{"id":13254,"date":"2022-03-04T13:57:33","date_gmt":"2022-03-04T13:57:33","guid":{"rendered":"https:\/\/www.winandwinnow.com\/site\/?p=13254"},"modified":"2026-03-24T13:30:14","modified_gmt":"2026-03-24T13:30:14","slug":"mdr-ivdr-new-translation-requirements-for-the-eu","status":"publish","type":"post","link":"https:\/\/winandwinnow.com\/site\/mdr-ivdr-new-translation-requirements-for-the-eu\/","title":{"rendered":"MDR &#038; IVDR: New Translation Requirements for the EU"},"content":{"rendered":"\n<p><span style=\"font-weight: 400;\">The European Union (EU) implemented new regulations concerning medical and in vitro devices called: the <\/span><b>MDR &amp; IVDR regulations<\/b><span style=\"font-weight: 400;\">. One of the important points that both companies and medical providers will have to take into account is the implementation of efficient, fast, and professional translation services.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">In the following blog, we will see what these new regulations are about, what impact they have on the European medical system, and why translation plays a key role in their implementation. Let&#8217;s get started!<\/span><\/p>\n\n\n\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Contents:<\/h3>\n\n\n\n<div class=\"wp-block-aioseo-table-of-contents\"><ul><li><a href=\"#aioseo-what-are-the-eu-mdr-ivdr\">What are the EU MDR\/IVDR?<\/a><\/li><li><a href=\"#aioseo-whats-new-about-mdrs-ivdrs\">What&#x27;s new about MDRs\/IVDRs?<\/a><\/li><li><a href=\"#aioseo-what-are-the-new-translation-requirements-set-out-in-the-mdr-ivdr\">What are the new translation requirements set out in the MDR\/IVDR?<\/a><ul><li><a href=\"#aioseo-clarity-and-quality-standards\">Clarity and quality standards<\/a><\/li><li><a href=\"#aioseo-translations-will-have-to-be-provided-in-more-languages\">Translations will have to be provided in more languages<\/a><\/li><li><a href=\"#aioseo-the-translated-information-will-be-uploaded-to-the-eudamed-database\">The translated information will be uploaded to the EUDAMED database<\/a><\/li><li><a href=\"#aioseo-translations-will-be-required-before-ce-marking\">Translations will be required before CE marking<\/a><\/li><\/ul><\/li><li><a href=\"#aioseo-we-support-you-in-your-global-expansion-strategy\">We support you in your global expansion strategy<\/a><\/li><\/ul><\/div>\n\n\n\n<div style=\"height:57px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"aioseo-what-are-the-eu-mdr-ivdr\">What are the EU MDR\/IVDR?<\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">They are the new regulations that will serve as a replacement for the previous <\/span><b>Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD)<\/b><span style=\"font-weight: 400;\">. Although both the MDR and IVDR were set to be implemented in 2020, the COVID-19 pandemic delayed their process, and they came into force in 2021 and 2022, respectively.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">The main thing to consider about these regulations is that they are focused on safeguarding <\/span><span style=\"font-weight: 400;\">patient safety<\/span><span style=\"font-weight: 400;\"> and ensuring the correct use of medical devices. This also means that all devices marketed within the EU need certification or recertification that complies with the new regulatory parameters.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">All this means that patients and users will need to be able to <a href=\"https:\/\/www.winandwinnow.com\/site\/why-should-patient-centricity-be-prioritized\/\">rely on an accurate understanding of the information<\/a> about the products they will be using, as well as being able to obtain clear instructions for use. However, this poses a challenge for healthcare companies.<\/span><\/p>\n\n\n\n<div class=\"hs-cta-embed hs-cta-simple-placeholder hs-cta-embed-185716202388\"\nstyle=\"max-width:100%; max-height:100%; width:1200px;height:292.0277862548828px\" data-hubspot-wrapper-cta-id=\"185716202388\">\n<a href=\"https:\/\/cta-service-cms2.hubspot.com\/web-interactives\/public\/v1\/track\/redirect?encryptedPayload=AVxigLIHVM8DhNTUpEcuNCD1%2F4Ksj0Bmqlgj4GhtDs2iv5yhC64x12tERovd2ElGuXnUX4E%2FmCdA9U7ejX7KCZq0duVp%2F25g3r3jrJiXKvC2Ccu8hZURRvClal1T2nHa1KV0WhAo6NN1hxjO%2FgRDlwllOl0cq4iYWpEAhm2jxSSniuw%2BLLvJhuv7UsNllrM01la5rA%3D%3D&#038;webInteractiveContentId=185716202388&#038;portalId=23472818\" target=\"_blank\" rel=\"noopener\" crossorigin=\"anonymous\">\n<img decoding=\"async\" alt=\"Curious how we could help {{ personalization_token('contact.company', 'your organization') }} reach its goals?\u00a0 \u00a0\" loading=\"lazy\" src=\"https:\/\/no-cache.hubspot.com\/cta\/default\/23472818\/interactive-185716202388.png\" style=\"height: 100%; width: 100%; object-fit: fill\"\nonerror=\"this.style.display='none'\" \/>\n<\/a>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"aioseo-whats-new-about-mdrs-ivdrs\">What&#8217;s new about MDRs\/IVDRs?<\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">As mentioned above, the new regulations emphasize transparency and traceability in devices. Let&#8217;s take a closer look:<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><span style=\"font-weight: 400;\"><strong>Quality management system<\/strong>: medical device manufacturers must, under the new regulation, establish and implement documentation within the EU-mandated quality management system (QMS).<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\"><strong>Unique device identifier:<\/strong> To seek easy traceability of all existing medical devices within the EU, they must be marked with a unique device identifier (UDI) on their labeling and packaging. Likewise, this identification must be registered in the EU&#8217;s central database called EUDAMED.&nbsp;<\/span><\/li>\n<\/ul>\n\n\n\n<p><span style=\"font-weight: 400;\">In turn, manufacturers and\/or suppliers will receive annual audits to verify compliance with regulations and ISO 13485:2016 standards. Similarly, clinical evaluation reports (CERS) will be carried out in a much stricter manner.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">According to the Notified Bodies for Medical Devices (NB-MED), translations must be accurate so manufacturers must ensure that <a href=\"https:\/\/winandwinnow.com\/site\/how-we-assess-the-quality-of-our-translation-services\/\">a reliable and quality translation process<\/a> is performed.<\/span><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"aioseo-what-are-the-new-translation-requirements-set-out-in-the-mdr-ivdr\">What are the new translation requirements set out in the MDR\/IVDR?<\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">Because the EU is made up of different countries, the new regulations implicitly require that the information they set out must be well translated. If this does not happen, the devices will not be able to receive their CE certification. In addition, there are other reasons why quality and professional translation services should be taken into account:<\/span><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"aioseo-clarity-and-quality-standards\"><strong>Clarity and quality standards<\/strong><\/h3>\n\n\n\n<p><span style=\"font-weight: 400;\">A company needs to be able to rely on trustworthy translation resources that can handle the broad scope of translation demands that will be imposed by the EU. The range of content and its variety will be extensive, and therefore investing in a quality service that can meet the deadlines of the new regulation will be critical.<\/span><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"aioseo-translations-will-have-to-be-provided-in-more-languages\"><span style=\"font-weight: 400;\"><strong>Translations will have to be provided in more languages<\/strong><\/span><\/h3>\n\n\n\n<p><span style=\"font-weight: 400;\">Medical device companies operating in the EU will have to <a href=\"https:\/\/winandwinnow.com\/site\/medical-device-labeling-the-risks-of-poor-translation-and-the-importance-of-compliance\/\" title=\"\">provide more detailed and accurate product descriptions<\/a> in more languages. Technical documentation will also have to be translated into all languages of the EU country (or countries) in which the product is to be sold or marketed. Depending on the scope of the product in the EU, up to 24 languages are currently required for translations.<\/span><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"aioseo-the-translated-information-will-be-uploaded-to-the-eudamed-database\"><strong>The translated information will be uploaded to the EUDAMED database<\/strong><\/h3>\n\n\n\n<p><span style=\"font-weight: 400;\">As one of its parameters, the MDR will require device manufacturers to store the information in the European EUDAMED database. For this, translation service providers will have to have their Translation Management System, which can be performed by an agency that certifies a consistent and traceable result.&nbsp;<\/span><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"aioseo-translations-will-be-required-before-ce-marking\"><strong>Translations will be required before CE marking<\/strong><\/h3>\n\n\n\n<p><span style=\"font-weight: 400;\">To comply with the new requirements, manufacturers will have to provide translations of their devices before receiving their CE marking. Translation of documents such as instructions for use, for example, must be provided as part of the dossier for conformity assessment by notified bodies before marketing and distribution.<\/span><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"aioseo-we-support-you-in-your-global-expansion-strategy\">We support you in your global expansion strategy<\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">Working closely with <a href=\"https:\/\/winandwinnow.com\/site\/language-solutions-for-the-pharmaceutical-industry\/\">a translation and localization provider that specializes in the life sciences sector<\/a>, is familiar with medical and technical terminology, and is ISO certified, is an important step in conquering the ever-changing international regulatory process. The choice of translation provider is vital to ensure accurate, consistent, efficient, and technically correct translations.<\/span><\/p>\n\n\n\n<p><b>Win &amp; Winnow<\/b><span style=\"font-weight: 400;\"> is an ISO-certified translation company that meets professional quality standards to accompany you in the translation process required by the new MDR-IVDR regulation. We have a team of professional linguists with experience in technical and medical documents; especially in the management of regulatory documentation.&nbsp;<\/span><span style=\"font-weight: 400;\">If you would like to learn more about our services, <\/span><strong><a href=\"https:\/\/www.winandwinnow.com\/site\/contact\/#contactform\">get in touch<\/a>.<\/strong><\/p>\n\n\n\n<div class=\"hs-cta-embed hs-cta-embed-185718638340\" style=\"max-width:100%; max-height:100%; width:1200px;height:1034.6666870117188px\" data-hubspot-wrapper-cta-id=\"185718638340\">\n<link rel=\"stylesheet\" href=\"https:\/\/js.hscta.com\/embeddable_cta_placeholder_v1.css\">\n<div class=\"hs-cta-loading-dot__container\">\n<div class=\"hs-cta-loading-dot\"><\/div>\n<div class=\"hs-cta-loading-dot\"><\/div>\n<div class=\"hs-cta-loading-dot\"><\/div>\n<\/div>\n<div class=\"hs-cta-embed__skeleton\"><\/div>\n<picture>\n<source srcset=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" media=\"(max-width: 480px)\" \/>\n<img decoding=\"async\" alt=\"Would you like to receive additional information?\" loading=\"lazy\" src=\"https:\/\/no-cache.hubspot.com\/cta\/default\/23472818\/interactive-185718638340.png\" style=\"height: 100%; width: 100%; object-fit: fill\" onerror=\"this.style.display='none'\" \/>\n<\/picture>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The European Union (EU) implemented new regulations concerning medical and in vitro devices called: the MDR &amp; IVDR regulations. One of the important points that both companies and medical providers will have to take into account is the implementation of efficient, fast, and professional translation services.&nbsp; In the following blog, we will see what these [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":13701,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[16,463],"tags":[],"class_list":["post-13254","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-sciences-en","category-medical-devices"],"_links":{"self":[{"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/posts\/13254","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/comments?post=13254"}],"version-history":[{"count":1,"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/posts\/13254\/revisions"}],"predecessor-version":[{"id":19070,"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/posts\/13254\/revisions\/19070"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/media\/13701"}],"wp:attachment":[{"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/media?parent=13254"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/categories?post=13254"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/winandwinnow.com\/site\/wp-json\/wp\/v2\/tags?post=13254"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}