{"id":11356,"date":"2026-06-12T11:47:29","date_gmt":"2026-06-12T09:47:29","guid":{"rendered":"https:\/\/www.entecerma.it\/legacy-medical-devices-and-regulation-2023-607-managing-compliance-risk\/"},"modified":"2026-06-12T17:03:01","modified_gmt":"2026-06-12T15:03:01","slug":"legacy-medical-devices-and-regulation-2023-607-managing-compliance-risk","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/legacy-medical-devices-and-regulation-2023-607-managing-compliance-risk\/","title":{"rendered":"Legacy Medical Devices and Regulation 2023\/607: Managing Compliance Risk"},"content":{"rendered":"\n<p>The current European regulatory landscape is undergoing a delicate transition. The introduction of Regulation (EU) 2023\/607, which amended the deadlines of the MDR (Medical Device Regulation), has given manufacturers more time to comply with the new rules. However, the practical application of these extensions is highlighting several shortcomings. Many manufacturers of so-called Legacy devices (devices placed on the market under MDD certificates that are still valid or have expired under specific conditions) do not fully meet the requirements necessary to benefit from the transitional regime.<\/p>\n\n<p>This situation exposes the entire supply chain, from distributors to end users, to significant risks of non-compliance. Without rigorous verification by the parties involved, there is a risk that devices that are no longer legally allowed to be on the market will be placed on the market, with the associated consequences.<\/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-00540f799a9b5b634a75da923e31b706\"><strong>THE CONFIRMATION LETTER: AN OBJECTIVE GUARANTEE INSTRUMENT<\/strong><\/h3>\n\n<p>To mitigate these risks and ensure supply chain continuity, adopting more stringent control procedures has become essential. In this context, the confirmation letter serves as an added value for the acceptance of Legacy Devices.<\/p>\n\n<p>The Confirmation Letter, which can only be issued by a Notified Body, certifies that:&#13;\n<\/p>\n\n<ul class=\"wp-block-list\">\n<li>The MDR contract between the manufacturer and the Notified Body was signed by September 26, 2024;&#13;\n<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li>There is an EC declaration of conformity prior to May 26, 2021;<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li>The official certification application was submitted to a Notified Body by May 26, 2024.&#13;\n<\/li>\n<\/ul>\n\n<p>In the absence of these conditions, the extended validity of the old certificates expires, and legacy devices can neither be manufactured nor placed on the market.&#13;\n<\/p>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-511f886cc5966cc35128b319b2f4a18a\">STRATEGIES FOR BUSINESS CONTINUITY<\/h3>\n\n<p>Organizations operating in the sector must therefore implement monitoring systems to ensure compliance with the above.&#13;\n<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The current European regulatory landscape is undergoing a delicate transition. The introduction of Regulation (EU)&#8230;<\/p>\n","protected":false},"author":2,"featured_media":11347,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-11356","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>Legacy Medical Devices and Regulation 2023\/607: Managing Compliance Risk - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"Acceptance of legacy devices can no longer be based on CE declarations of conformity issued by the manufacturer; it is also advisable to request a Letter of Confirmation.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.entecerma.it\/en\/legacy-medical-devices-and-regulation-2023-607-managing-compliance-risk\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Legacy Medical Devices and Regulation 2023\/607: Managing Compliance Risk - Ente Certificazione Macchine\" \/>\n<meta property=\"og:description\" content=\"Acceptance of legacy devices can no longer be based on CE declarations of conformity issued by the manufacturer; 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