{"id":6179,"date":"2022-06-17T13:26:16","date_gmt":"2022-06-17T11:26:16","guid":{"rendered":"https:\/\/www.rapharm.eu\/hr\/?p=6179"},"modified":"2022-06-17T13:28:31","modified_gmt":"2022-06-17T11:28:31","slug":"eu-mdcg-je-odobrio-novu-smjernicu","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/hr\/eu-mdcg-je-odobrio-novu-smjernicu\/","title":{"rendered":"EU: MDCG je odobrio novu smjernicu"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>Nova MDCG smjernica 2022-8 objavljena je na\nweb stranici Europske komisije u svibnju i odobrena od strane Koordinacijske\nskupine za medicinske proizvode (MDCG). Smjernice su pripremljene u suradnji s\ndionicima zastupljenim u razli\u010ditim radnim skupinama i nisu pravno obvezuju\u0107e,\nali pru\u017eaju zajedni\u010dko razumijevanje o tome kako se MDR i IVDR trebaju\nprimjenjivati u praksi za u\u010dinkovitu i uskla\u0111enu provedbu zakonodavstva.<\/p>\n\n\n\n<p>Smjernica <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-8_en.pdf\">MDCG Guideline 2022-8 Regulation (EU)\n2017\/746 &#8211; application of IVDR requirements to \u2018legacy devices\u2019 and to devices\nplaced on the market prior to 26 May 2022 in accordance with Directive 98\/79\/EC<\/a> objavljena je 20. svibnja 2022. godine. Dokumentom se utvr\u0111uju\nzakonske odredbe iz \u010dlanka 110. stavka 3. Uredbe (EU) 2017\/746 o in vitro\ndijagnosti\u010dkim medicinskim proizvodima (IVDR), dopunjene <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SL\/TXT\/PDF\/?uri=CELEX:32022R0112&amp;from=EN\">Uredbom (EU)\n2022\/112<\/a>. Uredba (EU) 2022-112 je pro\u0161irila prijelazne\nodredbe IVDR-a, posebno \u010dlanak 110. stavak 3., u pogledu opsega i vremenskog\nokvira. Ovaj dokument, sli\u010dno kao MDCG smjernica 2021-25 o prijelaznim\nodredbama Uredbe (EU) 2017\/745 o medicinskim proizvodima (MDR), daje smjernice\no primjenjivosti zahtjeva IVDR za &#8216;prijelazne proizvode&#8217; i &#8216;stare proizvode&#8217;.<\/p>\n\n\n\n<p>Dodatak sadr\u017ei nepotpunu tablicu koja\nprikazuje zahtjeve IVDR-a koji se koriste odn. ne odnose se na &#8216;prijelazne proizvode&#8217;.<\/p>\n\n\n\n<p>Kliknite<a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-8_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>Vir:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-8_en.pdf\">MDCG Guideline 2022-8 Regulation\n(EU) 2017\/746 &#8211; application of IVDR requirements to \u2018legacy devices\u2019 and to\ndevices placed on the market prior to 26 May 2022 in accordance with Directive\n98\/79\/EC, spletna stran EK, 20. maj 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nova MDCG smjernica 2022-8 objavljena je na web stranici Europske komisije u svibnju i odobrena od strane Koordinacijske skupine za medicinske proizvode (MDCG). Smjernice su pripremljene u suradnji s dionicima zastupljenim u razli\u010ditim radnim skupinama i nisu pravno obvezuju\u0107e, ali pru\u017eaju zajedni\u010dko razumijevanje o tome kako se MDR i IVDR trebaju primjenjivati u praksi za&#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-6179","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 odobrio novu smjernicu - 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-objavljena-je-nova-smernica-ki-jo-je-potrdila-mdcg\/\" \/>\n<meta property=\"og:locale\" content=\"hr_HR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: MDCG je odobrio novu smjernicu - raPHARM\" \/>\n<meta property=\"og:description\" content=\"Nova MDCG smjernica 2022-8 objavljena je na web stranici Europske komisije u svibnju i odobrena od strane Koordinacijske skupine za medicinske proizvode (MDCG). 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