{"id":5465,"date":"2022-04-19T09:32:00","date_gmt":"2022-04-19T07:32:00","guid":{"rendered":"https:\/\/www.entecerma.it\/?p=5465"},"modified":"2022-04-28T14:31:35","modified_gmt":"2022-04-28T12:31:35","slug":"ecm-increasingly-involved-in-the-regulatory-scenario-of-the-new-mdr","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/ecm-increasingly-involved-in-the-regulatory-scenario-of-the-new-mdr\/","title":{"rendered":"ECM increasingly involved in the regulatory scenario of the new MDR"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>ECM Medical Devices Division, moving closer to the designation for the MDR regulation, intensifies its international institutional commitments in the regulatory field.<\/em><\/strong><\/h2>\n\n<p>While waiting for the accreditation for the Regulation (EU) 2017\/745, in the last days we have been invited to attend the <strong>66th NBCG-MED meeting <\/strong>and the <strong>Ordinary General Assembly of Team-NB<\/strong>.<\/p>\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"has-text-color wp-block-heading\" style=\"color:#085f9b\"><strong>66TH COORDINATION MEETING OF NOTIFIED BODIES FOR MEDICAL DEVICES<\/strong><\/h3>\n\n<p>From 5 to 7 April 2022, the <strong>European Notified Bodies<\/strong> for medical devices met with authorities and industry groups to discuss the main regulatory issues.<\/p>\n\n<p>Among the topics covered:<\/p>\n\n<ul class=\"wp-block-list\"><li>The <strong>capacity of Notified Bodies<\/strong>, following the application of Regulation (EU) 2017\/745;<\/li><li>The definition of a <strong>harmonised approach<\/strong> to the guidances produced by the European authority;<\/li><li>In-depth examination of &#8220;<strong>hybrid audits<\/strong>&#8221; (onsite and offsite).<\/li><\/ul>\n\n<p>The debate with institutional authorities provided a particularly rich experience. Among the shared issues were the situation regarding Annex XVI of the MDR and the progress of the designations of notified bodies.<\/p>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"has-text-color wp-block-heading\" style=\"color:#085f9b\"><strong>ORDINARY GENERAL ASSEMBLY MEETING OF TEAM-NB<\/strong><\/h3>\n\n<p>The General Assembly of <a href=\"https:\/\/www.team-nb.org\/\" target=\"_blank\" rel=\"noopener\"><strong>Team-NB<\/strong><\/a>, the European Association of Notified Bodies for medical devices, is an important opportunity for <strong>dialogue<\/strong> and <strong>updating<\/strong> among certification bodies. Through the exchange of opinions and experiences, notified bodies address major regulatory issues and identify shared lines of interpretation.<\/p>\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p><strong>Ente Certificazione Macchine<\/strong> regularly participates in these and other institutional meetings, cooperating with the main actors of the European regulatory and normative landscape. Through its participation, ECM enhances the prestige and know-how of its staff, providing medical device companies around the world with a highly professional and recognised service.<\/p>\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<hr class=\"wp-block-separator\"\/>\n\n<p><strong>For further information<\/strong> on our services in the medical device field, please contact our Sales Manager Ing. Diego Stevanella at <a href=\"mailto:diego.s@entecerma.it\">diego.s@entecerma.it<\/a> | cell. (+39) 393 2471040.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ECM Medical Devices Division, moving closer to the designation for the MDR regulation, intensifies its&#8230;<\/p>\n","protected":false},"author":2,"featured_media":5459,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12,2],"tags":[282,128,404,123,497,185,503,496],"class_list":["post-5465","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-history-en","category-news","tag-dispositivi-medici-en","tag-mdr-2017-745-en","tag-medical-device-regulation-en","tag-medical-devices-en","tag-nbcg-med-meeting-en","tag-organismo-notificato-en","tag-regolamento-dispositivi-medici-en","tag-team-nb-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 increasingly involved in the regulatory scenario of the new MDR - 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