{"id":27704,"date":"2026-03-02T11:17:53","date_gmt":"2026-03-02T11:17:53","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27704"},"modified":"2026-09-03T07:32:09","modified_gmt":"2026-09-03T07:32:09","slug":"eu-commission-new-harmonised-mdr-standards","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/eu-commission-new-harmonised-mdr-standards\/","title":{"rendered":"EU Commission Publishes New Harmonised Standards Under the MDR"},"content":{"rendered":"<p>On January 30, 2026, the EU Commission published <strong>Implementing Decision (EU) 2026\/193<\/strong>, which lists <strong>12 further harmonised standards<\/strong> under the Medical Device Regulation (MDR).<\/p>\n<p>Particularly relevant for manufacturers of medical device software is <strong>EN ISO 14155:2020\/A11:2024<\/strong> on clinical investigations of medical devices in human subjects (Good Clinical Practice). The amendment aligns the terminology of ISO 14155 with the MDR and thereby creates a <strong>presumption of conformity<\/strong> for the requirements on clinical investigations set out in <strong>Annex XV of the MDR<\/strong>.<\/p>\n<p class=\"last-child\">You can find the implementing decision here: <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2026\/193\/oj\/\" target=\"_blank\" rel=\"noopener\">Implementing Decision (EU) 2026\/193<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27704","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>EU Publishes New Harmonised Standards Under the MDR<\/title>\n<meta name=\"description\" content=\"EU Decision 2026\/193 adds 12 harmonised MDR standards, including EN ISO 14155 for clinical 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