{"id":10587,"date":"2025-11-12T11:46:44","date_gmt":"2025-11-12T10:46:44","guid":{"rendered":"https:\/\/www.entecerma.it\/?p=10587"},"modified":"2025-11-12T14:43:48","modified_gmt":"2025-11-12T13:43:48","slug":"mdr-2017-745-certification-the-time-to-act-is-now","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-certification-the-time-to-act-is-now\/","title":{"rendered":"MDR 2017\/745 certification: the time to act is now"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><\/h2>\n\n\n\n<p>Failure to promptly comply with the requirements of the MDR Regulation\u2014which stipulates more robust technical documentation, the application of new classification rules, and a more rigorous post-market surveillance system\u2014will inevitably result in products being excluded from the European market.<\/p>\n\n\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-a66dedabb7cb4c3c360cd295127768df\" style=\"color:#085f9b\"><strong>CLASS I TO CLASS IIA (OR HIGHER) DEVICES: WHAT IS REALLY CHANGING?<\/strong><\/h3>\n\n\n\n<p>With the entry into force of the MDR, many manufacturers have faced a substantial change: devices classified as Class I under the MDD are now reclassified as Class IIa, IIb, or III, with much stricter requirements..<\/p>\n\n\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-01820bb54b431c9a544a743c19e100bf\" style=\"color:#085f9b\"><strong>WHO IS INVOLVED?<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Medical software<\/li>\n\n\n\n<li>Reusable surgical instruments<\/li>\n\n\n\n<li>Devices with a measuring function<\/li>\n\n\n\n<li>Long-term invasive products<br>All typical cases of reclassification, which now require mandatory assessment by a Notified Body (NB).<\/li>\n<\/ul>\n\n\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-ef410ffa0067e258e68a2e674e37445d\" style=\"color:#085f9b\"><strong>HAVE YOU ALREADY SUBMITTED THE DOCUMENTATION TO YOUR NB?<\/strong><\/h3>\n\n\n\n<p>With the entry into force of Regulation (EU) 2023\/607, new transitional terms have been introduced for all legacy devices, but only for those who have already started the process.<\/p>\n\n\n\n<p>Delaying submission could lead to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u26d4Overloading of Notified Bodies<\/li>\n\n\n\n<li>\u26d4 Delays in assessments<\/li>\n\n\n\n<li>\u26d4 Risk of not obtaining CE certification in time<\/li>\n<\/ul>\n\n\n\n<p>The right time to act is now.<br>Postponing means exposing yourself to regulatory uncertainties and possible interruptions in marketing.<\/p>\n\n\n\n<p>Contact us today to complete your MDR process safely, without unexpected events, and with the certainty of having an expert partner at your side.<\/p>\n\n\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-459b4166dfedf4f448c7b19bff984086\" style=\"color:#085f9b\"><\/h3>\n","protected":false},"excerpt":{"rendered":"<p>Failure to promptly comply with the requirements of the MDR Regulation\u2014which stipulates more robust technical&#8230;<\/p>\n","protected":false},"author":2,"featured_media":10594,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1,2],"tags":[],"class_list":["post-10587","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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