{"id":6131,"date":"2022-05-27T11:05:49","date_gmt":"2022-05-27T09:05:49","guid":{"rendered":"https:\/\/www.rapharm.eu\/hr\/?p=6131"},"modified":"2022-05-27T11:11:37","modified_gmt":"2022-05-27T09:11:37","slug":"eu-objavljene-su-nove-uskladene-norme-za-mdr-i-ivdr-regulativu","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/hr\/eu-objavljene-su-nove-uskladene-norme-za-mdr-i-ivdr-regulativu\/","title":{"rendered":"EU: Objavljene su nove uskla\u0111ene norme za MDR i IVDR regulativu"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>Provedbene odluke\nKomisije (EU) <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/HR\/TXT\/?uri=CELEX%3A32022D0757\">2022\/757<\/a> o novim uskla\u0111enim normama za MDR i <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/HR\/TXT\/?qid=1653472899783&amp;uri=CELEX%3A32022D0729\">2022\/729<\/a> o novim uskla\u0111enim normama za IVDR objavljene su\nu Slu\u017ebenom listu Europske unije u svibnju 2022. Nove norme drugi su dodatak\nprvim uskla\u0111enim normama za <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2021\/1182\/oj?locale=hr\">MDR<\/a> i <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2021\/1195\/oj?locale=hr\">IVDR<\/a> objavljenim u srpnju 2021.<\/p>\n\n\n\n<p>Uskla\u0111ena norma\nje europska norma koju je razvila priznata europska organizacija za norme: <a href=\"https:\/\/www.cencenelec.eu\/\">CEN<\/a>, <a href=\"https:\/\/www.cencenelec.eu\/\">CENELEC<\/a>\nili <a href=\"https:\/\/www.etsi.org\/\">ETSI<\/a> i objavljena u Slu\u017ebenom listu Europske unije. Proizvo\u0111a\u010di, drugi\ngospodarski subjekti ili prijavljena tijela mogu koristiti uskla\u0111ene norme kako\nbi dokazali da su ure\u0111aji, usluge ili postupci u skladu sa zahtjevima MDR\/IVDR.<\/p>\n\n\n\n<p>Dvije nove MDR\nnorme su uskla\u0111ene, a unos za jednu je a\u017euriran<\/p>\n\n\n\n<p>Provedbenom\nOdlukom Komisije (EU) 2022\/757 od 11. svibnja 2022 izmijenjena je Provedbena\nodluka (EU) 2021\/1182 u pogledu uskla\u0111enih normi za sustave upravljanja\nkvalitetom, sterilizaciju i primjenu upravljanja rizikom za medicinske proizvode.<\/p>\n\n\n\n<p>Dokument dodaje\ndvije nove uskla\u0111ene norme za MDR uz \u010detrnaest ve\u0107 objavljenih u prethodnim\nProvedbenim odlukama (EU) <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2021\/1182\/oj?locale=hr\">2021\/1182<\/a>\ni <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/6\/oj\">2022\/6<\/a>. A\u017euriran je unos za uskla\u0111enu normu za\nsustav upravljanja kvalitetom.<\/p>\n\n\n\n<p>Uskla\u0111ena je\njedna nova norma IVDR, a unos za jednu je a\u017euriran<\/p>\n\n\n\n<p>Provedbenom\nOdlukom Komisije (EU) 2022\/729 od 11. svibnja 2022 izmijenjena je Provedbena\nodluka (EU) 2021\/1195 u pogledu uskla\u0111enih normi za sustav upravljanja\nkvalitetom i primjenu upravljanja rizikom za medicinske proizvode.<\/p>\n\n\n\n<p>Dokument dodaje\njednu novu uskla\u0111enu normu za IVDR uz devet ve\u0107 objavljenih u prethodnim\nprovedbenim odlukama (EU) <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2021\/1195\/oj?locale=hr\">2021\/1195<\/a>\ni <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/15\/oj?locale=hr\">2022\/15<\/a> . A\u017euriran je unos za uskla\u0111enu\nnormu za sustav upravljanja kvalitetom.<\/p>\n\n\n\n<p>Uskla\u0111ena norma\nEN ISO 13485: 2016 za sustav upravljanja kvalitetom a\u017eurirana je novim dodatkom\nA11: 2021. Sadr\u017ei nove dodatke ZA i ZB koji normu povezuju sa zahtjevima MDR-a\ni IVDR-a, i to:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>op\u0107e\nobveze operatera prema \u010dlanku 10. MDR-a i IVDR-a, i<\/li><li>zahtjev\nsustava upravljanja kvalitetom iz Priloga o ocjenjivanju sukladnosti (Dodaci\nIX. i XI. MDR-a i IVDR-a).<\/li><\/ul>\n\n\n\n<p>Dodatno, prilozi\nuklju\u010duju opis regulatornih postupaka i aktivnosti koje provode prijavljena\ntijela, nadle\u017ena tijela i Europska komisija, koji nisu obuhva\u0107eni normom EN ISO\n13485.<\/p>\n\n\n\n<p><strong>Trebate li\ndodatno znanje ili pomo\u0107 u ispunjavanju zahtjeva za MDR\/IVDR?<\/strong><\/p>\n\n\n\n<p>Uz pomo\u0107 na\u0161ih <a href=\"https:\/\/www.rapharm.eu\/hr\/aktualne-edukacije\/\">edukacija<\/a> i <a href=\"https:\/\/www.rapharm.eu\/hr\/savjetovanje-i-usluge\/\">savjetovanja<\/a> mo\u017eemo vam u potpunosti pomo\u0107i u ispunjavanju\nzahtjeva MDR\/IVDR-a.<\/p>\n\n\n\n<p>Vir:<\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/HR\/TXT\/?uri=CELEX%3A32022D0757\">PROVEDBENA ODLUKA KOMISIJE (EU) 2022\/757,\nSlu\u017ebeni list Europske unije, 11. svibnja 2022.<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/HR\/TXT\/?qid=1653472899783&amp;uri=CELEX%3A32022D0729\">PROVEDBENA ODLUKA KOMISIJE (EU) 2022\/729,\nSlu\u017ebeni list Europske unije, 11. svibnja 2022.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Provedbene odluke Komisije (EU) 2022\/757 o novim uskla\u0111enim normama za MDR i 2022\/729 o novim uskla\u0111enim normama za IVDR objavljene su u Slu\u017ebenom listu Europske unije u svibnju 2022. Nove norme drugi su dodatak prvim uskla\u0111enim normama za MDR i IVDR objavljenim u srpnju 2021. Uskla\u0111ena norma je europska norma koju je razvila priznata europska&#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-6131","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 nove uskla\u0111ene norme za MDR i IVDR regulativu - 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-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo-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 nove uskla\u0111ene norme za MDR i IVDR regulativu - raPHARM\" \/>\n<meta property=\"og:description\" content=\"Provedbene odluke Komisije (EU) 2022\/757 o novim uskla\u0111enim normama za MDR i 2022\/729 o novim uskla\u0111enim normama za IVDR objavljene su u Slu\u017ebenom listu Europske unije u svibnju 2022. Nove norme drugi su dodatak prvim uskla\u0111enim normama za MDR i IVDR objavljenim u srpnju 2021. 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