{"id":6153,"date":"2022-06-07T14:45:10","date_gmt":"2022-06-07T12:45:10","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=6153"},"modified":"2022-06-08T14:48:10","modified_gmt":"2022-06-08T12:48:10","slug":"6153","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/6153\/","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 2022. The\ndocument provides guidance as regards the applicability of IVDR requirements to\n\u2018legacy devices\u2019 and \u2018old devices\u2019. <\/p>\n\n\n\n<p>The annex contains a\nnon-exhaustive table illustrating IVDR requirements applicable or not\napplicable to \u2018legacy devices\u2019.<\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/document\/download\/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf\">MDCG Guideline 2022-6 Guidance on significant changes\nregarding the transitional provision under Article 110(3) of the IVDR<\/a> was issued on 4 May 2022.\nThis document explains the concept of \u2018significant changes in the design and\nintended purpose\u2019 under IVDR Article 110(3). It concerns manufacturers of\ndevices that are compliant with Directive 98\/79\/EC (IVDD) and that are placed on\nthe market or put into service after 26 May 2022 during the transition period\nin accordance with Article 110(3) IVDR, irrespective of whether or not those\ndevices required notified body involvement under the IVDD.<\/p>\n\n\n\n<p>The conditions for the\napplication of the transitional provisions in Article 110(3) IVDR are that the\ndevices continue to comply with the IVDD and that there are no significant\nchanges in the design or intended purpose of the device after the date of\napplication of the IVDR. Therefore, it is important for manufacturers and\nnotified bodies to have a clear understanding as to what changes to design or\nintended purpose would be considered \u2018significant\u2019 under Article 110(3) IVDR.<\/p>\n\n\n\n<p>The annex to the\ndocument contains a chards of design changes and changes of the intended purpose\nwhich may be considered \u2018significant\u2019 when interpreting the first sentence of\nIVDR Art. 110(3).<\/p>\n\n\n\n<p>This document provides a\ntemplate of the Summary of safety and performance (SSP), which is required by Regulation (EU) 2017\/746 on in\nvitro diagnostic medical devices (IVDR). Article 29 of IVDR states that the\nmanufacturer shall draw up a SSP for class C and D devices, other\nthan devices for performance studies. The SSP shall be validated by a notified\nbody (NB) and made available to the public via the European database on medical\ndevices (Eudamed).<\/p>\n\n\n\n<p>The SSP template for\ndevices not intended for self-testing is presented in Section 1 and the SSP\ntemplate for devices intended for self-testing is presented in Section 2 of the\ndocument.<\/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>Resources:<\/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\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022R0112\">REGULATION (EU) 2022\/112 OF THE EUROPEAN PARLIAMENT\nAND OF THE COUNCIL, Official Journal of the EU, 25 January 2022<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/document\/download\/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf\">MDCG Guideline 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR<\/a><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-6.pdf\">, web page EC, 4 May 2022<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/document\/download\/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf\">M<\/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-6153","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-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg-2\/\" \/>\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. 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