{"id":6120,"date":"2022-05-12T09:09:41","date_gmt":"2022-05-12T07:09:41","guid":{"rendered":"https:\/\/www.rapharm.eu\/hr\/?p=6120"},"modified":"2022-05-16T09:57:50","modified_gmt":"2022-05-16T07:57:50","slug":"eu-objavljene-su-dvije-nove-smjernice-koje-je-odobrio-mdcg","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/hr\/eu-objavljene-su-dvije-nove-smjernice-koje-je-odobrio-mdcg\/","title":{"rendered":"EU: Objavljene su dvije nove smjernice koje je odobrio MDCG"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>Dvije nove smjernice, MDCG 2022-5 i MDCG\n2022-6, nedavno su objavljene na web stranici Europske komisije, koje je\npodr\u017eala Koordinacijska skupina za medicinske proizvode (MDCG). Smjernice su\npripremljene u suradnji s dionicima zastupljenim u razli\u010ditim radnim skupinama\ni nisu pravno obvezuju\u0107e, ali predstavljaju zajedni\u010dko shva\u0107anje kako se MDR i IVDR-u\ntreba primijeniti 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\/2022-04\/mdcg_2022-5_en_0.pdf\">MDCG\n2022-5 Guidance on borderline between medical devices and medicinal products\nunder Regulation (EU) 2017\/745 on medical devices<\/a> (MDR) izdana\nje 26. travnja 2022. Ova smjernica izra\u0111ena je na temelju \u010dlanka 103. MDR.\nPru\u017ea dodatna obja\u0161njenja i primjere koji poja\u0161njavaju odredbe navedene u MDR-u\ni Direktivi 2001\/83\/EZ o lijekovima za humanu primjenu (MPD), kao potporu\njedinstvenoj primjeni MDR-a u cijeloj EU. Rad zapo\u010dinje op\u0107om raspravom o\nrazgrani\u010denju medicinskih proizvoda i lijekova, uklju\u010duju\u0107i relevantne\ndefinicije i primjere. Zasebna poglavlja posve\u0107ena su biljnim lijekovima, proizvodima\nkoji sadr\u017ee tvari te kombinaciji medicinskih proizvoda i lijekova.<\/p>\n\n\n\n<p>Smjernica <a href=\"https:\/\/ec.europa.eu\/health\/document\/download\/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf\">MDCG Guideline 2022-6\nGuidance on significant changes regarding the transitional provision under\nArticle 110(3) of the IVDR<\/a> izdana je 4. svibnja 2022. Ovaj dokument poja\u0161njava koncept \u201ezna\u010dajnih\npromjena u izvedbi i namjeni\u201c u \u010dlanku 110. (3.) IVDR. To je relevantno za\nproizvo\u0111a\u010de proizvoda koji su u skladu s Direktivom 98\/79\/EZ (IVDD) i koji su\nstavljeni na tr\u017ei\u0161te ili u uporabu nakon 26. svibnja 2022 tijekom prijelaznog\nrazdoblja u skladu s \u010dlankom 110. stavkom 3. IVDR-a, bez obzira na to je li u\npostupku ocjenjivanja sukladnosti sa IVDD-vom za ove proizvode potrebno\nsudjelovanje prijavljenog tijela ili ne.<\/p>\n\n\n\n<p>Uvjeti za primjenu prijelaznih odredbi iz\n\u010dlanka 110. stavka 3. IVDR-a kako bi proizvodi i dalje bili u skladu s IVDD-om\nte da nakon datuma IVDR-a nema zna\u010dajnih promjena u izvedbi ili namjeni\nproizvoda. Stoga je va\u017eno da proizvo\u0111a\u010di i prijavljena tijela jasno razumiju\nkoje promjene u izvedbi ili namjeni bi se smatrale &#8216;zna\u010dajnim&#8217; u skladu s\n\u010dlankom 110. stavkom 3. IVDR-a.<\/p>\n\n\n\n<p>Dodatak dokumenta sadr\u017ei tablice promjena u\nizvedbi i promjena u namjeni, \u0161to bi se moglo smatrati &#8216;zna\u010dajnim&#8217; u tuma\u010denju\n\u010dlanka 110. stavka 3. IVDR-a.<\/p>\n\n\n\n<p>Kliknite <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-04\/mdcg_2022-5_en_0.pdf\">ovdje<\/a> i <a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-6.pdf\">ovdje<\/a> za vi\u0161e informacija.<\/p>\n\n\n\n<p><strong>Trebate li dodatno znanje ili pomo\u0107 u\nispunjavanju zahtjeva za MDR\/IVDR?<\/strong><\/p>\n\n\n\n<p>Uz pomo\u0107 na\u0161ih <a href=\"https:\/\/www.rapharm.eu\/hr\/aktualna-obrazovanja\/\">aktualnih 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>Poveznice:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-04\/mdcg_2022-5_en_0.pdf\">Smernica MDCG 2022-5 Guidance on borderline between medical\ndevices and medicinal products under Regulation (EU) 2017\/745 on medical\ndevices, spletna stran EK, 26. april 2022<\/a><strong><\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-05\/mdcg_2022-6.pdf\">Smernica MDCG Guideline 2022-6 Guidance on significant changes\nregarding the transitional provision under Article 110(3) of the IVDR, spletna\nstran EK, 4. maj 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dvije nove smjernice, MDCG 2022-5 i MDCG 2022-6, nedavno su objavljene na web stranici Europske komisije, koje je podr\u017eala Koordinacijska skupina za medicinske proizvode (MDCG). Smjernice su pripremljene u suradnji s dionicima zastupljenim u razli\u010ditim radnim skupinama i nisu pravno obvezuju\u0107e, ali predstavljaju zajedni\u010dko shva\u0107anje kako se MDR i IVDR-u treba primijeniti 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-6120","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 dvije nove smjernice koje je odobrio MDCG - 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-sta-dve-novi-smernici-ki-jih-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: Objavljene su dvije nove smjernice koje je odobrio MDCG - raPHARM\" \/>\n<meta property=\"og:description\" content=\"Dvije nove smjernice, MDCG 2022-5 i MDCG 2022-6, nedavno su objavljene na web stranici Europske komisije, koje je podr\u017eala Koordinacijska skupina za medicinske proizvode (MDCG). Smjernice su pripremljene u suradnji s dionicima zastupljenim u razli\u010ditim radnim skupinama i nisu pravno obvezuju\u0107e, ali predstavljaju zajedni\u010dko shva\u0107anje kako se MDR i IVDR-u treba primijeniti u praksi za...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/\" \/>\n<meta property=\"og:site_name\" content=\"raPHARM\" \/>\n<meta property=\"article:published_time\" content=\"2022-05-12T07:09:41+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-05-16T07:57:50+00:00\" \/>\n<meta name=\"author\" content=\"rapharm\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"rapharm\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/\",\"url\":\"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/\",\"name\":\"EU: Objavljene su dvije nove smjernice koje je odobrio MDCG - raPHARM\",\"isPartOf\":{\"@id\":\"https:\/\/www.rapharm.eu\/#website\"},\"datePublished\":\"2022-05-12T07:09:41+00:00\",\"dateModified\":\"2022-05-16T07:57:50+00:00\",\"author\":{\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/#breadcrumb\"},\"inLanguage\":\"hr\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.rapharm.eu\/hr\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"EU: Objavljene su dvije nove smjernice koje je odobrio MDCG\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.rapharm.eu\/#website\",\"url\":\"https:\/\/www.rapharm.eu\/\",\"name\":\"raPHARM\",\"description\":\"Just another WordPress site\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.rapharm.eu\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"hr\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1\",\"name\":\"rapharm\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"hr\",\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g\",\"caption\":\"rapharm\"},\"url\":\"https:\/\/www.rapharm.eu\/hr\/author\/rapharm\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"EU: Objavljene su dvije nove smjernice koje je odobrio MDCG - raPHARM","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/","og_locale":"hr_HR","og_type":"article","og_title":"EU: Objavljene su dvije nove smjernice koje je odobrio MDCG - raPHARM","og_description":"Dvije nove smjernice, MDCG 2022-5 i MDCG 2022-6, nedavno su objavljene na web stranici Europske komisije, koje je podr\u017eala Koordinacijska skupina za medicinske proizvode (MDCG). Smjernice su pripremljene u suradnji s dionicima zastupljenim u razli\u010ditim radnim skupinama i nisu pravno obvezuju\u0107e, ali predstavljaju zajedni\u010dko shva\u0107anje kako se MDR i IVDR-u treba primijeniti u praksi za...","og_url":"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/","og_site_name":"raPHARM","article_published_time":"2022-05-12T07:09:41+00:00","article_modified_time":"2022-05-16T07:57:50+00:00","author":"rapharm","twitter_card":"summary_large_image","twitter_misc":{"Written by":"rapharm","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/","url":"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/","name":"EU: Objavljene su dvije nove smjernice koje je odobrio MDCG - raPHARM","isPartOf":{"@id":"https:\/\/www.rapharm.eu\/#website"},"datePublished":"2022-05-12T07:09:41+00:00","dateModified":"2022-05-16T07:57:50+00:00","author":{"@id":"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1"},"breadcrumb":{"@id":"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/#breadcrumb"},"inLanguage":"hr","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.rapharm.eu\/eu-objavljeni-sta-dve-novi-smernici-ki-jih-je-potrdila-mdcg\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.rapharm.eu\/hr\/"},{"@type":"ListItem","position":2,"name":"EU: Objavljene su dvije nove smjernice koje je odobrio MDCG"}]},{"@type":"WebSite","@id":"https:\/\/www.rapharm.eu\/#website","url":"https:\/\/www.rapharm.eu\/","name":"raPHARM","description":"Just another WordPress site","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.rapharm.eu\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"hr"},{"@type":"Person","@id":"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1","name":"rapharm","image":{"@type":"ImageObject","inLanguage":"hr","@id":"https:\/\/www.rapharm.eu\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g","caption":"rapharm"},"url":"https:\/\/www.rapharm.eu\/hr\/author\/rapharm\/"}]}},"_links":{"self":[{"href":"https:\/\/www.rapharm.eu\/hr\/wp-json\/wp\/v2\/posts\/6120","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rapharm.eu\/hr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.rapharm.eu\/hr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.rapharm.eu\/hr\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rapharm.eu\/hr\/wp-json\/wp\/v2\/comments?post=6120"}],"version-history":[{"count":1,"href":"https:\/\/www.rapharm.eu\/hr\/wp-json\/wp\/v2\/posts\/6120\/revisions"}],"predecessor-version":[{"id":6121,"href":"https:\/\/www.rapharm.eu\/hr\/wp-json\/wp\/v2\/posts\/6120\/revisions\/6121"}],"wp:attachment":[{"href":"https:\/\/www.rapharm.eu\/hr\/wp-json\/wp\/v2\/media?parent=6120"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.rapharm.eu\/hr\/wp-json\/wp\/v2\/categories?post=6120"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.rapharm.eu\/hr\/wp-json\/wp\/v2\/tags?post=6120"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}