{"id":12074,"date":"2026-02-05T10:44:01","date_gmt":"2026-02-05T09:44:01","guid":{"rendered":"https:\/\/www.entecerma.it\/mdr-transitional-period-and-transfer-of-certification\/"},"modified":"2026-02-05T11:04:25","modified_gmt":"2026-02-05T10:04:25","slug":"mdr-transitional-period-and-transfer-of-certification","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-transitional-period-and-transfer-of-certification\/","title":{"rendered":"MDR Transitional Period and Transfer of Certification"},"content":{"rendered":"\n<p>The European Commission&#8217;s Q&amp;A, Revision 2 of July 2024, clarified that <strong>if a medical device manufacturer terminates its relationship with a Notified Body and simultaneously transfers its application to another Notified Body (also designated under the MDR), the conditions for accessing the transitional period are still fulfilled.<\/strong><\/p>\n\n<p>For instance, <strong>a manufacturer could benefit from the increased capacity available at a different Notified Body<\/strong> than the one to which the initial application was submitted at the start of the transitional period.<\/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-2090027077b72b0ef759d42ba27fcea6\"><strong>ECM DESIGNATION SCOPE UPDATED: EXTENSION TO CERTAIN CLASS III DEVICE TYPES<\/strong><\/h3>\n\n<p>With the directorial decree dated December 4, 2025, <a href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2026\/01\/Brochure-Notification-Scope_vers.12_2025.pdf\">ECM&#8217;s scope of designation was updated<\/a>, extending it to certain types of Class III devices. <a href=\"https:\/\/webgate.ec.europa.eu\/single-market-compliance-space\/notified-bodies\/notifications\/1021868?organizationVersion=7\">ECM\u2019s full scope of designation<\/a> is available on the NANDO system.<\/p>\n\n<p>Contact us for further information.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The European Commission&#8217;s Q&amp;A, Revision 2 of July 2024, clarified that if a medical device&#8230;<\/p>\n","protected":false},"author":2,"featured_media":12057,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-12074","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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