{"id":109537,"date":"2024-04-12T14:26:58","date_gmt":"2024-04-12T12:26:58","guid":{"rendered":"https:\/\/ade-germany.de\/?page_id=109537"},"modified":"2024-10-30T02:04:12","modified_gmt":"2024-10-30T01:04:12","slug":"mdr","status":"publish","type":"page","link":"https:\/\/ade-germany.de\/en\/mdr\/","title":{"rendered":"MDR"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column]<style type=\"text\/css\" data-type=\"the7_shortcodes-inline-css\">.carousel-shortcode.carousel-shortcode-id-e029bf360eac00c572f5688b74662762.owl-carousel .owl-nav div {\n  width: 36px;\n  height: 36px;\n  border-radius: 500px;\n}\n.dt-arrow-border-on.carousel-shortcode.carousel-shortcode-id-e029bf360eac00c572f5688b74662762.owl-carousel .owl-nav div:not(:hover):before {\n  border-width: 0px;\n}\n.dt-arrow-hover-border-on.carousel-shortcode.carousel-shortcode-id-e029bf360eac00c572f5688b74662762.owl-carousel .owl-nav div:hover:after {\n  border-width: 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data-col-gap=\"0\" data-stage-padding=\"0\" data-speed=\"600\" data-autoplay=\"false\" data-autoplay_speed=\"6000\" data-arrows=\"false\" data-bullet=\"true\" data-next-icon=\"icon-ar-017-r\" data-prev-icon=\"icon-ar-017-l\">[vc_row_inner css=&#8221;.vc_custom_1730250247861{padding-top: 200px !important;background-image: url(https:\/\/ade-germany.de\/wp-content\/uploads\/2024\/04\/Briefing-MDR-Landingpage.jpg?id=109501) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column_inner width=&#8221;5\/6&#8243; offset=&#8221;vc_col-lg-offset-3 vc_col-lg-6 vc_col-md-offset-2 vc_col-md-8 vc_col-sm-offset-1 vc_col-xs-offset-1 vc_col-xs-10&#8243; css=&#8221;.vc_custom_1579176531138{margin-bottom: 50px !important;padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;background-color: #ffffff !important;}&#8221;]<div id=\"ultimate-heading-40876a042f3fc4aa4\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-40876a042f3fc4aa4 uvc-8816  uvc-heading-default-font-sizes\" data-hspacer=\"no_spacer\"  data-halign=\"center\" style=\"text-align:center\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-40876a042f3fc4aa4 h1'  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}' ><h1 style=\"font-family:&#039;Roboto&#039;;font-weight:300;\">MDR<\/h1><\/div><div class=\"uvc-sub-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-40876a042f3fc4aa4 .uvc-sub-heading '  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}'  style=\"font-weight:normal;\">Medical Device Regulation<\/div><\/div>[\/vc_column_inner][\/vc_row_inner]<\/div>[\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221; equal_height=&#8221;yes&#8221; margin_bottom=&#8221;0px&#8221; css=&#8221;.vc_custom_1712305100191{margin-right: 0px !important;margin-left: 0px !important;background-color: #ffffff !important;}&#8221;][vc_column css=&#8221;.vc_custom_1712305154709{padding-top: 40px !important;padding-right: 40px !important;padding-left: 40px !important;}&#8221;]<div id=\"ultimate-heading-70066a042f3fc4b26\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-70066a042f3fc4b26 uvc-5133  uvc-heading-default-font-sizes\" data-hspacer=\"no_spacer\"  data-halign=\"left\" style=\"text-align:left\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-70066a042f3fc4b26 h2'  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}' ><h2 style=\"--font-weight:theme;margin-bottom:15px;\">MDR - Medical Device Regulation<\/h2><\/div><\/div>[vc_column_text css=&#8221;.vc_custom_1712911883123{padding-top: 40px !important;}&#8221;]<\/p>\n<h3><\/h3>\n<h3>New regulations for medical devices: The impact of the Medical Device Regulation (MDR)<\/h3>\n<p>On May 26, 2021, the Medical Device Regulation (MDR) of the European Union became binding, bringing changes for all manufacturers of medical products. But what exactly do these new regulations entail?[\/vc_column_text][\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1605599376371{margin-right: 0px !important;margin-left: 0px !important;background-color: #ffffff !important;}&#8221;][vc_column width=&#8221;1\/4&#8243; css=&#8221;.vc_custom_1712305219187{padding-right: 40px !important;padding-left: 40px !important;}&#8221;][vc_single_image image=&#8221;109549&#8243; img_size=&#8221;200&#215;200&#8243; css=&#8221;.vc_custom_1712916406735{padding-right: 20px !important;padding-left: 20px !important;}&#8221;][\/vc_column][vc_column width=&#8221;3\/4&#8243;][vc_column_text]<\/p>\n<h3>Safety, Quality, and Transparency<\/h3>\n<p>The MDR represents a new regulation of medical devices by placing a stronger emphasis on safety, quality, and transparency. The goal is to further enhance patient safety and make the entire lifecycle of medical devices safer and more transparent. These values are achieved through stricter requirements for the clinical evaluation of medical devices. Manufacturers must now conduct even more thorough testing and monitoring of their products to demonstrate safety and performance.[\/vc_column_text][\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1605599376371{margin-right: 0px !important;margin-left: 0px !important;background-color: #ffffff !important;}&#8221;][vc_column css=&#8221;.vc_custom_1712305286150{padding-right: 40px !important;padding-left: 40px !important;}&#8221;][vc_column_text]<\/p>\n<h3>Deadlines for Proper MDR Implementation<\/h3>\n<div class=\"flex flex-grow flex-col max-w-full\">\n<div class=\"min-h-[20px] text-message flex flex-col items-start gap-3 whitespace-pre-wrap break-words [.text-message+&amp;]:mt-5 overflow-x-auto\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"525f5b58-3318-468c-bf2a-496099cd3bb6\">\n<div class=\"markdown prose w-full break-words dark:prose-invert light\">\n<p>To facilitate the transition to the new regulation smoothly, certain deadlines must be observed. Manufacturers, like us, must ensure that their products comply with the requirements of the MDR and undergo the necessary approval procedures to remain authorized for market access.<\/p>\n<p>For further information, please refer to Regulation (EU) 2023\/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 with regard to transitional provisions for certain medical devices and in vitro diagnostic medical devices.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1605599376371{margin-right: 0px !important;margin-left: 0px !important;background-color: #ffffff !important;}&#8221;][vc_column css=&#8221;.vc_custom_1712306124053{padding-right: 40px !important;padding-left: 40px !important;}&#8221;][vc_single_image image=&#8221;109541&#8243; img_size=&#8221;full&#8221;][\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1605599376371{margin-right: 0px !important;margin-left: 0px !important;background-color: #ffffff !important;}&#8221;][vc_column css=&#8221;.vc_custom_1712305301743{padding-right: 40px !important;padding-left: 40px !important;}&#8221;][vc_column_text css=&#8221;&#8221;]The MDR introduces far-reaching changes aimed at improving the safety, quality, and transparency of medical devices. This enhances trust in the safety and efficacy of medical products.<\/p>\n<p>As a manufacturer, it is our priority to continue providing our customers with safe medical devices. Therefore, we are actively working towards certification in accordance with the requirements of the Medical Device Regulation (MDR).<\/p>\n<p>If you have any questions on this matter or require further information, please do not hesitate to contact us. We are at your disposal and happy to assist you.<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/ade-germany.de\/wp-content\/uploads\/2024\/10\/Confirmation_Letter_acc._EU_2023_607_with_regard_to_EU_2017_745.pdf\" target=\"_blank\" rel=\"noopener\">Confirmation Letter \u00a0acc. (EU) 2023\/607 with regard to (EU) 2017\/745 &gt;&gt;&gt;<\/a>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221; equal_height=&#8221;yes&#8221; margin_bottom=&#8221;0px&#8221; css=&#8221;.vc_custom_1712305100191{margin-right: 0px !important;margin-left: 0px !important;background-color: #ffffff !important;}&#8221;][vc_column css=&#8221;.vc_custom_1712305154709{padding-top: 40px !important;padding-right: 40px !important;padding-left: 40px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1712911883123{padding-top: 40px !important;}&#8221;] New regulations for medical devices: The impact of the Medical Device Regulation (MDR) On May 26, 2021, the Medical Device Regulation (MDR) of the European Union became binding, bringing changes for all manufacturers of&hellip;<\/p>\n","protected":false},"author":113,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-109537","page","type-page","status-publish","hentry","description-off"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR - ADE Germany<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ade-germany.de\/en\/mdr\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR - ADE Germany\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][\/vc_column][\/vc_row][vc_row type=&#8221;vc_default&#8221; 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