{"id":3421,"date":"2023-01-12T11:39:26","date_gmt":"2023-01-12T09:39:26","guid":{"rendered":"https:\/\/nicola-bernard.de\/en\/?p=3421"},"modified":"2024-03-18T11:47:27","modified_gmt":"2024-03-18T09:47:27","slug":"countering-bottlenecks-in-medical-devices-transition-periods-extended","status":"publish","type":"post","link":"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/","title":{"rendered":"Countering bottlenecks in medical devices: Transition periods extended"},"content":{"rendered":"<p>Since May 2021, the new Medical Device Regulation (MDR) has been mandatory for many medical devices &#8211; with consequences for their availability.<\/p>\n<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container hundred-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-overflow:visible;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:calc( 100% + 0px ) !important;max-width:calc( 100% + 0px ) !important;margin-left: calc(-0px \/ 2 );margin-right: calc(-0px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column fusion-flex-align-self-flex-start fusion-column-no-min-height\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-spacing-right-small:0px;--awb-spacing-left-small:0px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div id=\"attachment_3418\" style=\"width: 359px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg\"><img decoding=\"async\" aria-describedby=\"caption-attachment-3418\" class=\"lazyload  wp-image-3418\" src=\"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg\" data-orig-src=\"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg\" alt=\"\" width=\"349\" height=\"233\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27349%27%20height%3D%27233%27%20viewBox%3D%270%200%20349%20233%27%3E%3Crect%20width%3D%27349%27%20height%3D%27233%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979-200x133.jpg 200w, https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979-300x200.jpg 300w, https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979-400x267.jpg 400w, https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979-600x400.jpg 600w, https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979-768x512.jpg 768w, https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979-800x533.jpg 800w, https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979-1024x683.jpg 1024w, https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979-1200x800.jpg 1200w, https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg 5472w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 349px) 100vw, 349px\" \/><\/a><p id=\"caption-attachment-3418\" class=\"wp-caption-text\">Source: Pexels<\/p><\/div>\n<p><strong>Demand for improvement<\/strong><\/p>\n<p>As the DIHK and partners were able to show in a survey, there have been delays in certification since then, which in turn lead to bottlenecks. Particularly affected: Pediatric, orthopedic and obstetric products.<\/p>\n<p>On January 6, 2023, the EU Commission has now decided to extend the transition periods. &#8220;The availability of safe medical devices for patients in Europe is our priority,&#8221; the corresponding press release states.<\/p>\n<p><strong>Deadline extension according to risk factor<\/strong><\/p>\n<p>The extent to which the deadline is extended depends on the type of medical device. For medium- and low-risk products &#8211; which include syringes &#8211; the deadline now ends in December 2028. Medical devices with a higher risk &#8211; such as pacemakers &#8211; the transition period only applies until December 2027.<\/p>\n<p>Background information on the EU Medical Devices Regulation can be found <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-topics-interest_en\" target=\"_blank\" rel=\"noopener\">here<\/a>.<\/p>\n<p>Source: <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_23_23\" target=\"_blank\" rel=\"noopener\">EU Commission<\/a>, <a href=\"https:\/\/www.dihk.de\/de\/aktuelles-und-presse\/aktuelle-informationen\/eu-will-uebergangsfristen-fuer-medizinprodukte-verlaengern-89386\" target=\"_blank\" rel=\"noopener\">DIHK<\/a><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Since May 2021, the new Medical Device Regulation (MDR) has [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-3421","post","type-post","status-publish","format-standard","hentry","category-allgemein-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Countering bottlenecks in medical devices: Transition periods extended - Nicola Bernard<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Countering bottlenecks in medical devices: Transition periods extended - Nicola Bernard\" \/>\n<meta property=\"og:description\" content=\"Since May 2021, the new Medical Device Regulation (MDR) has [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/\" \/>\n<meta property=\"og:site_name\" content=\"Nicola Bernard\" \/>\n<meta property=\"article:published_time\" content=\"2023-01-12T09:39:26+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-03-18T09:47:27+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg\" \/>\n<meta name=\"author\" content=\"nicola.bernard\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"nicola.bernard\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/\",\"url\":\"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/\",\"name\":\"Countering bottlenecks in medical devices: Transition periods extended - Nicola Bernard\",\"isPartOf\":{\"@id\":\"https:\/\/nicola-bernard.de\/en\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg\",\"datePublished\":\"2023-01-12T09:39:26+00:00\",\"dateModified\":\"2024-03-18T09:47:27+00:00\",\"author\":{\"@id\":\"https:\/\/nicola-bernard.de\/en\/#\/schema\/person\/7a09693188c7e9880d798b5b412350a4\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/#primaryimage\",\"url\":\"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg\",\"contentUrl\":\"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg\"},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/nicola-bernard.de\/en\/#website\",\"url\":\"https:\/\/nicola-bernard.de\/en\/\",\"name\":\"Nicola Bernard\",\"description\":\"Serviceb\u00fcro f. Au\u00dfenhandelslogistik\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/nicola-bernard.de\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/nicola-bernard.de\/en\/#\/schema\/person\/7a09693188c7e9880d798b5b412350a4\",\"name\":\"nicola.bernard\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/nicola-bernard.de\/en\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/8d3599518b1eacb2124948dcad963c1058826f9c08aa578d51a435fdc4e6dbc7?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/8d3599518b1eacb2124948dcad963c1058826f9c08aa578d51a435fdc4e6dbc7?s=96&d=mm&r=g\",\"caption\":\"nicola.bernard\"},\"url\":\"https:\/\/nicola-bernard.de\/en\/author\/nicola-bernard\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Countering bottlenecks in medical devices: Transition periods extended - Nicola Bernard","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/","og_locale":"en_US","og_type":"article","og_title":"Countering bottlenecks in medical devices: Transition periods extended - Nicola Bernard","og_description":"Since May 2021, the new Medical Device Regulation (MDR) has [&hellip;]","og_url":"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/","og_site_name":"Nicola Bernard","article_published_time":"2023-01-12T09:39:26+00:00","article_modified_time":"2024-03-18T09:47:27+00:00","og_image":[{"url":"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg","type":"","width":"","height":""}],"author":"nicola.bernard","twitter_misc":{"Written by":"nicola.bernard","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/","url":"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/","name":"Countering bottlenecks in medical devices: Transition periods extended - Nicola Bernard","isPartOf":{"@id":"https:\/\/nicola-bernard.de\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/#primaryimage"},"image":{"@id":"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/#primaryimage"},"thumbnailUrl":"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg","datePublished":"2023-01-12T09:39:26+00:00","dateModified":"2024-03-18T09:47:27+00:00","author":{"@id":"https:\/\/nicola-bernard.de\/en\/#\/schema\/person\/7a09693188c7e9880d798b5b412350a4"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/nicola-bernard.de\/en\/countering-bottlenecks-in-medical-devices-transition-periods-extended\/#primaryimage","url":"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg","contentUrl":"https:\/\/nicola-bernard.de\/wp-content\/uploads\/2023\/01\/pexels-vidal-balielo-jr-4006979.jpg"},{"@type":"WebSite","@id":"https:\/\/nicola-bernard.de\/en\/#website","url":"https:\/\/nicola-bernard.de\/en\/","name":"Nicola Bernard","description":"Serviceb\u00fcro f. Au\u00dfenhandelslogistik","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/nicola-bernard.de\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/nicola-bernard.de\/en\/#\/schema\/person\/7a09693188c7e9880d798b5b412350a4","name":"nicola.bernard","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/nicola-bernard.de\/en\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/8d3599518b1eacb2124948dcad963c1058826f9c08aa578d51a435fdc4e6dbc7?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/8d3599518b1eacb2124948dcad963c1058826f9c08aa578d51a435fdc4e6dbc7?s=96&d=mm&r=g","caption":"nicola.bernard"},"url":"https:\/\/nicola-bernard.de\/en\/author\/nicola-bernard\/"}]}},"_links":{"self":[{"href":"https:\/\/nicola-bernard.de\/en\/wp-json\/wp\/v2\/posts\/3421","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nicola-bernard.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nicola-bernard.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nicola-bernard.de\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nicola-bernard.de\/en\/wp-json\/wp\/v2\/comments?post=3421"}],"version-history":[{"count":2,"href":"https:\/\/nicola-bernard.de\/en\/wp-json\/wp\/v2\/posts\/3421\/revisions"}],"predecessor-version":[{"id":5821,"href":"https:\/\/nicola-bernard.de\/en\/wp-json\/wp\/v2\/posts\/3421\/revisions\/5821"}],"wp:attachment":[{"href":"https:\/\/nicola-bernard.de\/en\/wp-json\/wp\/v2\/media?parent=3421"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nicola-bernard.de\/en\/wp-json\/wp\/v2\/categories?post=3421"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nicola-bernard.de\/en\/wp-json\/wp\/v2\/tags?post=3421"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}