{"id":27715,"date":"2025-12-18T14:13:32","date_gmt":"2025-12-18T14:13:32","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27715"},"modified":"2026-09-03T07:47:57","modified_gmt":"2026-09-03T07:47:57","slug":"mdr-update-classification-medical-device-software","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/mdr-update-classification-medical-device-software\/","title":{"rendered":"MDR Update: Classification of Medical Device Software"},"content":{"rendered":"<p>The EU Commission has completed a targeted <strong>evaluation of the MDR and IVDR<\/strong>, on the basis of which a current amendment proposal has been published.<\/p>\n<p>Among other things, adjustments to the <strong>classification rules for medical device software<\/strong> are proposed. A <strong>concrete draft<\/strong> of the possible new classification rules now exists.<\/p>\n<p>It places <strong>software in class I by default<\/strong>, unless criteria for a higher classification apply. This is a <strong>reversal of the previous logic<\/strong>, which defined class I via the exclusion principle.<\/p>\n<p class=\"last-child\">Rule 11, which is the most relevant one for software, can be found in the following extract from the draft:<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-24503\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/12\/Update-der-MDR_Klassifizierung-von-Medizinprodukt-Software.webp\" alt=\"MDR update: classification of medical device software\" width=\"888\" height=\"902\" srcset=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/12\/Update-der-MDR_Klassifizierung-von-Medizinprodukt-Software.webp 888w, https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/12\/Update-der-MDR_Klassifizierung-von-Medizinprodukt-Software-480x488.webp 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 888px, 100vw\" \/><\/p>\n<p style=\"text-align: center;\"><strong>The changes to Rule 11 of the MDR<\/strong><\/p>\n<p>The <strong>list of possible use cases<\/strong> for the classification rule has also been extended beyond diagnosis and treatment.<\/p>\n<p>It can be assumed, however, that the <strong>draft will not pass through the EU legislative process unchanged<\/strong>. Amendments to the Commission draft are likely to be <strong>prepared and discussed<\/strong>, and both Parliament and the EU Council of Ministers will negotiate with each other to find a common position.<\/p>\n<p class=\"last-child\">The draft can be read here: <a href=\"https:\/\/health.ec.europa.eu\/publications\/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en\/\" target=\"_blank\" rel=\"noopener\">Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices &#8211; Public Health<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27715","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR Update: Classification of Medical Device Software<\/title>\n<meta name=\"description\" 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