{"id":6219,"date":"2022-11-23T11:31:53","date_gmt":"2022-11-23T10:31:53","guid":{"rendered":"https:\/\/www.entecerma.it\/ecm-accepts-applications-to-certify-medical-devices-according-to-mdr\/"},"modified":"2022-11-23T11:35:34","modified_gmt":"2022-11-23T10:35:34","slug":"ecm-accepts-applications-to-certify-medical-devices-according-to-mdr","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/ecm-accepts-applications-to-certify-medical-devices-according-to-mdr\/","title":{"rendered":"ECM accepts applications to certify medical devices according to MDR"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>Ente Certificazione Macchine Notified Body No.1282 is accepting new applications from manufacturers wishing to certify their medical devices according to Regulation (EU) 2017\/745.<\/em><\/strong><\/h2>\n\n<div style=\"height:18px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"has-text-color wp-block-heading\" style=\"color:#085f9b\"><strong>THE CONTEXT<\/strong><\/h2>\n\n<p>The implementation of <strong>Regulation (EU) 2017\/745 (MDR)<\/strong> is a <strong>difficult challenge<\/strong> for the entire medical device industry. All stakeholders involved, from notified bodies to manufacturers, are facing a progressive substantial transition to the new regulation, which is much more complex and stringent than the previous one.<\/p>\n\n<p>However, despite their efforts, there are many <strong>concerns<\/strong> about the correct and sustainable implementation of the new regulatory regime by the entire system. The institutions themselves, aware of the current number of notified bodies compared to the number of certificates that will expire at the end of the transition period, invite all manufacturers to <strong>quickly comply<\/strong> with the MDR requirements and contact a notified body as soon as possible to start the certification process <em>[source:<\/em> <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-11-mdcg-position-paper-notice-manufacturers-ensure-timely-compliance-mdr-requirements-2022-06-13_en\" target=\"_blank\" rel=\"noopener\"><em>MDCG 2022-11 Position Paper \u2013 Notice to manufacturers to ensure timely compliance with MDR requirements<\/em><\/a><em>]<\/em>.<\/p>\n\n<p>On the other hand, the medical industry is expressing concerns about the <strong>capacity of notified bodies<\/strong> to handle the large number of certification activities required by 2024. As of today, indeed, only a small part of the approximately 24,000 certifications of the former MDD\/AIMDD directives have transitioned to MDR. Moreover, considering the high number of requests, a<strong>n increasing number of notified bodies is no longer able to accept new certification applications<\/strong>. <em>[For more data, see the EU Commission&#8217;s <\/em><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/notified-bodies-survey-certifications-and-applications-2022-10-26_en\" target=\"_blank\" rel=\"noopener\"><em>Notified bodies survey on certifications and applications<\/em><\/a><em>]<\/em>.<\/p>\n\n<p>There is a real risk of a <strong>shortage<\/strong> of medical devices on the market necessary for hospitals and end-patients.<\/p>\n\n<div style=\"height:18px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"has-text-color wp-block-heading\" style=\"color:#085f9b\"><strong>ECM&#8217;S CERTIFICATION ACTIVITY<\/strong><\/h2>\n\n<p>Even ECM has addressed the concerns of manufacturers, who met at <strong>MEDICA<\/strong> in Dusseldorf last week to present products and services and exchange experiences and opinions. Our Sales Manager, who visited the event, reported great interest from companies wishing to <strong>start the<\/strong> <strong>EU certification process<\/strong> as soon as possible according to MDR. Many of them, however, find it difficult to get the right Notified Body.<\/p>\n\n<p class=\"has-background\" style=\"background-color:#d3dbe5\"><strong>Ente Certificazione Macchine \u2013 <\/strong><a href=\"https:\/\/www.entecerma.it\/en\/activities\/certifications\/product-and-service\/medical-devices-regulation-eu-2017-745\/\" target=\"_blank\" rel=\"noopener\"><strong>Notified Body No. 1282<\/strong><\/a> for Regulation (EU) 2017\/745, designated on Nando on 14 October 2022, <strong>is accepting new applications<\/strong> from manufacturers wishing to certify their medical devices under the MDR.<\/p>\n\n<p>We therefore invite companies to contact us as soon as possible for more information, to know the timelines of the certification process and to obtain a tailor-made quotation. <strong>Contact us at<\/strong>:<\/p>\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p>Eng. Diego Stevanella \u2013 Sales Manager ECM<\/p>\n\n\n\n<p><a href=\"mailto:diego.s@entecerma.it\">diego.s@entecerma.it<\/a> | mob. (+39) 393 2471040<\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Ente Certificazione Macchine Notified Body No.1282 is accepting new applications from manufacturers wishing to certify&#8230;<\/p>\n","protected":false},"author":2,"featured_media":6215,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[923,128,404,123,917,185],"class_list":["post-6219","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-eu-certification-en","tag-mdr-2017-745-en","tag-medical-device-regulation-en","tag-medical-devices-en","tag-notified-body-mdr-en","tag-organismo-notificato-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ECM accepts applications to certify medical devices according to MDR - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"Ente Certificazione Macchine Notified Body No.1282 is accepting new applications from manufacturers wishing to certify their medical devices according to Regulation (EU) 2017\/745.\" \/>\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\/ecm-accepts-applications-to-certify-medical-devices-according-to-mdr\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ECM accepts applications to certify medical devices according to MDR - 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