{"id":10579,"date":"2022-11-14T10:20:56","date_gmt":"2022-11-14T09:20:56","guid":{"rendered":"https:\/\/www.citieffe.com\/in-pole-position-per-la-certificazione-mdr-medical-device-regulation\/"},"modified":"2023-04-06T17:20:22","modified_gmt":"2023-04-06T15:20:22","slug":"in-pole-position-for-mdr-medical-device-regulation-certification","status":"publish","type":"post","link":"https:\/\/www.citieffe.com\/en\/in-pole-position-for-mdr-medical-device-regulation-certification\/","title":{"rendered":"In pole position for MDR (Medical Device Regulation) certification!"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1081.6px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-text-transform:none;\"><p>Citieffe has obtained in November 2022 the certification of the products according to the new EU MDR 2017\/745 regulation on medical devices that came into force in 2021. A complex activity that required a new certification with the requirements set by the new Regulation for products already certified from 1998 to today, according to the old MDD directive 93\/42\/EEC.<\/p>\n<p>A record-breaking success, if it is estimated that by the end of October only 8.73% of the current 22,793 certificates due to expire by 2024 had already obtained certification and in 82% of cases certification of both the quality management system (QMS) and the products required a minimum time of 13 months up to 18 for the highest risk classes*.<\/p>\n<p>Citieffe completed the QMS and product certification process in just 9 months.<\/p>\n<p>The quality system certification has also been renewed in compliance with the UNI-EN-ISO 9001:2015 and UNI-EN-ISO 13485:2021 standards.<\/p>\n<p>*Source: European Commission: \u201cNotified Bodies Survey on certifications and applications (MDR\/MDCG &amp; Stakeholders)\u201d, 24 Oct 2022<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Citieffe has obtained in November 2022 the certification of the products according to the new EU MDR 2017\/745 regulation on medical devices that came into force in 2021. A complex activity that required a new certification with the requirements set by the new Regulation for products already certified from 1998 to today, according to the old MDD directive 93\/42\/EEC.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[93],"tags":[],"class_list":["post-10579","post","type-post","status-publish","format-standard","hentry","category-news-eventi-en"],"_links":{"self":[{"href":"https:\/\/www.citieffe.com\/en\/wp-json\/wp\/v2\/posts\/10579","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.citieffe.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.citieffe.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.citieffe.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.citieffe.com\/en\/wp-json\/wp\/v2\/comments?post=10579"}],"version-history":[{"count":3,"href":"https:\/\/www.citieffe.com\/en\/wp-json\/wp\/v2\/posts\/10579\/revisions"}],"predecessor-version":[{"id":10581,"href":"https:\/\/www.citieffe.com\/en\/wp-json\/wp\/v2\/posts\/10579\/revisions\/10581"}],"wp:attachment":[{"href":"https:\/\/www.citieffe.com\/en\/wp-json\/wp\/v2\/media?parent=10579"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.citieffe.com\/en\/wp-json\/wp\/v2\/categories?post=10579"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.citieffe.com\/en\/wp-json\/wp\/v2\/tags?post=10579"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}