{"id":14647,"date":"2026-07-29T11:54:57","date_gmt":"2026-07-29T09:54:57","guid":{"rendered":"https:\/\/www.entecerma.it\/more-and-more-ecm-clients-have-achieved-compliance-with-mdr-2017-745\/"},"modified":"2026-07-29T12:30:26","modified_gmt":"2026-07-29T10:30:26","slug":"more-and-more-ecm-clients-have-achieved-compliance-with-mdr-2017-745","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/more-and-more-ecm-clients-have-achieved-compliance-with-mdr-2017-745\/","title":{"rendered":"More and more ECM clients have achieved compliance with MDR 2017\/745!"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">An important achievement\u2014the result of preparation, technical expertise, and strategy\u2014that confirms ECM&#8217;s commitment to supporting medical device companies on their journey toward full compliance with Medical Device Regulation (EU) 2017\/745.<\/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-deb42a49585759613d0b5b0228cef781\"><strong>DEVICES FROM CLASS I TO CLASS IIA (OR HIGHER): WHAT DOES MDR COMPLIANCE REALLY ENTAIL?<\/strong><\/h3>\n\n<p class=\"wp-block-paragraph\">With the entry into force of the MDR, many manufacturers found themselves facing a substantial change: devices classified as Class I under the MDD are now reclassified into Class IIa, IIb, or III, subject to much stricter requirements.<\/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-e87931998f21badf43f56c6895fb6c82\"><strong>WHO IS INVOLVED?<\/strong><\/h3>\n\n<ul class=\"wp-block-list\">\n<li>Medical software<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li>Reusable surgical instruments<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li>Devices with measuring function<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li>Long-term invasive products<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">All typical cases of reclassification, which now require mandatory assessment by a Notified Body (NB).<\/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-1cbb8280492eefc4fc7e46490d5bc6ac\"><strong>HAVE YOU ALREADY SUBMITTED THE DOCUMENTATION TO YOUR NOTIFIED BODY?<\/strong><\/h3>\n\n<p class=\"wp-block-paragraph\"><p data-path-to-node=\"1\">With the entry into force of Regulation (EU) 2023\/607, new transitional deadlines were introduced for all legacy devices\u2014but only for those who have already initiated the process.<\/p><br\/><p data-path-to-node=\"2\">Delaying submission could lead to:<\/p><\/p>\n\n<ul class=\"wp-block-list\">\n<li>NB overload<\/li>\n\n\n\n<li>Delays in assessments<\/li>\n\n\n\n<li>Risk of not obtaining CE certification in time<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">The right time to act is now.<br\/>Delaying means exposing yourself to regulatory uncertainty and potential market disruptions.<\/p>\n\n<p class=\"wp-block-paragraph\">Contact us today to complete your MDR process safely, without surprises, and with the confidence of having an expert partner by your side.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>An important achievement\u2014the result of preparation, technical expertise, and strategy\u2014that confirms ECM&#8217;s commitment to supporting&#8230;<\/p>\n","protected":false},"author":2,"featured_media":9835,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-14647","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 v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>More and more ECM clients have achieved compliance with MDR 2017\/745! 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