{"id":11613,"date":"2026-01-26T14:44:14","date_gmt":"2026-01-26T13:44:14","guid":{"rendered":"https:\/\/www.entecerma.it\/ecm-strengthens-its-designation-expanded-list-of-recognized-class-iii-devices\/"},"modified":"2026-01-26T14:52:53","modified_gmt":"2026-01-26T13:52:53","slug":"ecm-strengthens-its-designation-expanded-list-of-recognized-class-iii-devices","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/ecm-strengthens-its-designation-expanded-list-of-recognized-class-iii-devices\/","title":{"rendered":"ECM strengthens its designation: expanded list of recognized Class III devices"},"content":{"rendered":"\n<p>With the directorate decree dated December 4, 2025, the scope of the ECM designation was updated, extending this designation to certain types of Class III devices. The complete <a href=\"https:\/\/webgate.ec.europa.eu\/single-market-compliance-space\/notified-bodies\/notifications\/1021868?organizationVersion=7\">ECM designation scope<\/a> is available on the NANDO system.<br\/><br\/>\u00a0<br\/><br\/>\u00a0<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-4e044827dd18d3336030924fe8f597be\">CATEGORIES OF CLASS III DEVICES NOW COVERED BY ECM<br\/><br\/>\u00a0<br\/><br\/>\u00a0<\/h3>\n\n<p>The ECM designation is now extended to the following types of Class III Medical Devices:<br\/><br\/>\u00a0<br\/><br\/>\u00a0<\/p>\n\n<p>Defibrillators<br\/><br\/>\u00a0<br\/><br\/>\u00a0<\/p>\n\n<p>Non-Active Dental Devices<br\/><br\/>\u00a0<br\/><br\/>\u00a0<\/p>\n\n<p>Software<br\/><br\/>\u00a0<br\/><br\/>\u00a0<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-e7f4988a666b22a234e0e9d3b10fb64c\">CONTACT US<br\/><br\/>\u00a0<br\/><br\/>\u00a0<\/h3>\n\n<p>Take advantage of this extension of our <a href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2026\/01\/Brochure-Notification-Scope_vers.12_2025.pdf\">Notification Scope<\/a> and contact us to find out if your medical devices fall within our updated <a href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2026\/01\/Brochure-Notification-Scope_vers.12_2025.pdf\">Notification Scope<\/a>.<br\/><br\/>\u00a0<br\/><br\/>\u00a0<\/p>\n\n<p>Contact our Sales Managers:<br\/>Diego Stevanella \u2013 <a href=\"mailto:diego.s@entecerma.it\">diego.s@entecerma.it<\/a><br\/>Marzia Pellegrini \u2013 <a href=\"mailto:marzia.p@entecerma.it\">marzia.p@entecerma.it<\/a><br\/><br\/>\u00a0<br\/><br\/>\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"<p>With the directorate decree dated December 4, 2025, the scope of the ECM designation was&#8230;<\/p>\n","protected":false},"author":2,"featured_media":11606,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-11613","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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