{"id":6194,"date":"2022-07-08T08:49:14","date_gmt":"2022-07-08T06:49:14","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=6194"},"modified":"2022-07-11T08:51:01","modified_gmt":"2022-07-11T06:51:01","slug":"eu-on-4-july-2022-the-european-commission-accepted-implementing-regulation-2022-1107-laying-down-common-specifications-for-certain-class-d-in-vitro-diagnostic-medical-devices-ivds-in-accordance-wi","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/eu-on-4-july-2022-the-european-commission-accepted-implementing-regulation-2022-1107-laying-down-common-specifications-for-certain-class-d-in-vitro-diagnostic-medical-devices-ivds-in-accordance-wi\/","title":{"rendered":"EU: On 4 July 2022, the European Commission accepted Implementing Regulation 2022\/1107 laying down common specifications for certain class D in vitro diagnostic medical devices (IVDs) in accordance with Regulation (EU) 2017\/746"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>In the document European Commission explains that for certain class D\nIVDs harmonised standards do not exist and since the risk associated with the\nuse of those devices is significant for public health and patient safety, it is\nappropriate to adopt common specifications for those devices. Commission also\nstates that the common technical specifications previously established for\ncertain devices covered by Directive 98\/79\/EC remain relevant, but are updated\nwhere necessary to reflect the state of the art.<\/p>\n\n\n\n<p>As defined by Regulation (EU) 2017\/746 \u2018common specifications\u2019 (CS)\nmeans a set of technical and\/or clinical requirements, other than a standard,\nthat provides a means of complying with the legal obligations applicable to a\ndevice, process or system.<\/p>\n\n\n\n<p>Commission Implementing Regulation (EU) 2022\/1107 contains 13 annexes. Annex\n1 lays down general common specifications as \u2018Requirements for performance\ncharacteristics of devices&#8217; presented in two parts and the rest of 12 annexes set\nout common specifications for specific types of IVDs, which are; blood group\nantigen detection devices for ABO, Rh, Kell, Duffy and Kidd blood group\nsystems, devices for detection or quantification of markers of human\nimmunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), hepatitis\nC virus (HCV), hepatitis B virus (HBV), hepatitis D virus (HDV),\nCreutzfeldt-Jakob disease (vCJD), cytomegalovirus (CMV), Epstein-Barr virus infection\n(EBV),&nbsp;Treponema pallidum,&nbsp;Trypanosoma cruzi, and severe acute\nrespiratory syndrome coronavirus 2 (SARS-CoV-2) infection.<\/p>\n\n\n\n<p>This Regulation shall apply from 25 July 2024. During the period from\n25&nbsp;July 2022 until 25&nbsp;July 2024, devices that are in conformity with\nthe common technical specifications set out in Decision 2002\/364\/EC, shall be\npresumed to be in conformity. Manufacturers of devices that are not in\nconformity with the common technical specifications set out in Decision\n2002\/364\/EC shall duly justify that they have adopted solutions that ensure a\nlevel of safety and performance that is at least equivalent thereto.<\/p>\n\n\n\n<p>This Regulation shall be binding in its entirety and directly applicable\nin all Member States.<\/p>\n\n\n\n<p>Click <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32022R1107\">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>Resource:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32022R1107\">Commission Implementing Regulation (EU) 2022\/1107 of\n4&nbsp;July 2022 laying down common specifications for certain class D in vitro\ndiagnostic medical devices in accordance with Regulation (EU) 2017\/746 of the\nEuropean Parliament and of the Council (Text with EEA relevance), web page EC,\n4 July 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the document European Commission explains that for certain class D IVDs harmonised standards do not exist and since the risk associated with the use of those devices is significant for public health and patient safety, it is appropriate to adopt common specifications for those devices. Commission also states that the common technical specifications previously&#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-6194","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 4 July 2022, the European Commission accepted Implementing Regulation 2022\/1107 laying down common specifications for certain class D in vitro diagnostic medical devices (IVDs) in accordance with Regulation (EU) 2017\/746 - 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-evropska-komisija-je-4-julija-2022-sprejela-izvedbeno-uredbo-2022-1107-o-dolocitvi-skupnih-specifikacij-za-nekatere-in-vitro-diagnosticne-medicinske-pripomocke-ivd-razreda-d-v-skladu-z-uredbo\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: On 4 July 2022, the European Commission accepted Implementing Regulation 2022\/1107 laying down common specifications for certain class D in vitro diagnostic medical devices (IVDs) in accordance with Regulation (EU) 2017\/746 - raPHARM\" \/>\n<meta property=\"og:description\" content=\"In the document European Commission explains that for certain class D IVDs harmonised standards do not exist and since the risk associated with the use of those devices is significant for public health and patient safety, it is appropriate to adopt common specifications for those devices. 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