{"id":26107,"date":"2021-10-28T13:22:09","date_gmt":"2021-10-28T13:22:09","guid":{"rendered":"https:\/\/translatebyhumans.com\/?p=26107"},"modified":"2023-01-24T09:01:12","modified_gmt":"2023-01-24T09:01:12","slug":"medical-device-translations-the-eu-mdr-perspective","status":"publish","type":"post","link":"https:\/\/translatebyhumans.com\/blog\/medical-device-translations-the-european-union-medical-device-regulation\/","title":{"rendered":"Medical Device Translations: The EU MDR Perspective"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"26107\" class=\"elementor elementor-26107\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4d561977 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4d561977\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-45a82535\" data-id=\"45a82535\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-19f242ae elementor-widget elementor-widget-tbhtheme-category-listing\" data-id=\"19f242ae\" data-element_type=\"widget\" data-widget_type=\"tbhtheme-category-listing.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<ul class=\"tbh-category-listing\"><li style=\"background-image: url(https:\/\/translatebyhumans.com\/wp-content\/uploads\/2020\/09\/banner3-01-1024x288.jpg)\"><a href=\"https:\/\/translatebyhumans.com\/blog\/category\/life-sciences\/\">Life Sciences<\/a><\/li><\/ul>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-52e58c67 tbh-author-info elementor-widget elementor-widget-post-info\" data-id=\"52e58c67\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/translatebyhumans.com\/wp-content\/plugins\/elementor\/assets\/css\/widget-icon-list.min.css\"><link rel=\"stylesheet\" href=\"https:\/\/translatebyhumans.com\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-a165090 elementor-inline-item\" itemprop=\"author\">\n\t\t\t\t\t\t<a href=\"https:\/\/translatebyhumans.com\/blog\/author\/shifa_translatebyhumans\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<img decoding=\"async\" class=\"elementor-avatar\" src=\"https:\/\/translatebyhumans.com\/wp-content\/uploads\/2021\/07\/Image-2021-07-08-13_44_07.70-150x150.jpg\" alt=\"Picture of Shifa Miyaji\" loading=\"lazy\">\n\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-author\">\n\t\t\t\t\t\t\t\t\t\tShifa Miyaji\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-47b2da2 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\t<time>October 28, 2021<\/time>\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-561c67ef elementor-widget elementor-widget-text-editor\" data-id=\"561c67ef\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.21.0 - 08-05-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">The medical device industry is one of the largest industries in healthcare, and its growth is exponentially on the rise.\u00a0The market size for <a href=\"https:\/\/www.precedenceresearch.com\/medical-devices-market#:~:text=The%20global%20medical%20devices%20market,forecast%20period%202020%20to%202027.\">global medical devices<\/a> was valued at US$ 447.63 Billion in 2019, and by 2027, its value is expected to be US$ 671.49 billion.\u00a0\u00a0<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">The latest medical devices are constantly driven by new technologies and innovations, requiring in-depth research, stringent testing and bio-technical mastery. Yet, this entire process is just the tip of the iceberg. When it comes to launching the final product or device in the market (both local and foreign), there is a long list of stringent regulations that companies must follow for their product to be eligible for use. These involve major administrative, linguistic and regulatory requirements where errors or inaccuracy can cost you a lot!<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">This immediately calls upon a dire need for multilingual translation services. <a href=\"https:\/\/translatebyhumans.com\/en\/services\/translation\/medical\/medical-device\/\">Medical device translation<\/a> is one of the most complex and demanding types of translation. And you need to be doing it 100% right to save lives.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">Firstly, let&#8217;s take a deeper look at what qualifies as a medical device. Here, we shall discuss the medical device product cycle, the changes brought by the Medical Device Regulation in the European Union and best practices for accurate translations.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-47bd8e50 elementor-widget elementor-widget-heading\" data-id=\"47bd8e50\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.21.0 - 08-05-2024 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">How is a medical device defined?  \n<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b760f5d elementor-widget elementor-widget-text-editor\" data-id=\"b760f5d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">According to the FDA (US Food &amp; Drug Administration), a medical device is used to diagnose, prevent, or treat a medical disease or condition without causing any chemical reaction on any part of the body.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">There are mainly 3 classes of medical devices, but they can slightly vary depending upon the country or the region, as is visible below.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f260a6a elementor-widget elementor-widget-image\" data-id=\"f260a6a\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.21.0 - 08-05-2024 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t<figure class=\"wp-caption\">\n\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"453\" height=\"221\" src=\"https:\/\/translatebyhumans.com\/wp-content\/uploads\/2021\/10\/medical-device-classification-1.png\" class=\"attachment-large size-large wp-image-34221\" alt=\"Medical Device Classification\" \/>\t\t\t\t\t\t\t\t\t\t\t<figcaption class=\"widget-image-caption wp-caption-text\">Medical Device Classification According To Different Countries<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-be43ce2 elementor-widget elementor-widget-heading\" data-id=\"be43ce2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">From Product Development To Market Launch<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d8d46dc elementor-widget elementor-widget-text-editor\" data-id=\"d8d46dc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">After a detailed market analysis and research about its market demand, a team of biotech experts and innovators finalise the concept and design of the medical device. The next few stages involve multiple rounds of clinical trials, testings, feedbacks and reviews until the device is error-free, safe and effective and its operability is crystal clear.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">Once the medical devices are manufactured, companies send forward their products to users and medical institutions on a global scale. Most countries and regions have their own medical device regulations for market entry. These are highly regulated &#8211; any content associated with the device is closely scrutinised before entering a new market. As such, these documents and their medical translations must be accurate.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000005714001\" data-doc-type=\"writer\">Check out this video that explains the difference in regulations and regulatory bodies in the USA and the European Union.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-65ddf2a9 elementor-widget elementor-widget-video\" data-id=\"65ddf2a9\" data-element_type=\"widget\" data-settings=\"{&quot;youtube_url&quot;:&quot;https:\\\/\\\/youtu.be\\\/UMp6TTU5D6k&quot;,&quot;show_image_overlay&quot;:&quot;yes&quot;,&quot;image_overlay&quot;:{&quot;url&quot;:&quot;https:\\\/\\\/translatebyhumans.com\\\/wp-content\\\/uploads\\\/2021\\\/02\\\/blog-3.svg&quot;,&quot;id&quot;:1617,&quot;size&quot;:&quot;&quot;},&quot;lazy_load&quot;:&quot;yes&quot;,&quot;video_type&quot;:&quot;youtube&quot;,&quot;controls&quot;:&quot;yes&quot;}\" data-widget_type=\"video.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.21.0 - 08-05-2024 *\/\n.elementor-widget-video .elementor-widget-container{overflow:hidden;transform:translateZ(0)}.elementor-widget-video .elementor-wrapper{aspect-ratio:var(--video-aspect-ratio)}.elementor-widget-video .elementor-wrapper iframe,.elementor-widget-video .elementor-wrapper video{height:100%;width:100%;display:flex;border:none;background-color:#000}@supports not (aspect-ratio:1\/1){.elementor-widget-video .elementor-wrapper{position:relative;overflow:hidden;height:0;padding-bottom:calc(100% \/ var(--video-aspect-ratio))}.elementor-widget-video .elementor-wrapper iframe,.elementor-widget-video .elementor-wrapper video{position:absolute;top:0;right:0;bottom:0;left:0}}.elementor-widget-video .elementor-open-inline .elementor-custom-embed-image-overlay{position:absolute;top:0;right:0;bottom:0;left:0;background-size:cover;background-position:50%}.elementor-widget-video .elementor-custom-embed-image-overlay{cursor:pointer;text-align:center}.elementor-widget-video .elementor-custom-embed-image-overlay:hover .elementor-custom-embed-play i{opacity:1}.elementor-widget-video .elementor-custom-embed-image-overlay img{display:block;width:100%;aspect-ratio:var(--video-aspect-ratio);-o-object-fit:cover;object-fit:cover;-o-object-position:center center;object-position:center center}@supports not (aspect-ratio:1\/1){.elementor-widget-video .elementor-custom-embed-image-overlay{position:relative;overflow:hidden;height:0;padding-bottom:calc(100% \/ var(--video-aspect-ratio))}.elementor-widget-video .elementor-custom-embed-image-overlay img{position:absolute;top:0;right:0;bottom:0;left:0}}.elementor-widget-video .e-hosted-video .elementor-video{-o-object-fit:cover;object-fit:cover}.e-con-inner>.elementor-widget-video,.e-con>.elementor-widget-video{width:var(--container-widget-width);--flex-grow:var(--container-widget-flex-grow)}<\/style>\t\t<div class=\"elementor-wrapper elementor-open-inline\">\n\t\t\t<div class=\"elementor-video\"><\/div>\t\t\t\t<div class=\"elementor-custom-embed-image-overlay\" style=\"background-image: url(https:\/\/translatebyhumans.com\/wp-content\/uploads\/2021\/02\/blog-3.svg);\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-custom-embed-play\" role=\"button\" aria-label=\"Play Video\" tabindex=\"0\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-play\"><\/i>\t\t\t\t\t\t\t<span class=\"elementor-screen-only\">Play Video<\/span>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b7349ae elementor-widget elementor-widget-text-editor\" data-id=\"5b7349ae\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">Some of the materials that regulatory bodies typically require to translate include:<\/p><ol><li class=\"zw-list zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-left=\"0.5in\" data-text-indent=\"-0.25in\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-list-id=\"70013811\" data-list-info=\"{&quot;id&quot;:&quot;70013811&quot;,&quot;l&quot;:0}\">packaging and labels<\/li><li class=\"zw-list zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-left=\"0.5in\" data-text-indent=\"-0.25in\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-list-id=\"70013811\" data-list-info=\"{&quot;id&quot;:&quot;70013811&quot;,&quot;l&quot;:0}\">marketing materials<\/li><li class=\"zw-list zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-left=\"0.5in\" data-text-indent=\"-0.25in\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-list-id=\"70013811\" data-list-info=\"{&quot;id&quot;:&quot;70013811&quot;,&quot;l&quot;:0}\">instructions for use<\/li><li class=\"zw-list zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-left=\"0.5in\" data-text-indent=\"-0.25in\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-list-id=\"70013811\" data-list-info=\"{&quot;id&quot;:&quot;70013811&quot;,&quot;l&quot;:0}\">software and user interface\u00a0<\/li><\/ol>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-680ec0b elementor-widget elementor-widget-text-editor\" data-id=\"680ec0b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">In general, you need to translate all documents such as clinical trials, administrative records, and quality management system certificates that regulators will use to assess a device and approve whether it can be imported and distributed to the target market.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">These requirements make medical device translation integral in the approval process.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">As over half a million different medical devices are available in the European Union alone, the European Union (EU), in 2017, published a comprehensive list of requirements for medical device companies to produce and commercialise their medical devices being distributed to the EU market. An essential element in this is how companies are required to handle their translation submittals.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f9d9b5 elementor-widget elementor-widget-heading\" data-id=\"5f9d9b5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">A Brief Introduction About The EU MDR<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad971cb elementor-widget elementor-widget-text-editor\" data-id=\"ad971cb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">The <strong>European Medical Device Regulation (MDR)<\/strong> is the latest set of regulations governing the production and distribution of medical devices in Europe. Compliance with the regulation is mandatory for medical device manufacturers, importers, and distributors that wish to target the European marketplace.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">The Medical Device Regulations were established on 5 April 2017. There were many reasons which required the previous MDD (Medical Devices Directive) to be updated.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">For instance, software as a medical device (SaMD) wasn&#8217;t yet evolved, and hence, there were no direct mentions of it in the directive, but now, they&#8217;re a substantial part of the medical device industry.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">The altering of demographics and the growing push for transparency of medical device technical information to the general public are also some reasons why the MDR was put in place for a more robust EU legislative framework that ensures better protection of public health and patient safety.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">The EU Regulations were first published in May 2017. The MDR initially provided for a three-year transition period; however, due to the global outbreak of Covid-19, the application of the MDR was extended and became fully applicable on 26 May 2021.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">Compared to its predecessor, the MDD, the new European MDR is less focused on the pre-approval stage of medical device manufacturing. Instead, it promotes a life-cycle approach to medical device regulation.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">\u00a0<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34ff65db elementor-widget elementor-widget-image\" data-id=\"34ff65db\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t<figure class=\"wp-caption\">\n\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"700\" height=\"304\" src=\"https:\/\/translatebyhumans.com\/wp-content\/uploads\/2021\/10\/hpra-infographic-timeline-and-transition-to-the-new-medical-device-regulations.jpeg\" class=\"attachment-full size-full wp-image-34217\" alt=\"EU MDR Timeline\" \/>\t\t\t\t\t\t\t\t\t\t\t<figcaption class=\"widget-image-caption wp-caption-text\">The EU MDR Timeline<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-15b13db elementor-widget elementor-widget-text-editor\" data-id=\"15b13db\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">You can access the entire EU Medical Device Regulation <a href=\"https:\/\/www.medical-device-regulation.eu\/wp-content\/uploads\/2019\/05\/CELEX_32017R0745_EN_TXT.pdf\">here<\/a>.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-30d792ce elementor-widget elementor-widget-heading\" data-id=\"30d792ce\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Language, Translations And The EU MDR\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1d9fc913 elementor-widget elementor-widget-text-editor\" data-id=\"1d9fc913\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">With the new EU MDR in place, translations are now even more critical than they were before. Now, manufacturers will be responsible for acquiring them themselves rather than relying on the EU member states for these. Make sure you adhere to the following points that talk about the language aspect of medical devices as part of the EU regulation:<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-61e173f elementor-widget elementor-widget-heading\" data-id=\"61e173f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">1. All medical device documents need to be translated into all 24 EU languages<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-267032c elementor-widget elementor-widget-text-editor\" data-id=\"267032c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000005714001\" data-doc-type=\"writer\"><span data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">The regulation states that to be compliant, all content must be translated into the 24 official languages of the EU member countries where the devices plan on being distributed. The official EU languages are: Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish &amp; Swedish. <\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eea2040 elementor-widget elementor-widget-heading\" data-id=\"eea2040\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">2. Translations, in some cases, are required even prior to the CE marking \n<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50c8402 elementor-widget elementor-widget-text-editor\" data-id=\"50c8402\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000005714001\" data-doc-type=\"writer\"><span data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">Each medical device must be certified with a &#8216;CE&#8217; (Conformit\u00e9 Europ\u00e9enne) mark to demonstrate compliance before it is sent out to the market. Some devices may even require more than one CE mark depending upon whether they are made up of different parts or accessories. Previously, translations came into the picture after a medical device received the CE marking, but now translations of documents like Instructions for Use (IFUs) must be submitted before the CE marking as part of the technical dossier, which is required by the notified bodies for conformity assessment.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e3b66f elementor-widget elementor-widget-heading\" data-id=\"5e3b66f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">3. All translations must be precise and clear\n<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9f11726 elementor-widget elementor-widget-text-editor\" data-id=\"9f11726\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000005714001\" data-doc-type=\"writer\"><span data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">It is crucial to ensure that the end-user\u2014healthcare staff, patients, or associated users &#8211; know how to operate any particular device. In particular, the utmost precision is required for medical device translation, as professionals worldwide will need to know the correct way to use the equipment. As such, appropriate and accurate medical device labelling is essential. Hence, choosing translators with expertise in the medical field isn&#8217;t enough. They need to be native speakers of the targeted language too.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-601ef08 elementor-widget elementor-widget-heading\" data-id=\"601ef08\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">4. All translated data must be stored in a European database\n<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0b1e493 elementor-widget elementor-widget-text-editor\" data-id=\"0b1e493\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-left=\"0in\" data-text-indent=\"0in\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">The MDR also introduced new databases for clinical investigations, product registration, and marketing surveillance &#8211; <a href=\"http:\/\/ec.europa.eu\/idabc\/en\/document\/2256\/5637.html\">EUDAMED (European Database for Medical Devices)<\/a>. This will function as part of a system of several databases that allows medical device companies, consumers, regulators, and even Notified Bodies to access the latest data on medical devices for sale in Europe. This will ensure that the data in all applicable languages is accessible to be logged and exchanged.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-01a7366 elementor-widget elementor-widget-heading\" data-id=\"01a7366\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">How to Select The Ideal Translation Agency To Prepare You For The EU MDR?<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75d6b9f elementor-widget elementor-widget-text-editor\" data-id=\"75d6b9f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">Experienced translation agencies understand and can help you adhere to the new requirements with timely compliance, accuracy and relevant skills. Don&#8217;t make the mistake of approaching translated device documents as an afterthought, especially when trying to enter a foreign market.<\/p><p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{&quot;fgc&quot;:&quot;rgb(0,0,0)&quot;,&quot;size&quot;:&quot;12.00&quot;,&quot;type&quot;:&quot;text&quot;}\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\">You know you can&#8217;t risk it as lives are at stake when it comes to medical devices. Just remember these simple rules to get quality medical device documentation translations.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e0da201 elementor-widget elementor-widget-image\" data-id=\"e0da201\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t<figure class=\"wp-caption\">\n\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"538\" height=\"613\" src=\"https:\/\/translatebyhumans.com\/wp-content\/uploads\/2021\/10\/Checklist-Medical-Device-Translations-1.png\" class=\"attachment-large size-large wp-image-34213\" alt=\"Checklist - Medical Device Translations\" \/>\t\t\t\t\t\t\t\t\t\t\t<figcaption class=\"widget-image-caption wp-caption-text\">Medical Device Translation Best Practices<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-975083c elementor-widget elementor-widget-heading\" data-id=\"975083c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Conclusion<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-823cb5e elementor-widget elementor-widget-text-editor\" data-id=\"823cb5e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"zw-paragraph heading0\" data-header=\"0\" data-textformat=\"{\" data-margin-bottom=\"0pt\" data-hd-info=\"0\" data-line-height=\"1.2\" data-doc-id=\"7232205000006206002\" data-doc-type=\"writer\">The EU MDR website recommends that you wisely select &#8216;the company or companies that will be developing, potentially producing and ultimately commercialising&#8217; your product. Hence, you must choose a translation company that is highly knowledgeable and experienced in <a href=\"https:\/\/translatebyhumans.com\/en\/services\/translation\/medical\/\">medical translations<\/a> and the legal and regulatory compliances of the targetted country.<\/p><p><a href=\"https:\/\/translatebyhumans.com\/\">Translate By Humans&#8217;<\/a> database of global translators with in-depth industry knowledge of medicine and technology, associated legalities, and specific jargon will allow your device to reach international markets and the patients in need.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Find out all about the European Union Medical Device Regulation, how it will impact the market launch and marketing of medical devices and why accurate translations are more necessary than ever. <\/p>\n","protected":false},"author":4,"featured_media":30362,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[59],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.7 - 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