{"id":6187,"date":"2022-06-21T13:21:30","date_gmt":"2022-06-21T11:21:30","guid":{"rendered":"https:\/\/www.rapharm.eu\/hr\/?p=6187"},"modified":"2022-06-24T13:25:48","modified_gmt":"2022-06-24T11:25:48","slug":"eu-mdcg-je-objavio-dokument-o-stajalistu","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/hr\/eu-mdcg-je-objavio-dokument-o-stajalistu\/","title":{"rendered":"EU: MDCG je objavio dokument o stajali\u0161tu"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>Dokument o stajali\u0161tu MDCG-a 2022-11\nobjavljen je na web stranici Europske komisije u lipnju, i odobren od strane\nKoordinacijske skupine za medicinske proizvode (MDCG). Dokument ne odra\u017eava\nslu\u017ebeni stav Europske komisije. Bilo koji stavovi izra\u017eeni u ovom dokumentu\nnisu pravno obvezuju\u0107i.<\/p>\n\n\n\n<p> <br>Dokument o<a> <\/a>stajali\u0161tu <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-06\/mdcg_2022-11_en_0.pdf\">MDCG 2022-11 &#8211; MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements<\/a> izdan je 13. lipnja 2022. U dokumentu MDCG nagla\u0161ava potrebu da svi proizvo\u0111a\u010di \u0161to prije i znatno prije kraja prijelaznog roka prilagode svoje sustave, finaliziraju prijelaz na MDR i prijave se prijavljenom tijelu, podno\u0161enjem potpunih i sukladnih zahtjeva kako bi se osigurala pravovremena uskla\u0111enost s MDR-om. To omogu\u0107uje, da se proizvodi i dalje stavljaju na tr\u017ei\u0161te i da se sprije\u010di nedostatak medicinskih proizvoda.<\/p>\n\n\n\n<p>Treba napomenuti, da \u0107e oko 70% certifikata\nuskla\u0111enih s AIMDD \/ MDD iste\u0107i 2024. godine (najkasnije do 26. svibnja 2024.).\nProizvo\u0111a\u010di bi trebali imati na umu da mo\u017eda ne\u0107e biti mogu\u0107e da prijavljena\ntijela imenovana u skladu s MDR-om mogu procijeniti sve relevantne datoteke u\nprvim mjesecima 2024.<\/p>\n\n\n\n<p>Kliknite <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-06\/mdcg_2022-11_en_0.pdf\">ovdje<\/a> za vi\u0161e informacija.<\/p>\n\n\n\n<p><strong>Trebate li dodatno znanje ili pomo\u0107 u\nispunjavanju zahtjeva 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> mo\u017eemo vam u potpunosti pomo\u0107i u\nispunjavanju zahtjeva MDR\/IVDR.<\/p>\n\n\n\n<p><strong>Vir:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-06\/mdcg_2022-11_en_0.pdf\">MDCG 2022-11 &#8211; MDCG Position Paper: Notice to\nmanufacturers to ensure timely compliance with MDR requirements, web stranica EK, 13. lipnja\n2022.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dokument o stajali\u0161tu MDCG-a 2022-11 objavljen je na web stranici Europske komisije u lipnju, i odobren od strane Koordinacijske skupine za medicinske proizvode (MDCG). Dokument ne odra\u017eava slu\u017ebeni stav Europske komisije. Bilo koji stavovi izra\u017eeni u ovom dokumentu nisu pravno obvezuju\u0107i. Dokument o stajali\u0161tu MDCG 2022-11 &#8211; MDCG Position Paper: Notice to manufacturers to ensure&#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-6187","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: MDCG je objavio dokument o stajali\u0161tu - 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-mdcg-je-objavil-dokument-o-staliscu\/\" \/>\n<meta property=\"og:locale\" content=\"hr_HR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: MDCG je objavio dokument o stajali\u0161tu - raPHARM\" \/>\n<meta property=\"og:description\" content=\"Dokument o stajali\u0161tu MDCG-a 2022-11 objavljen je na web stranici Europske komisije u lipnju, i odobren od strane Koordinacijske skupine za medicinske proizvode (MDCG). Dokument ne odra\u017eava slu\u017ebeni stav Europske komisije. Bilo koji stavovi izra\u017eeni u ovom dokumentu nisu pravno obvezuju\u0107i. 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