{"id":6159,"date":"2022-06-07T14:50:48","date_gmt":"2022-06-07T12:50:48","guid":{"rendered":"https:\/\/www.rapharm.eu\/hr\/?p=6159"},"modified":"2022-06-08T14:52:08","modified_gmt":"2022-06-08T12:52:08","slug":"6159","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/hr\/6159\/","title":{"rendered":"EU: Objavljene su dvije nove smjernice koje je odobrio MDCG"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>Dvije nove smjernice, MDCG 2022-9 i MDCG\n2022-10, objavljene su u svibnju na web stranici Europske komisije kojima se\npodr\u017eava Koordinacijska skupina za medicinske proizvode (MDCG). Smjernice su\npripremljene u suradnji s dionicima zastupljenim u razli\u010ditim radnim skupinama\ni nisu pravno obvezuju\u0107e, ali predstavljaju zajedni\u010dko shva\u0107anje kako se MDR u\nIVDR-u treba primijeniti u praksi za u\u010dinkovitu i uskla\u0111enu provedbu\nzakonodavstva.<\/p>\n\n\n\n<p>Smjernica <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-9_en.pdf\">MDCG Guideline 2022-9 Summary of safety and\nperformance template<\/a> izdana je 20. svibnja 2022. Dokument sadr\u017ei predlo\u017eak\nza sa\u017eetak o sigurnosti i u\u010dinkovitosti (SSP) propisan Uredbom (EU) 2017\/746 o\nin vitro dijagnosti\u010dkim medicinskim proizvodima (IVDR). \u010clankom 29. IVDR-a\npropisano je, da proizvo\u0111a\u010d mora izraditi SSP za proizvode klase C i D, osim za\nproizvode za studije u\u010dinkovitosti. <\/p>\n\n\n\n<p>SSP je odobren od strane prijavljenog tijela\n(NB) i dostupan je javnosti putem Europske baze podataka za medicinske\nproizvode (Eudamed).<\/p>\n\n\n\n<p>SSP predlo\u017eak za proizvode koji nisu za\nsamotestiranje predstavljen je u odjeljku 1, a SSP predlo\u017eak za proizvode za samotestiranje\npredstavljen je u odjeljku 2 dokumenta.<\/p>\n\n\n\n<p>Smjernica <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-10_en.pdf\">MDCG Guideline 2022-10 Q&amp;A on the interface\nbetween Regulation (EU) 536\/2014 on clinical trials for medicinal products for\nhuman use (CTR) and Regulation (EU) 2017\/746<\/a> izdana je 25.\nsvibnja 2022. Ove smjernice su odobrene od strane Koordinacijske skupine za\nmedicinske proizvode (MDCG) i Stru\u010dne skupine za klini\u010dka ispitivanja (CTEG),\nkoju predstavljaju predstavnici svih dr\u017eava \u010dlanica.<\/p>\n\n\n\n<p>Testovi koji se koriste u klini\u010dkim\nispitivanjima kre\u0107u se od in vitro dijagnosti\u010dkih medicinskih proizvoda (IVD) s\noznakom CE do testova, specifi\u010dnih za ispitivanje ili lijekova, koji nisu\nuvijek namjerno razvijeni kao IVD. Potreba za poja\u0161njenjem zahtjeva za ovim\ntestovima doveo je do razvoja smjernice s pitanjima i odgovorima (Q&amp;A) i\nkoncepta \u201emedicinske namjene testa u klini\u010dkom ispitivanju\u201c kao specifi\u010dno\nokru\u017eenje.<\/p>\n\n\n\n<p>Cilj ove smjernice je podr\u017eati postupak\nprocjene prijava, obuhva\u0107enim CTR-om i pru\u017eiti poja\u0161njenja o regulatornom statusu testova provedenih na ljudskim\nuzorcima koji se koriste u kontekstu klini\u010dkih ispitivanja, kao i o\nregulatornim o\u010dekivanjima prema sponzorima klini\u010dkih ispitivanja. Op\u0107i cilj je\npodr\u017eati provo\u0111enje klini\u010dkih ispitivanja pomo\u0107u dijagnosti\u010dkih testova,\nuklju\u010duju\u0107i kombinirana klini\u010dka ispitivanja za razvoj prate\u0107e dijagnostike\n(CDx). <\/p>\n\n\n\n<p>Neinterventne studije,\ndefinirane kao klini\u010dke studije osim klini\u010dkog ispitivanja u \u010dlanku 2. stavku\n4. CTR-a, izvan su opsega CTR-a (prema \u010dlanku 1.) i ovog dokumenta.<\/p>\n\n\n\n<p>Kliknite <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-9_en.pdf\">ovdje<\/a> i <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-10_en.pdf\">ovdje<\/a> za vi\u0161e informacija.<\/p>\n\n\n\n<p><strong>Trebate li dodatno znanje ili pomo\u0107 u ispunjavanju\nzahtjeva MDR\/IVDR?<\/strong><\/p>\n\n\n\n<p>Uz pomo\u0107 na\u0161ih <a href=\"https:\/\/www.rapharm.eu\/hr\/aktualna-obrazovanja\/\">obrazovanja<\/a> i <a href=\"https:\/\/www.rapharm.eu\/hr\/savjetovanje-i-usluge\/\">savjetovanja<\/a>\nmo\u017eemo vam u potpunosti pomo\u0107i u ispunjavanju zahtjeva MDR\/IVDR.<\/p>\n\n\n\n<p><strong>Viri:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-9_en.pdf\">Smjernica MDCG Guideline 2022-9\nSummary of safety and performance template, web stranica EK, 20. svibnja 2022<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-10_en.pdf\">Smjernica MDCG Guideline 2022-10 Q&amp;A on the interface\nbetween Regulation (EU) 536\/2014 on clinical trials for medicinal products for\nhuman use (CTR) and Regulation (EU) 2017\/746, web stranica EK, 25. svibnja 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dvije nove smjernice, MDCG 2022-9 i MDCG 2022-10, objavljene su u svibnju na web stranici Europske komisije kojima se podr\u017eava Koordinacijska skupina za medicinske proizvode (MDCG). Smjernice su pripremljene u suradnji s dionicima zastupljenim u razli\u010ditim radnim skupinama i nisu pravno obvezuju\u0107e, ali predstavljaju zajedni\u010dko shva\u0107anje kako se MDR u IVDR-u treba primijeniti u praksi&#8230;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46,31],"tags":[],"class_list":["post-6159","post","type-post","status-publish","format-standard","hentry","category-novice-hr","category-uncategorized-hr"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: Objavljene su dvije nove smjernice koje je odobrio 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=\"hr_HR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: Objavljene su dvije nove smjernice koje je odobrio MDCG - raPHARM\" \/>\n<meta property=\"og:description\" content=\"Dvije nove smjernice, MDCG 2022-9 i MDCG 2022-10, objavljene su u svibnju na web stranici Europske komisije kojima se podr\u017eava Koordinacijska skupina za medicinske proizvode (MDCG). 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