{"id":5913,"date":"2022-03-24T09:31:54","date_gmt":"2022-03-24T08:31:54","guid":{"rendered":"https:\/\/www.rapharm.eu\/hr\/?p=5913"},"modified":"2022-04-19T14:46:11","modified_gmt":"2022-04-19T12:46:11","slug":"eu-25-sijecnja-2022-europski-parlament-i-vijece-prihvatili-su-uredbu-2022-112-o-izmjeni-ivdr-uredbe-u-pogledu-prijelaznih-odredaba-za-odredene-ivd-uredaje-i-odgodene-primjene-uvjeta-za-interne-proiz","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/hr\/eu-25-sijecnja-2022-europski-parlament-i-vijece-prihvatili-su-uredbu-2022-112-o-izmjeni-ivdr-uredbe-u-pogledu-prijelaznih-odredaba-za-odredene-ivd-uredaje-i-odgodene-primjene-uvjeta-za-interne-proiz\/","title":{"rendered":"EU: 25. sije\u010dnja 2022 Europski parlament i Vije\u0107e prihvatili su Uredbu 2022\/112 o izmjeni IVDR Uredbe u pogledu prijelaznih odredaba za odre\u0111ene IVD ure\u0111aje i odgo\u0111ene primjene uvjeta za interne proizvode."},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SL\/TXT\/?uri=CELEX:32022R0112R(01)\">Uredba (EU) 2022\/112<\/a> od 25. sije\u010dnja 2022 objavljena je u Europskom slu\u017ebenom listu L 19\/6 od 28. sije\u010dnja 2022. Uredbom se izmjenjuje <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj\">Uredba (EU) 2017\/745<\/a> u odnosu prethodnih odredaba za odre\u0111ene IVD ure\u0111aje i odgo\u0111ene primjene uvjeta za interne proizvode.<\/p>\n\n\n\n<p>Izmjena uredbe\ndaje mnogim proizvo\u0111a\u010dima IVD-a vi\u0161e vremena za prijelaz na IVDR propis i\nomogu\u0107uje da testovi koji su trenutno na tr\u017ei\u0161tu ostanu dostupni pacijentima,\nlaboratorijima, bolnicama i zdravstvenim djelatnicima.<\/p>\n\n\n\n<p>Datum potpune\nprimjene Uredbe ostaje 26. svibnja 2022 i odnosi se na one IVD ure\u0111aje s\noznakom CE koji ne zahtijevaju sudjelovanje prijavljenog tijela (tj. nesterilne\nure\u0111aje klase A) i na \u201enove\u201c IVD ure\u0111aje (koji nisu certificirani ili nemaju izjave\no sukladnosti izdane u skladu s Direktivom 98\/79\/CE). Prijelazna razdoblja\npromijenila su se u odnosu na druge klase rizika:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>na ure\u0111aje\ns najve\u0107im rizikom (klasa D) primjenjuju se zahtjevi od 26. svibnja 2025.,<\/li><li>za\nure\u0111aje klase C, datum uvo\u0111enja je 26. svibnja 2026. i<\/li><li>na ure\u0111aje\nklase B i ure\u0111aje klase A, koji su stavljeni na tr\u017ei\u0161te u sterilnom stanju,\nprimjenjuju se zahtjevi od 26. svibnja 2027.<\/li><\/ul>\n\n\n\n<p><strong>Trebate\nli dodatno znanje ili pomo\u0107 u ispunjavanju zahtjeva MDR\/IVDR?<\/strong><\/p>\n\n\n\n<p>Uz pomo\u0107\nna\u0161ih <a href=\"https:\/\/www.rapharm.eu\/hr\/aktualna-obrazovanja\/\">obrazovanja<\/a>\ni <a href=\"https:\/\/www.rapharm.eu\/hr\/savjetovanje-i-usluge\/\">savjetovanja<\/a> mo\u017eemo\nvam u potpunosti pomo\u0107i u ispunjavanju zahtjeva MDR\/IVDR.<\/p>\n\n\n\n<p><strong>Vir: <\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SL\/TXT\/?uri=CELEX%3A32022R0112\">Uredba (EU) 2022\/112\nEuropskog parlamenta i Vije\u0107a od 25.&nbsp;sije\u010dnja 2022. o izmjeni Uredbe (EU)\n2017\/746 u pogledu prijelaznih odredaba za odre\u0111ene in vitro dijagnosti\u010dke medicinske\nproizvode i odgo\u0111ene primjene uvjeta za interne proizvode&nbsp;<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Uredba (EU) 2022\/112 od 25. sije\u010dnja 2022 objavljena je u Europskom slu\u017ebenom listu L 19\/6 od 28. sije\u010dnja 2022. Uredbom se izmjenjuje Uredba (EU) 2017\/745 u odnosu prethodnih odredaba za odre\u0111ene IVD ure\u0111aje i odgo\u0111ene primjene uvjeta za interne proizvode. Izmjena uredbe daje mnogim proizvo\u0111a\u010dima IVD-a vi\u0161e vremena za prijelaz na IVDR propis i omogu\u0107uje&#8230;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46],"tags":[],"class_list":["post-5913","post","type-post","status-publish","format-standard","hentry","category-novice-hr"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: 25. sije\u010dnja 2022 Europski parlament i Vije\u0107e prihvatili su Uredbu 2022\/112 o izmjeni IVDR Uredbe u pogledu prijelaznih odredaba za odre\u0111ene IVD ure\u0111aje i odgo\u0111ene primjene uvjeta za interne proizvode. - 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-evropski-parlament-in-svet-je-25-januarja-2022-sprejel-uredbo-2022-112-o-spremembi-uredbe-ivdr-v-zvezi-s-prehodnimi-odlocbami-za-nekatere-ivd-pripomocke-in-odlozeno-uporabo-pogojev-za-interne-pri\/\" \/>\n<meta property=\"og:locale\" content=\"hr_HR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: 25. sije\u010dnja 2022 Europski parlament i Vije\u0107e prihvatili su Uredbu 2022\/112 o izmjeni IVDR Uredbe u pogledu prijelaznih odredaba za odre\u0111ene IVD ure\u0111aje i odgo\u0111ene primjene uvjeta za interne proizvode. - raPHARM\" \/>\n<meta property=\"og:description\" content=\"Uredba (EU) 2022\/112 od 25. sije\u010dnja 2022 objavljena je u Europskom slu\u017ebenom listu L 19\/6 od 28. sije\u010dnja 2022. Uredbom se izmjenjuje Uredba (EU) 2017\/745 u odnosu prethodnih odredaba za odre\u0111ene IVD ure\u0111aje i odgo\u0111ene primjene uvjeta za interne proizvode. Izmjena uredbe daje mnogim proizvo\u0111a\u010dima IVD-a vi\u0161e vremena za prijelaz na IVDR propis i omogu\u0107uje...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rapharm.eu\/eu-evropski-parlament-in-svet-je-25-januarja-2022-sprejel-uredbo-2022-112-o-spremembi-uredbe-ivdr-v-zvezi-s-prehodnimi-odlocbami-za-nekatere-ivd-pripomocke-in-odlozeno-uporabo-pogojev-za-interne-pri\/\" \/>\n<meta property=\"og:site_name\" content=\"raPHARM\" \/>\n<meta property=\"article:published_time\" content=\"2022-03-24T08:31:54+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-04-19T12:46:11+00:00\" \/>\n<meta name=\"author\" content=\"rapharm\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"rapharm\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.rapharm.eu\/eu-evropski-parlament-in-svet-je-25-januarja-2022-sprejel-uredbo-2022-112-o-spremembi-uredbe-ivdr-v-zvezi-s-prehodnimi-odlocbami-za-nekatere-ivd-pripomocke-in-odlozeno-uporabo-pogojev-za-interne-pri\/\",\"url\":\"https:\/\/www.rapharm.eu\/eu-evropski-parlament-in-svet-je-25-januarja-2022-sprejel-uredbo-2022-112-o-spremembi-uredbe-ivdr-v-zvezi-s-prehodnimi-odlocbami-za-nekatere-ivd-pripomocke-in-odlozeno-uporabo-pogojev-za-interne-pri\/\",\"name\":\"EU: 25. sije\u010dnja 2022 Europski parlament i Vije\u0107e prihvatili su Uredbu 2022\/112 o izmjeni IVDR Uredbe u pogledu prijelaznih odredaba za odre\u0111ene IVD ure\u0111aje i odgo\u0111ene primjene uvjeta za interne proizvode. - 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