{"id":6140,"date":"2022-06-06T12:54:33","date_gmt":"2022-06-06T10:54:33","guid":{"rendered":"https:\/\/www.rapharm.eu\/hr\/?p=6140"},"modified":"2022-06-06T12:59:07","modified_gmt":"2022-06-06T10:59:07","slug":"eu-status-eu-svicarskog-sporazuma-o-medusobnom-priznavanju-mra-za-in-vitro-dijagnosticke-medicinske-proizvode","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/hr\/eu-status-eu-svicarskog-sporazuma-o-medusobnom-priznavanju-mra-za-in-vitro-dijagnosticke-medicinske-proizvode\/","title":{"rendered":"EU: Status EU-\u0160vicarskog sporazuma o me\u0111usobnom priznavanju (MRA) za in vitro dijagnosti\u010dke medicinske proizvode"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>\u0160vicarska sudjeluje na unutarnjem tr\u017ei\u0161tu\nEuropske unije kroz <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/HR\/TXT\/?uri=CELEX%3A22002A0430%2805%29\">Sporazum o me\u0111usobnom priznavanju u\nvezi s ocjenom sukladnosti (MRA)<\/a>. Budu\u0107i da MRA nije a\u017euriran kako bi\nuklju\u010dio Uredbu (EU) 2017\/746, dio poglavlja MRA koji pokriva in vitro\ndijagnosti\u010dke medicinske proizvode prestao se primjenjivati \u200b\u200b26. svibnja 2022.\n\u0160vicarska se stoga smatra tre\u0107om zemljom na podru\u010dju in vitro dijagnosti\u010dkih\nmedicinskih proizvoda. To je tako\u0111er jasno izra\u017eeno u <a href=\"https:\/\/ec.europa.eu\/health\/latest-updates\/notice-stakeholders-status-eu-switzerland-mutual-recognition-agreement-mra-vitro-diagnostic-medical-2022-05-24_en\">obavijesti Europske komisije<\/a> u kojoj se navode sljede\u0107e\nposljedice za in vitro dijagnostiku nakon 26. svibnja 2022. (citat):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Za\nsve nove in vitro dijagnosti\u010dke medicinske proizvode, \u0161vicarski \u0107e proizvo\u0111a\u010di\nbiti tretirani kao i svaki drugi proizvo\u0111a\u010d iz tre\u0107ih zemalja koji namjerava\nsvoje proizvode plasirati na tr\u017ei\u0161te EU-a. Konkretno, in vitro dijagnosti\u010dki\nmedicinski proizvodi \u0161vicarskih proizvo\u0111a\u010da koji zahtijevaju certifikaciju na\ntemelju postupka ocjenjivanja sukladnosti moraju biti certificirani od tijela\nza ocjenjivanje sukladnosti osnovanih unutar EU.<\/li><li>Certifikati\nkoje su prema MRA izdala tijela za ocjenjivanje sukladnosti osnovana u\n\u0160vicarskoj vi\u0161e ne\u0107e biti priznati kao va\u017ee\u0107i u EU \u010dak i ako su izdani prije\n26. svibnja 2022.<\/li><li>Za\nin vitro dijagnosti\u010dke medicinske proizvode stavljene na tr\u017ei\u0161te nakon 26.\nsvibnja 2022., \u0161vicarski proizvo\u0111a\u010di i proizvo\u0111a\u010di iz tre\u0107ih zemalja \u010diji je\novla\u0161teni zastupnik prethodno bio osnovan u \u0160vicarskoj moraju imenovati\novla\u0161tenog zastupnika sa sjedi\u0161tem u EU.<\/li><\/ul>\n\n\n\n<p>Posljedice su identi\u010dne posljedicama koje se odnose\nna medicinske proizvode od stupanja na snagu Uredbe (EU) 2017\/745 26. svibnja\n2021. i objavljene u <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/IP_21_2684\">obavijesti Europske komisije<\/a> od 26. svibnja 2021.<\/p>\n\n\n\n<p>\u0160vicarsko savezno vije\u0107e usvojilo je 19.\nsvibnja 2021. godine izmjenu i dopunu \u0161vicarskog pravilnika o medicinskim\nproizvodima (MedDO) kojim se uspostavljaju uvjeti za promet medicinskih\nproizvoda na \u0161vicarskom tr\u017ei\u0161tu, s certifikatima koje izdaje EU. To uklju\u010duje\npriznavanje postoje\u0107ih certifikata izdanih u okviru MRA od strane tijela za\nocjenu sukladnosti osnovanih u EU-u i prijelazne rokove za odre\u0111ivanje\npredstavnika u \u0160vicarskoj za proizvo\u0111a\u010de medicinskih proizvoda iz EU\/EEA.<\/p>\n\n\n\n<p>Za vi\u0161e informacija o MedDO, pogledajte <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/news\/mitteilungen\/neue-regulierug-mep-26-05-2021.html\">ovdje<\/a>.<\/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>Vir:<\/strong><strong><\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/api\/files\/document\/print\/en\/ip_21_2684\/IP_21_2684_EN.pdf\">Notice to Stakeholders: Status\nof the EU-Switzerland Mutual Recognition Agreement for Medical Devices<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/document\/download\/8dd260fd-0b67-415b-bf1e-36bdf8681674_en?filename=md_eu-switzerland_mra_in-vitro-diagnostic.pdf\">Notice to Stakeholders: Status\nof the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro\ndiagnostic medical devices<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u0160vicarska sudjeluje na unutarnjem tr\u017ei\u0161tu Europske unije kroz Sporazum o me\u0111usobnom priznavanju u vezi s ocjenom sukladnosti (MRA). Budu\u0107i da MRA nije a\u017euriran kako bi uklju\u010dio Uredbu (EU) 2017\/746, dio poglavlja MRA koji pokriva in vitro dijagnosti\u010dke medicinske proizvode prestao se primjenjivati \u200b\u200b26. svibnja 2022. \u0160vicarska se stoga smatra tre\u0107om zemljom na podru\u010dju in vitro&#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-6140","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: Status EU-\u0160vicarskog sporazuma o me\u0111usobnom priznavanju (MRA) za in vitro dijagnosti\u010dke medicinske 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-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/\" \/>\n<meta property=\"og:locale\" content=\"hr_HR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: Status EU-\u0160vicarskog sporazuma o me\u0111usobnom priznavanju (MRA) za in vitro dijagnosti\u010dke medicinske proizvode - raPHARM\" \/>\n<meta property=\"og:description\" content=\"\u0160vicarska sudjeluje na unutarnjem tr\u017ei\u0161tu Europske unije kroz Sporazum o me\u0111usobnom priznavanju u vezi s ocjenom sukladnosti (MRA). Budu\u0107i da MRA nije a\u017euriran kako bi uklju\u010dio Uredbu (EU) 2017\/746, dio poglavlja MRA koji pokriva in vitro dijagnosti\u010dke medicinske proizvode prestao se primjenjivati \u200b\u200b26. svibnja 2022. \u0160vicarska se stoga smatra tre\u0107om zemljom na podru\u010dju in vitro...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/\" \/>\n<meta property=\"og:site_name\" content=\"raPHARM\" \/>\n<meta property=\"article:published_time\" content=\"2022-06-06T10:54:33+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-06-06T10:59:07+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=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/\",\"url\":\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/\",\"name\":\"EU: Status EU-\u0160vicarskog sporazuma o me\u0111usobnom priznavanju (MRA) za in vitro dijagnosti\u010dke medicinske proizvode - raPHARM\",\"isPartOf\":{\"@id\":\"https:\/\/www.rapharm.eu\/#website\"},\"datePublished\":\"2022-06-06T10:54:33+00:00\",\"dateModified\":\"2022-06-06T10:59:07+00:00\",\"author\":{\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/#breadcrumb\"},\"inLanguage\":\"hr\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.rapharm.eu\/hr\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"EU: Status EU-\u0160vicarskog sporazuma o me\u0111usobnom priznavanju (MRA) za in vitro dijagnosti\u010dke medicinske proizvode\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.rapharm.eu\/#website\",\"url\":\"https:\/\/www.rapharm.eu\/\",\"name\":\"raPHARM\",\"description\":\"Just another WordPress site\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.rapharm.eu\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"hr\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1\",\"name\":\"rapharm\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"hr\",\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g\",\"caption\":\"rapharm\"},\"url\":\"https:\/\/www.rapharm.eu\/hr\/author\/rapharm\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"EU: Status EU-\u0160vicarskog sporazuma o me\u0111usobnom priznavanju (MRA) za in vitro dijagnosti\u010dke medicinske proizvode - raPHARM","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/","og_locale":"hr_HR","og_type":"article","og_title":"EU: Status EU-\u0160vicarskog sporazuma o me\u0111usobnom priznavanju (MRA) za in vitro dijagnosti\u010dke medicinske proizvode - raPHARM","og_description":"\u0160vicarska sudjeluje na unutarnjem tr\u017ei\u0161tu Europske unije kroz Sporazum o me\u0111usobnom priznavanju u vezi s ocjenom sukladnosti (MRA). 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