{"id":3361,"date":"2021-01-20T10:04:09","date_gmt":"2021-01-20T09:04:09","guid":{"rendered":"https:\/\/www.entecerma.it\/mdr-2017-745-ecm-closer-to-the-designation-as-notified-body\/"},"modified":"2021-01-20T10:09:30","modified_gmt":"2021-01-20T09:09:30","slug":"mdr-2017-745-ecm-closer-to-the-designation-as-notified-body","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-ecm-closer-to-the-designation-as-notified-body\/","title":{"rendered":"MDR 2017\/745: ECM closer to the designation as Notified Body"},"content":{"rendered":"\n<p style=\"font-size:21px\"><em>We are pleased to inform our customers, collaborators and the entire medical device industry that <strong>Ente Certificazione Macchine<\/strong> is moving in the final stage towards the designation as Notified Body according to the <strong>Regulation (EU) 2017\/745<\/strong>.<\/em><\/p>\n<p>Another step towards the <strong>goal<\/strong> has been achieved. In the last few days, we have received official communication from <em>Accredia<\/em> of the positive outcome of the assessment on our CAPA Plan, with the closure of the non-conformities raised during the audit. The task now passes to the <em>Italian<\/em> <em>Ministry of Health<\/em> for the further action required.<\/p>\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"has-text-color wp-block-heading\" style=\"color:#004e6f;font-size:26px\"><strong><em>The pathway to MDR<\/em><\/strong><\/h2>\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<p>The process to obtain the accreditation as <strong>Notified Body<\/strong> according to MDR 2017\/745 is not easy at all. After having been audited by the <em>JAT &#8211; the Joint Assessment Team<\/em> composed of the European Commission, the Ministry of Health and Accredia &#8211; ECM worked hard to solve all the non-conformities found and to fully comply with the <strong>requirements<\/strong> imposed by the new regulation.<\/p>\n<p>Even in the most difficult moment of the Covid-19 pandemic, our staff has worked non-stop in the certification activity of essential medical devices supporting the market, proceeding in parallel with the work of alignment with the provisions of <strong>EU<\/strong> <strong>Regulation 2017\/745<\/strong>. This commitment has allowed us, despite the one-year delay of the MDR application, to continue our designation path according to the deadlines we had set.<\/p>\n\n<p>Last October, we finalised a further documentary step, successfully assessed by <em>Accredia<\/em>, leading us to the <strong>final stage<\/strong> of the accreditation process. Now the <em>Italian Ministry of Health<\/em> will carry out further verifications and, as final step, will forward our case to the European Commission, which will conclude the process.<\/p>\n<p>Considering the difficulties and the complex situation caused by the Covid-19 outbreak, we are very proud of the work that has been done so far. ECM is continuing its activities with the <strong>commitment<\/strong> and <strong>professionalism<\/strong> that has always distinguished us. We are confident that we will soon be designated as Notified Body for the <strong>MDR 2017\/745<\/strong> and will be able to provide the medical industry with this new <strong>certification<\/strong> service as well.<\/p>\n<p>In the meantime, the work of our expert team for the certification of products under the <strong>Medical Device Directive (MDD) 93\/42\/EEC<\/strong> continues. With the application of the new MDR postponed by one year, companies have until <strong>26 May 2021<\/strong> to certify their devices according to the MDD, as well as to adapt their processes and products to the stringent standards imposed by the new regulation.<\/p>\n\n<hr class=\"wp-block-separator is-style-wide\"\/>\n\n<p class=\"has-background\" style=\"background-color:#e5f1fb\"><strong>For more information<\/strong> about our services, you can contact our Sales Manager Antonio Balassone at <a href=\"mailto:antonio@entecerma.it\">antonio@entecerma.it<\/a> | mob. +39 393 2471040. Or click on the button below to fill in the information request form.<\/p>\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons aligncenter is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-background\" href=\"https:\/\/www.entecerma.it\/en\/sectors\/medical-devices\/request-a-service\/\" style=\"background-color:#004e6f\" target=\"_blank\" rel=\"noreferrer noopener\">Request a service<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>We are pleased to inform our customers, collaborators and the entire medical device industry that&#8230;<\/p>\n","protected":false},"author":2,"featured_media":3353,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[282,128,123,367,185,127],"class_list":["post-3361","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-dispositivi-medici-en","tag-mdr-2017-745-en","tag-medical-devices-en","tag-notified-body-en","tag-organismo-notificato-en","tag-regulation-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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