{"id":5906,"date":"2022-03-24T09:12:22","date_gmt":"2022-03-24T08:12:22","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=5906"},"modified":"2022-04-19T14:51:42","modified_gmt":"2022-04-19T12:51:42","slug":"eu-on-25-january-2022-the-european-parliament-accepted-regulation-2022-112-amending-the-ivdr-regulation-as-regards-transitional-provisions-for-certain-ivd-devices-and-the-deferred-application-of-the","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/eu-on-25-january-2022-the-european-parliament-accepted-regulation-2022-112-amending-the-ivdr-regulation-as-regards-transitional-provisions-for-certain-ivd-devices-and-the-deferred-application-of-the\/","title":{"rendered":"EU: On 25 January 2022, the European Parliament accepted Regulation 2022\/112 amending the IVDR Regulation as regards transitional provisions for certain IVD devices and the deferred application of the conditions for in-house devices."},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p> <br><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SL\/TXT\/?uri=CELEX:32022R0112R(01)\">Regulation (EU) 2022\/112<\/a> of 25 January 2022 was published in European Official Journal L 19\/6 of 28 January 2022. The Regulation amends <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj\">Regulation (EU) 2017\/745<\/a> as regards transitional provisions for certain IVD devices and deferred application of the conditions for in-house devices.<\/p>\n\n\n\n<p>Amendment of the\nregulation provides IVD manufacturers more time to switch to the IVDR regulation\nand allows the currently tests on the market to remain available to patients,\nlaboratories, hospitals, and healthcare professionals.<\/p>\n\n\n\n<p>The date of full\napplication of the regulation remains on 26 May 2022 and applies to those\nCE-marked IVD devices that do not require the participation of a notified body (non-sterile\nClass A devices) and to &#8220;new&#8221; IVD devices (that are not certified, or\ndeclarations of conformity issued in accordance with Directive 98\/79\/CE). <\/p>\n\n\n\n<p>Transitional\nperiods have changed in relation to other risk classes:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>for\ndevices with the highest risk (class D) are subject to the requirements from 26\nMay 2025,<\/li><li>for class\nC devices, the date of introduction is 26 May 2026 and<\/li><li>for class\nB devices and class, A, devices placed on the market in a sterile state are\nsubject to requirements from 26 May 2027.<\/li><\/ul>\n\n\n\n<p><strong>Do you\nneed additional knowledge or assistance in meeting the requirements of\nMDR\/IVDR?<\/strong><\/p>\n\n\n\n<p>With the help of our <a href=\"https:\/\/www.rapharm.eu\/en\/actual-educations\/\">educations<\/a> and <a href=\"https:\/\/www.rapharm.eu\/en\/consulting-services\/\">consulting\nservices<\/a>, we can\nhelp you meet the requirements of the MDR\/IVDR.<strong><\/strong><\/p>\n\n\n\n<p><strong>Resource:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SL\/TXT\/?uri=CELEX%3A32022R0112\">Regulation\n(EU) 2022\/112 of the European Parliament and of the Council of 25&nbsp;January\n2022 amending Regulation (EU) 2017\/746 as regards transitional provisions for\ncertain in vitro diagnostic medical devices and the deferred application of\nconditions for in-house devices<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Regulation (EU) 2022\/112 of 25 January 2022 was published in European Official Journal L 19\/6 of 28 January 2022. The Regulation amends Regulation (EU) 2017\/745 as regards transitional provisions for certain IVD devices and deferred application of the conditions for in-house devices. Amendment of the regulation provides IVD manufacturers more time to switch to the&#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-5906","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: On 25 January 2022, the European Parliament accepted Regulation 2022\/112 amending the IVDR Regulation as regards transitional provisions for certain IVD devices and the deferred application of the conditions for in-house devices. - 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-evropski-parlament-in-svet-je-25-januarja-2022-sprejel-uredbo-2022-112-o-spremembi-uredbe-ivdr-v-zvezi-s-prehodnimi-odlocbami-za-nekatere-ivd-pripomocke-in-odlozeno-uporabo-pogojev-za-interne-pri\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: On 25 January 2022, the European Parliament accepted Regulation 2022\/112 amending the IVDR Regulation as regards transitional provisions for certain IVD devices and the deferred application of the conditions for in-house devices. - raPHARM\" \/>\n<meta property=\"og:description\" content=\"Regulation (EU) 2022\/112 of 25 January 2022 was published in European Official Journal L 19\/6 of 28 January 2022. The Regulation amends Regulation (EU) 2017\/745 as regards transitional provisions for certain IVD devices and deferred application of the conditions for in-house devices. 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