{"id":5951,"date":"2022-03-28T12:54:28","date_gmt":"2022-03-28T10:54:28","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=5951"},"modified":"2022-05-12T13:58:50","modified_gmt":"2022-05-12T11:58:50","slug":"eu-two-new-and-one-updated-guideline-have-been-published-and-approved-by-the-mdcg","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/eu-two-new-and-one-updated-guideline-have-been-published-and-approved-by-the-mdcg\/","title":{"rendered":"EU: Two new and one updated guideline have been published and approved by the MDCG"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>In February 2020, two new guidelines MDCG 2022-3 and MDCG 2022-4 and a new version of guideline MDCG 2021-21 Rev.1 were 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 should be applied in practice aiming at an effective and harmonised implementation of the legislation.<\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/latest-updates\/mdcg-2022-3-verification-manufactured-class-d-ivds-notified-bodies-2022-02-15_en\">MDCG Guideline 2022-3 Verification of\nmanufactured class D IVDs by notified bodies<\/a> was issued on 15 February 2022. This guideline is\nimportant for manufacturers of Class D IVD devices because it provides a\ndetailed specification of the requirements for a test plan for samples of\nmanufactured Class D devices or batches of devices and arrangements to be made\nbetween manufacturers, notified bodies (NBs) and EU reference laboratories\n(EURLs) to maintain these devices on the EU market. Without a successful batch\nverification process a Class D device is not permitted to be placed on the EU\nmarket.<\/p>\n\n\n\n<p>EURL will be\nimportant in the conformity assessment process for Class D devices, but no EURL\nhas been named so far. According to the <a href=\"https:\/\/ec.europa.eu\/health\/latest-updates\/updated-joint-implementation-plan-actions-considered-necessary-ensure-sound-functioning-new-2022-02-07_en\">IVDR joint implementation and preparation\nplan<\/a>, they will be designated\nin the first quarter of 2023. If no appropriate EURL is designated, the\nguideline opens the possibility for the NB to carry out a verification of manufactured\nClass D devices or batches of Class D devices without EURL involvement.<\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/latest-updates\/mdcg-2022-4-guidance-appropriate-surveillance-regarding-transitional-provisions-under-article-120-2022-02-16_en\">MDCG Guideline 2022-4 Guidance on\nAppropriate Surveillance of Transitional Provisions under Article 120 of the\nMDR<\/a> was issued on 16\nFebruary 2022. The guideline explains how notified bodies implement assessments\nof transitional devices * during the period specified in Article 20 of the MDR.\nThe document provides guidance on four different assessment options. For MDD\ndevices of Class IIa and IIb, the assessments of the technical documentation\nshall be continued based on sampling in accordance with the existing sampling\nplan prepared by the notified body within the MDD.<\/p>\n\n\n\n<p>The annex to the\ndocument contains a comparison table \u2013 quality management system requirements\nin the MDD and the MDR.<\/p>\n\n\n\n<p>* Legacy device means a device that complies with the\nthird paragraph of Article 120 of the MDR placed on the market after the date\nof application of the MDR and until 26 May 2024, if certain conditions are fulfilled.\nThose devices can be: &nbsp;devices which are\nclass I devices under MDD, for which an EC declaration of conformity was drawn\nup prior to 26 May 2021 and for which the conformity assessment procedure under\nthe MDR requires the involvement of a notified body or devices covered by a\nvalid EC certificate issued in accordance with AIMDD or the MDD prior to 26 May\n2021..<\/p>\n\n\n\n<p>An updated\nguideline <a href=\"https:\/\/ec.europa.eu\/health\/latest-updates\/update-mdcg-2021-21-rev1-guidance-performance-evaluation-sars-cov-2-vitro-diagnostic-medical-devices-2022-02-15_en\">MDCG 2021-21 Rev.1 &#8211; Guidance on the\nperformance evaluation of SARS-CoV-2 in vitro diagnostic medical devices<\/a>\nwas issued on 15 February 2022. These are minor editorial explanations in\nTables 1, 2, 4, 5, 6 and 7. The Guideline is addressed to all stakeholders, to IVD\nmanufacturers of SARS-CoV-2, as well as to notified bodies and competent\nauthorities, authorized representatives, other market players, professional\nassociations, and patient associations.<\/p>\n\n\n\n<p>The content of\nthis guidance document is intended as a basis for common specifications to be\nadopted in accordance with Article 9 of the IVDR in the coming months.<\/p>\n\n\n\n<p><strong>Do you need\nadditional knowledge or assistance in meeting 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\/\">educations<\/a> and <a href=\"https:\/\/www.rapharm.eu\/en\/consulting-services\/\">consulting services<\/a>, we can help you meet\nthe 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\/latest-updates\/mdcg-2022-3-verification-manufactured-class-d-ivds-notified-bodies-2022-02-15_en\">Guideline\nMDCG 2022-3 Verification of manufactured class D IVDs by notified bodies,\nweb page EK, 15 February 2022<\/a> <\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/latest-updates\/mdcg-2022-4-guidance-appropriate-surveillance-regarding-transitional-provisions-under-article-120-2022-02-16_en\">Guideline\nMDCG 2022-4 Guidance on appropriate surveillance regarding the transitional\nprovisions under Article 120 of the MDR, web\npage EK, 16 February 2022<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/latest-updates\/update-mdcg-2021-21-rev1-guidance-performance-evaluation-sars-cov-2-vitro-diagnostic-medical-devices-2022-02-15_en\">Guideline MDCG 2021-21 Rev.1 &#8211;\nGuidance on performance evaluation of SARS-CoV-2, web page EK, 15 February 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In February 2020, two new guidelines MDCG 2022-3 and MDCG 2022-4 and a new version of guideline MDCG 2021-21 Rev.1 were 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&#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-5951","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: Two new and one updated guideline have 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-objavljeni-sta-dve-novi-in-ena-posodobljena-smernica-ki-jih-je-potrdil-mdcg\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: Two new and one updated guideline have been published and approved by the MDCG - raPHARM\" \/>\n<meta property=\"og:description\" content=\"In February 2020, two new guidelines MDCG 2022-3 and MDCG 2022-4 and a new version of guideline MDCG 2021-21 Rev.1 were published on the website of the European Commission and approved by the Medical Devices Coordination Group (MDCG). 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