturer\u2019s name or address, etc.)' >Administrative changes (e.g., change in EU AR, changes to manufacturer\u2019s name or address, etc.)<\/option><option value='Manufacturing process change' >Manufacturing process change<\/option><option value='QMS changes (e.g., updates to procedures)' >QMS changes (e.g., updates to procedures)<\/option><option value='Updates or corrections to information supplied with the device' >Updates or corrections to information supplied with the device<\/option><option value='None of the above' >None of the above<\/option><\/select><\/div><\/div><div id=\"field_12_18\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_18\" ><label class='gfield_label gform-field-label' for='input_12_18'>What type of change is occurring to the product information?<\/label><div class='ginput_container ginput_container_select'><select name='input_18' id='input_12_18' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Correction of spelling mistakes or merely editorial changes of the information to be supplied with the device' >Correction of spelling mistakes or merely editorial changes of the information to be supplied with the device<\/option><option value='Clarifications that are required by EU legislation other than the MDR (e.g. CLP Regulation (EC) No 1272\/2008 on classification) that do not adversely affect the devices\u2019 safety and performance' >Clarifications that are required by EU legislation other than the MDR (e.g. CLP Regulation (EC) No 1272\/2008 on classification) that do not adversely affect the devices\u2019 safety and performance<\/option><option value='Clarifications of intended purpose, population, clinical application in the information to be supplied with the device in line with the original certification' >Clarifications of intended purpose, population, clinical application in the information to be supplied with the device in line with the original certification<\/option><option value='None of the above' >None of the above<\/option><\/select><\/div><\/div><div id=\"field_12_19\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--has-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_19\" ><label class='gfield_label gform-field-label' for='input_12_19'>What type of change is occurring to the manufacturing process?<\/label><div class='gfield_description' id='gfield_description_12_19'>NOTE: Examples of changes that do not affect the intended use, sterilization or design include the following: relocation or addition of new manufacturing sites, changing the supplier of a material, substance or component, provided the specifications of the new material, substance or component do not change, or a new process validation as part of manufacturing improvements or scale-up of manufacturing.<\/div><div class='ginput_container ginput_container_select'><select name='input_19' id='input_12_19' class='large gfield_select'  aria-describedby=\"gfield_description_12_19\"   aria-invalid=\"false\" ><option value='' ><\/option><option value='A change that does not affect the intended use, material\/substance, sterilization or design' >A change that does not affect the intended use, material\/substance, sterilization or design<\/option><option value='A change that affects the intended use, material\/substance, sterilization or design' >A change that affects the intended use, material\/substance, sterilization or design<\/option><\/select><\/div><\/div><div id=\"field_12_20\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--has-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_20\" ><label class='gfield_label gform-field-label' for='input_12_20'>What type of change is occurring to the QMS?<\/label><div class='gfield_description' id='gfield_description_12_20'>NOTE: An example of a change that does not impact intended use, material\/substance, sterilization is a change in the monitoring and control of production and operations environment.<\/div><div class='ginput_container ginput_container_select'><select name='input_20' id='input_12_20' class='large gfield_select'  aria-describedby=\"gfield_description_12_20\"   aria-invalid=\"false\" ><option value='' ><\/option><option value='A change that does not affect the intended use, material\/substance, sterilization or design' >A change that does not affect the intended use, material\/substance, sterilization or design<\/option><option value='A change that affects the intended use, material\/substance, sterilization or design' >A change that affects the intended use, material\/substance, sterilization or design<\/option><option value='A change that impacts the conditions for which the conformity assessment certification was granted' >A change that impacts the conditions for which the conformity assessment certification was granted<\/option><\/select><\/div><\/div><div id=\"field_12_9\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--has-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_9\" ><label class='gfield_label gform-field-label' for='input_12_9'>Is this a change related to corrective actions (including changes to shelf-life)?<\/label><div class='gfield_description' id='gfield_description_12_9'>NOTE: This question relates to design and intended use changes that are resulting from a corrective action and have been assessed and accepted by the competent authority of the Member State in which the manufacturer or its authorized representative has its registered place of business.\n<p>\n<\/p>\n<p>\nThe assessment and acceptance of an FSCA by by a competent authority does not exempt the manufacturer from submitting changes to the relevant notified body under the AIMDD\/MDD nor the notified body from assessing the change in line with the\nagreed arrangements.<\/div><div class='ginput_container ginput_container_select'><select name='input_9' id='input_12_9' class='large gfield_select'  aria-describedby=\"gfield_description_12_9\"   aria-invalid=\"false\" ><option value='' ><\/option><option value='Yes' >Yes<\/option><option value='No' >No<\/option><\/select><\/div><\/div><div id=\"field_12_7\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_7\" ><label class='gfield_label gform-field-label' for='input_12_7'>Is this a change related to the intended purpose?<\/label><div class='ginput_container ginput_container_select'><select name='input_7' id='input_12_7' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Yes' >Yes<\/option><option value='No' >No<\/option><\/select><\/div><\/div><div id=\"field_12_3\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_3\" ><label class='gfield_label gform-field-label' for='input_12_3'>What type of change is occurring to the intended purpose?<\/label><div class='ginput_container ginput_container_select'><select name='input_3' id='input_12_3' class='large gfield_select'     aria-invalid=\"false\" ><option value='' selected='selected'><\/option><option value='Limitation of the intended purpose, e.g., restriction or deletion of certain indications, applications or restriction of the target population' >Limitation of the intended purpose, e.g., restriction or deletion of certain indications, applications or restriction of the target population<\/option><option value='Extension of the intended purpose, e.g., additional or new indications or clinical conditions, addition of specimen type(s) or additional device functions such as screening, monitoring or diagnosis' >Extension of the intended purpose, e.g., additional or new indications or clinical conditions, addition of specimen type(s) or additional device functions such as screening, monitoring or diagnosis<\/option><option value='New user or patient population, e.g. additional or new target population or user (change from professional to layman use)' >New user or patient population, e.g. additional or new target population or user (change from professional to layman use)<\/option><option value='New way of clinical application, e.g., additional or new anatomical site or applications (different stage or severity of disease) or new delivery pathway or deployment method' >New way of clinical application, e.g., additional or new anatomical site or applications (different stage or severity of disease) or new delivery pathway or deployment method<\/option><option value='IVDs only: Other major changes to the intended purpose, e.g., change of specimen type(s) or change of assay type,' >IVDs only: Other major changes to the intended purpose, e.g., change of specimen type(s) or change of assay type,<\/option><option value='None of the above' >None of the above<\/option><\/select><\/div><\/div><div id=\"field_12_8\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_8\" ><label class='gfield_label gform-field-label' for='input_12_8'>Is this a design change?<\/label><div class='ginput_container ginput_container_select'><select name='input_8' id='input_12_8' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Yes' >Yes<\/option><option value='No' >No<\/option><\/select><\/div><\/div><div id=\"field_12_5\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--has-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_5\" ><label class='gfield_label gform-field-label' for='input_12_5'>What type of change is occurring to the design?<\/label><div class='gfield_description' id='gfield_description_12_5'>NOTE: Examples of design changes that do not fall into these categories (as long as they do not negatively affect the risk\/benefit ratio of the\ndevice) are change of color of an assembly or device, change to design for an easier operation, modification of a part (e.g. a connector) to adhere to a new or revised standard, change of the swab intended to be used with a device or change from refrigerated to room temperature storage conditions.\n<p>\n<\/p>\n<p>\nExamples of changes that fall into these categories include the change from manual to software driven device, reduction of battery operating time, change of instructions for use to refer to reduced sensitivity of the device based on data obtained as a result of post-market surveillance or change from immunofluorescence to ELISA.\n<p>\n<\/p>\n<p>\nSee MDCG 2020-3 (MDs) or MDCG 2022-6 (IVDs) for more examples.<\/div><div class='ginput_container ginput_container_select'><select name='input_5' id='input_12_5' class='large gfield_select'  aria-describedby=\"gfield_description_12_5\"   aria-invalid=\"false\" ><option value='' ><\/option><option value='Change of built-in control mechanism, operating principles, source of energy or alarm systems' >Change of built-in control mechanism, operating principles, source of energy or alarm systems<\/option><option value='Change affecting the safety or performance and negatively affecting the benefit\/risk ratio of the device' >Change affecting the safety or performance and negatively affecting the benefit\/risk ratio of the device<\/option><option value='None of the above' >None of the above<\/option><\/select><\/div><\/div><div id=\"field_12_6\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--has-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_6\" ><label class='gfield_label gform-field-label' for='input_12_6'>Is this a software change?<\/label><div class='gfield_description' id='gfield_description_12_6'>NOTE: This item may impact standalone software or a device that incorporates software. <\/div><div class='ginput_container ginput_container_select'><select name='input_6' id='input_12_6' class='large gfield_select'  aria-describedby=\"gfield_description_12_6\"   aria-invalid=\"false\" ><option value='' ><\/option><option value='Yes' >Yes<\/option><option value='No' >No<\/option><\/select><\/div><\/div><div id=\"field_12_10\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_10\" ><label class='gfield_label gform-field-label' for='input_12_10'>What type of change is occurring to the software?<\/label><div class='ginput_container ginput_container_select'><select name='input_10' id='input_12_10' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='New or major change of operating system or any component' >New or major change of operating system or any component<\/option><option value='New or modification of architecture or database structure, change of an algorithm' >New or modification of architecture or database structure, change of an algorithm<\/option><option value='Required user input replaced by closed loop algorithm' >Required user input replaced by closed loop algorithm<\/option><option value='New user interface, medical feature, channel of interoperability or presentation of data' >New user interface, medical feature, channel of interoperability or presentation of data<\/option><option value='A change that negatively affects the benefit\/risk ratio of the device' >A change that negatively affects the benefit\/risk ratio of the device<\/option><option value='None of the above' >None of the above<\/option><\/select><\/div><\/div><div id=\"field_12_11\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_11\" ><label class='gfield_label gform-field-label' for='input_12_11'>Is an ingredient, substance or material change occurring?<\/label><div class='ginput_container ginput_container_select'><select name='input_11' id='input_12_11' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Yes' >Yes<\/option><option value='No' >No<\/option><\/select><\/div><\/div><div id=\"field_12_12\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_12\" ><label class='gfield_label gform-field-label' for='input_12_12'>What type of change is occurring to the ingredient, substance or material?<\/label><div class='ginput_container ginput_container_select'><select name='input_12' id='input_12_12' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Change to or addition of a new material of human\/animal origin' >Change to or addition of a new material of human\/animal origin<\/option><option value='Change to the excipient of an medicinal substance (MS) or to the MS itself' >Change to the excipient of an medicinal substance (MS) or to the MS itself<\/option><option value='Change to a material or substance that comes into contact for more than 30 days with patient tissue or fluids' >Change to a material or substance that comes into contact for more than 30 days with patient tissue or fluids<\/option><option value='Change to a material or substance that is absorbed (surgically invasive devices only)' >Change to a material or substance that is absorbed (surgically invasive devices only)<\/option><option value='Change affecting the safety or performance and negatively affecting the benefit\/risk ratio of the device' >Change affecting the safety or performance and negatively affecting the benefit\/risk ratio of the device<\/option><option value='IVDs only: change to an ingredient or material essential for the operating principle' >IVDs only: change to an ingredient or material essential for the operating principle<\/option><option value='None of the above' >None of the above<\/option><\/select><\/div><\/div><div id=\"field_12_22\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_22\" ><label class='gfield_label gform-field-label' for='input_12_22'>Is the product a Medical Device or an IVD?<\/label><div class='ginput_container ginput_container_select'><select name='input_22' id='input_12_22' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Medical Device' >Medical Device<\/option><option value='IVD' >IVD<\/option><\/select><\/div><\/div><div id=\"field_12_13\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_13\" ><label class='gfield_label gform-field-label' for='input_12_13'>Is a terminal sterilization method changing or is the packaging design changing, impacting the sterilization of the device (including shelf-life changes)?<\/label><div class='ginput_container ginput_container_select'><select name='input_13' id='input_12_13' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Yes' >Yes<\/option><option value='No' >No<\/option><\/select><\/div><\/div><div id=\"field_12_23\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_23\" ><label class='gfield_label gform-field-label' for='input_12_23'>Is a sterilization method changing or is the packaging design changing, impacting the sterilization of the device (including shelf-life changes)?<\/label><div class='ginput_container ginput_container_select'><select name='input_23' id='input_12_23' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Yes' >Yes<\/option><option value='No' >No<\/option><\/select><\/div><\/div><div id=\"field_12_14\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_14\" ><label class='gfield_label gform-field-label' for='input_12_14'>What type of change is occurring to the device sterilization?<\/label><div class='ginput_container ginput_container_select'><select name='input_14' id='input_12_14' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Change to the terminal sterilization method' >Change to the terminal sterilization method<\/option><option value='Change that adversely affects the sterility assurance level (review respective sterilization standards for guidance assessing effectiveness of the sterilization process)' >Change that adversely affects the sterility assurance level (review respective sterilization standards for guidance assessing effectiveness of the sterilization process)<\/option><option value='Change in packaging design which affects sterility, stability or microbiological state of the device, including seal integrity' >Change in packaging design which affects sterility, stability or microbiological state of the device, including seal integrity<\/option><option value='Shelf-life extension' >Shelf-life extension<\/option><option value='None of the above' >None of the above<\/option><\/select><\/div><\/div><div id=\"field_12_24\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_24\" ><label class='gfield_label gform-field-label' for='input_12_24'>What type of change is occurring to the IVD sterilization?<\/label><div class='ginput_container ginput_container_select'><select name='input_24' id='input_12_24' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Change to the sterilization method' >Change to the sterilization method<\/option><option value='Change that adversely affects the sterility assurance level (review respective sterilization standards for guidance assessing effectiveness of the sterilization process)' >Change that adversely affects the sterility assurance level (review respective sterilization standards for guidance assessing effectiveness of the sterilization process)<\/option><option value='Change in packaging design which affects sterility, stability or microbiological state of the device, including seal integrity' >Change in packaging design which affects sterility, stability or microbiological state of the device, including seal integrity<\/option><option value='Shelf-life extension' >Shelf-life extension<\/option><option value='None of the above' >None of the above<\/option><\/select><\/div><\/div><div id=\"field_12_15\" class=\"gfield gfield--type-select gfield--width-full field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_15\" ><label class='gfield_label gform-field-label' for='input_12_15'>Is the shelf-life extension validated according to protocols approved by the notified body?<\/label><div class='ginput_container ginput_container_select'><select name='input_15' id='input_12_15' class='large gfield_select'     aria-invalid=\"false\" ><option value='' ><\/option><option value='Yes' >Yes<\/option><option value='No' >No<\/option><\/select><\/div><\/div><div id=\"field_12_4\" class=\"gfield gfield--type-html gfield--width-full gfield_html gfield_html_formatted gfield_no_follows_desc field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_4\" ><h4><strong><span style=\"color: #2e4972;\">Change is Significant<\/span><\/strong><\/h4><p>\n<\/p>\n<p>\nThe change is considered significant per Art.\n120(3c), point (b) MDR or per IVDR Art. 110(3).\n<p>\n<\/p>\n<p>\nThis means the device will not maintain 'legacy' status and must be certified under the MDR or IVDR to market with this change.<\/div><div id=\"field_12_16\" class=\"gfield gfield--type-html gfield--width-full gfield_html gfield_html_formatted gfield_no_follows_desc field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_16\" ><h4><strong><span style=\"color: #2e4972;\">Change is Non-Significant<\/span><\/strong><\/h4><p>\n<p>\n<\/p>\n<p>\nThe change is considered a non-significant change per Art. 120(3c), point (b) MDR or per IVDR Art. 110(3).\n<p>\n<\/p>\n<p>\nIf a change is non-significant, allowing the device to maintain 'legacy' status, it should still be documented in the manufacturer's QMS and may still need to be reported to the Notified Body.\n<p>\n<\/p>\n<p><\/div><div id=\"field_12_21\" class=\"gfield gfield--type-html gfield--width-full gfield_html gfield_html_formatted gfield_no_follows_desc field_sublabel_below gfield--no-description field_description_above field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_12_21\" ><h4><strong><span style=\"color: #2e4972;\">Change is Non-Significant<\/span><\/strong><\/h4><p>\n<p>\n<\/p>\n<p>\nThe change is considered a non-significant change per Art. 120(3c), point (b) MDR or per IVDR Art. 110(3).\n<p>\n<\/p>\n<p>\nIf a change is non-significant, allowing the device to maintain 'legacy' status, it should still be documented in the manufacturer's QMS.  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\n\t\t\t\t\t\t\t\t\tdata-type=\"row\"\n\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\tdata-dim=\"minh:300px,220px,auto,auto;\"\n\t\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\tdata-margin=\"t:150,150,70,70;b:150;\"\n\t\t\t\t\t\t\t\t\tdata-padding=\"r:65,75,50,50;l:65,75,50,50;\"\n\t\t\t\t\t\t\t\t\tdata-frame_1=\"sR:10;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8690;sA:9000;\"\n\t\t\t\t\t\t\t\t\tstyle=\"z-index:5;\"\n\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-6\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:0,100px,0,0;yo:0,100px,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/shutterstock_2197042063-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-16\" \n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-color=\"#c5a477\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:5px,5px,0,0;yo:5px,5px,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:15;l:15;ls:2px;fw:600;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:0,0,150,150;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:40;r:20;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:8;font-family:'Poppins';display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t> \n\t\t\t\t\t\t\t\t\t\t<\/rs-layer><!--\n\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-3\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/eu-language-translation-requirements\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>EU Language Requirements Tool \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-7\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:278px,347px,0,0;yo:0,0,321px,321px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:9;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/06\/EU-Medical-Device-and-IVD-Registration-Requirements-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-15\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/eu-registration-requirements\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:10;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>EU Registration Requirements Tool \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-8\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:556px,694px,694px,694px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:12;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/11\/Significant-Changes-MDR-IVDR-legacy-devices-scaled.jpg') no-repeat right center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-19\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/mdr-ivdr-legacy-medical-device-2020-3-ivd-2022-6-mdcg-significant-change-guidance\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:5px,0,0,0;yo:5px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:13;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Significant Changes Assessment Tool \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-13\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:15;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/06\/EU-Vigilance-Contacts-Medical-Devices-and-IVDs-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-17\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/eu-vigilance-requirements\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:16;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>EU Vigilance Requirements Tool \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\t\t\t\t\t\t\t\t--><\/rs-row><!--\n\t\t\t\t\t\t\t--><\/rs-zone><!--\n-->\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t\t<rs-slide style=\"position: absolute;\" data-key=\"rs-405\" data-title=\"Slide\" data-anim=\"ms:600;\" data-in=\"o:0;\" data-out=\"a:false;\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/\/casusconsulting.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/dummy.png\" alt=\"Slide\" title=\"MDR\/IVDR Legacy Devices: Significant Change Assessment Tool\" class=\"rev-slidebg tp-rs-img rs-lazyload\" data-lazyload=\"\/\/casusconsulting.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/transparent.png\" data-bg=\"c:#eeeeee;\" data-parallax=\"off\" data-no-retina>\n<!--\t\t\t\t\t\t--><rs-zone id=\"rrzt_405\" class=\"rev_row_zone_top\" style=\"z-index: 5;\"><!--\n\n\t\t\t\t\t\t\t\t--><rs-row\n\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-5\" \n\t\t\t\t\t\t\t\t\tdata-type=\"row\"\n\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\tdata-dim=\"minh:300px,220px,auto,auto;\"\n\t\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\tdata-margin=\"t:150,150,70,70;b:150;\"\n\t\t\t\t\t\t\t\t\tdata-padding=\"r:65,75,50,50;l:65,75,50,50;\"\n\t\t\t\t\t\t\t\t\tdata-frame_1=\"sR:10;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8690;sA:9000;\"\n\t\t\t\t\t\t\t\t\tstyle=\"z-index:5;\"\n\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-6\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:0,100px,0,0;yo:0,100px,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/01\/shutterstock_1405283762-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-3\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/list-mdr-ivdr-harmonized-standards-common-specifications\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Harmonized Standards & Common Specifications \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-7\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:278px,347px,0,0;yo:0,0,321px,321px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:9;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/03\/shutterstock_1636720918-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-15\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/ukca-marking-medical-devices-ivds\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:10;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>UKCA Marking Medical Devices \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-8\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:556px,694px,694px,694px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:12;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/11\/shutterstock_258687632-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-19\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/gmdn-emdn-and-cnd\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:5px,0,0,0;yo:5px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:13;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Overview of GMDN, EMDN and CND \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-13\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:15;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/07\/shutterstock_665882575-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-17\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/registering-devices-in-eudamed\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:16;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Guide to Registering Devices in EUDAMED \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\t\t\t\t\t\t\t\t--><\/rs-row><!--\n\t\t\t\t\t\t\t--><\/rs-zone><!--\n-->\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t<\/rs-slides>\n\t\t\t\t\t<rs-static-layers class=\"rs-stl-visible\"><!--\n\n\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\tid=\"slider-184-slide-176-layer-1\" \n\t\t\t\t\t\t\t\tclass=\"rs-layer-static\"\n\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\tdata-xy=\"x:c;xo:10px,0,0,0;yo:0,130px,55px,55px;\"\n\t\t\t\t\t\t\t\tdata-text=\"s:15,15,12,12;l:38,38,28,28;ls:2px;fw:500,600,600,600;a:inherit;\"\n\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\tdata-rsp_o=\"off\"\n\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\tdata-onslides=\"s:1;\"\n\t\t\t\t\t\t\t\tdata-margin=\"t:60,0,0,0;\"\n\t\t\t\t\t\t\t\tdata-padding=\"t:2;r:40,40,30,30;l:42,42,32,32;\"\n\t\t\t\t\t\t\t\tdata-frame_0=\"o:1;\"\n\t\t\t\t\t\t\t\tdata-frame_0_sfx=\"se:blocktoright;\"\n\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.inOut;sp:50;\"\n\t\t\t\t\t\t\t\tdata-frame_1_sfx=\"se:blocktoright;\"\n\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8250;\"\n\t\t\t\t\t\t\t\tstyle=\"z-index:5;background-color:#000000;font-family:'Poppins';text-transform:uppercase;\"\n\t\t\t\t\t\t\t>Additional Resources \n\t\t\t\t\t\t\t<\/rs-layer><!--\n\t\t\t\t\t--><\/rs-static-layers>\n\t\t\t\t<\/rs-module>\n\t\t\t\t<script>\n\t\t\t\t\tsetREVStartSize({c: 'archives',rl:[1240,1024,778,480],el:[600,300,960,720],gw:[1240,1024,778,480],gh:[400,300,960,720],type:'carousel',justify:'',layout:'fullwidth',mh:\"0\"});if (window.RS_MODULES!==undefined && window.RS_MODULES.modules!==undefined && window.RS_MODULES.modules[\"archives\"]!==undefined) {window.RS_MODULES.modules[\"archives\"].once = false;window.revapi184 = undefined;if (window.RS_MODULES.checkMinimal!==undefined) window.RS_MODULES.checkMinimal()}\n\t\t\t\t<\/script>\n\t\t\t<\/rs-module-wrap>\n\t\t\t<!-- END REVOLUTION SLIDER -->\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Our tool helps assess if a device change is non-significant, maintaining legacy status. Or if a change is significant, requiring MDR\/IVDR CE Marking.<\/p>\n","protected":false},"author":1,"featured_media":9366,"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\/2023\/11\/Significant-Changes-MDR-IVDR-legacy-devices-scaled.jpg","_links":{"self":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/9082"}],"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\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/comments?post=9082"}],"version-history":[{"count":33,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/9082\/revisions"}],"predecessor-version":[{"id":11715,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/9082\/revisions\/11715"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media\/9366"}],"wp:attachment":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media?parent=9082"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}