{"id":47843,"date":"2026-07-01T15:46:12","date_gmt":"2026-07-01T13:46:12","guid":{"rendered":"https:\/\/comlogos.com\/mdr-ivdr-konforme-uebersetzung\/"},"modified":"2026-09-01T21:33:50","modified_gmt":"2026-09-01T19:33:50","slug":"mdr-ivdr-compliant-translation","status":"publish","type":"page","link":"https:\/\/comlogos.com\/en\/mdr-ivdr-compliant-translation\/","title":{"rendered":"MDR\/IVDR-Compliant Translation of Medical Devices"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"47843\" class=\"elementor elementor-47843 elementor-46563\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-11f6730f elementor-section-height-min-height elementor-section-content-middle header-home-bg elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"11f6730f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_tablet&quot;:&quot;fadeIn&quot;,&quot;shape_divider_bottom&quot;:&quot;mountains&quot;,&quot;jet_parallax_layout_list&quot;:[],&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" aria-hidden=\"true\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 100\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" opacity=\"0.33\" d=\"M473,67.3c-203.9,88.3-263.1-34-320.3,0C66,119.1,0,59.7,0,59.7V0h1000v59.7 c0,0-62.1,26.1-94.9,29.3c-32.8,3.3-62.8-12.3-75.8-22.1C806,49.6,745.3,8.7,694.9,4.7S492.4,59,473,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" opacity=\"0.66\" d=\"M734,67.3c-45.5,0-77.2-23.2-129.1-39.1c-28.6-8.7-150.3-10.1-254,39.1 s-91.7-34.4-149.2,0C115.7,118.3,0,39.8,0,39.8V0h1000v36.5c0,0-28.2-18.5-92.1-18.5C810.2,18.1,775.7,67.3,734,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" d=\"M766.1,28.9c-200-57.5-266,65.5-395.1,19.5C242,1.8,242,5.4,184.8,20.6C128,35.8,132.3,44.9,89.9,52.5C28.6,63.7,0,0,0,0 h1000c0,0-9.9,40.9-83.6,48.1S829.6,47,766.1,28.9z\"\/>\n<\/svg>\t\t<\/div>\n\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-1d6ab9e3\" data-id=\"1d6ab9e3\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation_tablet&quot;:&quot;none&quot;}\">\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-2d0a5b15 elementor-widget elementor-widget-heading\" data-id=\"2d0a5b15\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Knowledge \u00b7 Medical devices &amp; IVDR<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-21cf868 elementor-widget elementor-widget-heading\" data-id=\"21cf868\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">MDR\/IVDR-compliant translation of medical devices<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4f2112d3 elementor-widget elementor-widget-html\" data-id=\"4f2112d3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>\n.cl-hero-cta { display: flex; gap: 16px; justify-content: center; flex-wrap: wrap; margin: 20px 0; }\n.cl-hero-cta a { display: inline-flex; align-items: center; justify-content: center; min-width: 220px; min-height: 52px; padding: 14px 32px; border-radius: 30px; font-size: 16px; font-weight: 600; text-decoration: none; letter-spacing: 0.3px; transition: all 0.25s ease; box-sizing: border-box; font-family: inherit; }\n.cl-hero-primary { background: #8a9a1e; color: #ffffff !important; border: 2px solid #8a9a1e; }\n.cl-hero-primary:hover { background: #ffffff; color: #3d4a00 !important; border-color: #ffffff; }\n.cl-hero-secondary { background: transparent; color: #ffffff !important; border: 2px solid #ffffff; }\n.cl-hero-secondary:hover { background: #ffffff; color: #3d4a00 !important; }\n@media (max-width: 600px) {\n  .cl-hero-cta a { min-width: 100%; }\n}\n<\/style>\n\n<div class=\"cl-hero-cta\">\n  <a class=\"cl-hero-primary\" href=\"https:\/\/comlogos.com\/en\/book-a-consultation\/\">Book a Consultation<\/a>\n  <a class=\"cl-hero-secondary\" href=\"https:\/\/comlogos.com\/en\/free-quote\/\">Free Quote<\/a>\n<\/div>\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-46e9c025 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"46e9c025\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_top&quot;:&quot;mountains&quot;,&quot;shape_divider_bottom&quot;:&quot;mountains&quot;,&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"elementor-shape elementor-shape-top\" aria-hidden=\"true\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 100\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" opacity=\"0.33\" d=\"M473,67.3c-203.9,88.3-263.1-34-320.3,0C66,119.1,0,59.7,0,59.7V0h1000v59.7 c0,0-62.1,26.1-94.9,29.3c-32.8,3.3-62.8-12.3-75.8-22.1C806,49.6,745.3,8.7,694.9,4.7S492.4,59,473,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" opacity=\"0.66\" d=\"M734,67.3c-45.5,0-77.2-23.2-129.1-39.1c-28.6-8.7-150.3-10.1-254,39.1 s-91.7-34.4-149.2,0C115.7,118.3,0,39.8,0,39.8V0h1000v36.5c0,0-28.2-18.5-92.1-18.5C810.2,18.1,775.7,67.3,734,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" d=\"M766.1,28.9c-200-57.5-266,65.5-395.1,19.5C242,1.8,242,5.4,184.8,20.6C128,35.8,132.3,44.9,89.9,52.5C28.6,63.7,0,0,0,0 h1000c0,0-9.9,40.9-83.6,48.1S829.6,47,766.1,28.9z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" aria-hidden=\"true\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 100\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" opacity=\"0.33\" d=\"M473,67.3c-203.9,88.3-263.1-34-320.3,0C66,119.1,0,59.7,0,59.7V0h1000v59.7 c0,0-62.1,26.1-94.9,29.3c-32.8,3.3-62.8-12.3-75.8-22.1C806,49.6,745.3,8.7,694.9,4.7S492.4,59,473,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" opacity=\"0.66\" d=\"M734,67.3c-45.5,0-77.2-23.2-129.1-39.1c-28.6-8.7-150.3-10.1-254,39.1 s-91.7-34.4-149.2,0C115.7,118.3,0,39.8,0,39.8V0h1000v36.5c0,0-28.2-18.5-92.1-18.5C810.2,18.1,775.7,67.3,734,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" d=\"M766.1,28.9c-200-57.5-266,65.5-395.1,19.5C242,1.8,242,5.4,184.8,20.6C128,35.8,132.3,44.9,89.9,52.5C28.6,63.7,0,0,0,0 h1000c0,0-9.9,40.9-83.6,48.1S829.6,47,766.1,28.9z\"\/>\n<\/svg>\t\t<\/div>\n\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-3102c470\" data-id=\"3102c470\" data-element_type=\"column\" data-e-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-00e06da elementor-widget elementor-widget-html\" data-id=\"00e06da\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>\n.cl-trustline{display:flex;flex-wrap:wrap;align-items:center;gap:.5rem .9rem;padding:.7rem 1rem;background:#f5f6e6;border:1px solid #e2e6c4;border-radius:10px;color:#5b5f4a;font-size:.92rem;font-family:inherit;box-sizing:border-box;}\n.cl-trustline b{color:#4f5519;}\n.cl-trustline svg{flex:0 0 auto;}\n<\/style>\n<div class=\"cl-trustline\">\n  <svg width=\"18\" height=\"18\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"#4f5519\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><rect x=\"3\" y=\"11\" width=\"18\" height=\"11\" rx=\"2\"><\/rect><path d=\"M7 11V7a5 5 0 0 1 10 0v4\"><\/path><\/svg>\n  <span><b>Strictly confidential<\/b> \u00b7 no use of your texts for AI training \u00b7 EU-hosted \u00b7 GDPR-compliant \u00b7 <b>contractually assured<\/b><\/span>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8fb823d elementor-widget elementor-widget-html\" data-id=\"8fb823d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<!-- ============================================================\n  COMLOGOS \u00b7 Wissensseite \u2014 MDR\/IVDR-konforme \u00dcbersetzung\n  Slug: \/mdr-ivdr-konforme-uebersetzung\/  \u00b7  Wissen-Cluster (informativ \/ E-E-A-T, Risiko-Winkel)\n  Stand 2026-07-03 (Cross-Link GMP-Wissensseite erg\u00e4nzt) \u00b7 paste-ready Body-Module (Goldstandard, Praefix cl-mdr-)\n  HINWEISE:\n   \u00b7 Hero + H1 baut der Mensch nativ (Goldstandard-Hero); Lead als ABSATZ, nicht H2. Darunter dieses eine HTML-Widget.\n   \u00b7 Schema-Widget (FAQPage + BreadcrumbList) ganz unten als SEPARATES HTML-Widget einsetzen; Elementor-FAQ-Schema-Toggle AUS.\n   \u00b7 Yoast-Seitentyp: Web Page. Title\/Meta siehe Go-Live-Paket.\n   \u00b7 Modul setzt keine eigene max-width (Breite steuert der Elementor-Container).\n   \u00b7 Regulatorik-Angaben Stand Juli 2026, web-verifiziert; vor Go-Live gegen geltende Verordnungen gegenpruefen.\n============================================================ -->\n<style>\n.cl-mdr{ --mdr-accent:#b3b810; --mdr-dark:#4f5519; --mdr-teal:#1B5B6F; --mdr-line:#e1e49f;\n  --mdr-grey:#3f4417; --mdr-bg:#f6f7ec; width:100%; box-sizing:border-box; font-family:inherit; }\n.cl-mdr *{ box-sizing:border-box; }\n.cl-mdr .cl-mdr-sec{ width:100%; margin:0 0 2.4rem; }\n.cl-mdr h2{ color:var(--mdr-accent); font-size:clamp(1.45rem,2.4vw,2rem); line-height:1.2; margin:0 0 .9rem; }\n.cl-mdr h3{ color:var(--mdr-accent); font-size:clamp(1.1rem,1.6vw,1.3rem); line-height:1.25; margin:0 0 .4rem; }\n.cl-mdr p{ color:var(--mdr-grey); line-height:1.65; margin:0 0 .9rem; }\n.cl-mdr .cl-mdr-lead{ font-size:1.05rem; }\n.cl-mdr .cl-mdr-note{ font-size:.85rem; color:var(--mdr-grey); opacity:.85; margin-top:.6rem; }\n.cl-mdr-grid{ display:grid; grid-template-columns:repeat(auto-fit,minmax(250px,1fr)); gap:1rem; }\n.cl-mdr-card{ background:#fff; border:1px solid var(--mdr-line); border-radius:12px; padding:1.1rem 1.2rem;\n  box-shadow:0 4px 14px rgba(79,85,25,.06); }\n.cl-mdr-card p{ margin:0; font-size:.95rem; }\n.cl-mdr-panel{ background:var(--mdr-bg); border:1px solid var(--mdr-line); border-radius:12px; padding:1.2rem 1.3rem; }\n.cl-mdr-panel ul{ margin:.2rem 0 0; padding-left:1.1rem; color:var(--mdr-grey); line-height:1.75; }\n\/* Mid-CTA band *\/\n.cl-mdr-band{ background:var(--mdr-dark); border-radius:14px; padding:1.6rem 1.5rem; text-align:center; }\n.cl-mdr-band h2{ color:#f5f7e8; margin:0 0 .3rem; }\n.cl-mdr-band p{ color:#cdd2b0; margin:0 0 1rem; }\n.cl-mdr-btns{ display:flex; flex-wrap:wrap; gap:.7rem; justify-content:center; }\n.cl-mdr a.cl-mdr-btn{ display:inline-block; padding:.7rem 1.3rem; border-radius:8px; font-weight:700; text-decoration:none; transition:background .15s ease,color .15s ease; }\n.cl-mdr a.cl-mdr-btn--p{ background:var(--mdr-accent); color:#fff; }\n.cl-mdr a.cl-mdr-btn--p:hover{ background:var(--mdr-dark); color:#fff; }\n.cl-mdr a.cl-mdr-btn--s{ background:transparent; border:2px solid var(--mdr-accent); }\n.cl-mdr-band a.cl-mdr-btn--s{ color:#f5f7e8; }\n.cl-mdr-end a.cl-mdr-btn--s{ color:var(--mdr-dark); }\n.cl-mdr a.cl-mdr-btn--s:hover{ background:var(--mdr-accent); color:#fff; }\n\/* Tiles (Cross-Links) *\/\n.cl-mdr-tiles{ display:grid; grid-template-columns:repeat(auto-fit,minmax(210px,1fr)); gap:1rem; }\n.cl-mdr-tile{ display:block; background:#fff; border:1px solid var(--mdr-line); border-radius:12px;\n  padding:1rem 1.1rem; text-decoration:none; color:var(--mdr-dark); font-weight:600;\n  box-shadow:0 4px 14px rgba(79,85,25,.06); }\n.cl-mdr-tile span{ display:block; font-weight:400; font-size:.9rem; color:var(--mdr-grey); margin-top:.25rem; }\n\/* FAQ *\/\n.cl-mdr-faq{ display:grid; gap:.6rem; }\n.cl-mdr-faq-item{ background:#fff; border:1px solid var(--mdr-line); border-radius:10px; overflow:hidden; }\n.cl-mdr-faq-item summary{ list-style:none; cursor:pointer; position:relative; padding:.95rem 2.6rem .95rem 1.1rem;\n  font-weight:700; color:var(--mdr-dark); font-size:1.02rem; line-height:1.35; }\n.cl-mdr-faq-item summary::-webkit-details-marker{ display:none; }\n.cl-mdr-faq-item summary:hover{ color:var(--mdr-accent); }\n.cl-mdr-faq-item summary::after{ content:\"+\"; position:absolute; right:1rem; top:50%; transform:translateY(-50%);\n  font-size:1.4rem; font-weight:700; color:var(--mdr-accent); }\n.cl-mdr-faq-item[open] summary::after{ content:\"\\2013\"; }\n.cl-mdr-faq-a{ padding:0 1.1rem 1.05rem; } .cl-mdr-faq-a p{ margin:0; }\n.cl-mdr-faq-a a, .cl-mdr p a{ color:var(--mdr-dark); text-decoration:underline; text-decoration-color:var(--mdr-accent); font-weight:600; }\n.cl-mdr-end{ background:var(--mdr-bg); border:1px solid var(--mdr-line); border-radius:14px; padding:1.8rem 1.5rem; text-align:center; }\n.cl-mdr-trust{ margin-top:1rem; font-size:.85rem; color:var(--mdr-grey); letter-spacing:.03em; }\n<\/style>\n<div class=\"cl-mdr\">\n  <!-- 2 \u00b7 Was MDR\/IVDR verlangen (zitierfaehig) ============ -->\n  <section class=\"cl-mdr-sec\">\n    <h2>What MDR and IVDR require for translations<\/h2>\n    <p class=\"cl-mdr-lead\">The EU Medical Devices Regulation <strong>MDR<\/strong> (Regulation (EU) 2017\/745) and the In Vitro Diagnostic Medical Devices Regulation <strong>IVDR<\/strong> (Regulation (EU) 2017\/746) require instructions for use, labelling, safety-relevant information and parts of the technical documentation to be available in the official languages of the Member States in which a product is made available. Each Member State defines the specific language requirements at national level. Manufacturers, authorised representatives, importers and distributors are responsible for complete and correct translations.<\/p>\n  <\/section>\n  <!-- 3 \u00b7 Welche Dokumente ================================= -->\n  <section class=\"cl-mdr-sec\">\n    <h2>Which documents need to be translated<\/h2>\n    <div class=\"cl-mdr-grid\">\n      <div class=\"cl-mdr-card\"><h3>Instructions for use (IFU)<\/h3><p>Instructions for use and user information in the user's language.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>Marking &amp; labelling<\/h3><p>Labels, packaging and safety-relevant symbols.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>Software, app &amp; eIFU<\/h3><p>Surface texts and electronic instructions for use.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>technical documentation<\/h3><p>Conformity documents and parts of the technical documentation.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>SSCP (implants &amp; class III)<\/h3><p>Summary of safety and clinical performance in the national languages.<\/p><\/div>\n    <\/div>\n  <\/section>\n  <!-- 4 \u00b7 Risiko-Winkel: 3 Fallen ========================= -->\n  <section class=\"cl-mdr-sec\">\n    <h2>Why in-house translation poses a compliance risk<\/h2>\n    <p>\u201cOur developer will translate that\u201d or \u201cour foreign subsidiary will handle it\u201d may sound reasonable, but in regulated environments it is risky. Three pitfalls:<\/p>\n    <div class=\"cl-mdr-grid\">\n      <div class=\"cl-mdr-card\"><h3>Liability &amp; marketing authorisation<\/h3><p>The manufacturer is liable for conformity and for the correct language version. Errors in the instructions for use can jeopardise the conformity assessment and may even lead to product recalls or withdrawal from the market.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>Lack of an audit trail<\/h3><p>Without a documented, qualified process, due diligence in translation cannot be demonstrated in an audit. \u201cDone in-house\u201d does not constitute verifiable quality assurance.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>Terminology &amp; safety<\/h3><p>In safety-critical texts, precision is decisive. Inconsistent terminology or careless mistakes can result in misuse, with consequences for patient safety and liability.<\/p><\/div>\n    <\/div>\n  <\/section>\n \n \n<!-- ======================= TEIL 1 : NORMEN-GRID (einf\u00fcgen VOR \"Fristen\") ======================= -->\n  <!-- 4b \u00b7 Einschl\u00e4gige Normen und Regelwerke (NEU 18.07.2026) -->\n  <section class=\"cl-mdr-sec\">\n    <h2>Applicable standards and regulations<\/h2>\n    <p>For medical devices and in vitro diagnostic devices, a complex framework of EU regulations and harmonised standards applies. These regulations determine which documents must be available in which language and in which format.<\/p>\n    <div class=\"cl-mdr-grid\">\n      <div class=\"cl-mdr-card\"><h3>MDR: Regulation (EU) 2017\/745<\/h3><p>Medical Devices Regulation: Instructions for use, labelling and safety-related information in the official languages of the member states where the device is made available.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>IVDR: Regulation (EU) 2017\/746<\/h3><p>In Vitro Diagnostics Regulation: analogous language and labelling requirements for IVDs, with its own risk classification A\u2013D.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>EN ISO 13485<\/h3><p>Quality management system for medical devices is the framework within which the control of translated documents must also be demonstrable.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>EN ISO 14971<\/h3><p>Risk management: safety-critical wording in IFUs and labelling must be consistent with the risk analysis in every language version.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>EN ISO 15223-1<\/h3><p>Symbols for the labelling of medical devices reduce the amount of text, but still require linguistically correct accompanying information.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>EN ISO 20417 &amp; IEC 62366-1<\/h3><p>Both the information to be supplied by the manufacturer (20417) and the usable, comprehensible user information (62366-1) are directly relevant to the translation.<\/p><\/div>\n      <div class=\"cl-mdr-card\"><h3>Regulation (EU) 2021\/2226: eIFU<\/h3><p>Electronic instructions for use for certain products: more digital, version-controlled content and therefore increasing, recurring translation volumes.<\/p><\/div>\n    <\/div>\n    <p class=\"cl-mdr-note\">Status as of July 2026; information without guarantee. For IVDs, additional specific labelling standards apply (including the EN ISO 18113 series). The currently applicable versions of the regulations and harmonised standards are authoritative.<\/p>\n  <\/section>\n \n  <!-- 5 \u00b7 Fristen ========================================= -->\n  <section class=\"cl-mdr-sec\">\n    <h2>Staying on top of deadlines and developments<\/h2>\n    <div class=\"cl-mdr-panel\">\n      <ul>\n        <li>To benefit from the MDR transitional periods,  <strong>a written agreement with a Notified Body had to be signed by<\/strong> 26 September 2024.<\/li>\n        <li>By <strong>31 December 2027<\/strong>: End of the transitional period for Class III and Class IIb implantable devices.<\/li>\n        <li>By <strong>31 December 2028<\/strong>: End of the transitional period for other product classes.<\/li>\n        <li>Digital content (eIFU, portals, in\u2011app texts) is growing and with it the volume of translations.<\/li>\n\n        <li>On 16 December 2025, the European Commission presented a proposal to revise the MDR and IVDR. It includes, among other aspects, a lower risk classification for certain products (medical software is to be assigned predominantly to class I), the removal of the previous five\u2011year maximum validity period of certificates, and an extended reporting deadline for serious incidents (30 days instead of 15). For products in direct contact with patients and end users, the obligation to provide translations remains in place. This is a proposal and has not yet entered into force.<\/li>\n<!-- ======================= ENDE TEIL 2 ======================= -->\n      \n      <\/ul>\n      <p class=\"cl-mdr-note\">Status as of July 2026; information without guarantee. The applicable EU regulations and the national language requirements of the respective target markets are authoritative.<\/p>\n    <\/div>\n  <\/section>\n  <!-- 6 \u00b7 Mid-CTA ========================================= -->\n  <section class=\"cl-mdr-sec\">\n    <div class=\"cl-mdr-band\">\n      <h2>Medical device translations that stand up to scrutiny in an audit<\/h2>\n      <p>From instructions for use to technical documentation, in line with ISO 17100 processes, with specialised translators and traceable quality assurance.<\/p>\n      <div class=\"cl-mdr-btns\">\n        <a class=\"cl-mdr-btn cl-mdr-btn--p\" href=\"https:\/\/comlogos.com\/en\/request-a-trial-translation\/\">Request a sample translation<\/a>\n        <a class=\"cl-mdr-btn cl-mdr-btn--s\" href=\"https:\/\/comlogos.com\/en\/book-a-consultation\/\">Schedule a consultation<\/a>\n      <\/div>\n    <\/div>\n  <\/section>\n  <!-- 7 \u00b7 Prueffester Prozess ============================= -->\n  <section class=\"cl-mdr-sec\">\n    <h2>An audit-ready translation process at COMLOGOS<\/h2>\n    <p>COMLOGOS translates medical device documentation in compliance with <a href=\"https:\/\/comlogos.com\/en\/certified-quality\/\">ISO 17100 processes<\/a> (certified): Specialised translators with a medical-technical background, a binding four-eyes principle and consistently maintained <a href=\"https:\/\/comlogos.com\/en\/technology\/terminology-database\/\">terminology<\/a> and clear documentation of every step in the translation process. Where artificial intelligence adds value, we use it in a controlled way with human post-editing in accordance with ISO 18587 (certified). Industry context: <a href=\"https:\/\/comlogos.com\/en\/medical-technology\/\">Medical technology<\/a> and <a href=\"https:\/\/comlogos.com\/en\/pharmaceuticals-and-chemicals\/\">Pharmaceuticals &amp; Chemicals<\/a>, and for medicinal products rather than medical devices: <a href=\"https:\/\/comlogos.com\/en\/gmp-compliant-translation\/\">GMP-Compliant Translation<\/a>.<\/p>\n  <\/section>\n  <!-- 8 \u00b7 Verwendete Technologien ========================= -->\n  <section class=\"cl-mdr-sec\">\n    <h2>Technologies used<\/h2>\n    <div class=\"cl-mdr-tiles\">\n      <a class=\"cl-mdr-tile\" href=\"https:\/\/comlogos.com\/en\/technology\/translation-memory-systems\/\">Translation Memory<span>consistency &amp; traceability<\/span><\/a>\n      <a class=\"cl-mdr-tile\" href=\"https:\/\/comlogos.com\/en\/technology\/terminology-database\/\">Terminology database<span>consistent specialist terminology<\/span><\/a>\n      <a class=\"cl-mdr-tile\" href=\"https:\/\/comlogos.com\/en\/technology\/ai-assisted-translations\/\">Controlled AI<span>with human post-editing<\/span><\/a>\n    <\/div>\n  <\/section>\n  <!-- 9 \u00b7 FAQ ============================================= -->\n  <section class=\"cl-mdr-sec\">\n    <h2>Frequently asked questions about MDR\/IVDR-compliant translations<\/h2>\n    <div class=\"cl-mdr-faq\">\n      <details class=\"cl-mdr-faq-item\"><summary>Do instructions for use of medical devices need to be translated?<\/summary><div class=\"cl-mdr-faq-a\"><p>Yes. MDR and IVDR require that the instructions for use, labelling and safety-relevant information are available in the official languages of the Member States in which the product is placed on the market. Each Member State defines the specific language requirements at national level.<\/p><\/div><\/details>\n      <details class=\"cl-mdr-faq-item\"><summary>Which documents fall under the translation requirement?<\/summary><div class=\"cl-mdr-faq-a\"><p>Primarily the instructions for use (IFU), the marking and labelling, software and app interfaces, including electronic instructions for use, as well as parts of the technical documentation. For implantable devices and Class III products, the Summary of Safety and Clinical Performance (SSCP) is also required.<\/p><\/div><\/details>\n      <details class=\"cl-mdr-faq-item\"><summary>Can the translation be done internally or by the foreign subsidiary?<\/summary><div class=\"cl-mdr-faq-a\"><p>The regulations do not specify who is responsible for carrying out the translation. However, the manufacturer is liable for the correctness of the content. Without a qualified, documented process, you cannot demonstrate due diligence during audits, and errors in safety\u2011relevant texts can jeopardise compliance. A certified process in accordance with ISO 17100 reduces this risk.<\/p><\/div><\/details>\n      <details class=\"cl-mdr-faq-item\"><summary>What does an audit-proof translation process involve?<\/summary><div class=\"cl-mdr-faq-a\"><p>A process whose quality can be demonstrated during audits: Specialised translators with a relevant background, a binding four-eyes principle in accordance with ISO 17100, maintained terminology and documented traceability of the processing steps.<\/p><\/div><\/details>\n      <details class=\"cl-mdr-faq-item\"><summary>What deadlines apply to MDR and IVDR?<\/summary><div class=\"cl-mdr-faq-a\"><p>Under the MDR, legacy devices may still be placed on the market, depending on their risk class, until 31 December 2027 (Class III and Class IIb implantable devices) or 31 December 2028 (other classes), provided that, among other things, an agreement with a Notified Body was signed by 26 December 2024. Under the IVDR, separate, staggered deadlines apply: 31 December 2027 (Class D), 31 December 2028 (Class C) and 31 December 2029 (Class B and Class A sterile). The applicable regulations in force at the time are decisive; the information is provided without guarantee.<\/p><\/div><\/details>\n      <details class=\"cl-mdr-faq-item\"><summary>Are medical device translations allowed to be produced using AI?<\/summary><div class=\"cl-mdr-faq-a\"><p>Artificial intelligence can support the process when it is used in a controlled manner and combined with human post-editing in line with ISO 18587. Qualified human expert review and documented quality assurance remain essential, particularly for safety-relevant content.<\/p><\/div><\/details>\n        <details class=\"cl-mdr-faq-item\"><summary>Which standards are relevant for MDR\/IVDR compliant translations?<\/summary><div class=\"cl-mdr-faq-a\"><p>In addition to the MDR (EU) 2017\/745 and IVDR (EU) 2017\/746 regulations, the harmonised standards are particularly relevant: EN ISO 13485 (quality management), EN ISO 14971 (risk management), EN ISO 15223-1 (symbols), EN ISO 20417 (information to be supplied by the manufacturer) and IEC 62366-1 (usability). For electronic instructions for use, Regulation (EU) 2021\/2226 also applies. For the translation itself, we work in accordance with ISO 17100 using the four-eyes principle; where AI support is used in a controlled manner, human post-editing in line with ISO 18587 is added. This ensures that the language version remains consistent with risk analysis, labelling and technical documentation. The information is provided without guarantee; the applicable versions in force are binding.<\/p><\/div><\/details>\n    <\/div>\n \n<!-- COMLOGOS \u00b7 Referenzblock \u00b7 nur diese Seite \u00b7 Stand 01.09.2026\n     Eine Karte: MedTec Medizintechnik GmbH.\n     Warum nur eine: Diese Seite behauptet regulatorische Konformitaet. Hier steht die einzige\n     Kundenstimme aus Qualitaetsmanagement und Regulatory Affairs - der Abteilung, die dafuer\n     geradesteht. Die uebrigen Referenzen stehen auf den Seiten, deren Aussage sie stuetzen.\n     Auswahl, Begruendung und die anderen sieben Bloecke:\n     20_Entwuerfe\/Strom-II_Website-Entwicklung\/Referenzbloecke_2026-09-01\/_README_Einbauplan.md -->\n<style>\n.cl-ref{font-family:inherit;color:#33373f;max-width:100%;margin:0;padding:46px 0 44px;border-top:1px solid #e6e7dd}\n.cl-ref>h2{margin-top:8px}\n.cl-ref h2{font-size:1.6rem;color:#33373f;margin:0 0 .2rem}\n.cl-ref .sub{color:#6b6f5e;font-size:1rem;margin:0 0 1.3rem}\n.cl-ref .grid{display:grid;gap:18px}\n.cl-ref .grid.zwei{grid-template-columns:repeat(auto-fit,minmax(300px,1fr))}\n.cl-ref .grid.eins{grid-template-columns:minmax(300px,620px)}\n.cl-ref .card{border:1px solid #e3e4d8;border-radius:14px;padding:20px 22px;background:#fff;display:flex;flex-direction:column}\n.cl-ref .logo{height:74px;display:flex;align-items:center;margin-bottom:10px}\n.cl-ref .logo img{max-height:56px;max-width:210px;width:auto;object-fit:contain}\n.cl-ref .card.wortmarke .logo img{max-height:74px;max-width:250px}\n.cl-ref .stars{color:#b3b810;letter-spacing:2px;font-size:1.05rem;line-height:1}\n.cl-ref .role{color:#6b6f5e;font-size:.85rem;text-transform:uppercase;letter-spacing:.04em;margin:4px 0 10px}\n.cl-ref blockquote{margin:0 0 14px;font-size:1rem;line-height:1.6;color:#3c4048;font-style:italic}\n.cl-ref .who{margin-top:auto;font-weight:700}\n.cl-ref .who a{color:#4f5519;text-decoration:none}\n.cl-ref .who a:hover{text-decoration:underline}\n<\/style>\n<div class=\"cl-ref\">\n  <h2>What the regulatory department of a medical device manufacturer says<\/h2>\n  <p class=\"sub\">This voice comes from Quality Management and Regulatory Affairs &mdash; the department that answers for conformity.<\/p>\n  <div class=\"grid eins\">\n\n    <div class=\"card\">\n      <div class=\"logo\"><img decoding=\"async\" src=\"https:\/\/comlogos.com\/wp-content\/uploads\/2026\/09\/Logo_MBST_2024.png\" alt=\"MedTec Medizintechnik GmbH logo\"><\/div>\n      <div class=\"stars\" aria-label=\"Rated 5 out of 5\">&#9733;&#9733;&#9733;&#9733;&#9733;<\/div>\n      <div class=\"role\">Quality Management &middot; Regulatory Affairs<\/div>\n      <blockquote>&ldquo;For years, we have relied on COMLOGOS&rsquo;s specialist translators to translate our medical technology documents. Even when international authorities impose special requirements, we can always count on their helpful team. Many thanks!&rdquo;<\/blockquote>\n      <div class=\"who\"><a href=\"https:\/\/mbst.com\/de\/patient\/\" target=\"_blank\" rel=\"noopener\">MedTec Medizintechnik GmbH<\/a><\/div>\n    <\/div>\n\n  <\/div>\n<\/div>    \n \n  <\/section>\n  <!-- 10 \u00b7 End-CTA v4 ===================================== -->\n  <section class=\"cl-mdr-sec\">\n    <div class=\"cl-mdr-end\">\n      <h2>Request a project &amp; receive expert advice<\/h2>\n      <p>Do you need instructions for use, labelling or technical documentation translated as MDR\/IVDR-compliant? Please send us 1\u20132 sample files. You will receive a specific recommendation and a quote within 24 hours.<\/p>\n      <div class=\"cl-mdr-btns\">\n        <a class=\"cl-mdr-btn cl-mdr-btn--p\" href=\"https:\/\/comlogos.com\/en\/request-a-trial-translation\/\">Request a sample translation<\/a>\n        <a class=\"cl-mdr-btn cl-mdr-btn--s\" href=\"https:\/\/comlogos.com\/en\/book-a-consultation\/\">Schedule a consultation<\/a>\n      <\/div>\n      <div class=\"cl-mdr-trust\">ISO 9001 \u00b7 ISO 17100 \u00b7 ISO 18587 \u00b7 four-eyes principle<\/div>\n    <\/div>\n  <\/section>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-63c242d elementor-widget elementor-widget-html\" data-id=\"63c242d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<!-- ============================================================\n  SCHEMA-WIDGET (separat einsetzen; Elementor-FAQ-Schema AUS)\n  KORRIGIERT 18.07.2026: 7. 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