{"id":15355,"date":"2022-05-30T11:09:22","date_gmt":"2022-05-30T11:09:22","guid":{"rendered":"https:\/\/trans.pakumed.de\/uncategorized\/mdr-implementation-at-pakumed\/"},"modified":"2024-08-08T13:21:45","modified_gmt":"2024-08-08T13:21:45","slug":"mdr-implementation-at-pakumed","status":"publish","type":"post","link":"https:\/\/pakumed.de\/en\/uncategorized\/mdr-implementation-at-pakumed\/","title":{"rendered":"MDR IMPLEMENTATION AT PAKUMED"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"15355\" class=\"elementor elementor-15355 elementor-10087\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1ddf2e81 elementor-section-full_width elementor-section-height-min-height elementor-section-items-stretch elementor-section-content-bottom elementor-section-height-default\" data-id=\"1ddf2e81\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-4f54f675\" data-id=\"4f54f675\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4fd661ba elementor-widget elementor-widget-heading\" data-id=\"4fd661ba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">MDR IMPLEMENTATION AT PAKUMED<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f4d484d elementor-widget elementor-widget-post-info\" data-id=\"2f4d484d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-9093a23 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\t<time>20.12.2022<\/time>\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-4b7a5310\" data-id=\"4b7a5310\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4f54e39 elementor-widget elementor-widget-image\" data-id=\"4f54e39\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"770\" height=\"257\" src=\"https:\/\/pakumed.de\/wp-content\/uploads\/2022\/05\/EU_MDR_226201655_fotohansel_DEA1AD79-4A1F-4633-9E9A-6CF293DBE1FF.webp\" class=\"attachment-full size-full wp-image-17042\" alt=\"\" srcset=\"https:\/\/pakumed.de\/wp-content\/uploads\/2022\/05\/EU_MDR_226201655_fotohansel_DEA1AD79-4A1F-4633-9E9A-6CF293DBE1FF.webp 770w, https:\/\/pakumed.de\/wp-content\/uploads\/2022\/05\/EU_MDR_226201655_fotohansel_DEA1AD79-4A1F-4633-9E9A-6CF293DBE1FF-300x100.webp 300w, https:\/\/pakumed.de\/wp-content\/uploads\/2022\/05\/EU_MDR_226201655_fotohansel_DEA1AD79-4A1F-4633-9E9A-6CF293DBE1FF-768x256.webp 768w, https:\/\/pakumed.de\/wp-content\/uploads\/2022\/05\/EU_MDR_226201655_fotohansel_DEA1AD79-4A1F-4633-9E9A-6CF293DBE1FF-600x200.webp 600w\" sizes=\"(max-width: 770px) 100vw, 770px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3fd20ab3 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"3fd20ab3\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-1c0bbf70\" data-id=\"1c0bbf70\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-4fe957ca\" data-id=\"4fe957ca\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-38a42215 elementor-widget elementor-widget-text-editor\" data-id=\"38a42215\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Article on the Medical Devices Directive <span style=\"color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; background-color: var( --e-global-color-e09aa68 ); font-size: 1rem;\">EU 2017\/745<\/span><\/strong><\/p>\n<p><span style=\"background-color: var( --e-global-color-e09aa68 ); color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); font-size: 1rem;\">At PakuMed medical products gmbh, intensive preparations are underway to implement the new requirements of the MDR as quickly as possible.<\/span><\/p>\n<p>Here we have compiled some information on the subject of MDR for you:<\/p>\n<\/p>\n<p>In May 2017, the new European Medical Device Regulation (MDR) EU 2017\/745 came into force.<\/p>\n<p>The new regulation replaces the existing Medical Device Directive (MDD).<\/p>\n<p>Until the end of the transition period in May 2021, medical devices could continue to be certified according to the previous directive. Since the effective date, only the provisions of the new Medical Devices Ordinance apply.<\/p>\n<p>During the transfer phase from MDD to MDR, PakuMed medical products gmbh is monitored and audited by T\u00dcV NORD CERT. The implementation of the MDR on existing products, especially Class IIb and III, is a complex administrative process &#8211; this will also continue to be carried out with T\u00dcV NORD CERT.<\/p>\n<p>In future, around 500,000 existing medical devices in Europe will be (re)certified according to new, extended rules for obtaining the &#8220;CE mark&#8221;.<\/p>\n<\/p>\n<p>However, it is estimated that only about 65% of medical devices are certified according to the new regulations. Most Notified Bodies are currently in the accreditation phase. Due to the increasing requirements for Notified Bodies and manufacturers, adjustments in the product portfolios are to be expected and unavoidable.<\/p><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-346c3a1b elementor-widget elementor-widget-gallery\" data-id=\"346c3a1b\" data-element_type=\"widget\" data-e-type=\"widget\" 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elementor-animated-content\" href=\"https:\/\/pakumed.de\/wp-content\/uploads\/2022\/05\/EU.png\" data-elementor-open-lightbox=\"yes\" data-elementor-lightbox-slideshow=\"346c3a1b\" data-elementor-lightbox-title=\"EU\" data-e-action-hash=\"#elementor-action%3Aaction%3Dlightbox%26settings%3DeyJpZCI6MTAwOTAsInVybCI6Imh0dHBzOlwvXC9wYWt1bWVkLmRlXC93cC1jb250ZW50XC91cGxvYWRzXC8yMDIyXC8wNVwvRVUucG5nIiwic2xpZGVzaG93IjoiMzQ2YzNhMWIifQ%3D%3D\">\n\t\t\t\t\t<div class=\"e-gallery-image elementor-gallery-item__image\" data-thumbnail=\"https:\/\/pakumed.de\/wp-content\/uploads\/2022\/05\/EU.png\" data-width=\"520\" data-height=\"265\" aria-label=\"\" role=\"img\" ><\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-gallery-item__overlay\"><\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2214361 elementor-post-navigation-borders-yes elementor-widget elementor-widget-post-navigation\" data-id=\"2214361\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"post-navigation.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-post-navigation\" role=\"navigation\" aria-label=\"Post Navigation\">\n\t\t\t<div class=\"elementor-post-navigation__prev elementor-post-navigation__link\">\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-post-navigation__separator-wrapper\">\n\t\t\t\t\t<div class=\"elementor-post-navigation__separator\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"elementor-post-navigation__next elementor-post-navigation__link\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-43695960\" data-id=\"43695960\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3dd1e0eb animated-slow elementor-invisible elementor-widget elementor-widget-spacer\" data-id=\"3dd1e0eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Information regarding the new (EU) MDR 2017\/745<\/p>\n","protected":false},"author":3,"featured_media":19523,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-15355","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-unkategorisiert"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-05-03 10:30:03","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/posts\/15355","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/comments?post=15355"}],"version-history":[{"count":14,"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/posts\/15355\/revisions"}],"predecessor-version":[{"id":19520,"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/posts\/15355\/revisions\/19520"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/media\/19523"}],"wp:attachment":[{"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/media?parent=15355"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/categories?post=15355"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pakumed.de\/en\/wp-json\/wp\/v2\/tags?post=15355"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}