{"id":6184,"date":"2022-06-21T14:27:43","date_gmt":"2022-06-21T12:27:43","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=6184"},"modified":"2022-06-21T14:29:41","modified_gmt":"2022-06-21T12:29:41","slug":"eu-mdcg-position-paper-has-been-published","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/eu-mdcg-position-paper-has-been-published\/","title":{"rendered":"EU: MDCG Position paper has been published"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>In June, a Position\npaper MDCG 2022-11 was published on the website of the European Commission and\napproved by the Medical Devices Coordination Group (MDCG). The document does not reflect the official position of the European\nCommission. Any views expressed in this document are not legally binding.<\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-06\/mdcg_2022-11_en_0.pdf\">MDCG 2022-11 &#8211; MDCG Position Paper: Notice to\nmanufacturers to ensure timely compliance with MDR requirements<\/a> was issued on 13 June 2022. In the document MDCG points out\nthat in order to ensure that devices can continue to be placed on the market\nand to avoid shortages of medical devices, it is essential that all\nmanufacturers adjust their system, finalise transition to the MDR and apply to a\nnotified body, submitting complete and compliant applications, as soon as\npossible and well in advance of the end of the transition period to ensure\ntimely compliance with the MDR.<\/p>\n\n\n\n<p>It should\nbe noted that around 70 % of AIMDD\/MDD certificates will expire in 2024 (by 26\nMay 2024 at the latest). Manufacturers should take into consideration that it\nmight not be possible that notified bodies designated under the MDR would be\nable to assess all corresponding files within the first months of 2024.<\/p>\n\n\n\n<p>Click <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-06\/mdcg_2022-11_en_0.pdf\">here <\/a>for more information.&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\nservices<\/a>, we can help you meet the requirements of the\nMDR\/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\/2022-06\/mdcg_2022-11_en_0.pdf\">MDCG 2022-11 &#8211; MDCG\nPosition Paper: Notice to manufacturers to ensure timely compliance with MDR\nrequirements, web page EC, 13 June 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In June, a Position paper MDCG 2022-11 was published on the website of the European Commission and approved by the Medical Devices Coordination Group (MDCG). The document does not reflect the official position of the European Commission. Any views expressed in this document are not legally binding. MDCG 2022-11 &#8211; MDCG Position Paper: Notice to&#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-6184","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: MDCG Position paper has been published - 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-mdcg-je-objavil-dokument-o-staliscu\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: MDCG Position paper has been published - raPHARM\" \/>\n<meta property=\"og:description\" content=\"In June, a Position paper MDCG 2022-11 was published on the website of the European Commission and approved by the Medical Devices Coordination Group (MDCG). 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