{"id":34702,"date":"2025-09-23T09:21:04","date_gmt":"2025-09-23T07:21:04","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34702"},"modified":"2025-10-23T10:57:36","modified_gmt":"2025-10-23T08:57:36","slug":"eu-mdr-language-requirements-tables-updated","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/09\/23\/eu-mdr-language-requirements-tables-updated\/","title":{"rendered":"EU: MDR Language Requirements Tables Updated"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p style=\"text-align: right;\"><strong><em>Translated with AI<\/em><\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>On <strong>August 29, 2025<\/strong>, the European Commission published <strong>Revision 3<\/strong> of the document <a href=\"https:\/\/health.ec.europa.eu\/publications\/overview-language-requirements-manufacturers-medical-devices_en\"><strong>&#8220;MDR &#8211; Language Requirements for manufacturers.&#8221;<\/strong><\/a> This tool collects and summarizes the language requirements applicable in various member states for medical device <strong>manufacturers<\/strong>.<\/p>\n<p>This guide, organized in a table format, clarifies <strong>which languages are accepted for each type of documentation<\/strong>, in accordance with the MDR Regulation (EU) 2017\/745.<\/p>\n<h3>What&#8217;s in the Table: Documents Subject to Language Requirements<\/h3>\n<p>The general principle of <strong>Article 10(11) of the MDR<\/strong> requires <strong>manufacturers<\/strong> to provide devices with the necessary information in the <strong>official language(s)<\/strong> <strong>of the member state<\/strong> where the device is made available to the user or patient.<\/p>\n<p>Specifically, this includes:<\/p>\n<ul>\n<li>Device labels<\/li>\n<li>Instructions for Use (IFU)<\/li>\n<li>Implant card (Art. 18 MDR)<\/li>\n<li>Summary of Safety and Clinical Performance (SSCP) for implantable and Class III devices<\/li>\n<li>Mandatory information for users or patients (e.g., warnings, precautions, conditions of use)<\/li>\n<li>Any post-market documentation intended for patients or end-users.<\/li>\n<\/ul>\n<p>Each country retains the right to <strong>establish exceptions or accept additional languages<\/strong>, such as English, in specific circumstances.<\/p>\n<p>The table provides the necessary information for proper compliance, tailored to each device type.<\/p>\n<h3>The Updates and Their Practical Impact<\/h3>\n<p>Revision 3 confirms the general principle of Article 10(11) of the MDR but introduces significant clarifications, particularly for two member states:<\/p>\n<ul>\n<li><strong>Portugal<\/strong>: Translation into Portuguese remains mandatory. However, for documentation intended exclusively for healthcare professionals, the use of English is permitted.<\/li>\n<li><strong>Romania<\/strong>: English may be accepted, but only with prior authorization from the competent authorities.<\/li>\n<\/ul>\n<h3>Practical Implications for Manufacturers<\/h3>\n<p>The &#8220;MDR &#8211; Language Requirements for manufacturers&#8221; document remains a key tool for navigating the diverse language regulations of the European Union, while confirming the core principle already in place.<\/p>\n<p>This update reinforces a central concept: <strong>there is no single, standardized approach to language requirements in Europe<\/strong>. Each market requires a specific and dedicated analysis. For <strong>manufacturers<\/strong>, this necessitates a strategic approach, as translations can impact the time and cost of commercialization. Translations must be planned in advance to avoid delays that could block a device from being placed on the market.<\/p>\n<p>The <strong>quality of translations<\/strong> is a fundamental aspect of regulatory compliance. A translation error can compromise a device&#8217;s safety and effectiveness. Translations must be:<\/p>\n<ul>\n<li><strong>Accurate<\/strong>: Correct terminology, consistent with current medical and regulatory standards.<\/li>\n<li><strong>Understandable<\/strong>: Clear to the user or patient, avoiding ambiguities that could lead to usage risks.<\/li>\n<li><strong>Traceable<\/strong>: Who translated and revised it, and which version was approved.<\/li>\n<\/ul>\n<p>It is advisable to integrate translations into your Quality Management System (QMS) as a structured and controllable process.<\/p>\n<p>\ud83d\udc49<em>Thema consultants can assist you with all necessary aspects of compliance with MDR (EU) 2017\/745 and the entire <\/em><a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\"><em>CE certification process<\/em><\/a><em>.<\/em><\/p>\n<p><strong>SOURCES: <\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/health.ec.europa.eu\/publications\/overview-language-requirements-manufacturers-medical-devices_en\">European Commission &#8211; Overview: Language Requirements for manufacturers<\/a><\/li>\n<li><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf\">Updated MDR Table (Rev. 3, 2025)<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":34689,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[2044,2131,2089,1934,2132,2134,2135,2133],"class_list":["post-34702","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-ce-marking-en","tag-language-requirements","tag-mdr","tag-mdr-regulation","tag-mdr-translations","tag-portugal-en","tag-romania-en","tag-translations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: MDR Language Requirements Tables Update<\/title>\n<meta name=\"description\" content=\"The European Commission has published Revision 3 on MDR language requirements. 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