{"id":11125,"date":"2025-12-16T14:09:55","date_gmt":"2025-12-16T13:09:55","guid":{"rendered":"https:\/\/www.entecerma.it\/updated-scope-of-ecm-designation-extension-to-some-types-of-class-iii-devices\/"},"modified":"2025-12-17T09:26:18","modified_gmt":"2025-12-17T08:26:18","slug":"updated-scope-of-ecm-designation-extension-to-some-types-of-class-iii-devices","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/updated-scope-of-ecm-designation-extension-to-some-types-of-class-iii-devices\/","title":{"rendered":"Updated scope of ECM designation: extension to some types of Class III devices"},"content":{"rendered":"\n<p>The ministerial decree dated December 4, 2025, updated the scope of the ECM designation, extending this designation to certain types of Class III devices. The <a href=\"https:\/\/webgate.ec.europa.eu\/single-market-compliance-space\/notified-bodies\/notifications\/1021868?organizationVersion=7\">complete ECM designation scope<\/a> is available on the NANDO system.<\/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-fef4623e212491af23af3dc6bff87d96\">CLASS III DEVICE CATEGORIES NOW FALLING WITHIN THE ECM SCOPE<\/h3>\n\n<p>The ECM designation is now extended to the following types of Class III Medical Devices:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Non-Active Dental Devices<\/li>\n\n\n\n<li>Software<\/li>\n\n\n\n<li>Defibrillators<\/li>\n<\/ul>\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-0dce17885f4cf986b6b91d95af7beaad\">CONTACT US<\/h3>\n\n<p>Take advantage of this extension to our Notification Scope and contact us to find out if your Medical Devices fall within our updated Notification Scope.<\/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><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ministerial decree dated December 4, 2025, updated the scope of the ECM designation, extending&#8230;<\/p>\n","protected":false},"author":2,"featured_media":11101,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-11125","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 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Updated scope of ECM designation: extension to some types of Class III devices - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"The ministerial decree dated December 4, 2025, updated the scope of the ECM designation, extending this designation to certain types of Class III devices. 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