{"id":1401,"date":"2023-06-06T17:44:28","date_gmt":"2023-06-06T15:44:28","guid":{"rendered":"https:\/\/tradee.ch\/blog\/zertifizierung-von-medizinprodukten-unter-mdr\/"},"modified":"2023-07-06T15:30:28","modified_gmt":"2023-07-06T13:30:28","slug":"certification-of-medical-devices-under-mdr","status":"publish","type":"post","link":"https:\/\/tradee.yelpix.net\/en\/blog\/certification-of-medical-devices-under-mdr\/","title":{"rendered":"Certification of medical devices under MDR"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"1401\" class=\"elementor elementor-1401\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc16ad9 e-flex e-con-boxed e-con e-parent\" data-id=\"dc16ad9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-c0bc56a e-con-full e-flex e-con e-parent\" data-id=\"c0bc56a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fbe33be elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-text-editor\" data-id=\"fbe33be\" 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>In this blog post, you will get an introduction to the requirements for medical device certification under the new EU Medical Device Regulation (MDR).<\/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-75c06ce elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"75c06ce\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d358c1 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"5d358c1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#t1\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Amendment MDR Status May 2021<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#t2\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Product shortage as a result<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#t3\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Solution approach of the EU Commission<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1675316 e-con-full e-flex e-con e-parent\" data-id=\"1675316\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9119701 elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"9119701\" 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>In this blog post, you will get an introduction to the requirements for medical device certification under the new EU Medical Device Regulation (MDR).<\/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-dede15a elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"dede15a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aef93cc elementor-widget elementor-widget-heading\" data-id=\"aef93cc\" data-element_type=\"widget\" data-e-type=\"widget\" id=\"t1\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Amendment MDR Status May 2021<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d19e79e elementor-widget elementor-widget-text-editor\" data-id=\"d19e79e\" 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><span style=\"font-weight: 400;\">Certification of medical devices under the new EU Medical Device Regulation (MDR) is a challenge for many manufacturers. The MDR, which goes into effect May 26, 2021, will require manufacturers to comprehensively overhaul their approval processes and make a significant investment in compliance with the new rules. According to the MDR, the import of  <\/span><span style=\"font-weight: 400;\">medical devices and IVDs into the Swiss market the official appointment of a Swiss authorized representative.  <\/span><\/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-ace9e4a elementor-widget elementor-widget-heading\" data-id=\"ace9e4a\" data-element_type=\"widget\" data-e-type=\"widget\" id=\"t2\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Product shortage as a result<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7cd2ca7 elementor-widget elementor-widget-text-editor\" data-id=\"7cd2ca7\" 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><span style=\"font-weight: 400;\">Due to the high requirements and scope of the changeover, many manufacturers are having difficulty meeting the deadlines. This has led to bottlenecks in the approval of medical devices and a shortage of important products on the market.  <\/span><span style=\"font-weight: 400;\">To address this issue, the EU Commission has adopted a proposal to allow more time for certification of medical devices under the MDR. The proposal is to extend the validity of MDD certificates and to introduce a longer transition period for adaptation to the new MDR rules. However, the extension of the deadlines is subject to certain conditions, so that more time will only be granted for products that are safe and for which manufacturers have already taken steps to transition to the MDR regulations.<\/span><\/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-1cd5a6a elementor-widget elementor-widget-image\" data-id=\"1cd5a6a\" 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=\"1024\" height=\"679\" src=\"https:\/\/tradee.yelpix.net\/wp-content\/uploads\/2023\/06\/Zertifizierung-von-Medizinprodukten-unter-MDR2-1024x679.png\" class=\"attachment-large size-large wp-image-1063\" alt=\"\" srcset=\"https:\/\/tradee.yelpix.net\/wp-content\/uploads\/2023\/06\/Zertifizierung-von-Medizinprodukten-unter-MDR2-1024x679.png 1024w, https:\/\/tradee.yelpix.net\/wp-content\/uploads\/2023\/06\/Zertifizierung-von-Medizinprodukten-unter-MDR2-300x199.png 300w, https:\/\/tradee.yelpix.net\/wp-content\/uploads\/2023\/06\/Zertifizierung-von-Medizinprodukten-unter-MDR2-768x509.png 768w, https:\/\/tradee.yelpix.net\/wp-content\/uploads\/2023\/06\/Zertifizierung-von-Medizinprodukten-unter-MDR2.png 1376w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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<div class=\"elementor-element elementor-element-d6df6f5 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"d6df6f5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-44de98b elementor-widget elementor-widget-text-editor\" data-id=\"44de98b\" 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><span style=\"font-weight: 400;\">The EU Commission grants an extension of the transition period for medical devices.<\/span><\/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-9a7de1e elementor-widget elementor-widget-heading\" data-id=\"9a7de1e\" data-element_type=\"widget\" data-e-type=\"widget\" id=\"t3\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Solution approach of the EU Commission<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-572ffbf elementor-widget elementor-widget-text-editor\" data-id=\"572ffbf\" 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><span style=\"font-weight: 400;\">The EU Commission&#8217;s proposal includes an extension of the transition period for medical devices in the lower risk classes (Ix and II, with the exception of IIb implantable) until December 31, 2028. For medical devices in the higher risk classes (IIb implantable and III), the deadline is extended to December 31, 2027. A transition period until May 26, 2026, is proposed for Class III implantable custom devices.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In addition, the Commission proposes to remove the &#8220;sell-by&#8221; period currently set forth in the MDR and IVDR. This deadline specifies that products certified after the MDR or IVDR certification expiration date must be sold within 18 months. This regulation may lead to unnecessary waste of medical devices and affect the supply of essential products.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Extending the deadlines for medical device certification under the MDR is an important step in avoiding bottlenecks in medical device approvals and ensuring that important products are available on the market. However, the extension of the deadlines is subject to certain conditions to ensure that only products with a high safety standard and a conversion process already underway are given more time. The proposal must now be adopted by the European Parliament and the Council in order to enter into force.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(Source: https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/de\/ip_23_23)<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>In this blog post, you will get an introduction to the requirements for medical device certification under the new EU Medical Device Regulation (MDR). Amendment MDR Status May 2021 Product shortage as a result Solution approach of the EU Commission In this blog post, you will get an introduction to the requirements for medical device [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1060,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[25,26],"tags":[],"class_list":["post-1401","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-import","category-medical-products"],"acf":[],"_links":{"self":[{"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/posts\/1401","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/comments?post=1401"}],"version-history":[{"count":0,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/posts\/1401\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/media\/1060"}],"wp:attachment":[{"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/media?parent=1401"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/categories?post=1401"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/tags?post=1401"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}