{"id":5320,"date":"2022-12-19T18:59:19","date_gmt":"2022-12-20T00:59:19","guid":{"rendered":"https:\/\/casusconsulting.com\/?page_id=5320"},"modified":"2024-01-23T16:17:46","modified_gmt":"2024-01-23T22:17:46","slug":"eu-registration-requirements","status":"publish","type":"page","link":"https:\/\/casusconsulting.com\/eu-registration-requirements\/","title":{"rendered":"European Registration Requirements"},"content":{"rendered":"<p>[vc_row][vc_column]\n\t\t\t<!-- START Registration Requirements Tool REVOLUTION SLIDER 6.7.1 --><p class=\"rs-p-wp-fix\"><\/p>\n\t\t\t<rs-module-wrap id=\"rev_slider_187_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_187_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-408\" 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_408\" 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-187-slide-408-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-187-slide-408-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-187-slide-408-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:40,40,30,30;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>Europe Registration<br \/>\nRequirements 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-187-slide-408-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-187-slide-408-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>Find out the registration requirements for Class I, Class IIa, IIb and III medical devices, and all risk classes of IVDs in Europe, the UK, and Switzerland. Plus, the submission process & fees. \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-187-slide-408-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_187_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[\"revslider1871\"]!==undefined) {window.RS_MODULES.modules[\"revslider1871\"].once = false;window.revapi187 = 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[vc_column_text]<\/p>\r\n<div class=\"wp-block-columns\">\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis: 100%;\">\r\n<div class=\"wp-block-themepunch-revslider revslider\" data-modal=\"false\" data-slidertitle=\"Registration Requirements Tool\"><script src=\"https:\/\/9931674141ca41baa2023404fd2333a2.js.ubembed.com\" async=\"\"><\/script><\/div>\r\n<\/div>\r\n<\/div>\r\n<div class=\"wp-block-columns\">\r\n<div class=\"wp-block-column\" style=\"flex-basis: 85%;\">\r\n<div class=\"wp-block-group\">\r\n<p><br \/><br \/><script src=\"https:\/\/9931674141ca41baa2023404fd2333a2.js.ubembed.com\" async=\"\"><\/script><a href=\"https:\/\/casusconsulting.com\/eu-registration-requirements#tool\"><strong>JUMP TO REGISTRATION REQUIREMENTS<\/strong><\/a><\/p>\r\n<br \/><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-b1b28bcc-3a57-4a84-9301-6e6e3e312ab7\" 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\/eu-registration-requirements\/#0-registration-requirements-tool-features->Registration Requirements Tool Features<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-registration-requirements\/#1-which-medical-devices-amp-ivds-require-registration->Which Medical Devices &amp; IVDs Require Registration?<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-registration-requirements\/#2-eudamed-amp-swissdamed->EUDAMED &amp; SWISSDAMED<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-registration-requirements\/#3-disclaimer->Disclaimer<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-registration-requirements\/#4-registration-requirements-tool->Registration Requirements Tool<\/a><\/li><\/ul><\/div><\/div><\/div><br \/>\r\n<div class=\"wp-block-spacer\" style=\"height: 20px;\" aria-hidden=\"true\">\u00a0<\/div>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">Once a device is CE Marked, there may be additional registration\/notification requirements to consider for individual countries.<\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">Until <strong><a href=\"https:\/\/casusconsulting.com\/eudamed_basics\/\" target=\"_blank\" rel=\"noreferrer noopener\">EUDAMED<\/a><\/strong> is fully functional, the requirements under the old Directives (MDD\/AIMDD\/IVDD) continue to apply. Brexit and the withdrawal of Switzerland from the European Single Market for medical devices further complicate the process.<\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">Our tool helps you keep track of the medical device registration process across 33 countries.<\/span><\/p>\r\n<br \/>\r\n<div class=\"wp-block-spacer\" style=\"height: 20px;\" aria-hidden=\"true\">\u00a0<\/div>\r\n<br \/>\r\n<h2 id=\"0-registration-requirements-tool-features-\" class=\"wp-block-heading has-black-color has-text-color has-large-font-size\"><span style=\"color: #000000;\"><strong>Registration Requirements Tool Features<\/strong><\/span><\/h2>\r\n<br \/>\r\n<ul>\r\n<li style=\"list-style-type: none;\">\r\n<ul>\r\n<li style=\"list-style-type: none;\">\r\n<ul>\r\n<li><span style=\"color: #000000;\">Confirms if a local registration is needed in the <\/span><span class=\"tooltip tooltip-txt\" data-tooltip=\"The European Single Market includes: all 27 EU member states, Iceland, Liechtenstein, Norway, Northern Ireland and Turkey. The EU countries are specifically: Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.\" data-position=\"top\">European Single Market,<\/span>\n the United Kingdom (UK) and Switzerland<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<br \/>\r\n<ul>\r\n<li style=\"list-style-type: none;\">\r\n<ul>\r\n<li><span style=\"color: #000000;\">Outlines the submission process, including who can submit, how to submit, what to include in the application, and when you can begin marketing the device<\/span><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<br \/>\r\n<ul>\r\n<li style=\"list-style-type: none;\">\r\n<ul>\r\n<li><span style=\"color: #000000;\">Provides fee amount for the registration, if required<\/span><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<br \/>\r\n<ul>\r\n<li style=\"list-style-type: none;\">\r\n<ul>\r\n<li><span style=\"color: #000000;\">Includes additional notes, where available, to better understand the requirements and submission process<\/span><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<br \/>\r\n<ul>\r\n<li><span style=\"color: #000000;\">Provides helpful links and citations to each Competent Authority (CA) website and any applicable registration forms and\/or databases<\/span><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<p><br \/><br \/><br \/><!-- 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>\r\n<br \/>\r\n<div class=\"wp-block-spacer\" style=\"height: 20px;\" aria-hidden=\"true\">\u00a0<\/div>\r\n<br \/>\r\n<h2 id=\"1-which-medical-devices-amp-ivds-require-registration-\" class=\"wp-block-heading has-black-color has-text-color has-large-font-size\"><span style=\"color: #000000;\"><strong>Which Medical Devices &amp; IVDs Require Registration?<\/strong><\/span><\/h2>\r\n<p><br \/><br \/><span style=\"color: #000000;\"><strong>Directives versus Regulations<\/strong><\/span><\/p>\r\n<p><br \/><br \/><span style=\"color: #000000;\">The information in our tool applies to all devices CE marked under both the Directives (MDD, IVDD and AIMDD) and the Regulations (MDR and IVDR).<\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\">Until EUDAMED is mandatory, all medical devices (Regulation and Directive legacy devices) are subject to the registration requirements under the Directives.<\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\"><strong>Class I devices and IVDs<\/strong><\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\">P<span style=\"color: #000000;\">er the MDD, all Class I devices must be registered by the manufacturer (or its authorized representative) in the member state where they are located. Per the IVDD, all IVDs must be registered by the manufacturer (or its authorized representative) in the member state where they are located.<\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><strong>Class IIa, IIb, III\/AIMD Devices<\/strong><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">Per the MDD\/AIMDD, each Competent Authority (e.g., AEMPS in Spain) may decide on a case-by-case basis if they wish to be informed of Class IIa, IIb and III\/AIMD devices being placed onto their market. <\/span>Each country may also maintain its own medical device registration database, e.g., Italy&#8217;s &#8220;Repertorio&#8221;.<\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><strong>Annex II List A, List B, and self-test IVDs<\/strong><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\">Per the IVDD, each member state may decide on a case-by-case basis if they wish to receive additional details related to Annex II, List A, List B and\/or self-test products (e.g., label and IFU).<\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><strong>What products are included in this registration tool?<\/strong><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">Since the registration requirements are clear for Class I and IVD products, our tool covers requirements for Class IIa, IIb, III, active implantable medical devices, Annex II, List A, List B, and self-test IVDs. That said, there are some exceptions, which are noted in the tool below.<\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\"><strong>Foreign versus Local Entity Requirements<\/strong><\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">The requirements detailed below apply to foreign manufacturers placing devices in each market.<\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">Most (if not all) markets have additional or different registration requirements for local Authorized Representatives and Manufacturers. Specific requirements for local economic operators are not included and may include both additional entity and device registration requirements.<\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\"><strong>Custom-Made Devices<\/strong><\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">Casus\u2019 tool includes requirements for CE Marked products. It does <em>not<\/em> include requirements for custom-made devices, which may have their own registration process in each market. Manufacturers should review the Competent Authority websites linked below to confirm information related to custom-made devices.<\/span><\/p>\r\n<p><br \/><br \/><strong>Switzerland and the UK<\/strong><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\">Now that Switzerland and the UK are no longer part of the European Single Market, different registration requirements apply. Our tool includes these requirements.<\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color\">NOTE: The UK is made up of two territories. Great Britain (England, Scotland, Wales), which is governed by the UK medical device legislation (UK MDR 2002). Northern Ireland, the fourth UK country, is still part of the European Single Market.<\/p>\r\n<br \/>\r\n<h2 id=\"2-eudamed-amp-swissdamed-\" class=\"wp-block-heading has-black-color has-text-color has-large-font-size\"><span style=\"color: #000000;\"><strong>EUDAMED &amp; SWISSDAMED<\/strong><\/span><\/h2>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color has-medium-font-size\"><span style=\"color: #000000;\"><strong>EUDAMED<\/strong><\/span><\/p>\r\n<p><br \/><br \/><span style=\"color: #000000;\">Under the MDR and IVDR, EUDAMED was introduced as a mechanism to reduce the burden of submitting individual country notifications. However, the device registration module of EUDAMED is not yet mandatory. Therefore, the registration requirements established under the Directives apply, unless otherwise stated by a specific Competent Authority.<\/span><\/p>\r\n<p><br \/><br \/><span style=\"color: #000000;\">Many of the below local registration requirements will be removed once the device registration module of EUDAMED becomes mandatory. For the most current understanding of EUDAMED&#8217;s deadlines, please read: <strong><a href=\"https:\/\/casusconsulting.com\/new-eu-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout\/\" target=\"_blank\" rel=\"noreferrer noopener\" data-type=\"link\" data-id=\"https:\/\/casusconsulting.com\/new-eu-commission-proposal-delay-postpone-ivdr-2027-to-2029-eudamed-gradual-rollout\/\">EU Commission Proposes EUDAMED Gradual Rollout<\/a><\/strong><\/span><\/p>\r\n<br \/>\r\n<p class=\"has-black-color has-text-color has-medium-font-size\"><span style=\"color: #000000;\"><strong>SWISSDAMED<\/strong><\/span><\/p>\r\n<p><br \/><br \/><span style=\"color: #000000;\">Swissmedic is also developing a registration system expected to launch in 2024.<\/span><\/p>\r\n<p><br \/><br \/><span style=\"color: #000000;\">For more information, please read:<\/span> <strong><a href=\"https:\/\/casusconsulting.com\/swissdamed-2023-2024-release-dates-confirmed\/\" target=\"_blank\" rel=\"noopener\">Switzerland Registration Database (Swissdamed)<\/a><\/strong><\/p>\r\n<br \/>\r\n<h2 id=\"3-disclaimer-\" class=\"wp-block-heading has-black-color has-text-color has-large-font-size\"><strong>Disclaimer<\/strong><\/h2>\r\n<p><br \/><br \/>The registration requirements 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 registration requirements 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>\r\n<p><br \/><br \/>The registration requirements are publicly available on each Competent Authority website. Links are provided in the tool and individuals should verify the information as published by the Competent Authority before taking any action. Further, if there is a question on a specific requirement, Casus suggests reaching out to the Competent Authority directly to confirm.<\/p>\r\n<br \/>\r\n<h2 id=\"4-registration-requirements-tool-\" class=\"wp-block-heading has-black-color has-text-color has-large-font-size\"><span style=\"color: #000000;\"><strong>Registration Requirements Tool<\/strong><\/span><\/h2>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_id=&#8221;tool&#8221;][vc_column full_width=&#8221;&#8221; gap=&#8221;0&#8243; full_height=&#8221;&#8221; columns_placement=&#8221;middle&#8221; equal_height=&#8221;&#8221; rtl_reverse=&#8221;&#8221; content_placement=&#8221;&#8221; disable_element=&#8221;&#8221;]<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_chrome gform_wrapper gravity-theme gform-theme--no-framework' data-form-theme='gravity-theme' data-form-index='0' id='gform_wrapper_7' style='display:none'><div id='gf_7' class='gform_anchor' tabindex='-1'><\/div><form method='post' enctype='multipart\/form-data' target='gform_ajax_frame_7' id='gform_7'  action='\/wp-json\/wp\/v2\/pages\/5320#gf_7' data-formid='7' novalidate>\n                        <div class='gform-body gform_body'><div id='gform_fields_7' class='gform_fields top_label form_sublabel_below description_below validation_below'><div id=\"field_7_43\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_43\" ><h4><span style=\"color: #2e4972;\">For which market(s) would you like to see the requirements?<\/span><\/h4><\/div><fieldset id=\"field_7_5\" class=\"gfield gfield--type-checkbox gfield--type-choice gfield--width-full field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_5\" ><legend class='gfield_label gform-field-label gfield_label_before_complex' >-<\/legend><div class='ginput_container ginput_container_checkbox'><div class='gfield_checkbox' id='input_7_5'><div class='gchoice gchoice_7_5_1'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_5.1' type='checkbox'  value='All Markets'  id='choice_7_5_1'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_5_1' id='label_7_5_1' class='gform-field-label gform-field-label--type-inline'>All Markets<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_5_2'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_5.2' type='checkbox'  value='All markets requiring registration'  id='choice_7_5_2'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_5_2' id='label_7_5_2' class='gform-field-label gform-field-label--type-inline'>All markets requiring registration<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_5_3'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_5.3' type='checkbox'  value='All markets not requiring registration'  id='choice_7_5_3'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_5_3' id='label_7_5_3' class='gform-field-label gform-field-label--type-inline'>All markets not requiring registration<\/label>\n\t\t\t\t\t\t\t<\/div><\/div><\/div><\/fieldset><fieldset id=\"field_7_2\" class=\"gfield gfield--type-checkbox gfield--type-choice gfield--width-quarter field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_2\" ><legend class='gfield_label gform-field-label gfield_label_before_complex' >-<\/legend><div class='ginput_container ginput_container_checkbox'><div class='gfield_checkbox' id='input_7_2'><div class='gchoice gchoice_7_2_1'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_2.1' type='checkbox'  value='Austria'  id='choice_7_2_1'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_2_1' id='label_7_2_1' class='gform-field-label gform-field-label--type-inline'>Austria<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_2_2'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_2.2' type='checkbox'  value='Belgium'  id='choice_7_2_2'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_2_2' id='label_7_2_2' class='gform-field-label gform-field-label--type-inline'>Belgium<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_2_3'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_2.3' type='checkbox'  value='Bulgaria'  id='choice_7_2_3'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_2_3' id='label_7_2_3' class='gform-field-label gform-field-label--type-inline'>Bulgaria<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_2_4'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_2.4' type='checkbox'  value='Croatia'  id='choice_7_2_4'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_2_4' id='label_7_2_4' class='gform-field-label gform-field-label--type-inline'>Croatia<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_2_5'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_2.5' type='checkbox'  value='Cyprus'  id='choice_7_2_5'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_2_5' id='label_7_2_5' class='gform-field-label gform-field-label--type-inline'>Cyprus<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_2_6'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_2.6' type='checkbox'  value='Czech Republic'  id='choice_7_2_6'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_2_6' id='label_7_2_6' class='gform-field-label gform-field-label--type-inline'>Czech Republic<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_2_7'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_2.7' type='checkbox'  value='Denmark'  id='choice_7_2_7'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_2_7' id='label_7_2_7' class='gform-field-label gform-field-label--type-inline'>Denmark<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_2_8'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_2.8' type='checkbox'  value='Estonia'  id='choice_7_2_8'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_2_8' id='label_7_2_8' class='gform-field-label gform-field-label--type-inline'>Estonia<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_2_9'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_2.9' type='checkbox'  value='Finland'  id='choice_7_2_9'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_2_9' id='label_7_2_9' class='gform-field-label gform-field-label--type-inline'>Finland<\/label>\n\t\t\t\t\t\t\t<\/div><\/div><\/div><\/fieldset><fieldset id=\"field_7_6\" class=\"gfield gfield--type-checkbox gfield--type-choice gfield--width-quarter field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_6\" ><legend class='gfield_label gform-field-label gfield_label_before_complex' >-<\/legend><div class='ginput_container ginput_container_checkbox'><div class='gfield_checkbox' id='input_7_6'><div class='gchoice gchoice_7_6_1'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.1' type='checkbox'  value='France'  id='choice_7_6_1'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_6_1' id='label_7_6_1' class='gform-field-label gform-field-label--type-inline'>France<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_6_2'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.2' type='checkbox'  value='Germany'  id='choice_7_6_2'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_6_2' id='label_7_6_2' class='gform-field-label gform-field-label--type-inline'>Germany<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_6_3'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.3' type='checkbox'  value='Greece'  id='choice_7_6_3'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_6_3' id='label_7_6_3' class='gform-field-label gform-field-label--type-inline'>Greece<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_6_4'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.4' type='checkbox'  value='Hungary'  id='choice_7_6_4'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_6_4' id='label_7_6_4' class='gform-field-label gform-field-label--type-inline'>Hungary<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_6_5'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.5' type='checkbox'  value='Iceland'  id='choice_7_6_5'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_6_5' id='label_7_6_5' class='gform-field-label gform-field-label--type-inline'>Iceland<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_6_6'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.6' type='checkbox'  value='Ireland'  id='choice_7_6_6'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_6_6' id='label_7_6_6' class='gform-field-label gform-field-label--type-inline'>Ireland<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_6_7'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.7' type='checkbox'  value='Italy'  id='choice_7_6_7'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_6_7' id='label_7_6_7' class='gform-field-label gform-field-label--type-inline'>Italy<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_6_8'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.8' type='checkbox'  value='Latvia'  id='choice_7_6_8'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_6_8' id='label_7_6_8' class='gform-field-label gform-field-label--type-inline'>Latvia<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_6_9'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.9' type='checkbox'  value='Lithuania'  id='choice_7_6_9'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_6_9' id='label_7_6_9' class='gform-field-label gform-field-label--type-inline'>Lithuania<\/label>\n\t\t\t\t\t\t\t<\/div><\/div><\/div><\/fieldset><fieldset id=\"field_7_7\" class=\"gfield gfield--type-checkbox gfield--type-choice gfield--width-quarter field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_7\" ><legend class='gfield_label gform-field-label gfield_label_before_complex' >-<\/legend><div class='ginput_container ginput_container_checkbox'><div class='gfield_checkbox' id='input_7_7'><div class='gchoice gchoice_7_7_1'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.1' type='checkbox'  value='Liechtenstein'  id='choice_7_7_1'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_7_1' id='label_7_7_1' class='gform-field-label gform-field-label--type-inline'>Liechtenstein<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_7_2'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.2' type='checkbox'  value='Luxembourg'  id='choice_7_7_2'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_7_2' id='label_7_7_2' class='gform-field-label gform-field-label--type-inline'>Luxembourg<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_7_3'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.3' type='checkbox'  value='Malta'  id='choice_7_7_3'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_7_3' id='label_7_7_3' class='gform-field-label gform-field-label--type-inline'>Malta<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_7_4'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.4' type='checkbox'  value='The Netherlands'  id='choice_7_7_4'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_7_4' id='label_7_7_4' class='gform-field-label gform-field-label--type-inline'>The Netherlands<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_7_5'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.5' type='checkbox'  value='Norway'  id='choice_7_7_5'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_7_5' id='label_7_7_5' class='gform-field-label gform-field-label--type-inline'>Norway<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_7_6'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.6' type='checkbox'  value='Poland'  id='choice_7_7_6'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_7_6' id='label_7_7_6' class='gform-field-label gform-field-label--type-inline'>Poland<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_7_7'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.7' type='checkbox'  value='Portugal'  id='choice_7_7_7'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_7_7' id='label_7_7_7' class='gform-field-label gform-field-label--type-inline'>Portugal<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_7_8'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.8' type='checkbox'  value='Romania'  id='choice_7_7_8'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_7_8' id='label_7_7_8' class='gform-field-label gform-field-label--type-inline'>Romania<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_7_9'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.9' type='checkbox'  value='Slovakia'  id='choice_7_7_9'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_7_9' id='label_7_7_9' class='gform-field-label gform-field-label--type-inline'>Slovakia<\/label>\n\t\t\t\t\t\t\t<\/div><\/div><\/div><\/fieldset><fieldset id=\"field_7_8\" class=\"gfield gfield--type-checkbox gfield--type-choice gfield--width-quarter field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_8\" ><legend class='gfield_label gform-field-label gfield_label_before_complex' >-<\/legend><div class='ginput_container ginput_container_checkbox'><div class='gfield_checkbox' id='input_7_8'><div class='gchoice gchoice_7_8_1'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_8.1' type='checkbox'  value='Slovenia'  id='choice_7_8_1'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_8_1' id='label_7_8_1' class='gform-field-label gform-field-label--type-inline'>Slovenia<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_8_2'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_8.2' type='checkbox'  value='Spain'  id='choice_7_8_2'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_8_2' id='label_7_8_2' class='gform-field-label gform-field-label--type-inline'>Spain<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_8_3'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_8.3' type='checkbox'  value='Sweden'  id='choice_7_8_3'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_8_3' id='label_7_8_3' class='gform-field-label gform-field-label--type-inline'>Sweden<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_8_4'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_8.4' type='checkbox'  value='Switzerland'  id='choice_7_8_4'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_8_4' id='label_7_8_4' class='gform-field-label gform-field-label--type-inline'>Switzerland<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_8_5'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_8.5' type='checkbox'  value='Turkey'  id='choice_7_8_5'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_8_5' id='label_7_8_5' class='gform-field-label gform-field-label--type-inline'>Turkey<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_7_8_6'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_8.6' type='checkbox'  value='United Kingdom'  id='choice_7_8_6'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_7_8_6' id='label_7_8_6' class='gform-field-label gform-field-label--type-inline'>United Kingdom<\/label>\n\t\t\t\t\t\t\t<\/div><\/div><\/div><\/fieldset><div id=\"field_7_9\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_9\" ><h4><span style=\"color: #2e4972;\">Austria<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.basg.gv.at\/en\/medical-devices\/\" target=\"_blankrel=\"noopener\">Austrian Federal Office for Safety in Healthcare (BASG)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n<li><a href=\"https:\/\/medizinprodukteregister.at\/WER\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n<\/ul>\n<p>\n<\/p>\n<p><\/div><div id=\"field_7_10\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_10\" ><h4><span style=\"color: #2e4972;\">Belgium<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.famhp.be\/en\/human_use\/health_products\/medical_devices_accessories\" target=\"_blank\" rel=\"noopener\">Federal Agency for Medicines and Health Products (famhp)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<p>\n<\/p>\n<p>\n<strong>Registration Process: <\/strong>A notification form must be submitted in an online database before the product is placed on the market. The notification must be submitted by the importer or distributor.  If the importer is not located in Belgium, there is a specific module in the FAMHP database the company should use for entities based outside of the country.\n<p>\n<\/p>\n<p>\nThere is no fee associated with the notification.  However, distributors and importers notifying devices in the database pay an annual fee to FAMHP.  More information about fee payments can be found <a href=\"https:\/\/www.afmps.be\/fr\/items-HOME\/Redevances\" target=\"_blank\" rel=\"noopener\">here<\/a>.\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> All devices require registration, including class I products.\n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Database form entry to include general device info, general info about the manufacturer, AR and distributor\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/www.famhp.be\/en\/human_use\/health_products\/medical_devices_accessories\/distribution-export\/medical_devices\"target=\"_blank\" rel=\"noopener\">Registration Database Overview<\/a><\/li>\n \t<li><a href=\"https:\/\/www.vas.ehealth.fgov.be\/portal\/en\/\" target=\"_blank\" rel=\"noopener\">Registration Database<\/a><\/li>\n<li><a href=\"https:\/\/www.famhp.be\/en\/faq_webportal\" target=\"_blank\" rel=\"noopener\">Registration FAQs<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_11\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_11\" ><h4><span style=\"color: #2e4972;\">Bulgaria<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.bda.bg\/en\/information-for-companies\/114-medical-devices-category\" target=\"_blank\" rel=\"noopener\">Bulgarian Drug Agency (BDA)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> The Bulgarian Competent Authority established the below notification process for companies to follow, but it is not mandatory by the Medical Device Law (linked below).\n<p>\n<\/p>\n<p>\n<strong>Registration Process: <\/strong> A notification form can be submitted via email to the Bulgarian CA at bda@bda.bg before the product is placed on the market.  The notification can be completed by the Manufacturer, Authorized Representative or Distributor.  There is no fee to complete the notification.\n<p>\n<\/p>\n<p>\nManufacturers can begin commercializing their device upon submission \u2013 no formal confirmation from BDA is needed.\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> While not required by law, the Bulgarian Competent Authority also has a form to complete IVD notifications per <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/ALL\/?uri=celex%3A31998L0079\" target=\"_blank\" rel=\"noopener\">IVDD<\/a> article 10(6), if manufacturers choose to submit this information. \n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Application form (linked below), DoC, CE certificate, label, Bulgarian IFU\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/www.bda.bg\/images\/stories\/documents\/legal_acts\/20210208_ZMI_english.pdf\" target=\"_blank\" rel=\"noopener\">Medical Devices Act<\/a> - Registration Requirement in Article 30<\/li>\n \t<li><a href=\"https:\/\/www.bda.bg\/bg\/60-business-info\/medical-products-biz\/180-forms\" target=\"_blank\" rel=\"noopener\">Registration Forms<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_24\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_24\" ><h4><span style=\"color: #2e4972;\">Croatia<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.halmed.hr\/Medicinski-proizvodi\/\" target=\"_blank\" rel=\"noopener\">Agency for Medicinal Products and Medical Devices (HALMED)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<p>\n<\/p>\n<p>\n<strong>Registration Process: <\/strong>A notification form must be submitted via email to the Croatian Competent Authority at medpro@halmed.hr within 15 days of placing the product on the market.  The notification can be completed by any legal or natural persons who place the product on the market.  There is no fee to complete the notification.\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong>Croatia requires registration of class IIa, IIb, III and AIMD medical devices, and for all classes of IVDs, including other\/self-certified.\n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Application form (linked below), list of products appendix (linked below), DoC, CE certificate, label, Croatian IFU\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/www.halmed.hr\/Medicinski-proizvodi\/Upute-za-podnositelje-zahtjeva-41\/Postupak-upisa-u-ocevidnik-i-obavijesti-o-medicinskim-proizvodima\/\" target=\"_blank\" rel=\"noopener\">Registration Process<\/a><\/li>\n \t<li><a href=\"https:\/\/www.halmed.hr\/O-HALMED-u\/Obrasci\/\" target=\"_blank\" rel=\"noopener\">Registration Forms<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_23\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_23\" ><h4><span style=\"color: #2e4972;\">Cyprus<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.moh.gov.cy\/moh\/mphs\/mphs.nsf\/page21_en\/page21_en?opendocument\" target=\"_blank\" rel=\"noopener\">Cyprus Medical Devices Authority<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<\/p>\n<p>\n<\/p> \n<strong>Registration Process: <\/strong> A notification form must be submitted via email to the Competent Authority at cymda@mphs.moh.gov.cy before the product is placed on the market.  The notification must be submitted by the entity placing the device on the market.  There is no fee for the notification.\n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Notification of medical devices form (linked below)\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n\t<li><a href=\"https:\/\/www.moh.gov.cy\/moh\/mphs\/mphs.nsf\/All\/A82FE3D75F4BF2CAC225850A0036075A?OpenDocument\" target=\"_blank\" rel=\"noopener\">Registration Process<\/a><\/li>\n \t<li><a href=\"https:\/\/www.moh.gov.cy\/moh\/mphs\/mphs.nsf\/page23_gr\/page23_gr?OpenDocument\" target=\"_blank\" rel=\"noopener\">Registration Forms<\/a><\/li>\n<\/ul>\n<p>\n<\/p>\n<p><\/div><div id=\"field_7_22\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_22\" ><h4><span style=\"color: #2e4972;\">Czech Republic<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.niszp.cz\/odbor-zdravotnickych-prostredku\" target=\"_blank\" rel=\"noopener\">State Institute for Drug Control (SUKL)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<\/p>\n<p>\n<\/p> \n<strong>Registration Process: <\/strong> The notification must be submitted in an online database within 15 days of placing the product on the market.  The notification must be submitted by each entity placing the product on the market, which in most cases is the importer or distributor.\n<p>\n<\/p>\n<p>\nSUKL will review the notification submission in the database and may follow up to request additional information.  Upon completion of the review, the CA will mark the entry as accepted.  There is no fee for the device notification. \n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> In cases where the manufacturer is placing the product directly on the market (e.g, SaMD), the Authorized Representative must submit the notification.\n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Database form entry to include general device info, manufacturer info, Basic UDI-DI (if available) plus upload of CE certificate, label and Czech IFU\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t\n<li><a href=\"https:\/\/www.niszp.cz\/sites\/default\/files\/dokumenty\/bezpecnostni_napravna_opatreni\/ZoZPaIVD_0.pdf\" target=\"_blank\" rel=\"noopener\">Law on medical devices and in vitro diagnostic medical devices \u2013 requirements included in \u00a7 23 - 25 of Act No. 375\/2022 Coll.<\/a><\/li>\n\t<li><a href=\"https:\/\/www.niszp.cz\/cs\/registr-zdravotnickych-prostredku\/manualy\" target=\"_blank\" rel=\"noopener\">Database Help Guides<\/a><\/li>\n \t<li><a href=\"https:\/\/eregpublicsecure.ksrzis.cz\/Registr\/RZPRO\" target=\"_blank\" rel=\"noopener\">Database Link<\/a><\/li>\n<\/ul>\n<p>\n<\/p>\n<p><\/div><div id=\"field_7_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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_21\" ><h4><span style=\"color: #2e4972;\">Denmark<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/laegemiddelstyrelsen.dk\/da\/udstyr\/\" target=\"_blank\" rel=\"noopener\">Danish Medicines Agency<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n\t<li><a href=\" https:\/\/laegemiddelstyrelsen.dk\/da\/udstyr\/registrering\/\" target=\"_blank\" rel=\"noopener\"> Registration Requirements<\/a><\/li>\n<\/ul>\n<p>\n<\/p>\n<p><\/div><div id=\"field_7_20\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_20\" ><h4><span style=\"color: #2e4972;\">Estonia<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.terviseamet.ee\/en\/medical-devices\" target=\"_blank\" rel=\"noopener\">Republic of Estonia Health Board<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<\/p>\n<p>\n<strong>Registration Process:<\/strong> The notification must be submitted in an online database within 10 days of placing the product on the market - there is no fee.  The notification must be submitted by the primary distributor.  Each distributor is not required to submit a notification. This is because the Estonian Competent Authority uses the database to understand if a specific product was placed on the market for post-market surveillance purposes (e.g., in case of a recall).  However, they don\u2019t need to know about each individual entity commercializing the device.\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> In cases where the manufacturer is placing the product directly on the market (e.g, SaMD), the Authorized Representative can create a database account and submit the notification.  For professional-use devices, hospitals also have the option to register the device in the database directly, in place of an importer or distributor. \n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Database entry form to include general device info, manufacturer and AR info plus upload of the label, original and Estonian IFU, CE Certificate, DoC\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/www.terviseamet.ee\/en\/medical-devices\/regulatory-controls\" target=\"_blank\" rel=\"noopener\"> Registration Requirements<\/a><\/li>  \n<li><a href=\"https:\/\/msa.sm.ee\/\" target=\"_blank\" rel=\"noopener\">Database Link<\/a> - Restricted to users in Estonia or users that have requested access<\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_19\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_19\" ><h4><span style=\"color: #2e4972;\">Finland<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.fimea.fi\/en\/medical-devices\" target=\"_blank\" rel=\"noopener\">Finnish Medicines Agency (Fimea)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes, but only for local Economic Operators and certain devices in the case of foreign manufacturers\n<p>\n<\/p>\n<p>\n<strong>Registration Process: <\/strong> Local Economic Operators, including manufacturers of device for non-medical purposes (per Annex XVI of the MDR), are required to notify Fimea. Further, distributors of self-test IVDs and devices that contain human tissue or substances derived from human blood or plasma must notify themselves and these types of products in Fimea\u2019s local database, CERE.\n<p>\n<\/p>\n<p>\nDevices supplied by Finnish distributors to hospitals and retailers previously required notification to Fimea.  However, Fimea issued an announcement (linked below) in June 2023 stating that these notifications are not required until further notice.\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/www.fimea.fi\/en\/medical-devices\/registrations\/device-and-operator-notifications-to-eudamed\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n\t<li><a href=\"https:\/\/www.fimea.fi\/en\/medical-devices\/registrations\/device-and-operator-notifications-to-cere\" target=\"_blank\" rel=\"noopener\">CERE Registration Process<\/a><\/li>\n\n<li><a href=\"https:\/\/www.fimea.fi\/en\/-\/medical-device-distributors-not-required-to-submit-device-notifications-until-further-notice\" target=\"_blank\" rel=\"noopener\">Fimea Announcement \u2013 Medical device distributors not required to submit device notifications until further notice<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_16\" ><h4><span style=\"color: #2e4972;\">France<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/ansm.sante.fr\/\" target=\"_blank\" rel=\"noopener\">Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<\/p>\n<p>\n<\/p>\n<p>\n<strong>Registration Process:<\/strong> The notification must be submitted via email to the French CA at communications.dm@ansm.sante.fr before the product is placed on the market.  The notification may be submitted by the Manufacturer, Authorized Representative or Distributor. There is no fee for the notification.\n<p>\n<\/p>\n<p>\nThe manufacturer can begin commercializing as soon as the notification is submitted.\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> ANSM announced that devices can be registered in EUDAMED now to fulfill the national registration requirement, instead of the email notification described above.  If a device is notified in EUDAMED, ANSM does not need to be informed directly.  However, they may audit devices to confirm accuracy of the information submitted.\n<p>\n<\/p>\n<p>\n<strong>Info Required (for email notification): <\/strong> Application form (linked below), label, French IFU, CE certificate, DoC, Certificate of Incorporation (or equivalent document) from entity submitting the notification\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/ansm.sante.fr\/vos-demarches\/industriel\/impression\/113\" target=\"_blank\" rel=\"noopener\">Registration Requirements and Forms (downloadable PDF)<\/a><\/li>\n<li><a href=\"https:\/\/ansm.sante.fr\/uploads\/2021\/07\/02\/20210702-eudamed-dispositions-nationales.pdf \" target=\"_blank\" rel=\"noopener\">ANSM Announcement \u2013 Use of EUDAMED<\/a><\/li> \n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_18\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_18\" ><h4><span style=\"color: #2e4972;\">Germany<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.bfarm.de\/DE\/Home\/_node.html\" target=\"_blank\" rel=\"noopener\">Germany Federal Institute for Drugs and Medical Devices (BfArM)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Registration may be required, see additional notes\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> Registration of a medical device or IVD may be required if an Importer, Authorized Representative or Manufacturer located in Germany is placing the product on the market for the first time.  However, BfArM is transitioning some of the registration obligations from their local database (DMIDS) to EUDAMED and altering the overall requirements.  Therefore, if a manufacturer is selling through a German importer, we suggest confirming directly with this entity which registration obligations may apply to their products.  \n<p>\n<\/p>\n<p>\nAuthorized Representatives and manufacturers not based in Germany do not have any registration obligations.  Therefore, manufacturers selling direct to the end-user do not need to notify, unless they or their Authorized Representative is based in Germany.\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/www.bfarm.de\/DE\/Medizinprodukte\/_FAQ\/DMIDS\/_node.html\" target=\"_blank\" rel=\"noopener\">BfArM Registration Database FAQs<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_17\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_17\" ><h4><span style=\"color: #2e4972;\">Greece<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.eof.gr\/web\/guest\/medicaldevices\" target=\"_blank\" rel=\"noopener\">National Organization for Medicines (EOF)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<\/p>\n<p>\n<\/p>\n<strong>Registration Process:<\/strong> The notification must be submitted via email to the Greek CA at  medicaldevices@eof.gr before the product is placed on the market. The notification may be submitted by the Manufacturer or Authorized Representative.  There is no fee to submit the notification.\n<p>\n<\/p>\n<p>\nThe manufacturer can begin commercializing as soon as the notification is submitted.\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> Distributors have an additional obligation to register devices in the Greek CA\u2019s database (announcement linked below).\n<p>\n<\/p>\n<p>\n<strong>Info Required (for Manufacturer\/AR notification): <\/strong> DoC, CE Certificate, label, Greek IFU\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/casusconsulting.com\/registration-requirements-greece\/\" target=\"_blank\" rel=\"noopener\">Registration Requirements \u2013 see section \u201cNotification of Medical Devices\"<\/a><\/li>\n \t<li><a href=\"https:\/\/casusconsulting.com\/distributor-notification-requirement-greece\/\" target=\"_blank\" rel=\"noopener\">EOF Announcement \u2013 Distributor Notification Requirement<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_15\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_15\" ><h4><span style=\"color: #2e4972;\">Hungary<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/ogyei.gov.hu\/main_page\" target=\"_blank\" rel=\"noopener\">National Institute of Pharmacy and Nutrition (OGYEI)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/ogyei.gov.hu\/az_orvostechnikai_eszkozok_legalis_forgalomba_hozatalanak_feltetelei\" target=\"_blank\" rel=\"noopener\">Registration Requirements \u2013 Directives<\/a><\/li>\n\t<li><a href=\"https:\/\/ogyei.gov.hu\/regisztracio_nyilvantartasba_vetel_eudamed\" target=\"_blank\" rel=\"noopener\">Registration Requirements \u2013 Regulations<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_14\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_14\" ><h4><span style=\"color: #2e4972;\">Iceland<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.ima.is\/medical-devices\/\" target=\"_blank\" rel=\"noopener\">Icelandic Medicines Agency (IMA)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only certain local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> If a manufacturer is selling direct, it is unclear from the website if manufacturers or their ARs need to notify.  To err on the side of caution, the manufacturer or the AR can register, but may not receive confirmation of receipt from the CA.  In these cases, manufacturers can begin marketing upon submission of the notification form.\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n<li><a href=\"https:\/\/www.ima.is\/medical-devices\/medical-device-registration-2\/\" target=\"_blank\" rel=\"noopener\">Registration Requirements and Form <\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_13\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_13\" ><h4><span style=\"color: #2e4972;\">Ireland<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.hpra.ie\/homepage\/medical-devices\" target=\"_blank\" rel=\"noopener\">Health Products Regulatory Authority (HPRA)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/www.hpra.ie\/homepage\/medical-devices\/registration\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_12\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_12\" ><h4><span style=\"color: #2e4972;\">Italy<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/casusconsulting.com\/ministerodellasalute\" target=\"_blank\" rel=\"noopener\">Ministero della Salute<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<p>\n<\/p>\n<p>\n<strong>Registration Process:<\/strong> The notification must be submitted in Italy\u2019s registration database before the product is placed on the market. The notification can be made by the Authorized Representative, Manufacturer or Distributor.  Or, the manufacturer can formally delegate any entity with a database account to submit the notification.  There is no fee associated with the notification.\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> It can be challenging for non-Italian entities to obtain a database account as a special type of e-Signature is required that is issued with an authorized certifier in Italy or is compliant with EU Regulation No. 910\/2014- The eIDAS (electronic IDentification Authentication and Signature) Regulation.\n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong>Database form entry to include general device info, manufacturer info, Authorized Representative info and VAT number plus upload of DoC, CE Certificate, label, Italian IFU\n<p>\n<\/p>\n<p>\nIf the manufacturer is designating an entity that is not the AR or distributor to submit, an official delegation letter must also be provided with the database submission.  A template for this letter is available on the Italian CA\u2019s website. \n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/casusconsulting.com\/italydevicerequirements\" target=\"_blank\" rel=\"noopener\">Medical Device Registration Requirements<\/a><\/li>\n \t<li><a href=\"https:\/\/casusconsulting.com\/ivd-registration-requirements-italy\" target=\"_blank\" rel=\"noopener\">IVD Registration Requirements<\/a><\/li>\n \t<li><a href=\"https:\/\/casusconsulting.com\/italyregistrationdatabase\/\" target=\"_blank\" rel=\"noopener\">Database Registration Forms<\/a><\/li>\n \t<li><a href=\"https:\/\/casusconsulting.com\/registration-database-italy\" target=\"_blank\">Registration Database<\/a><\/li>\n<\/ul> \n<\/p>\n<p>\n<\/div><div id=\"field_7_31\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_31\" ><h4><span style=\"color: #2e4972;\">Latvia<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.zva.gov.lv\/lv\/industrijai\/medicinisko-iericu-razotaji-pilnvarotie-parstavji\" target=\"_blank\" rel=\"noopener\">State Agency of Medicines of Latvia (ZVA)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<\/p>\n<p>\n<\/p>\n<strong>Registration Process:<\/strong> The notification must be submitted via the Latvian CA\u2019s online form before the product is placed on the market. The notification must be made the by the Authorized Representative, Manufacturer or Distributor.  There is no fee to submit the form.\n<p>\n<\/p>\n<p>\nThe manufacturer can begin commercializing as soon as the notification is submitted.\n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Registration form entry to include general device info, manufacturer and AR info, DoC, CE Certificate\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/latmed.zva.gov.lv\/public\/pazinojumsZaluValstsAgenturai.aspx?lang=en\" target=\"_blank\" rel=\"noopener\">Online Registration Form<\/a> - Requirement to register noted at the top of the form<\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_30\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_30\" ><h4><span style=\"color: #2e4972;\"> Liechtenstein<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.llv.li\/de\/landesverwaltung\/amt-fuer-gesundheit\" target=\"_blank\" rel=\"noopener\"> Office of Public Health (Amt f\u00fcr Gesundheit - AG)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 medical devices that meet the regulatory requirements in either the EU or Switzerland can be placed on the market with no further requirements\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/www.llv.li\/de\/unternehmen\/branchen-berufe-verbaende\/gesundheitsberufe-und-heilmittel\/medizinprodukte-in-vitro-diagnostika\/marktzugang\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n<\/ul>\n<p>\n<\/p>\n<p><\/div><div id=\"field_7_29\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_29\" ><h4><span style=\"color: #2e4972;\">Lithuania<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/vaspvt.gov.lt\/\" target=\"_blank\" rel=\"noopener\">The State Health Care Accreditation Agency (VASPVT)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<p>\n<\/p>\n<p>\n<strong>Registration Process:<\/strong> The notification must be submitted via email to the Lithuanian CA at vaspvt@vaspvt.gov.lt. It must be submitted within 14 days of placing the product on the market and can be submitted by the Authorized Representative, Manufacturer or Distributor. There is no fee for the notification.\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> Only class IIa, IIb, III and AIMD medical devices require notification.  IVDs do not require notification.\n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Application form (linked below), label, Lithuanian IFU\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n<li><a href=\"https:\/\/www.e-tar.lt\/portal\/lt\/legalAct\/TAR.E91E7064BE7D\/cQmYniZrpG\" target=\"_blank\" rel=\"noopener\">Order V-938: APPROVAL OF THE DESCRIPTION OF THE PROCEDURE FOR THE SUBMISSION OF DATA ON CLASS IIA, IIB, III AND MADE TO ORDER ACTIVE IMPLANTABLE MEDICAL DEVICES<\/a><\/li>\n<li><a href=\"https:\/\/vaspvt.lrv.lt\/lt\/medicinos-priemones-pagal-es-direktyvas\/registravimas\/\" target=\"_blank\" rel=\"noopener\">Registration Requirements and Forms<\/a> (scroll to bottom of page)<\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_28\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_28\" ><h4><span style=\"color: #2e4972;\"> Luxembourg<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\" https:\/\/sante.public.lu\/fr\/espace-professionnel\/domaines\/pharmacies-et-medicaments\/dispositifs-medicaux.html\" target=\"_blank\" rel=\"noopener\">Ministry of Health<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/sante.public.lu\/fr\/espace-professionnel\/domaines\/pharmacies-et-medicaments\/dispositifs-medicaux.html\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_27\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_27\" ><h4><span style=\"color: #2e4972;\">Malta<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/medicinesauthority.gov.mt\/medicaldevices\" target=\"_blank\" rel=\"noopener\"> Malta Medicines Authority<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Additional Information:<\/strong> The Maltese CA website does not explicitly state that registration is only required for local economic operators.  However, the CA confirmed via email in December 2022 that foreign manufacturers do not have registration obligations.\n<p>\n<\/p>\n<p><\/div><div id=\"field_7_26\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_26\" ><h4><span style=\"color: #2e4972;\">Netherlands<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.igj.nl\/\" target=\"_blank\" rel=\"noopener\"> Dutch Health and Youth Care Inspectorate (IGJ)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/www.farmatec.nl\/medische-hulpmiddelen\/notificaties\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_33\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_33\" ><h4><span style=\"color: #2e4972;\">Norway<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\" https:\/\/legemiddelverket.no\/english\/medical-devices\" target=\"_blank\" rel=\"noopener\">The Norwegian Medicines Agency<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/legemiddelverket.no\/medisinsk-utstyr\/registrering-og-eudamed\/registrering-av-medisinsk-utstyr\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_25\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_25\" ><h4><span style=\"color: #2e4972;\">Poland<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.urpl.gov.pl\/pl\/wyroby-medyczne-1\" target=\"_blank\" rel=\"noopener\">Office for Registration of Medicinal Products, Medical Devices and Biocidal Products<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<\/p>\n<p>\n<strong>Registration Process:<\/strong> The importer or distributor making product available on the market must notify the Polish CA within 7 days of placing the product on market.  The application and accompanying documents can be submitted via email or as a hard copy mailing to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.  If submitting the notification via email, application form Annex 1 (linked below) automatically generates the email that is sent to the CA once the submitter clicks the \u201cconfirm\u201d button as the bottom of the form.  There is no fee for the notification. \n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> All devices require notification, including self-certified medical devices and IVDs. \n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Application forms Annex 1 and Annex 4 (linked below), label, Polish IFU, promotional materials specifying the intended use for Poland (if available), DoC, CE Certificate\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n\t<li><a href=\" https:\/\/www.urpl.gov.pl\/pl\/wyroby-medyczne\/powiadomienia-o-wyrobach-medycznych\" target=\"_blank\" rel=\"noopener\"> Registration Requirements<\/a><\/li>\n<li><a href=\"https:\/\/www.urpl.gov.pl\/pl\/wyroby-medyczne\/powiadomienia-o-wyrobach-medycznych\/formularze\" target=\"_blank\" rel=\"noopener\">Registration Forms<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_34\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_34\" ><h4><span style=\"color: #2e4972;\">Portugal<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.infarmed.pt\/web\/infarmed\/entidades\/dispositivos-medicos\" target=\"_blank\" rel=\"noopener\">Infarmed - National Authority of Medicines and Health Products<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<p>\n<\/p>\n<p>\n<strong>Registration Process:<\/strong> The Portuguese notification must be submitted in an online database prior to placing the product on the market.  The product can be placed on the market as soon as the notification is processed in the database.  The notification can be submitted by the Authorized Representative or Manufacturer.  The submitter must apply for or already have an Infarmed database account.  There is no fee for the Infarmed notification.\n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> General device info, manufacturer and AR info, label, Portuguese IFU, DoC, CE certificate\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n\t<li><a href=\"https:\/\/www.infarmed.pt\/web\/infarmed\/entidades\/dispositivos-medicos\/registo-de-dm-e-div\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n<li><a href=\"https:\/\/extranet.infarmed.pt\/SIDM-fo\/\" target=\"_blank\" rel=\"noopener\">Infarmed Database<\/a><\/li> \n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_35\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_35\" ><h4><span style=\"color: #2e4972;\">Romania<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.anm.ro\/\" target=\"_blank\" rel=\"noopener\">National Agency for Medicines and Medical Devices of Romania (ANMDMR)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> Until recently, ANMDMR required foreign manufacturers to notify high risk devices once they were placed on the market.  However, on 20 July 2021, the CA announced that this requirement no longer applies.  Therefore, notifications for foreign manufacturers are no longer needed in this market.  Romanian manufacturers still have notification obligations for certain device classes (see below link).\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n \t<li><a href=\"https:\/\/www.anm.ro\/anunt-important-20-07-2021\/\" target=\"_blank\" rel=\"noopener\">ANMDMR Announcement \u2013 Registration Not Required for Foreign Manufacturers<\/a><\/li>\n<li><a href=\"https:\/\/www.anm.ro\/dispozitive-medicale\/inregistrare-dispozitive-medicale-in-baza-nationala-de-date\/\" target=\"_blank\" rel=\"noopener\">Registration Requirements - Romanian ARs and Manufacturers<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_36\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_36\" ><h4><span style=\"color: #2e4972;\">Slovakia<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.sukl.sk\/sk\/zdravotnicke-pomocky-informacie?page_id=495\" target=\"_blank\" rel=\"noopener\">State Institute for Drug Control, Medical Devices Section (SUKL)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<p>\n<\/p>\n<p>\n<strong>Registration Process:<\/strong> The Slovakian notification is submitted via an online form.  The notification must be submitted before the product is placed on the market. SUKL will review the notification and may follow up to ask questions or request additional information.\n<p>\n<\/p>\n<p>\nThe notification can be submitted by the Authorized Representative, Manufacturer, Distributor or Importer.  There is also an option for the Manufacturer to formally appoint another entity to submit on their behalf.  There is a small fee associated with the notification - \u20ac20.00 per notification.\n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Cover letter (template linked below), application form (linked below), device appendix (linked below), billing proposal (included in form link below), label, Slovakian IFU, DoC, CE certificate\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n\t<li><a href=\"https:\/\/www.sukl.sk\/sk\/zdravotnicke-pomocky-informacie\/informacie-tykajuce-sa-registracie-oznamenia-zp\/oznamenie-vyrobcu-o-zp?page_id=4138\" target=\"_blank\" rel=\"noopener\">Registration Requirements and Forms<\/a><\/li>\n<li><a href=\"https:\/\/portal.sukl.sk\/zpextra\/\" target=\"_blank\" rel=\"noopener\">Submission Form<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_37\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_37\" ><h4><span style=\"color: #2e4972;\">Slovenia<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href= https:\/\/www.jazmp.si\/en\/\" target=\"_blank\" rel=\"noopener\">Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n<li><a href=\"https:\/\/www.jazmp.si\/medicinski-pripomocki\/registracija-medicinskih-pripomockov\/\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_38\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_38\" ><h4><span style=\"color: #2e4972;\">Spain<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.aemps.gob.es\/productos-sanitarios\/productossanitarios_prodsanitarios\/\" target=\"_blank\" rel=\"noopener\">Agency for Medicines and Health Products (AEMPS)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<p>\n<\/p>\n<p>\n<strong>Registration Process:<\/strong> The Spanish notification must be submitted in an online database prior to placing the product on the market.  The product can be placed on the market as soon as the notification is processed in the database.  However, AEMPS will eventually review the submission to check it has been made correctly and may follow up to ask additional questions. \n<p>\n<\/p>\n<p>\nThe notification can be submitted by the Authorized Representative, Manufacturer or Distributor.  However, the submitter must apply for or already have an AEMPS database account.  AEMPS charges a fee of approximately \u20ac100.00 per notification. \n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> AEMPS requires that labels include the product\u2019s description or intended purpose in Spanish.  This is noted in Royal Decree 1591\/2009, Article 4(2), which references Annex 1, Article 13.  The label requirement is noted specifically in 13.1.\n<p>\n<\/p>\n<p>\nEconomic Operators must update and\/or confirm their company and device details in the AEMPS database annually.  If the details are not confirmed annually, AEMPS may delete the Economic Operator and device information from the database, and the company would need to re-register before continuing commercialization of the device(s). \n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Database form entry to include general device info, manufacturer and Authorized Representative info plus upload of label (including Spanish description on label), Spanish IFU, DoC, CE certificate\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n\t<li><a href=\"https:\/\/www.boe.es\/buscar\/doc.php?id=BOE-A-2023-7416\" target=\"_blank\" rel=\"noopener\"> Royal Decree 192\/2023<\/a><\/li>\n<li><a href=\"https:\/\/www.aemps.gob.es\/informa\/notasinformativas\/productossanitarios\/2010\/ni-cumplimiento-legislacion-ps\/\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n<li><a href=\"https:\/\/sede.aemps.gob.es\/PSCH\/PS\/docs\/CCPS-faqs.pdf\" target=\"_blank\" rel=\"noopener\">Registration Database FAQs<\/a><\/li>\n<li><a href=\"https:\/\/ccps.aemps.es\/\" target=\"_blank\" rel=\"noopener\">AEMPS Database<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_42\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_42\" ><h4><span style=\"color: #2e4972;\">Sweden<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.lakemedelsverket.se\/en\/medical-devices\" target=\"_blank\" rel=\"noopener\"> Swedish Medical Products Agency, Department of Medical Devices (L\u00e4kemedelsverket)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 only local Economic Operators have registration obligations\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n<li><a href=\" https:\/\/www.lakemedelsverket.se\/sv\/lagar-och-regler\/foreskrifter\/hslf-fs-2021-32-konsoliderad-foreskrift#hmainbody2\" target=\"_blank\" rel=\"noopener\">Registration Requirements (HSLF-FS 2021:32, Article 2 includes registration requirements)<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_39\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_39\" ><h4><span style=\"color: #2e4972;\">Switzerland<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices.html\" target=\"_blank\" rel=\"noopener\">Swissmedic<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> No \u2013 registration of some devices currently only required for Swiss Manufacturers (<a href=\"https:\/\/casusconsulting.com\/services\/switzerland\/device-registration\/\" target=\"_blank\" rel=\"noopener\">see requirements here<\/a>)\n<\/p>\n<p>\n<strong>Additional Notes:<\/strong> Swissmedic is introducing a registration system (<a href=\" https:\/\/casusconsulting.com\/swissdamed-2023-2024-release-dates-confirmed\/\" target=\"_blank\" rel=\"noopener\">swissdamed<\/a>), similar to EUDAMED.  A pilot program was conducted in early 2023, and it is expected that the device registration module will be available for use in 2024.  Device registration will not become mandatory until the Swiss Medical Device Ordinance (MedDO) and IVD Ordinance (IvDO) are updated with the new device registration requirements. \n<p>\n<\/p>\n<p>\nAdditional requirements still apply for Switzerland, including appointment of a Swiss AR, as it is no longer a part of the EU single market for medical devices.  Read more about the requirements <a href=\"https:\/\/casusconsulting.com\/services\/switzerland\/steps-to-market\/\" target=\"_blank\" rel=\"noopener\">here<\/a>. \n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n<li><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/market-access\/meldung-medizinprodukten.html\" target=\"_blank\" rel=\"noopener\">Medical Device Registration Requirements<\/a><\/li>\n<li><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/market-access\/meldung-ivd.html\" target=\"_blank\" rel=\"noopener\">IVD Registration Requirements<\/a><\/li>\n<li><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank.html\" target=\"_blank\" rel=\"noopener\">swissdamed Overview<\/a><\/li>\n<\/ul>\n<\/p>\n<p><\/div><div id=\"field_7_40\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_40\" ><h4><span style=\"color: #2e4972;\">Turkey<\/span><\/h4>\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.titck.gov.tr\/\" target=\"_blank\" rel=\"noopener\">Turkish Medicines and Medical Devices Agency,\nMinistry of Health (TITCK)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<\/p>\n<p>\n<strong>Registration Process:<\/strong> The Turkish notification must be submitted in an online database prior to placing the product on the market.  The local importer is required to submit the notification.  There is a fee associated with the notification.\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> All classes of devices and IVDs require notification. For products sold direct to the consumer, an importer must be identified \u201cin-name only\u201d to submit he notification in the database.\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n\t<li><a href=\"https:\/\/utsuygulama.saglik.gov.tr\/UTS\/\" target=\"_blank\" rel=\"noopener\">Registration Database Login<\/a><\/li>\n<li><a href=\"https:\/\/utsuygulama.saglik.gov.tr\/UTS\/vatandas#\/vatTibbiCihazListele\" target=\"_blank\" rel=\"noopener\">Public Registration Database<\/a><\/li>\n<\/ul>\n<\/p><\/div><div id=\"field_7_41\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_41\" ><h4><span style=\"color: #2e4972;\">United Kingdom<\/span><\/h4>\t\n<strong> Competent Authority:<\/strong> <a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\" target=\"_blank\" rel=\"noopener\">Medicines and Healthcare products Regulatory Agency (MHRA)<\/a>\n<p>\n<\/p>\n<p>\n<strong>Is additional registration required:<\/strong> Yes\n<p>\n<\/p>\n<p>\n<strong>Registration Process: <\/strong> Device information must be submitted in the MHRA\u2019s online database before the product can be placed on the market.  The MHRA will review the application.  The review time quoted by the agency is one week.  A formal registration letter is issued as proof of a completed registration.  Manufacturers can begin commercializing their device once this letter is issued.\n<p>\n<\/p>\n<p>\nThe application must be made by the manufacturer\u2019s UK Responsible person unless the manufacturer is based in the UK. A fee of GBP 240 applies per submission.\n<p>\n<\/p>\n<p>\n<strong>Additional Notes: <\/strong> Post-Brexit, additional requirements apply for the UK, including appointment of a UK Responsible Person.  Read more about the requirements <a href=\"https:\/\/casusconsulting.com\/services\/uk\/market-access\/\" target=\"_blank\" rel=\"noopener\">here<\/a>. \n<p>\n<\/p>\n<p>\n<strong>Info Required: <\/strong> Device info, manufacturer and UKRP info, GMDN code, DoC (for self-certified products), CE Certificate (if applicable), agreement\/mandate between AR and manufacturer\n<p>\n<\/p>\n<p>\n<strong>Helpful Links: <\/strong>\n<ul>\n\t<li><a href=\" https:\/\/www.gov.uk\/guidance\/register-medical-devices-to-place-on-the-market\" target=\"_blank\" rel=\"noopener\">Registration Requirements<\/a><\/li>\n<li><a href=\"https:\/\/mhrabpm.appiancloud.com\/suite\/sites\/MHRAServices\/page\/applications?signin=native\" target=\"_blank\" rel=\"noopener\">Registration Database<\/a><\/li>\n<\/ul>\n<\/p>\n<p\n<\/div><div id=\"field_7_44\" 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_below field_validation_below gfield_visibility_visible\"  data-js-reload=\"field_7_44\" ><em>*\u201cNot requiring registration\u201d refers to registration requirements for foreign devices and manufacturers. All markets generally have certain registration requirements for local economic operators (Manufacturers, Authorized Representatives, Importers and\/or Distributors). These registration requirements may be related to entity registration and\/or device registration.<\/em>\n<p>\n<\/p>\n<p>\n<em>Manufacturers based outside the EU should confirm if their Competent Authority has any local registration requirements that apply to their AR and\/or their devices.<\/em><\/div><\/div><\/div>\n        <div class='gform_footer top_label'> <input type='submit' id='gform_submit_button_7' class='gform_button button' value='Submit'  onclick='if(window[\"gf_submitting_7\"]){return false;}  if( !jQuery(\"#gform_7\")[0].checkValidity || jQuery(\"#gform_7\")[0].checkValidity()){window[\"gf_submitting_7\"]=true;}  ' onkeypress='if( event.keyCode == 13 ){ if(window[\"gf_submitting_7\"]){return false;} if( !jQuery(\"#gform_7\")[0].checkValidity || jQuery(\"#gform_7\")[0].checkValidity()){window[\"gf_submitting_7\"]=true;}  jQuery(\"#gform_7\").trigger(\"submit\",[true]); }' \/> <input type='hidden' name='gform_ajax' 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\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=\"European Registration Requirements\" 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[\/vc_column][\/vc_row]<\/p>","protected":false},"excerpt":{"rendered":"<p>Find out which markets require registration for Class IIa, IIb and III medical devices, self-test and Annex II, List A, List B IVDs in Europe, UK and Switzerland. Plus, the submission process &#038; fees.<\/p>\n","protected":false},"author":4,"featured_media":8386,"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\/06\/EU-Medical-Device-and-IVD-Registration-Requirements-scaled.jpg","_links":{"self":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/5320"}],"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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/comments?post=5320"}],"version-history":[{"count":67,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/5320\/revisions"}],"predecessor-version":[{"id":10906,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/5320\/revisions\/10906"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media\/8386"}],"wp:attachment":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media?parent=5320"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}