{"id":1020,"date":"2025-08-11T11:17:37","date_gmt":"2025-08-11T10:17:37","guid":{"rendered":"https:\/\/www.omnilingua.co.uk\/healthcare\/?page_id=1020"},"modified":"2026-01-13T11:39:03","modified_gmt":"2026-01-13T11:39:03","slug":"ivdr-mdr-translation-services","status":"publish","type":"page","link":"https:\/\/www.omnilingua.co.uk\/healthcare\/services\/ivdr-mdr-translation-services\/","title":{"rendered":"IVDR &amp; MDR Translation Services"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; animation_style=&#8221;fade&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_header title=&#8221;IVDR &#038; MDR Translation Services&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; title_level=&#8221;h3&#8243; title_font=&#8221;|||on|||||&#8221; title_text_align=&#8221;center&#8221; title_font_size=&#8221;50px&#8221; title_line_height=&#8221;1.2em&#8221; 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admin_label=&#8221;Section 1&#8243; _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||true|false&#8221; locked=&#8221;off&#8221; collapsed=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;3_5,2_5&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; width=&#8221;100%&#8221; max_width=&#8221;100%&#8221; custom_padding=&#8221;0px||0px||true|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;3_5&#8243; _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;8%|10%|8%|10%|true|true&#8221; animation_style=&#8221;fade&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text module_class=&#8221;pa-bullet-list-1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; header_text_align=&#8221;left&#8221; header_2_font=&#8221;Mulish|600|||||||&#8221; header_2_font_size=&#8221;30px&#8221; header_2_line_height=&#8221;1.2em&#8221; max_width=&#8221;800px&#8221; module_alignment=&#8221;center&#8221; custom_margin=&#8221;||15px|-220px|false|false&#8221; header_2_font_size_tablet=&#8221;30px&#8221; header_2_font_size_phone=&#8221;24px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2 style=\"text-align: left;\">Our IVDR Translation Services<\/h2>\n<p>[\/et_pb_text][et_pb_text module_class=&#8221;pa-bullet-list-1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; header_2_font=&#8221;Mulish|600|||||||&#8221; header_2_font_size=&#8221;30px&#8221; max_width=&#8221;800px&#8221; module_alignment=&#8221;center&#8221; custom_margin=&#8221;|||-220px||&#8221; text_font_size_tablet=&#8221;18px&#8221; text_font_size_phone=&#8221;16px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\">In Vitro Diagnostic Device Documentation:<\/p>\n<ul>\n<li class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\"><strong>IFU Translation<\/strong> &#8211; Instructions for Use for all device classifications<\/li>\n<li class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\"><strong>Labelling Translation<\/strong> &#8211; Device, packaging, and transport labels<\/li>\n<li class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\"><strong>Technical Documentation<\/strong> &#8211; Regulatory submission files<\/li>\n<li class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\"><strong>Summary of Safety &amp; Performance (SSP)<\/strong> &#8211; Class C &amp; D device requirements<\/li>\n<li class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\"><strong>Post-Market Surveillance<\/strong> &#8211; Ongoing compliance documentation<\/li>\n<\/ul>\n<ul class=\"[&amp;:not(:last-child)_ul]:pb-1 [&amp;:not(:last-child)_ol]:pb-1 list-disc space-y-1.5 pl-7\"><\/ul>\n<p class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\">IVDR Compliance Support:<\/p>\n<p class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\">\n<ul>\n<li>Translation into all official EU languages<\/li>\n<li>Terminology consistency across device portfolios<\/li>\n<li>Quality assurance for regulatory acceptance<\/li>\n<li>Updates for evolving IVDR requirements<\/li>\n<\/ul>\n<p>[\/et_pb_text][et_pb_button button_url=&#8221;https:\/\/www.omnilingua.co.uk\/healthcare\/request-a-medical-translation-quote\/&#8221; 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Complete regulatory file translation<\/li>\n<li class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\"><strong>Clinical Evaluation Reports<\/strong> &#8211; Specialist medical translation<\/li>\n<li class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\"><strong>Risk Management Files<\/strong> &#8211; ISO 14971 documentation<\/li>\n<li class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\"><strong>Quality Management Systems<\/strong> &#8211; ISO 13485 compliance materials<\/li>\n<li class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\"><strong>Declaration of Conformity<\/strong> &#8211; Regulatory submission documents<\/li>\n<\/ul>\n<ul class=\"[&amp;:not(:last-child)_ul]:pb-1 [&amp;:not(:last-child)_ol]:pb-1 list-disc space-y-1.5 pl-7\"><\/ul>\n<p class=\"text-lg font-bold text-text-100 mt-1 -mb-1.5\">MDR Documentation Translation<\/p>\n<ul>\n<li>All medical device risk classifications<\/li>\n<li>Notified Body submission materials<\/li>\n<li>Post-market clinical follow-up documentation<\/li>\n<li>Authorised representative files<\/li>\n<\/ul>\n<p>Planning your MDR Translation? Try our online <a href=\"https:\/\/www.omnilingua.co.uk\/healthcare\/mdr-translation-compliance-checklist\">MDR Translation Compliance Checklist<\/a>. You can track and download your planning and progress.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_5,3_5,1_5&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#ffffff&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_5&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;3_5&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1 style=\"text-align: center;\"><span>Request a Medical Translation Quote<\/span><\/h1>\n<p><span><noscript 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