{"id":6027,"date":"2022-10-14T09:51:29","date_gmt":"2022-10-14T07:51:29","guid":{"rendered":"https:\/\/www.entecerma.it\/ecm-notified-body-for-mdr-regulation-eu-2017-745\/"},"modified":"2022-12-12T12:38:36","modified_gmt":"2022-12-12T11:38:36","slug":"ecm-notified-body-for-mdr-regulation-eu-2017-745","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/ecm-notified-body-for-mdr-regulation-eu-2017-745\/","title":{"rendered":"ECM Notified Body for MDR Regulation (EU) 2017\/745"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>The Italian Ministry of Health has designated Ente Certificazione Macchine Srl as new Notified Body for the MDR Regulation (EU) 2017\/745.<\/em><\/strong><\/h2>\n\n<p><strong>Ente Certificazione Macchine Srl<\/strong> is <strong>Notified Body no. 1282<\/strong> for the new European Regulation for Medical Devices (MDR), designated by the <em>Italian Ministry of Health<\/em>, with publication of the notification on the European Commission&#8217;s NANDO portal on <strong>14 October 2022<\/strong>.<\/p>\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe designation of ECM is a great milestone for our company,\u201d\u00a0<\/em>says the\u00a0<strong>ECM Sole Administrator Luca Bedonni<\/strong>,\u00a0<em>\u201ca special thanks goes to all our staff, who worked hard to carry out a complex accreditation process, performing in parallel the certification activities according to the MDD, non-stop, even during the most difficult period of the pandemic.\u201d<\/em><\/p>\n<\/blockquote>\n\n<div style=\"height:22px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"has-text-color wp-block-heading\" style=\"color:#085f9b\"><strong>THE REGULATION (EU) 2017\/745<\/strong><\/h2>\n\n<p><strong>Regulation (EU) 2017\/745 (MDR)<\/strong>, which replaces Directives 93\/42\/EEC (MDD) and 90\/385\/EEC (AIMD), applies to all manufacturers wishing to place their medical devices on the European Union market from 26 May 2021.<\/p>\n\n<p>The MDR imposes <strong>strong compliance requirements<\/strong> to ensure high standards of quality and safety, including:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Stricter and more precise requirements regarding technical documentation and clinical assessments and investigations;<\/li>\n\n\n\n<li>Increased post-market surveillance and follow-up obligations;<\/li>\n\n\n\n<li>New traceability and registration rules for medical devices.<\/li>\n<\/ul>\n\n<p><strong>From 27 May 2024<\/strong>, Regulation (EU) 2017\/745 will be fully applicable to all medical devices, which will have to be certified according to the MDR in order to be placed on the EU market.<\/p>\n\n<div style=\"height:30px\" 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 EXPERTISE<\/strong><\/h2>\n\n<p>Since 2017, Ente Certificazione Macchine has been Notified Body No. 1282 for the <strong>Medical Device Directive 93\/42\/EEC (MDD) <\/strong>and an accredited body for the certification of Quality Management Systems to the international standard <strong>EN ISO 13485:2016<\/strong>.<\/p>\n\n<p>ECM is also an active member of <a href=\"https:\/\/www.team-nb.org\/\" target=\"_blank\" rel=\"noopener\">Team-NB<\/a> \u2013 the European Association of Notified Bodies for Medical Devices &#8211; and participates in the periodic coordination meetings of European Notified Bodies, bringing its experience and expertise in regulatory matters.<\/p>\n\n<p class=\"has-cyan-bluish-gray-background-color has-background\"><strong>As of today, Ente Certificazione Macchine is able to provide manufacturers with the conformity assessment service for medical devices under Regulation (EU) 2017\/745, for which ECM operates as Notified Body No. 1282. <\/strong>The list of devices that fall under the scope of ECM is available on the <a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=notifiedbody.notifiedbody&amp;refe_cd=EPOS%5F50158\" target=\"_blank\" rel=\"noopener\">NANDO<\/a> portal.<\/p>\n\n<p>Considering the current number of Notified Bodies compared to the number of certificates that will expire in 2024, it is essential for companies to promptly comply with the requirements of the MDR and contact a Notified Body to assess their compliance well in advance of the end of the transition period.<\/p>\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are ready and excited to start the MDR conformity assessment activities and we invite all manufacturers to contact us as soon as possible, in order to ensure that devices can continue to be placed on the market and avoid shortages of medical devices\u201d<\/em>\u00a0<strong>Bedonni<\/strong>\u00a0concludes.<\/p>\n<\/blockquote>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-default\"\/>\n\n<p><strong>For information on CME services for medical devices:<\/strong><\/p>\n\n<p>SALES MANAGER ECM &#8211; Eng. Diego Stevanella <a href=\"mailto:diego.s@entecerma.it\">diego.s@entecerma.it<\/a> | mob. (+39) 393 2471040<\/p>\n\n<p>Download the official press release &gt;&gt; <\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Italian Ministry of Health has designated Ente Certificazione Macchine Srl as new Notified Body&#8230;<\/p>\n","protected":false},"author":2,"featured_media":6022,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[282,128,404,123,66,888,185],"class_list":["post-6027","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-dispositivi-medici-en","tag-mdr-2017-745-en","tag-medical-device-regulation-en","tag-medical-devices-en","tag-nando-en","tag-notified-body-1282-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 Notified Body for MDR Regulation (EU) 2017\/745 - 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