{"id":6218,"date":"2022-10-27T09:39:04","date_gmt":"2022-10-27T07:39:04","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=6218"},"modified":"2022-10-27T09:40:46","modified_gmt":"2022-10-27T07:40:46","slug":"eu-two-new-guidelines-have-been-published-and-approved-by-the-mdcg","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/eu-two-new-guidelines-have-been-published-and-approved-by-the-mdcg\/","title":{"rendered":"EU: Two new guidelines have been published and approved by the MDCG"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>On 14 September, two\nnew guidelines, MDCG 2022-15 and MDCG 2021-22, were published on the website of\nthe European Commission and approved by the Medical Devices Coordination Group\n(MDCG). The guidelines are drafted in collaboration with interested parties\nrepresented in the various groups and are not legally binding. They present a\ncommon understanding of how the MDR and IVDR should be applied in practice\naiming at an effective and harmonized implementation of the legislation.<\/p>\n\n\n\n<p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2022-15_en.pdf\">MDCG Guideline 2022-15 Guidance\non appropriate surveillance regarding the transitional provisions under Article\n110 of the IVDR with regard to devices covered by certificates according to the\nIVDD<\/a> outlines the activities to be\nperformed by notified bodies as part of the appropriate surveillance defined in\nArticle 110(3) last subparagraph IVDR. To clarify elements to be verified by\nnotified bodies, this guidance document also covers requirements concerning\ncertain manufacturers\u2019 obligations, especially in respect of their quality\nmanagement system. The document applies to notified bodies that have lawfully\nissued certificates under the IVDD, regardless of whether or not those notified\nbodies have applied for designation or are designated under the IVDR (see MDCG\n2019-10 rev.1) as long as the respective authority responsible for notified\nbodies has the right to and does monitor the notified body\u2019s activities under\nArticle 110(3) IVDR.<\/p>\n\n\n\n<p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2021-22_en.pdf\">MDCG Guideline 2021-22 rev.1 Clarification on \u201cfirst certification for\nthat type of device\u201d and corresponding procedures to be followed by notified\nbodies (September 2022)<\/a> was issued in context of\nthe consultation of the expert panel referred to in Article 48(6) of Regulation\n(EU) 2017\/746 on IVD. For class D devices, the Article mentioned, establishes\nthe conditions to be applied by the notified body to determine whether it has\nto consult the expert panel on the performance evaluation report of the\nmanufacturer. These conditions are:<\/p>\n\n\n\n<p>(1) the absence of common specifications for the class D device in\nquestion,<br>\nAND<br>\n(2) where it is also the first certification for that type of device.<\/p>\n\n\n\n<p>This guidance provides clarification on the meaning of these conditions\nand on the corresponding procedures to be followed by the notified body. Itcovers\ntopics including:<\/p>\n\n\n\n<p>\u00b7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; What is the meaning of \u201cthe first certification for that\ntype of device\u201d in accordance with Article 48(6) of Regulation (EU) 2017\/746?<\/p>\n\n\n\n<p>\u00b7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; What procedure should a notified body follow to determine\nwhether a given certification is the first for that type of device?<\/p>\n\n\n\n<p>\u00b7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; How should the notified body indicate the type of device in\nits submission to the IVD expert panel?<\/p>\n\n\n\n<p>\u00b7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; What is the meaning of the phrase \u201cwhere no CS are\navailable\u201d in Art 48(6)?<\/p>\n\n\n\n<p>\u00b7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; If a notified body identifies that a consultation of an expert\npanel is currently ongoing for that type of device, what should it do regarding\nthe certification process?<\/p>\n\n\n\n<p>Click <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2022-15_en.pdf\">here <\/a>and <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2021-22_en.pdf\">here<\/a> for more information.&nbsp;<\/p>\n\n\n\n<p><strong>Do you need additional knowledge or assistance in meeting\nthe 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>Resources:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2022-15_en.pdf\">MDCG\nGuideline 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR\nwith regard to devices covered by certificates according to the IVDD, web page\nEC, 30 September 2022<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/mdcg_2021-22_en.pdf\">MDCG Guideline 2021-22 rev.1 Clarification on \u201cfirst certification for that type of device\u201d and\ncorresponding procedures to be followed by notified bodies (September 2022),\nweb page EC, 30 September 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 14 September, two new guidelines, MDCG 2022-15 and MDCG 2021-22, 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&#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-6218","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 guidelines 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-smernici-ki-jih-je-potrdila-mdcg-3\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: Two new guidelines have been published and approved by the MDCG - raPHARM\" \/>\n<meta property=\"og:description\" content=\"On 14 September, two new guidelines, MDCG 2022-15 and MDCG 2021-22, 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. 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