{"id":5919,"date":"2022-03-24T09:49:24","date_gmt":"2022-03-24T08:49:24","guid":{"rendered":"https:\/\/www.rapharm.eu\/hr\/?p=5919"},"modified":"2022-05-25T14:35:50","modified_gmt":"2022-05-25T12:35:50","slug":"eu-objavljeni-su-novi-uskladeni-standardi-za-mdr-i-ivdr-uredbu","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/hr\/eu-objavljeni-su-novi-uskladeni-standardi-za-mdr-i-ivdr-uredbu\/","title":{"rendered":"EU: Objavljeni su novi uskla\u0111eni standardi za MDR i IVDR uredbu"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>U prvom tjednu\nsije\u010dnja 2022 u Slu\u017ebenom listu Europske unije objavljene su Provedbene odluke\nKomisije (EU) <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/6\/oj?locale=hr\">2022<\/a>\/6 o novim uskla\u0111enim normama za MDR i <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/15\/oj?locale=hr\">2022\/15<\/a> o novim uskla\u0111enim normama za IVDR. Standardi su\ndodatak prvim 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\neuropska je 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> ili <a href=\"https:\/\/www.etsi.org\/\">ETSI<\/a> i objavljene su u Slu\u017ebenom listu Europske unije.\nProizvo\u0111a\u010di, drugi gospodarski subjekti ili prijavljena tijela mogu koristiti\nuskla\u0111ene norme kako bi dokazali da su ure\u0111aji, usluge ili postupci u skladu sa\nzahtjevima MDR\/IVDR.<\/p>\n\n\n\n<p>Devet novih MDR normi je uskla\u0111eno<\/p>\n\n\n\n<p>Provedbenom odlukom Komisije (EU) 2022\/6 od 4. sije\u010dnja 2022 izmijenjena je Provedbena odluka (EU) 2021\/1182 o uskla\u0111enim normama za biolo\u0161ku procjenu medicinskih proizvoda, sterilizaciju proizvoda za zdravstvenu skrb, asepti\u010dke postupke za proizvode zdravstvene za\u0161tite, sustave upravljanja kvalitetom, simbole koji se upotrebljavaju s podacima koje mora osigurava proizvo\u0111a\u010d, postupke za proizvode zdravstvene za\u0161tite i ure\u0111aje za svjetlosnu terapiju za ku\u0107nu uporabu. <\/p>\n\n\n\n<p>Dokument dodaje pet\nnovih uskla\u0111enih normi za IVDR uz \u010detiri ve\u0107 objavljenih u prethodnoj provedbenoj\nodluci (EU) 2021\/1195.<\/p>\n\n\n\n<p>Pet novih IVDR\nnormi je uskla\u0111eno<\/p>\n\n\n\n<p>Provedbenom\nodlukom Komisije (EU) 2022\/15 od 6. sije\u010dnja 2022 izmijenjena je Provedbena\nodluka (EU) 2021\/1195 o uskla\u0111enim normama za sterilizaciju medicinskoga\npribora, asepti\u010dke postupke za proizvode zdravstvene za\u0161tite, sustave\nupravljanja kvalitetom, simbole koji se upotrebljavaju s podacima koje\nosigurava proizvo\u0111a\u010d i zahtjeve za uspostavljanje mjeriteljske sljedivosti\nvrijednosti dodijeljenih kalibratorima, tvarima za nadzor istinitosti i\nuzorcima ljudskog tkiva.<\/p>\n\n\n\n<p>Dokument dodaje\ndevet novih uskla\u0111enih normi za MDR uz \u010detiri koja su ve\u0107 objavljene u\nprethodnoj provedbenoj odluci (EU) 2021\/1182.<\/p>\n\n\n\n<p>Posebno treba spomenuti dvije nove uskla\u0111ene norme, EN ISO 13485: 2016 i EN ISO 15223-1:\n2021, koje mogu koristiti svi gospodarski subjekti, uklju\u010duju\u0107i distributere i\nuvoznike, kako bi ispunili zahtjeve MDR\/IVDR.<\/p>\n\n\n\n<p><strong>EN ISO\n13485:2016<\/strong><\/p>\n\n\n\n<p>Medicinski <a>ure\u0111aji<\/a> &#8211; Sustavi upravljanja kvalitetom &#8211; Zahtjevi za\nzakonsku namjenu (ISO 13485:2016)<\/p>\n\n\n\n<p>EN ISO 13485:2016\n\/ A11:2021<\/p>\n\n\n\n<p><strong>EN ISO\n15223-1:2021<\/strong><\/p>\n\n\n\n<p>Medicinski\nure\u0111aji &#8211; Simboli koji se upotrebljavaju s podacima koje osigurava proizvo\u0111a\u010d &#8211;\n1. dio: Op\u0107i zahtjevi (ISO 15223-1:2021)<\/p>\n\n\n\n<p>Pojedina\u010dne\nsadr\u017eaje navedenih standarda uklju\u010dili smo u na\u0161e edukacije iz podru\u010dja\nskladi\u0161tenja, distribucije i uvoza ure\u0111aja te pregleda ure\u0111aja.<\/p>\n\n\n\n<p>U pripremi je i\nnova edukacija u kojoj \u0107e biti predstavljena norma EN ISO 15223-1:2021 i neki\nnovi simboli u njihovoj upotrebi, kao i nova norma EN ISO 20417:2021\nInformacije koje je dostavio proizvo\u0111a\u010d, a koje jo\u0161 nisu uskla\u0111ene , ali u\nkombinaciji s EN ISO 15223-1: 2021 od velike je pomo\u0107i u pripremi informacija\nkoje proizvo\u0111a\u010dima daju naljepnice, ambala\u017eu, upute za uporabu kao i provjeru\ninformacija od strane distributera i uvoznika.<\/p>\n\n\n\n<p><strong>Trebate li\ndodatno znanje ili pomo\u0107 u ispunjavanju 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 ispunjavanju\nzahtjeva MDR\/IVDR.<\/p>\n\n\n\n<p><strong>Vir:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/6\/oj?locale=hr\">PROVEDBENA\nODLUKA KOMISIJE (EU) 2022\/6, Slu\u017ebeni list Europske unije, 4. sije\u010danj 2022<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/15\/oj?locale=hr\">PROVEDBENA\nODLUKA KOMISIJE (EU) 2022\/15, Slu\u017ebeni list Europske unije, 6. sije\u010danj 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>U prvom tjednu sije\u010dnja 2022 u Slu\u017ebenom listu Europske unije objavljene su Provedbene odluke Komisije (EU) 2022\/6 o novim uskla\u0111enim normama za MDR i 2022\/15 o novim uskla\u0111enim normama za IVDR. Standardi su dodatak prvim uskla\u0111enim normama za MDR i IVDR objavljenim u srpnju 2021. Uskla\u0111ena norma europska je 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],"tags":[],"class_list":["post-5919","post","type-post","status-publish","format-standard","hentry","category-novice-hr"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: Objavljeni su novi uskla\u0111eni standardi za MDR i IVDR uredbu - 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\/\" \/>\n<meta property=\"og:locale\" content=\"hr_HR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: Objavljeni su novi uskla\u0111eni standardi za MDR i IVDR uredbu - raPHARM\" \/>\n<meta property=\"og:description\" content=\"U prvom tjednu sije\u010dnja 2022 u Slu\u017ebenom listu Europske unije objavljene su Provedbene odluke Komisije (EU) 2022\/6 o novim uskla\u0111enim normama za MDR i 2022\/15 o novim uskla\u0111enim normama za IVDR. Standardi su dodatak prvim uskla\u0111enim normama za MDR i IVDR objavljenim u srpnju 2021. 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