{"id":6176,"date":"2022-06-17T13:24:00","date_gmt":"2022-06-17T11:24:00","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=6176"},"modified":"2022-06-17T13:26:31","modified_gmt":"2022-06-17T11:26:31","slug":"eu-new-guideline-has-been-published-and-approved-by-the-mdcg","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/eu-new-guideline-has-been-published-and-approved-by-the-mdcg\/","title":{"rendered":"EU: New guideline has been published and approved by the MDCG"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>In May, a new\nguideline, MDCG 2022-8 was published on the website of the European Commission\nand approved by the Medical Devices Coordination Group (MDCG). The guidelines\nare drafted in collaboration with interested parties represented in the various\ngroups and are not legally binding. They present a common understanding of how\nthe MDR and IVDR should be applied in practice aiming at an effective and harmonized\nimplementation of the legislation.<\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-8_en.pdf\">MDCG Guideline 2022-8 Regulation\n(EU) 2017\/746 &#8211; application of IVDR requirements to \u2018legacy devices\u2019 and to\ndevices placed on the market prior to 26 May 2022 in accordance with Directive\n98\/79\/EC<\/a> was issued on 20 May\n2022. The document states legal provisions as per Article 110(3) of Regulation\n(EU) 2017\/746 on in vitro diagnostic medical devices (IVDR), amended by <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022R0112\">Regulation (EU) 2022\/112<\/a>. Regulation (EU) 2022\/112 extended the transitional\nprovisions of IVDR, in particular its Article 110(3), in terms of scope and\ntiming. Similar as the guideline <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2021-10\/md_mdcg_2021_25_en_0.pdf\">MDCG 2021-25<\/a> on transitional provisions of Regulation (EU) 2017\/745 on\nmedical devices (MDR), this document provides guidance as regards the\napplicability of IVDR requirements to \u2018legacy devices\u2019 and \u2018old\u2019 devices. <\/p>\n\n\n\n<p>The\nannex contains a non-exhaustive table illustrating IVDR requirements applicable\nor not applicable to \u2018legacy devices\u2019.<\/p>\n\n\n\n<p>Click <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-8_en.pdf\">here <\/a>for more\ninformation.&nbsp;<\/p>\n\n\n\n<p><strong>Do you need additional knowledge or assistance in\nmeeting the requirements of MDR\/IVDR?<\/strong><\/p>\n\n\n\n<p>With the help of our <a href=\"https:\/\/www.rapharm.eu\/en\/actual-educations\/\">actual\neducations<\/a> and <a href=\"https:\/\/www.rapharm.eu\/en\/consulting-services\/\">consulting services<\/a>, we can help you meet the requirements of the MDR\/IVDR.<\/p>\n\n\n\n<p><strong>Resource:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-8_en.pdf\">MDCG Guideline 2022-8 Regulation (EU) 2017\/746 &#8211; application of\nIVDR requirements to \u2018legacy devices\u2019 and to devices placed on the market prior\nto 26 May 2022 in accordance with Directive 98\/79\/EC, web page EC, 20 May 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In May, a new guideline, MDCG 2022-8 was published on the website of the European Commission and approved by the Medical Devices Coordination Group (MDCG). The guidelines are drafted in collaboration with interested parties represented in the various groups and are not legally binding. They present a common understanding of how the MDR and IVDR&#8230;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[45,30],"tags":[],"class_list":["post-6176","post","type-post","status-publish","format-standard","hentry","category-novice-en","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: New guideline has been published and approved by the MDCG - raPHARM<\/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:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: New guideline has been published and approved by the MDCG - raPHARM\" \/>\n<meta property=\"og:description\" content=\"In May, a new guideline, MDCG 2022-8 was published on the website of the European Commission and approved by the Medical Devices Coordination Group (MDCG). The guidelines are drafted in collaboration with interested parties represented in the various groups and are not legally binding. They present a common understanding of how the MDR and IVDR...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/\" \/>\n<meta property=\"og:site_name\" content=\"raPHARM\" \/>\n<meta property=\"article:published_time\" content=\"2022-06-17T11:24:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-06-17T11:26:31+00:00\" \/>\n<meta name=\"author\" content=\"rapharm\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"rapharm\" \/>\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:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/\",\"url\":\"https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/\",\"name\":\"EU: New guideline has been published and approved by the MDCG - raPHARM\",\"isPartOf\":{\"@id\":\"https:\/\/www.rapharm.eu\/#website\"},\"datePublished\":\"2022-06-17T11:24:00+00:00\",\"dateModified\":\"2022-06-17T11:26:31+00:00\",\"author\":{\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.rapharm.eu\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"EU: New guideline has been published and approved by the MDCG\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.rapharm.eu\/#website\",\"url\":\"https:\/\/www.rapharm.eu\/\",\"name\":\"raPHARM\",\"description\":\"Just another WordPress site\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.rapharm.eu\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1\",\"name\":\"rapharm\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g\",\"caption\":\"rapharm\"},\"url\":\"https:\/\/www.rapharm.eu\/en\/author\/rapharm\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"EU: New guideline has been published and approved by the MDCG - raPHARM","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:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/","og_locale":"en_US","og_type":"article","og_title":"EU: New guideline has been published and approved by the MDCG - raPHARM","og_description":"In May, a new guideline, MDCG 2022-8 was published on the website of the European Commission and approved by the Medical Devices Coordination Group (MDCG). The guidelines are drafted in collaboration with interested parties represented in the various groups and are not legally binding. They present a common understanding of how the MDR and IVDR...","og_url":"https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/","og_site_name":"raPHARM","article_published_time":"2022-06-17T11:24:00+00:00","article_modified_time":"2022-06-17T11:26:31+00:00","author":"rapharm","twitter_card":"summary_large_image","twitter_misc":{"Written by":"rapharm","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/","url":"https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/","name":"EU: New guideline has been published and approved by the MDCG - raPHARM","isPartOf":{"@id":"https:\/\/www.rapharm.eu\/#website"},"datePublished":"2022-06-17T11:24:00+00:00","dateModified":"2022-06-17T11:26:31+00:00","author":{"@id":"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1"},"breadcrumb":{"@id":"https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.rapharm.eu\/eu-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.rapharm.eu\/en\/"},{"@type":"ListItem","position":2,"name":"EU: New guideline has been published and approved by the MDCG"}]},{"@type":"WebSite","@id":"https:\/\/www.rapharm.eu\/#website","url":"https:\/\/www.rapharm.eu\/","name":"raPHARM","description":"Just another WordPress site","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.rapharm.eu\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1","name":"rapharm","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.rapharm.eu\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g","caption":"rapharm"},"url":"https:\/\/www.rapharm.eu\/en\/author\/rapharm\/"}]}},"_links":{"self":[{"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/posts\/6176","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/comments?post=6176"}],"version-history":[{"count":1,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/posts\/6176\/revisions"}],"predecessor-version":[{"id":6177,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/posts\/6176\/revisions\/6177"}],"wp:attachment":[{"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/media?parent=6176"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/categories?post=6176"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/tags?post=6176"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}