{"id":3283,"date":"2022-05-05T09:52:20","date_gmt":"2022-05-05T14:52:20","guid":{"rendered":"https:\/\/casusconsulting.com\/?page_id=3283"},"modified":"2024-04-08T10:07:17","modified_gmt":"2024-04-08T15:07:17","slug":"eu-language-translation-requirements","status":"publish","type":"page","link":"https:\/\/casusconsulting.com\/eu-language-translation-requirements\/","title":{"rendered":"Language Requirements Tool"},"content":{"rendered":"\n<div class=\"wp-block-themepunch-revslider revslider\" data-modal=\"false\" data-slidertitle=\"Language Requirements Tool\" style=\"\">\n\t\t\t<!-- START Language Requirements Tool REVOLUTION SLIDER 6.7.1 --><p class=\"rs-p-wp-fix\"><\/p>\n\t\t\t<rs-module-wrap id=\"rev_slider_185_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_185_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-406\" 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_406\" 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-185-slide-406-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-185-slide-406-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-185-slide-406-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 Language <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-185-slide-406-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-185-slide-406-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>Confirm IFU and labeling translation requirements for medical devices & IVDs in Europe, the UK, and Switzerland. Plus, if exemptions are allowed.  \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-185-slide-406-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_185_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[\"revslider1851\"]!==undefined) {window.RS_MODULES.modules[\"revslider1851\"].once = false;window.revapi185 = undefined;if (window.RS_MODULES.checkMinimal!==undefined) window.RS_MODULES.checkMinimal()}\n\t\t\t\t<\/script>\n\t\t\t<\/rs-module-wrap>\n\t\t\t<!-- END REVOLUTION SLIDER -->\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-3 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:90%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-black-color has-text-color\"><script src=\"https:\/\/9931674141ca41baa2023404fd2333a2.js.ubembed.com\" async=\"\"><\/script><\/p>\n\n\n\n<p><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/casusconsulting.com\/eu-language-translation-requirements\/#language_tool\"><b>JUMP TO LANGUAGE TOOL<\/b><\/a><\/span><\/p>\n\n\n<div class=\"wp-block-ub-table-of-contents-block ub_table-of-contents\" data-showtext=\"show\" data-hidetext=\"hide\" data-scrolltype=\"auto\" id=\"ub_table-of-contents-385b9a32-feb7-44b4-958d-049ce806cbfd\" 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-language-translation-requirements\/#0-what-is-included-in-the-language-requirements-tool->What is included in the Language Requirements Tool?<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-language-translation-requirements\/#1-translation-responsibility->Translation Responsibility<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-language-translation-requirements\/#2-layperson-versus-professional-use->Layperson versus Professional Use<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-language-translation-requirements\/#3-exemptions>Exemptions<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-language-translation-requirements\/#4-disclaimer->Disclaimer<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-language-translation-requirements\/#5-language-requirements-tool->Language Requirements Tool<\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">With 27 national languages throughout Europe, navigating the language requirements can be challenging. Knowing whether the labels, packaging and Instructions for Use (IFU) \/ User Manual (UM) must be translated is confusing and over-translating can result in unnecessary expense.<\/span> <!-- Smartsupp Live Chat script -->\r\n\r\n<script type=\"text\/javascript\">\r\n\r\nvar _smartsupp = _smartsupp || {};\r\n\r\n_smartsupp.key = 'aa3132da0431967288b8cf85dfdfa7626d7ecfd3';\r\n\r\nwindow.smartsupp||(function(d) {\r\n\r\n         var s,c,o=smartsupp=function(){ o._.push(arguments)};o._=[];\r\n\r\n         s=d.getElementsByTagName('script')[0];c=d.createElement('script');\r\n\r\n         c.type='text\/javascript';c.charset='utf-8';c.async=true;\r\n\r\n         c.src='https:\/\/www.smartsuppchat.com\/loader.js?';s.parentNode.insertBefore(c,s);\r\n\r\n})(document);\r\n\r\n<\/script><\/p>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"0-what-is-included-in-the-language-requirements-tool-\"><strong>What is included in the Language Requirements Tool?<\/strong><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">To help you maintain compliance, Casus has developed a free Language Requirements Tool, which:<\/span><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul class=\"has-black-color has-text-color\">\n<li><span style=\"color: #000000;\">Provides the MDR\/IVDR language translation requirements for the <span class=\"tooltip tooltip-txt\" data-tooltip=\"The European Single Market includes: all 27 EU member states, Iceland, Liechtenstein, Norway, Northern Ireland and Turkey.\" data-position=\"top\">European Single Market,<\/span>\nthe United Kingdom (UK), and Switzerland<\/span><\/li>\n\n\n\n<li><span style=\"color: #000000;\">Outlines the requirements for devices intended for the lay person versus those for healthcare professionals<\/span><\/li>\n\n\n\n<li><span style=\"color: #000000;\">Specifies if an EU member state allows the IFU\/user manual to be provided only in English<\/span><\/li>\n\n\n\n<li><span style=\"color: #000000;\">Confirms if a National Competent Authority has published if manufacturers may request a language exemption<\/span><\/li>\n\n\n\n<li><span style=\"color: #000000;\">The regulation excerpt and link citation for reference<\/span><\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">We strongly recommend reading the below information in full prior to using the tool.<\/span><\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"1-translation-responsibility-\"><span style=\"color: #000000;\"><strong>Translation Responsibility<\/strong><\/span><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">The <span class=\"tooltip tooltip-txt\" data-tooltip=\"Medical Device Regulation 2017\/745. Date of application was 26 May 2021.\" data-position=\"top\">MDR<\/span>\n and <span class=\"tooltip tooltip-txt\" data-tooltip=\"In Vitro Diagnostic Medical Device Regulation 2017\/746. Date of application was 26 May 2022.\" data-position=\"top\">IVDR<\/span>\n state that it is the manufacturer\u2019s responsibility to translate documentation into the local language, as required. <\/span><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-background\" style=\"background-color:#f9f9f9\"><span style=\"color: #000000;\">MDR Art.10(11):<\/span> <span style=\"color: #000000;\"><em>&#8220;Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.&#8221;<\/em><\/span><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">As noted in the above excerpt, each member state determines the language\/translation requirements in its country.<\/span><\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"2-layperson-versus-professional-use-\"><span style=\"color: #000000;\"><strong>Layperson versus Professional Use<\/strong><\/span><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">The requirement to translate IFUs\/user manuals into the local language may differ within a single market, depending on the intended user of the device. Some member states dictate a requirement for all \u2018users\u2019, whereas others differentiate the requirements between layperson versus professional use\/use by healthcare professionals. In these cases, the following definitions\/notes should be considered:<\/span><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-2 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul class=\"has-black-color has-text-color\">\n<li><span style=\"color: #000000;\"><strong style=\"font-style: inherit;\">User<\/strong>: Any healthcare professional or lay person who uses a device<\/span><\/li>\n\n\n\n<li><span style=\"color: #000000;\"><strong style=\"font-style: inherit;\">Layperson<\/strong>: An individual who does not have formal education in a relevant field of healthcare or medical discipline.<\/span><\/li>\n\n\n\n<li><span style=\"color: #000000;\"><strong style=\"font-style: inherit;\">Professional<\/strong>: This generally refers to healthcare professionals<\/span><\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">The differing requirements between a layperson versus professional is generally based on the expected language knowledge of the end user. If the local authority believes that professional users are likely to have English language proficiency, they may allow the instructions for use\/user manual to be provided in English instead of the national language(s).<\/span><\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"3-exemptions\">Exemptions<\/h2>\n\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">Some member states may allow translation &#8216;exemptions&#8217; to their language requirements.<\/span><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">When a member state offers an exemption, it generally means that the manufacturer may submit a request to provide the IFU in a language not specified in the regulation, such as English. The manufacturer must have a strong justification that their end-users will fully understand the language in which they would like to provide the document.<\/span><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">Exemption allowances are typically related to professional-use products. It is not common practice for manufacturers to request exemptions and the process to request an exemption may not be clearly detailed in the member state&#8217;s regulation.<\/span><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><span style=\"color: #000000;\">If an exemption is of interest, you may contact the national competent authority to confirm if exemptions are possible and what information is required, if so.<\/span><\/p>\n\n\n\n<p><span style=\"color: #000000;\">We have noted within the Language Requirements Tool where exemptions may be possible.<\/span><\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"4-disclaimer-\"><strong>Disclaimer<\/strong><\/h2>\n\n\n\n<p>The regulation excerpts provided below are for reference only. In cases where an English translation of the regulation is not available, a Google translated version has been included instead. Casus Consulting LLC does not take responsibility for the accuracy of these translations. For full and complete information, manufacturers should review the full regulatory text linked within the tool.<\/p>\n\n\n\n<p>Casus Consulting LLC has taken due care in preparing this Language Requirements Tool. However, we do not guarantee, nor do assume legal liability or responsibility for, the accuracy or completeness of the information contained in these materials. The language requirements are publicly available on each Competent Authority website. Links are provided in the tool and individuals should verify the information published directly by the Competent Authority prior to taking action.<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"5-language-requirements-tool-\"><strong>Language Requirements Tool<\/strong><\/h2>\n\n\n\n<p>[vc_row el_id=&#8221;language_tool&#8221;][vc_column width=&#8221;1\/6&#8243;][\/vc_column]<\/p>\n\n\n\n<p><script type=\"text\/javascript\">var gform;gform||(document.addEventListener(\"gform_main_scripts_loaded\",function(){gform.scriptsLoaded=!0}),window.addEventListener(\"DOMContentLoaded\",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,initializeOnLoaded:function(o){gform.domLoaded&&gform.scriptsLoaded?o():!gform.domLoaded&&gform.scriptsLoaded?window.addEventListener(\"DOMContentLoaded\",o):document.addEventListener(\"gform_main_scripts_loaded\",o)},hooks:{action:{},filter:{}},addAction:function(o,n,r,t){gform.addHook(\"action\",o,n,r,t)},addFilter:function(o,n,r,t){gform.addHook(\"filter\",o,n,r,t)},doAction:function(o){gform.doHook(\"action\",o,arguments)},applyFilters:function(o){return gform.doHook(\"filter\",o,arguments)},removeAction:function(o,n){gform.removeHook(\"action\",o,n)},removeFilter:function(o,n,r){gform.removeHook(\"filter\",o,n,r)},addHook:function(o,n,r,t,i){null==gform.hooks[o][n]&&(gform.hooks[o][n]=[]);var e=gform.hooks[o][n];null==i&&(i=n+\"_\"+e.length),gform.hooks[o][n].push({tag:i,callable:r,priority:t=null==t?10:t})},doHook:function(n,o,r){var t;if(r=Array.prototype.slice.call(r,1),null!=gform.hooks[n][o]&&((o=gform.hooks[n][o]).sort(function(o,n){return o.priority-n.priority}),o.forEach(function(o){\"function\"!=typeof(t=o.callable)&&(t=window[t]),\"action\"==n?t.apply(null,r):r[0]=t.apply(null,r)})),\"filter\"==n)return r[0]},removeHook:function(o,n,t,i){var r;null!=gform.hooks[o][n]&&(r=(r=gform.hooks[o][n]).filter(function(o,n,r){return!!(null!=i&&i!=o.tag||null!=t&&t!=o.priority)}),gform.hooks[o][n]=r)}});<\/script>\n                <div class='gf_browser_unknown gform_wrapper gravity-theme gform-theme--no-framework' data-form-theme='gravity-theme' data-form-index='0' id='gform_wrapper_4' style='display:none'><div id='gf_4' class='gform_anchor' tabindex='-1'><\/div><form method='post' enctype='multipart\/form-data' target='gform_ajax_frame_4' id='gform_4'  action='\/wp-json\/wp\/v2\/pages\/3283#gf_4' data-formid='4' novalidate>\n                        <div class='gform-body gform_body'><div id='gform_fields_4' class='gform_fields top_label form_sublabel_below description_below validation_below'><div id=\"field_4_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_4_18\" ><h4><span style=\"color: #2e4972;\">For which market(s) would like like to see the requirements?<\/span><\/h4><\/div><fieldset id=\"field_4_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_4_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_4_6'><div class='gchoice gchoice_4_6_1'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.1' type='checkbox'  value='All Markets'  id='choice_4_6_1'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_6_1' id='label_4_6_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_4_6_2'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.2' type='checkbox'  value='Austria'  id='choice_4_6_2'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_6_2' id='label_4_6_2' class='gform-field-label gform-field-label--type-inline'>Austria<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_6_3'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.3' type='checkbox'  value='Belgium'  id='choice_4_6_3'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_6_3' id='label_4_6_3' class='gform-field-label gform-field-label--type-inline'>Belgium<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_6_4'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.4' type='checkbox'  value='Bulgaria'  id='choice_4_6_4'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_6_4' id='label_4_6_4' class='gform-field-label gform-field-label--type-inline'>Bulgaria<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_6_5'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.5' type='checkbox'  value='Croatia'  id='choice_4_6_5'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_6_5' id='label_4_6_5' class='gform-field-label gform-field-label--type-inline'>Croatia<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_6_6'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.6' type='checkbox'  value='Cyprus'  id='choice_4_6_6'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_6_6' id='label_4_6_6' class='gform-field-label gform-field-label--type-inline'>Cyprus<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_6_7'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.7' type='checkbox'  value='Czech Republic'  id='choice_4_6_7'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_6_7' id='label_4_6_7' 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_4_6_8'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.8' type='checkbox'  value='Denmark'  id='choice_4_6_8'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_6_8' id='label_4_6_8' class='gform-field-label gform-field-label--type-inline'>Denmark<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_6_9'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_6.9' type='checkbox'  value='Estonia'  id='choice_4_6_9'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_6_9' id='label_4_6_9' class='gform-field-label gform-field-label--type-inline'>Estonia<\/label>\n\t\t\t\t\t\t\t<\/div><\/div><\/div><\/fieldset><fieldset id=\"field_4_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_4_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_4_7'><div class='gchoice gchoice_4_7_1'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.1' type='checkbox'  value='Finland'  id='choice_4_7_1'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_7_1' id='label_4_7_1' class='gform-field-label gform-field-label--type-inline'>Finland<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_7_2'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.2' type='checkbox'  value='France'  id='choice_4_7_2'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_7_2' id='label_4_7_2' class='gform-field-label gform-field-label--type-inline'>France<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_7_3'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.3' type='checkbox'  value='Germany'  id='choice_4_7_3'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_7_3' id='label_4_7_3' class='gform-field-label gform-field-label--type-inline'>Germany<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_7_4'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.4' type='checkbox'  value='Greece'  id='choice_4_7_4'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_7_4' id='label_4_7_4' class='gform-field-label gform-field-label--type-inline'>Greece<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_7_5'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.5' type='checkbox'  value='Hungary'  id='choice_4_7_5'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_7_5' id='label_4_7_5' class='gform-field-label gform-field-label--type-inline'>Hungary<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_7_6'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.6' type='checkbox'  value='Iceland'  id='choice_4_7_6'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_7_6' id='label_4_7_6' class='gform-field-label gform-field-label--type-inline'>Iceland<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_7_7'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.7' type='checkbox'  value='Ireland'  id='choice_4_7_7'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_7_7' id='label_4_7_7' class='gform-field-label gform-field-label--type-inline'>Ireland<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_7_8'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.8' type='checkbox'  value='Italy'  id='choice_4_7_8'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_7_8' id='label_4_7_8' class='gform-field-label gform-field-label--type-inline'>Italy<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_7_9'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_7.9' type='checkbox'  value='Latvia'  id='choice_4_7_9'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_7_9' id='label_4_7_9' class='gform-field-label gform-field-label--type-inline'>Latvia<\/label>\n\t\t\t\t\t\t\t<\/div><\/div><\/div><\/fieldset><fieldset id=\"field_4_16\" 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_4_16\" ><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_4_16'><div class='gchoice gchoice_4_16_1'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_16.1' type='checkbox'  value='Lithuania'  id='choice_4_16_1'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_16_1' id='label_4_16_1' class='gform-field-label gform-field-label--type-inline'>Lithuania<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_16_2'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_16.2' type='checkbox'  value='Lichtenstein'  id='choice_4_16_2'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_16_2' id='label_4_16_2' class='gform-field-label gform-field-label--type-inline'>Lichtenstein<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_16_3'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_16.3' type='checkbox'  value='Luxembourg'  id='choice_4_16_3'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_16_3' id='label_4_16_3' class='gform-field-label gform-field-label--type-inline'>Luxembourg<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_16_4'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_16.4' type='checkbox'  value='Malta'  id='choice_4_16_4'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_16_4' id='label_4_16_4' class='gform-field-label gform-field-label--type-inline'>Malta<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_16_5'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_16.5' type='checkbox'  value='The Netherlands'  id='choice_4_16_5'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_16_5' id='label_4_16_5' 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_4_16_6'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_16.6' type='checkbox'  value='Norway'  id='choice_4_16_6'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_16_6' id='label_4_16_6' class='gform-field-label gform-field-label--type-inline'>Norway<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_16_7'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_16.7' type='checkbox'  value='Poland'  id='choice_4_16_7'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_16_7' id='label_4_16_7' class='gform-field-label gform-field-label--type-inline'>Poland<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_16_8'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_16.8' type='checkbox'  value='Portugal'  id='choice_4_16_8'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_16_8' id='label_4_16_8' class='gform-field-label gform-field-label--type-inline'>Portugal<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_16_9'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_16.9' type='checkbox'  value='Romania'  id='choice_4_16_9'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_16_9' id='label_4_16_9' class='gform-field-label gform-field-label--type-inline'>Romania<\/label>\n\t\t\t\t\t\t\t<\/div><\/div><\/div><\/fieldset><fieldset id=\"field_4_19\" 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_4_19\" ><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_4_19'><div class='gchoice gchoice_4_19_1'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_19.1' type='checkbox'  value='Slovakia'  id='choice_4_19_1'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_19_1' id='label_4_19_1' class='gform-field-label gform-field-label--type-inline'>Slovakia<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_19_2'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_19.2' type='checkbox'  value='Slovenia'  id='choice_4_19_2'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_19_2' id='label_4_19_2' class='gform-field-label gform-field-label--type-inline'>Slovenia<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_19_3'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_19.3' type='checkbox'  value='Spain'  id='choice_4_19_3'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_19_3' id='label_4_19_3' class='gform-field-label gform-field-label--type-inline'>Spain<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_19_4'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_19.4' type='checkbox'  value='Sweden'  id='choice_4_19_4'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_19_4' id='label_4_19_4' class='gform-field-label gform-field-label--type-inline'>Sweden<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_19_5'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_19.5' type='checkbox'  value='Switzerland'  id='choice_4_19_5'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_19_5' id='label_4_19_5' class='gform-field-label gform-field-label--type-inline'>Switzerland<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_19_6'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_19.6' type='checkbox'  value='Turkey'  id='choice_4_19_6'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_19_6' id='label_4_19_6' class='gform-field-label gform-field-label--type-inline'>Turkey<\/label>\n\t\t\t\t\t\t\t<\/div><div class='gchoice gchoice_4_19_7'>\n\t\t\t\t\t\t\t\t<input class='gfield-choice-input' name='input_19.7' type='checkbox'  value='United Kingdom'  id='choice_4_19_7'   \/>\n\t\t\t\t\t\t\t\t<label for='choice_4_19_7' id='label_4_19_7' 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_4_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_4_9\" ><h4><span style=\"color: #2e4972;\">Austria<\/span><\/h4>\n<strong>Layperson Use:<\/strong> German \n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> German or English\n<\/p>\n<p>\n<strong>Citation:<\/strong> <a href=\"https:\/\/www.ris.bka.gv.at\/Dokumente\/BgblAuth\/BGBLA_2021_I_122\/BGBLA_2021_I_122.html\" target=\"_blank\" rel=\"noopener\">Federal law amending the Medical Devices Act and the Health and Food Safety Act<\/a>\n<p style=\"text-align: left; padding-left: 80px;\"><em>Article 1 \u00a7 7.(1) Medical devices may only be given to the user or patient if the information accompanying the medical device is in German. For medical devices, the use of which is reserved exclusively for professional users, this information may also be in English.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_11\" ><h4><span style=\"color: #2e4972;\">Belgium<\/span><\/h4>\n<strong>Layperson Use:<\/strong> French, Dutch and German\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> French, Dutch German or English, but if providing in English, professional user may require that manufacturer provides the information in the national language of their choice, i.e., the manufacturer may be required provide information in French, Dutch or German.\n<\/p>\n<p>\n<strong>Regulation:<\/strong> <a href=\"http:\/\/www.ejustice.just.fgov.be\/eli\/loi\/2020\/12\/22\/2021030071\/moniteur\" target=\"_blank\" rel=\"noopener\">Law relating to medical devices<\/a>\n<p style=\"text-align: left; padding-left: 80px;\"><em>Article 9. \u00a7 1. Pursuant to Article 10(11) of the regulation 2017\/745, the manufacturers support the devices made available to the user or patient on the Belgian territory of the information referred to in Annex I, section 23, of Regulation 2017\/745<\/em>\n<em>in the three national languages. By way of exception, for devices whose users are exclusively healthcare professionals, this information may be provided in English. In this case, however, the user may require the manufacturer to provide this information in the national language of their choice.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_50\" 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_4_50\" ><h4><span style=\"color: #2e4972;\">Bulgaria<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Bulgarian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Bulgarian\n<\/p>\n<p>\n<strong>Citation:<\/strong> <a href=\"https:\/\/www.bda.bg\/images\/stories\/documents\/legal_acts\/20210208_ZMI_english.pdf\" target=\"_blank\" rel=\"noopener\">Medical Devices Act<\/a>\n<p style=\"text-align: left; padding-left: 80px;\"><em>Article 16 (3) The instruction for use shall also be written in Bulgarian language.<\/em><\/p>\n<\/p>\n<\/div><div id=\"field_4_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_4_15\" ><h4><span style=\"color: #2e4972;\">Croatia<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Croatian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Croatian and\/or English\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/narodne-novine.nn.hr\/clanci\/sluzbeni\/2018_11_100_1930.html\" target=\"_blank\" rel=\"noopener\">Act on the Implementation of Medical Devices Regulation (EU) 2017\/745 and In Vitro Medical Device Regulation (EU) 2017\/746 (Official Gazette No. 100\/18)<\/a>\n<p style=\"padding-left: 80px;\"><em>Article 30: (1) Data and documentation used in the implementation of the regulations referred to in Article 2 of this Act, and intended for patients and lay people, must be in the Croatian language. (2) Data and documentation used in the implementation of the regulations referred to in Article 2 of this Act, and intended for the competent authorities or exclusively for use in the performance of health care activities, may be in Croatian and \/ or English.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_20\" ><h4><span style=\"color: #2e4972;\">Cyprus<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Greek\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Greek or English\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.moh.gov.cy\/moh\/mphs\/mphs.nsf\/All\/A82FE3D75F4BF2CAC225850A0036075A?OpenDocument\" target=\"_blank\" rel=\"noopener\">Requirements for the placement of Medical Devices in the Cypriot Market<\/a>\n<p style=\"padding-left: 80px;\"><em> We also inform you that the Competent Authority of Medical Equipment of Cyprus accepts Greek as the official language for products intended to be used by non-health professionals, while for products intended for health professionals the English language is also acceptable.<\/em><\/p><\/div><div id=\"field_4_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_4_22\" ><h4><span style=\"color: #2e4972;\">Czech Republic<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Czech\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Czech\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.niszp.cz\/sites\/default\/files\/dokumenty\/89_2021%20MD_AJ.pdf \" target=\"_blank\" rel=\"noopener\">Act No. 89\/2021 Coll., on Medical Devices and on Amendment to Act No 378\/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals)<\/a>\n<p style=\"padding-left: 80px;\"><em>Section 8. (2) The manufacturer shall be obliged to provide the information referred to under Art. 10(11) of the Medical Device Regulation and information listed under Art. 18(1)(a) to (d) of the Medical Device Regulation in the Czech language.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_23\" ><h4><span style=\"color: #2e4972;\">Denmark<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Danish\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Danish, with possible exemptions\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.retsinformation.dk\/eli\/lta\/2023\/837\" target=\"_blank\" rel=\"noopener\"> Executive order no. 837 of 20 June 2023 on medical devices etc. (in Danish only)<\/a>\n<p style=\"padding-left: 80px;\"><em> \u00a7 3. Labeling and instructions for use for equipment and IVD equipment must be written in Danish when the equipment is made available to the end user or patient in Denmark, cf. however subsection 2.\n<\/p>\n<p>\n<\/a>\n<p style=\"padding-left: 80px;\"><em>PCS. 2. The Danish Medicines Agency may exceptionally allow the information on the labeling and in the instructions for use not to be written in Danish, if health considerations justify this, cf. however subsection 3 as regards medical devices for in vitro diagnostics.\n<\/p>\n<p>\n<\/a>\n<p style=\"padding-left: 80px;\"><em>PCS. 3. The Danish Medicines Agency cannot grant permission pursuant to subsection 2, if the medical equipment for in vitro diagnostics is for self-testing or near-patient testing, as defined in the regulation on medical equipment for in vitro diagnostics article 2, no. 5 and 6. <\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_42\" ><h4><span style=\"color: #2e4972;\">Estonia<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Estonian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Estonian or English\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.riigiteataja.ee\/en\/eli\/ee\/515032023005\/consolide\/current\" target=\"_blank\" rel=\"noopener\"> Estonia's 2004 Medical Devices Act<\/a>\n<p style=\"padding-left: 80px;\"><em>16(3) The manufacturer, relying on a risk analysis, determines the information necessary for the safe and appropriate use of the device, and the information accompanying the medical device placed on the market, made available on the market, distributed and put into use in Estonia is presented:\n<\/p>\n<p>\n<p style=\"padding-left: 80px;\"><em>1) in the Estonian language and in an appropriate manner if the medical device is intended for the use of lay users;\n<\/p>\n<p>\n<p style=\"padding-left: 80px;\"><em>2) in the Estonian or English language and in an appropriate manner if the medical device is intended only for the use of professional users;\n<\/p>\n<p>\n<p style=\"padding-left: 80px;\"><em>3) in the language understandable to a specific user and in an appropriate manner in case of a custom-made medical device.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_38\" ><h4><span style=\"color: #2e4972;\">Finland<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Finnish and Swedish. Exception may be possible for custom-made devices (see regulation excerpt below)\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Information necessary for 'safe use' must be in Finnish and Swedish.  Other information can be provided in Finnish, Swedish or English. The manufacturer must determine, based on a risk assessment, which information is necessary for 'safe use'.\n<\/p>\n<p>\nException may be possible for custom-made devices (see regulation excerpt below)\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\" https:\/\/www.finlex.fi\/fi\/laki\/kaannokset\/2021\/en20210719.pdf\" target=\"_blank\" rel=\"noopener\"> Medical Devices Act (719\/2021)<\/a>\n<p style=\"padding-left: 80px;\"><em> Section 5: Requirements for the language to be used - the information and documents referred to in Article 10(11) of the MD Regulation and in Article 10(10) of the IVD Regulation must be in Finnish, Swedish or English, unless the information is provided in the form of internationally recognised symbols. Information necessary for the safe use of a device must, however, be available in Finnish and in Swedish. The manufacturer must determine, based on a risk assessment, which information is necessary for safe use. If a device is intended for use by patients or other consumers, instructions for use and other information necessary for safe use must be available in Finnish and in Swedish. The user manuals and markings of devices manufactured for individual use referred to in the MD regulation must be in either Finnish or Swedish or in both languages \u200b\u200baccording to the user's needs.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_39\" ><h4><span style=\"color: #2e4972;\">France<\/span><\/h4>\n<strong>Layperson Use:<\/strong> French\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> French\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.legifrance.gouv.fr\/codes\/article_lc\/LEGIARTI000006916207\/#:~:text=L'%C3%A9tiquetage%20d'un%20dispositif,une%20version%20r%C3%A9dig%C3%A9e%20en%20fran%C3%A7ais.\" target=\"_blank\" rel=\"noopener\">Decree no. 95-292 of March 16, 1995 relating to the medical devices defined in article L. 665-3 of the public health code and modifying this code (second part: Decrees in Council of State)<\/a>\n<p style=\"padding-left: 80px;\"><em>Item R5211-20, The labeling of a medical device given to the end user or the patient, the leaflet that accompanies it, as well as any other information relating to its functioning or its use include a version written in French.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_37\" ><h4><span style=\"color: #2e4972;\">Germany<\/span><\/h4>\n<strong>Layperson Use:<\/strong> German\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> German, with possible exemptions\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.bundesgesundheitsministerium.de\/fileadmin\/Dateien\/3_Downloads\/Gesetze_und_Verordnungen\/GuV\/M\/Anpassung_des_Medizinprodukterechts.pdf\" target=\"_blank\" rel=\"noopener\">Medical Devices EU Adaptation Act \u2013 MPEUAnpG Medical Device Law Implementation Act (MPDG)<\/a>\n<p style=\"padding-left: 80px;\"><em>\u00a7 8th language regime for the EU Declaration of Conformity and for product information:\n(1) The manufacturer has made available on the market for products within the scope of this Act the EU declaration of conformity according to Article 19 Paragraph 1 of Regulation (EU) 2017\/745 in German or to be made available in English.\n(2) Within the scope of this Act, products may only be sold to users and patients if the users and patients certain information in German will be provided. In justified cases, the information may also be in English or another for the user of the medical device easy-to-understand language provided if this information is solely for professional users are intended and the safety-related information is also available in German or in the language of the user be asked.\n(3) The manufacturer of an implantable device has the information according to Article 18 paragraph 1 subparagraph 1 of Regulation (EU) 2017\/745 in German to provide language.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_40\" ><h4><span style=\"color: #2e4972;\">Greece<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Greek\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Greek, with possible exemptions\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.e-nomothesia.gr\/kat-ygeia\/farmakeia\/ya-du8d-gpoik-130648-2009.html\" target=\"_blank\" rel=\"noopener\"> Ministerial Decision \u0394\u03a58\u03b4 \/ \u0393.\u03a0.\u03bf\u03b9\u03ba. \/ 130648\/2009 - \u03a6\u0395\u039a 2198 \/ B \/ 2-10-2009<\/a>\n<p style=\"padding-left: 80px;\"><em> Article 4 (4) The information that must be available to the user and the patient according to Annex I point 13, must be complete and accurate in the Greek language, upon delivery to the end user, whether it is for professional use or another. Any contraindications or side effects should be clearly stated.\nThe EOF may, by way of derogation from the provisions of this Decision, decide on a case-by-case basis, for products intended exclusively for professional use, the exemption from the mandatory use of the Greek language in the information in Annex I, point 13, taking into account the principle of proportionality and in particular the possibility of indicating such indications by means of harmonized or recognized symbols or other measures, as well as the intended use of the product. In this case it is mandatory to indicate this information in English. <\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_35\" ><h4><span style=\"color: #2e4972;\">Hungary<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Hungarian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Hungarian\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/ogyei.gov.hu\/medical_devices \" target=\"_blank\" rel=\"noopener\">Hungarian National Institute of Pharmacy and Nutrition Website<\/a>\n<p style=\"padding-left: 80px;\"><em>The essential requirements (e.g. language requirements, etc.) should be fulfilled according to the relevant Hungarian decree.\nIf the product is available on the Hungarian market, the IFU and label of medical devices and IVD medical devices must be available in Hungarian.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_32\" 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_4_32\" ><h4><span style=\"color: #2e4972;\">Iceland<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Class I\/IIa - English or a Nordic language other than Finnish, Class IIb\/III - Icelandic\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> English, or a Nordic language other than Finnish\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.ima.is\/instructions-for-use\/\" target=\"_blank\" rel=\"noopener\">Icelandic Medicines Agency Website<\/a>\n<p style=\"padding-left: 80px;\"><em>Medical devices instructions for use intended for use by healthcare professionals may be published in English, or a Nordic language other than Finnish.<em><\/p>\n<p style=\"padding-left: 80px;\"><em>The general rule is that instructions for use intended for the general public shall be in Icelandic. In the case of medical devices in risk classes I and IIa, the instructions for use may be in English or a Nordic language other than Finnish.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_36\" ><h4><span style=\"color: #2e4972;\">Ireland<\/span><\/h4>\n<strong>Layperson Use:<\/strong> English\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> English\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.irishstatutebook.ie\/eli\/2017\/si\/547\/made\/en\/print\" target=\"_blank\" rel=\"noopener\">S.I. No. 547\/2017 - European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017<\/a>\n<p style=\"padding-left: 80px;\"><em>5. For the purposes of\u2014 (a) Articles 10(11) and (14), 11(3)(d), 18(1), 19(1), 41, 52(12), 56 and 89(8) of Regulation (EU) 2017\/745, and (b) Articles 10(10) and (13), 11(3)(d), 17(1), 37, 48(11), 51 and 88(8) of Regulation (EU) 2017\/746, the language determined by the State is the English language or both the Irish language and the English language.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_34\" ><h4><span style=\"color: #2e4972;\">Italy<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Italian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Italian\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.trovanorme.salute.gov.it\/norme\/dettaglioAtto?id=88953&completo=true\" target=\"_blank\" rel=\"noopener\">Decreto legislativo 137 del 5 agosto 2022<\/a>\n<p style=\"padding-left: 80px;\"><em>Article 6 (2.) Information and indications relating to any type of medical device, provided in writing by the manufacturer to the user and the patient in accordance with Annex I, paragraph 23 of the regulation, are expressed in Italian at time of delivery to the end user, for professional use\nor for any other use.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_41\" ><h4><span style=\"color: #2e4972;\">Latvia<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Latvian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Latvian\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.zva.gov.lv\/lv\/jaunumi-un-publikacijas\/jaunumi\/stingraks-es-regulejums-mediciniskam-iericem-nodrosinas-labaku-pacientu-veselibas-aizsardzibu-un\" target=\"_blank\" rel=\"noopener\">Press Release - May 26, 2021 - State Agency of Medicines<\/a>\n<p style=\"padding-left: 80px;\"><em>When medical devices are purchased, they must be accompanied by the instructions for use in the official language and must contain all the information necessary for their safe and proper use and for the manufacturer.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_33\" ><h4><span style=\"color: #2e4972;\">Lithuania<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Lithuanian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Lithuanian\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/vaspvt.gov.lt\/en\/node\/275\" target=\"_blank\" rel=\"noopener\">Lithuanian State Health Care Accreditation Agency Website<\/a>\n<p style=\"padding-left: 80px;\"><em>At the point when the device reaches the final user, irrespective of the users competence (professional or not), all information supplied by the manufacturer (label, instructions for use) must be in Lithuanian language.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_30\" ><h4><span style=\"color: #2e4972;\"> Lichtenstein<\/span><\/h4>\n<strong>Layperson Use:<\/strong> German\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> German or English (if all below criteria specified in regulation is met)\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\" https:\/\/www.gesetze.li\/konso\/2021161000?search_text=ewr-mepv&search_loc=text&lrnr=947.1&lgblid_von=&observe_date=02.11.2021\" target=\"_blank\" rel=\"noopener\">Liechtenstein State Law Gazette No. 161<\/a>\n<p style=\"padding-left: 80px;\"><em> Article 10, Defining the language - 1) The labeling and the instructions for use (product information) according to Art. 10 Para. 11 of Regulation (EU) 2017\/745 must be written in German. Symbols that are specified by technical standards can replace verbal statements. 2) Deviating from paragraph 1, the product information can be written in English, provided that: a) the product is only given to professionals or the product is a custom-made product or a product manufactured and used in a healthcare facility; b) it is ensured that the user has the necessary technical and linguistic requirements and agrees to the writing in English; c) the protection of patients, users and third parties is guaranteed; and d) the effective and performance-related application is not jeopardized.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_31\" ><h4><span style=\"color: #2e4972;\"> Luxembourg<\/span><\/h4>\n<strong>Layperson Use:<\/strong> French, German or Luxembourgish\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> French, German or Luxembourgish\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/data.legilux.public.lu\/file\/eli-etat-leg-memorial-1996-61-fr-pdf.pdf\" target=\"_blank\" rel=\"noopener\">DISPOSITIFS MEDICAUX<\/a>\n<p style=\"padding-left: 80px;\"><em> Article 4 - 4. The information which must be provided to the user and the patient in accordance with point 13 of Annex I must be written in one of the French, German or Luxembourgish languages when delivered to the end user, whether either for professional or other use. When the device is exclusively intended for professional use, these indications may also be written in English.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_29\" ><h4><span style=\"color: #2e4972;\">Malta<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Maltese or English\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Maltese or English\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/legislation.mt\/eli\/sl\/427.44\/eng\" target=\"_blank\" rel=\"noopener\">SUBSIDIARY LEGISLATION 427.44 - MEDICAL DEVICES REGULATIONS<\/a>\n<p style=\"padding-left: 80px;\"><em>5. (11) When a device reaches the final user, regardless of whetherit is for professional or other use, the information which must bemade available to the user and the patient in accordance with section 13 of Schedule I, shall be provided in, at least, the Maltese or English language<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_28\" ><h4><span style=\"color: #2e4972;\">Netherlands<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Dutch\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Dutch or English (if below criteria are met)\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/wetten.overheid.nl\/BWBR0043450\/2021-05-26\" target=\"_blank\" rel=\"noopener\">Medical Devices Regulation<\/a>\n<p style=\"padding-left: 80px;\"><em>Article 1 - Language requirements: 1. The information and general summary \nreferred to in Articles 10, paragraph 11, 18, paragraph 1, second subparagraph, and Annex XV, Chapter II, point 3.1.5 of Regulation (EU) 2017\/745 and 10, paragraph 10, of Regulation (EU) 2017\/746, are drawn up in the Dutch language. 2. By way of derogation from the first paragraph, the information referred to in Article 10, paragraph 11, of Regulation (EU) 2017\/745 and Article 10, paragraph 10, of Regulation (EU) 2017\/746 may be drawn up in the English language, insofar as the medical device or medical device for in vitro diagnostics is intended to be used exclusively by a healthcare provider and on the condition that the healthcare provider has an adequate command of the English language.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_27\" ><h4><span style=\"color: #2e4972;\">Norway<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Norwegian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Norwegian, with possible exemptions\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/lovdata.no\/dokument\/SF\/forskrift\/2021-05-09-1476#KAPITTEL_3\" target=\"_blank\" rel=\"noopener\">Regulations on medical equipment<\/a>\n<p style=\"padding-left: 80px;\"><em>\u00a7 8. \u00a7 8. Labeling and instructions for use - Information on the label and in the instructions for use of medical equipment must be given in Norwegian, cf. regulation (EU) 2017\/745 (MDR) article 10 no. 11 and regulation (EU) 2017\/746 (IVDR) article 10 no. 10. \u00a7 17. Exceptions - If safe and correct use is ensured, the Norwegian Medicines Agency can make exceptions to the Norwegian language requirement in section 8. <\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_26\" ><h4><span style=\"color: #2e4972;\">Poland<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Polish\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Polish or English with healthcare provider\u2019s written consent\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/lexlege.pl\/ustawa-o-wyrobach-medycznych\/art-14\/\" target=\"_blank\" rel=\"noopener\">Act of 7 April 2022 on Medical Devices (the \"Act\")<\/a>\n<p style=\"padding-left: 80px;\"><em> Polish language requirement for product markings and instructions\n1. Products intended for use in the territory of the Republic of Poland have markings and instructions for use in Polish or expressed with harmonized symbols or recognizable codes.\n2. It is allowed for devices intended for use in the territory of the Republic of Poland to be provided to healthcare providers, with their written consent, to have markings or instructions for use in English, with the exception of information intended for the patient, which is given in Polish or expressed with harmonized symbols or recognizable symbols. codes.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_25\" ><h4><span style=\"color: #2e4972;\">Portugal<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Portuguese\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Portuguese\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.infarmed.pt\/documents\/15786\/1076625\/122-A_DL_145_2009_2ALT.pdf\" target=\"_blank\" rel=\"noopener\">Decree-Law n.\u00ba 145\/2009, of June 17th<\/a>\n<p style=\"padding-left: 80px;\"><em>Article 5 (6) - The labeling and instructions for use of any devices must be written in Portuguese and comply with the provisions of paragraph 13 of Annex I of the present decree-law, of which it forms an integral part, or, in the case of provisions active implantable doctors, in numbers 17, 18 and 19 of annex x of this decree-law, of which it forms an integral part, regardless of whether or not they are intended for a professional use.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_24\" ><h4><span style=\"color: #2e4972;\">Romania<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Romanian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Romanian\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.anm.ro\/en\/_\/DM\/LEGISLATIE\/HG%20%20Nr%2054%20din%2029%20ianuarie%202009.pdf\" target=\"_blank\" rel=\"noopener\">Government Decision no. 54 of 29 January 2009 on conditions for placing on the market of medical devices, as amended<\/a>\n<p style=\"padding-left: 80px;\"><em> ART 11.(4) When a device reaches the end user, whether or not the device is in use professionally, the information provided in point 13 of annex no. 1, provided to the user and patient, must be written in Romanian.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_47\" 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_4_47\" ><h4><span style=\"color: #2e4972;\">Slovakia<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Slovakian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Slovakian\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.sukl.sk\/sk\/zdravotnicke-pomocky\/cko-faq\/vseobecne-otazky?page_id=5704\" target=\"_blank\" rel=\"noopener\">State Institute for Drug Control Website - FAQ Page<\/a>\n<p style=\"padding-left: 80px;\"><em>6. Must the marking of the device (label) and instructions for use for the medical device from a foreign manufacturer be in the Slovak language? Yes, this obligation results from \u00a7 110b paragraph 1 of Act No. 362\/2011 Coll. and \u00a7 2 paragraph 2 of Government Regulation No. 569\/2001 Coll.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_46\" 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_4_46\" ><h4><span style=\"color: #2e4972;\">Slovenia<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Slovenian\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Slovenian, with possible exemptions\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"http:\/\/www.pisrs.si\/Pis.web\/pregledPredpisa?id=ZAKO5503\" target=\"_blank\" rel=\"noopener\">Medical Devices Act (Official Gazette of the Republic of Slovenia, No. 98\/09)<\/a>\n<p style=\"padding-left: 80px;\"><em> Article 33 (5) Instructions for use must be written in the Slovenian language, legible and user-friendly, and must contain the date of issue or the date of the last correction or amendment. If they are translated into Slovenian, the content of the translation must be the same as the original instructions for use. If the medical device is intended exclusively for use in the performance of activities entered in a court or business register, the instructions for use may be written in a user-friendly language.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_45\" 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_4_45\" ><h4><span style=\"color: #2e4972;\">Spain<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Spanish\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Spanish\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.aemps.gob.es\/productosSanitarios\/prodSanitarios\/docs\/regulacion-Espana-PS.pdf?x25508\" target=\"_blank\" rel=\"noopener\">INFORMATION ON THE REGULATION IN SPAIN OF MEDICAL DEVICES (Summary updated on 03-21-2010)<\/a>\n<p style=\"padding-left: 80px;\"><em>LABELING OF MEDICAL DEVICES - The labeling of medical devices consists of the label and the instructions for use. The data that must appear on the label will comply with the provisions of point 13 of Annex I. The name and address of the manufacturer and, when the manufacturer is not in the European Union, the name and address of the authorized representative in the European Union must also appear on the label or in the instructions for use. At the time of distribution in Spain, the labeling of the products must appear in Spanish, as established in article 4.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_44\" ><h4><span style=\"color: #2e4972;\">Sweden<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Swedish\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Swedish, with possible exemptions\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.lakemedelsverket.se\/4afff9\/globalassets\/dokument\/lagar-och-regler\/hslf-fs\/hslf-fs-2021-96.pdf\" target=\"_blank\" rel=\"noopener\">Regulation (2021: 631) with supplementary provisions to EU regulations on medical devices<\/a>\n<p style=\"padding-left: 80px;\"><em> Chapter 3 Labeling, information and documentation\nSection 1 - The information referred to in Articles 18 (1) and 89 (8) and in section 23 of Annex I to Regulation (EU) 2017\/745 and the information referred to in Article 84 (8) and section 20 of Annex I to Regulation (EU) 2017\/746 shall be in Swedish when a product is provided to users or patients in Sweden, regardless of whether it is intended for professional or other use.<\/em><\/p>\n<\/p><\/div><div id=\"field_4_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_4_43\" ><h4><span style=\"color: #2e4972;\">Switzerland<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Italian, French and German\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Italian, French and German, exceptions noted in regulation excerpt below\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/en#art_16\" target=\"_blank\" rel=\"noopener\"> Medical Devices Ordinance (MedDO) of 1 July 2020 (Status as of 26 May 2021)<\/a>\n<p style=\"padding-left: 80px;\"><em> Art. 16 Product information \u2013 1. Product information comprises the labelling and instructions for use. It is governed by Chapter III of Annex I to EU-MDR23. 2. It must be written in all three official languages of Switzerland. Symbols established by means of technical standards may be used to replace written statements. 3.\tThe product information may be provided in fewer than the three official languages of Switzerland or in English, provided that: a. the device is supplied exclusively to professionals or is a custom-made device or a medical device manufactured and used in a healthcare institution; b. it is certain that the user meets the necessary professional and linguistic requirements and qualifications, and is in agreement; c. the protection of patients, users and third parties is ensured; and d. the efficacy and performance of the medical device are not placed at risk. 4. If requested, additional information must be provided to users in one of the official languages of Switzerland. <\/em><\/p>\n<\/p><\/div><div id=\"field_4_49\" 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_4_49\" ><h4><span style=\"color: #2e4972;\">Turkey<\/span><\/h4>\n<strong>Layperson Use:<\/strong> Turkish\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> Turkish\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.resmigazete.gov.tr\/eskiler\/2011\/06\/20110607-1.htm\" target=\"_blank\" rel=\"noopener\">MEDICAL DEVICE REGULATION<\/a>\n<p style=\"padding-left: 80px;\"><em>Article 6: (4) The information, user manuals, labels, maintenance-repair booklet and other explanations that must be given together with the medical device by the manufacturer for patients, users and practitioners, as specified in section (13) of Annex I , must be in Turkish when the medical device is placed on the market.<\/em><\/p>\n<\/p>\n<\/div><div id=\"field_4_48\" 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_4_48\" ><h4><span style=\"color: #2e4972;\">United Kingdom<\/span><\/h4>\n<strong>Layperson Use:<\/strong> English\n<p>\n<\/p>\n<p>\n<strong>Professional Use:<\/strong> English\n<\/p>\n<p>\n<strong>Citation: <\/strong><a href=\"https:\/\/www.legislation.gov.uk\/uksi\/2002\/618\/contents\" target=\"_blank\" rel=\"noopener\">The Medical Devices Regulations 2002<\/a>\n<p style=\"padding-left: 80px;\"><em>(3) In the case of a relevant device which is being or has been put into service\u2014 (a) the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and (b) the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if\u2014 (i) such instructions are in English or another Community language, and (ii) if the instructions are not in English, any packaging, label or promotional literature carries a clear statement in English stating the language in which the instructions are given.<\/em><\/p>\n<\/p><\/div><\/div><\/div>\n        <div class='gform_footer top_label'> <input type='submit' id='gform_submit_button_4' class='gform_button button' value='Submit'  onclick='if(window[\"gf_submitting_4\"]){return false;}  if( !jQuery(\"#gform_4\")[0].checkValidity || jQuery(\"#gform_4\")[0].checkValidity()){window[\"gf_submitting_4\"]=true;}  ' 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\n\t\t\t\t\t\t\t\t\tdata-type=\"row\"\n\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\tdata-dim=\"minh:300px,220px,auto,auto;\"\n\t\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\tdata-margin=\"t:150,150,70,70;b:150;\"\n\t\t\t\t\t\t\t\t\tdata-padding=\"r:65,75,50,50;l:65,75,50,50;\"\n\t\t\t\t\t\t\t\t\tdata-frame_1=\"sR:10;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8690;sA:9000;\"\n\t\t\t\t\t\t\t\t\tstyle=\"z-index:5;\"\n\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-6\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:0,100px,0,0;yo:0,100px,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/12\/shutterstock_2197042063-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-16\" \n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-color=\"#c5a477\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:5px,5px,0,0;yo:5px,5px,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:15;l:15;ls:2px;fw:600;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:0,0,150,150;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:40;r:20;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:8;font-family:'Poppins';display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t> \n\t\t\t\t\t\t\t\t\t\t<\/rs-layer><!--\n\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-3\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/eu-language-translation-requirements\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>EU Language Requirements Tool \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-7\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:278px,347px,0,0;yo:0,0,321px,321px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:9;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/06\/EU-Medical-Device-and-IVD-Registration-Requirements-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-15\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/eu-registration-requirements\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:10;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>EU Registration Requirements Tool \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-8\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:556px,694px,694px,694px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:12;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/11\/Significant-Changes-MDR-IVDR-legacy-devices-scaled.jpg') no-repeat right center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-19\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/mdr-ivdr-legacy-medical-device-2020-3-ivd-2022-6-mdcg-significant-change-guidance\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:5px,0,0,0;yo:5px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:13;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Significant Changes Assessment Tool \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-13\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:15;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/06\/EU-Vigilance-Contacts-Medical-Devices-and-IVDs-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-404-layer-17\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/eu-vigilance-requirements\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:16;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>EU Vigilance Requirements Tool \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\t\t\t\t\t\t\t\t--><\/rs-row><!--\n\t\t\t\t\t\t\t--><\/rs-zone><!--\n-->\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t\t<rs-slide style=\"position: absolute;\" data-key=\"rs-405\" data-title=\"Slide\" data-anim=\"ms:600;\" data-in=\"o:0;\" data-out=\"a:false;\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/\/casusconsulting.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/dummy.png\" alt=\"Slide\" title=\"Language Requirements Tool\" class=\"rev-slidebg tp-rs-img rs-lazyload\" data-lazyload=\"\/\/casusconsulting.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/transparent.png\" data-bg=\"c:#eeeeee;\" data-parallax=\"off\" data-no-retina>\n<!--\t\t\t\t\t\t--><rs-zone id=\"rrzt_405\" class=\"rev_row_zone_top\" style=\"z-index: 5;\"><!--\n\n\t\t\t\t\t\t\t\t--><rs-row\n\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-5\" \n\t\t\t\t\t\t\t\t\tdata-type=\"row\"\n\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\tdata-dim=\"minh:300px,220px,auto,auto;\"\n\t\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\tdata-margin=\"t:150,150,70,70;b:150;\"\n\t\t\t\t\t\t\t\t\tdata-padding=\"r:65,75,50,50;l:65,75,50,50;\"\n\t\t\t\t\t\t\t\t\tdata-frame_1=\"sR:10;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8690;sA:9000;\"\n\t\t\t\t\t\t\t\t\tstyle=\"z-index:5;\"\n\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-6\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:0,100px,0,0;yo:0,100px,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/01\/shutterstock_1405283762-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-3\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/list-mdr-ivdr-harmonized-standards-common-specifications\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Harmonized Standards & Common Specifications \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-7\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:278px,347px,0,0;yo:0,0,321px,321px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:9;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/03\/shutterstock_1636720918-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-15\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/ukca-marking-medical-devices-ivds\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:10;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>UKCA Marking Medical Devices \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-8\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:556px,694px,694px,694px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;b:0,0,30,30;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-border=\"bor:0px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:12;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/11\/shutterstock_258687632-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-19\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/gmdn-emdn-and-cnd\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:5px,0,0,0;yo:5px,0,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:13;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Overview of GMDN, EMDN and CND \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-13\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:100px;yo:100px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"l:22;a:inherit;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:25%;a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-margin=\"r:15,5,0,0;l:15,5,0,0;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:50;sp:750;sR:40;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:15;background:url('https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/07\/shutterstock_665882575-scaled.jpg') no-repeat center center;background-size:cover;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><a\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-184-slide-405-layer-17\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rs-layer tp-linkmod\"\n\t\t\t\t\t\t\t\t\t\t\thref=\"https:\/\/casusconsulting.com\/registering-devices-in-eudamed\/\" target=\"_blank\" rel=\"noopener\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;l:30;fw:500,400,400,400;a:center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:100%;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:-55;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"t:70;r:20;b:40;l:20;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.out;st:50;sp:750;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8200;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"c:#fff;bgc:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);oX:50;oY:50;td:underline;sp:0;e:none;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:16;background:linear-gradient(rgba(45,48,50,0) 0%, rgba(45,48,50,0.85) 100%);font-family:'Poppins';cursor:pointer;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Guide to Registering Devices in EUDAMED \n\t\t\t\t\t\t\t\t\t\t<\/a><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\t\t\t\t\t\t\t\t--><\/rs-row><!--\n\t\t\t\t\t\t\t--><\/rs-zone><!--\n-->\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t<\/rs-slides>\n\t\t\t\t\t<rs-static-layers class=\"rs-stl-visible\"><!--\n\n\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\tid=\"slider-184-slide-176-layer-1\" \n\t\t\t\t\t\t\t\tclass=\"rs-layer-static\"\n\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\tdata-xy=\"x:c;xo:10px,0,0,0;yo:0,130px,55px,55px;\"\n\t\t\t\t\t\t\t\tdata-text=\"s:15,15,12,12;l:38,38,28,28;ls:2px;fw:500,600,600,600;a:inherit;\"\n\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\tdata-rsp_o=\"off\"\n\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\tdata-onslides=\"s:1;\"\n\t\t\t\t\t\t\t\tdata-margin=\"t:60,0,0,0;\"\n\t\t\t\t\t\t\t\tdata-padding=\"t:2;r:40,40,30,30;l:42,42,32,32;\"\n\t\t\t\t\t\t\t\tdata-frame_0=\"o:1;\"\n\t\t\t\t\t\t\t\tdata-frame_0_sfx=\"se:blocktoright;\"\n\t\t\t\t\t\t\t\tdata-frame_1=\"e:power4.inOut;sp:50;\"\n\t\t\t\t\t\t\t\tdata-frame_1_sfx=\"se:blocktoright;\"\n\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;sR:8250;\"\n\t\t\t\t\t\t\t\tstyle=\"z-index:5;background-color:#000000;font-family:'Poppins';text-transform:uppercase;\"\n\t\t\t\t\t\t\t>Additional Resources \n\t\t\t\t\t\t\t<\/rs-layer><!--\n\t\t\t\t\t--><\/rs-static-layers>\n\t\t\t\t<\/rs-module>\n\t\t\t\t<script>\n\t\t\t\t\tsetREVStartSize({c: 'archives',rl:[1240,1024,778,480],el:[600,300,960,720],gw:[1240,1024,778,480],gh:[400,300,960,720],type:'carousel',justify:'',layout:'fullwidth',mh:\"0\"});if (window.RS_MODULES!==undefined && window.RS_MODULES.modules!==undefined && window.RS_MODULES.modules[\"archives\"]!==undefined) {window.RS_MODULES.modules[\"archives\"].once = false;window.revapi184 = undefined;if (window.RS_MODULES.checkMinimal!==undefined) window.RS_MODULES.checkMinimal()}\n\t\t\t\t<\/script>\n\t\t\t<\/rs-module-wrap>\n\t\t\t<!-- END REVOLUTION SLIDER -->\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Free EU MDR\/IVDR Language Translation Tool. Confirm IFU translation requirements for medical devices &#038; IVDs in Europe, UK and Switzerland, plus if exemptions are allowed.<\/p>\n","protected":false},"author":2,"featured_media":8389,"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-MDR-Translation-Requirements-Medical-Devices-and-IVDs-scaled.jpg","_links":{"self":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/3283"}],"collection":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/comments?post=3283"}],"version-history":[{"count":62,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/3283\/revisions"}],"predecessor-version":[{"id":11712,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/pages\/3283\/revisions\/11712"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media\/8389"}],"wp:attachment":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media?parent=3283"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}