{"id":14702,"date":"2026-08-04T12:39:13","date_gmt":"2026-08-04T10:39:13","guid":{"rendered":"https:\/\/www.entecerma.it\/mdr-certification-time-to-accelerate-technical-documentation\/"},"modified":"2026-08-04T12:49:26","modified_gmt":"2026-08-04T10:49:26","slug":"mdr-certification-time-to-accelerate-technical-documentation","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-certification-time-to-accelerate-technical-documentation\/","title":{"rendered":"MDR Certification: Time to accelerate technical documentation"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><em>Notified bodies under pressure and manufacturers: The strategic role of technical documentation in MDR certification for medical devices.<\/em><\/p>\n\n<div style=\"height:35px\" 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-fd689df3302bb5ce7c6dda7e65cd4811\"><strong>THE CURRENT SITUATION: A BOTTLENECK IN CERTIFICATIONS<\/strong><\/h3>\n\n<p class=\"wp-block-paragraph\">While certification requests and contracts signed with Notified Bodies are significantly increasing, the number of MDR certificates actually issued is not keeping pace. This imbalance risks creating a critical situation: delays in placing devices on the market and significant impacts on the entire European healthcare 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-09fbb75c0bf16d0bd2475cbf87ef9744\"><strong>A CONCRETE ACCELERATION IS NEEDED<\/strong><\/h3>\n\n<p class=\"wp-block-paragraph\">Manufacturers who fail to act in time risk losing access to the European market. This risk goes beyond business competitiveness \u2013 it directly affects continuity of care, patient safety, and the sustainability of the healthcare 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-1a27b2290b7011d92671b6c5dfc5d2e1\"><b data-path-to-node=\"0\" data-index-in-node=\"0\"><span class=\"citation-17 citation-end-17\">THE ACTIVE ROLE OF ECM AS A NOTIFIED BODY<\/span><\/b><\/h3>\n\n<p class=\"wp-block-paragraph\">As <a href=\"https:\/\/www.entecerma.it\/en\/activities\/certifications\/product-and-service\/medical-devices-regulation-eu-2017-745\/\">Notified Body No. 1282<\/a> for the MDR Regulation, ECM reaffirms its commitment alongside manufacturers. Our goal is twofold:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Providing manufacturers with procedural details, timelines, and relevant regulatory requirements related to the certification process through the <a href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2025\/02\/Structured-Dialogue_ECM-for-Medical-Devices.pdf\">Structured Dialogue service<\/a>;<\/li>\n\n\n\n<li>Proactively managing certification requests through an efficient and professional assessment process.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">Responsibility is shared, but the first step belongs to the manufacturers: to anticipate, prepare, and deliver all necessary documentation, enabling Notified Bodies to assess, certify, and \u2013 above all \u2013 ensure market continuity.<\/p>\n\n<p class=\"wp-block-paragraph\">For information on MDR certification procedures and to request a quote, the ECM team is at your disposal.<\/p>\n\n<p class=\"wp-block-paragraph\"><b data-path-to-node=\"0\" data-index-in-node=\"0\">Contact us at:<\/b> Diego Stevanella <a href=\"mailto:diego.s@entecerma.it\">diego.s@entecerma.it<\/a> | Marzia Pellegrini <a href=\"mailto:marzia.p@entecerma.it\">marzia.p@entecerma.it<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Notified bodies under pressure and manufacturers: The strategic role of technical documentation in MDR certification&#8230;<\/p>\n","protected":false},"author":2,"featured_media":14699,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-14702","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 - 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