{"id":5717,"date":"2021-04-11T14:48:53","date_gmt":"2021-04-11T12:48:53","guid":{"rendered":"http:\/\/www.rapharm.eu\/hr\/?p=5717"},"modified":"2021-04-11T19:57:43","modified_gmt":"2021-04-11T17:57:43","slug":"spremni-ste-na-pocetak-upotrebe-mdr","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/hr\/spremni-ste-na-pocetak-upotrebe-mdr\/","title":{"rendered":"Spremni ste na po\u010detak upotrebe MDR?"},"content":{"rendered":"<style type=\"text\/css\"><\/style><p>26. svibnja\/maja 2021. po\u010dinje se koristiti Uredba o medicinskim proizvodima (EU) 2017\/745, koja donosi puno noviteta za djelovanje svih gospodarskih subjekata i dokazivanje sukladnost medicinskih proizvoda. Tako\u0111er zahtjeva poja\u010dani nadzor tr\u017ei\u0161ta dr\u017eavama \u010dlanicama, predvi\u0111aju\u0107i periodi\u010dne obvezne inspekcijske nadzore za sve gospodarske subjekte.<\/p>\n<p>Kao dio na\u0161ih savjetodavnih usluga, posljednjih godina usredoto\u010dili smo se na pomo\u0107 svim vrstama gospodarskih subjekata koji djeluju na podru\u010dju medicinskih proizvoda pri ispunjavanju opse\u017enih zahtjeva Uredbe o medicinskim proizvodima i Uredbe o in-vitro dijagnosti\u010dkim medicinskim proizvodima (po\u010detak upotrebe od 26.05.2022).<\/p>\n<p>Na\u0161 tim \u010dine najbolji stru\u010dnjaci u podru\u010dju regulative medicinskih proizvoda s desetlje\u0107ima iskustva u tom podru\u010dju.<\/p>\n<p><strong>Proizvo\u0111a\u010dima medicinskih proizvoda<\/strong> poma\u017eemo:<\/p>\n<ul>\n<li>prilagoditi postoje\u0107e poslovne procese i uvesti nove poslovne procese koji proizlaze iz novog zakonodavstva;<\/li>\n<li>prilagoditi postoje\u0107u tehni\u010dku dokumentaciju i pripremiti dodatnu dokumentaciju koja proizlazi iz novog zakonodavstva;<\/li>\n<li>educirati i osposobiti osoblje (regulativa, razvoj, proizvodnja, nabava, prodaja, logistika, ljudski resursi, odnosi s kupcima itd.);<\/li>\n<li>educirati i osposobiti Osobu odgovornu za sukladnost sa zaknodavstvom predvi\u0111enom novim zakonodavstvom (mogu\u0107 je i tzv. outsourcing za SME);<\/li>\n<li>kod potrebnih upisa i registracija njihovih aktivnosti i proizvoda u europskim i nacionalnim evidencijama;<\/li>\n<li>razjasniti sve nejasno\u0107e povezane s razumijevanjem novog zakonodavstva.<\/li>\n<\/ul>\n<p><strong>Distributerima i uvoznicima medicinskih proizvoda<\/strong> poma\u017eemo:<\/p>\n<ul>\n<li>prilagoditi postoje\u0107e poslovne procese i uvesti nove poslovne procese koji proizlaze iz novog zakonodavstva;<\/li>\n<li>provjeriti sukladnost proizvoda prije stavljanja na tr\u017ei\u0161te;<\/li>\n<li>educirati i osposobiti osoblje (regulativa, nabava, prodaja, logistika, ljudski resursi, odnosi s kupcima, itd.);<\/li>\n<li>kod potrebnih upisa i registracije njihovih aktivnosti i proizvoda u europskim i nacionalnim evidencijama;<\/li>\n<li>razjasniti sve nejasno\u0107e povezane s razumijevanjem novog zakonodavstva.<\/li>\n<\/ul>\n<p>Stojimo vam na raspolaganju na <strong><a href=\"mailto:info@rapharm.eu\">info@rapharm.eu<\/a><\/strong>.<br \/>\nRado \u0107emo vam pomo\u0107i na putu do regulatorne izvrsnosti!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>26. svibnja\/maja 2021. po\u010dinje se koristiti Uredba o medicinskim proizvodima (EU) 2017\/745, koja donosi puno noviteta za djelovanje svih gospodarskih subjekata i dokazivanje sukladnost medicinskih proizvoda. Tako\u0111er zahtjeva poja\u010dani nadzor tr\u017ei\u0161ta dr\u017eavama \u010dlanicama, predvi\u0111aju\u0107i periodi\u010dne obvezne inspekcijske nadzore za sve gospodarske subjekte. Kao dio na\u0161ih savjetodavnih usluga, posljednjih godina usredoto\u010dili smo se na pomo\u0107 svim&#8230;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[41,31],"tags":[],"class_list":["post-5717","post","type-post","status-publish","format-standard","hentry","category-regulatorne-vijesti","category-uncategorized-hr"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Spremni ste na po\u010detak upotrebe MDR? - 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\/ste-pripravljeni-na-pricetek-uporabe-mdr\/\" \/>\n<meta property=\"og:locale\" content=\"hr_HR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Spremni ste na po\u010detak upotrebe MDR? - raPHARM\" \/>\n<meta property=\"og:description\" content=\"26. svibnja\/maja 2021. po\u010dinje se koristiti Uredba o medicinskim proizvodima (EU) 2017\/745, koja donosi puno noviteta za djelovanje svih gospodarskih subjekata i dokazivanje sukladnost medicinskih proizvoda. Tako\u0111er zahtjeva poja\u010dani nadzor tr\u017ei\u0161ta dr\u017eavama \u010dlanicama, predvi\u0111aju\u0107i periodi\u010dne obvezne inspekcijske nadzore za sve gospodarske subjekte. 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