{"id":3639,"date":"2021-02-23T10:27:52","date_gmt":"2021-02-23T09:27:52","guid":{"rendered":"https:\/\/www.entecerma.it\/mdr-art-120-point-3-news-on-surveillances-for-ce-marked-products-under-mdd\/"},"modified":"2021-02-23T10:34:28","modified_gmt":"2021-02-23T09:34:28","slug":"mdr-art-120-point-3-news-on-surveillances-for-ce-marked-products-under-mdd","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-art-120-point-3-news-on-surveillances-for-ce-marked-products-under-mdd\/","title":{"rendered":"MDR art. 120, point 3 \u2013 News on surveillances for CE marked products under MDD"},"content":{"rendered":"\n<p>The new <strong><span class=\"has-inline-color\" style=\"color: #0071a1;\">Medical Device Regulation 2017\/745<\/span><\/strong> introduces important news for medical device manufacturers. <strong>Article 120 <\/strong><em>&#8216;Transitional Provisions&#8217;<\/em>, in <strong>point 3<\/strong>, states:<\/p>\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p><em>\u201c[\u2026] the requirements of this Regulation (MDR) relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.\u201d<\/em><\/p><\/blockquote>\n\n<p>This means that manufacturers holding an EC certificate, even if issued in accordance with Directive 93\/42\/EEC, will be required during annual surveillance to<strong> comply with certain requirements<\/strong> <strong>on <span class=\"has-inline-color\" style=\"color: #0071a1;\">Post-Marketing activities<\/span><\/strong>\u00a0in accordance with the new Regulation (EU) 2017\/745.<\/p>\n\n<p>Elements that manufacturers will have to meet include:<\/p>\n\n<ul class=\"wp-block-list\"><li><strong>Post Market Surveillance:<\/strong><ul><li>Vigilance<\/li><li>Complaints management<\/li><li>Trends reporting<\/li><li>Periodic Safety Update Report (PSUR)<\/li><\/ul><\/li><li><strong>Post-Marketing Clinical Follow-up<\/strong><\/li><\/ul>\n\n<ul class=\"wp-block-list\"><li><strong>CER updated every 1 or 2 years<\/strong>, depending on the risk class:<ul><li>State of the Art<\/li><li>Literature pivotal data<\/li><li>Vigilance data about competitor\/equivalence devices.<\/li><\/ul><\/li><\/ul>\n\n<p>Even if surveillance is carried out for an EC certificate issued according to Directive 93\/42\/EEC, the above-mentioned points must be <strong>updated<\/strong> in accordance with the new MDR. Otherwise a <strong>non-conformity<\/strong> will be detected during the surveillance, which may lead in some cases to the suspension of the certificate.<\/p>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p class=\"has-background has-medium-font-size\" style=\"background-color:#dfdfdf\"><strong>For more information<\/strong>, please contact our Sales Manager Antonio Balassone at <a href=\"mailto:antonio@entecerma.it\">antonio@entecerma.it<\/a> | mob. (+39) 393 2471040<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The new Medical Device Regulation 2017\/745 introduces important news for medical device manufacturers. Article 120&#8230;<\/p>\n","protected":false},"author":2,"featured_media":3634,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[406,407,282,405,128,404,123],"class_list":["post-3639","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-articolo-120-mdr-en","tag-certificazione-ce-en","tag-dispositivi-medici-en","tag-eu-regulation-en","tag-mdr-2017-745-en","tag-medical-device-regulation-en","tag-medical-devices-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR art. 120, point 3 \u2013 News on surveillances for CE marked products under MDD - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"Manufacturers holding an EC certificate, even if issued in accordance with Directive 93\/42\/EEC, will be required during annual surveillance to comply with certain requirements on post-marketing activities in accordance with the new 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\/mdr-art-120-point-3-news-on-surveillances-for-ce-marked-products-under-mdd\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR art. 120, point 3 \u2013 News on surveillances for CE marked products under MDD - 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