{"id":2500,"date":"2020-05-26T13:50:57","date_gmt":"2020-05-26T11:50:57","guid":{"rendered":"https:\/\/blogs.dlapiper.com\/advocatus\/?p=2500"},"modified":"2022-03-03T15:45:16","modified_gmt":"2022-03-03T14:45:16","slug":"ujabb-evet-nyertek-az-orvostechnikai-eszkozok-gyartoi-es-forgalmazoi-az-egyseges-szigoru-europai-unios-szabalyokra-valo-felkeszuleshez","status":"publish","type":"post","link":"https:\/\/blogs.dlapiper.com\/advocatus\/2020\/05\/ujabb-evet-nyertek-az-orvostechnikai-eszkozok-gyartoi-es-forgalmazoi-az-egyseges-szigoru-europai-unios-szabalyokra-valo-felkeszuleshez\/","title":{"rendered":"\u00dajabb \u00e9vet nyertek az orvostechnikai eszk\u00f6z\u00f6k gy\u00e1rt\u00f3i \u00e9s forgalmaz\u00f3i az egys\u00e9ges, szigor\u00fa eur\u00f3pai uni\u00f3s szab\u00e1lyokra val\u00f3 felk\u00e9sz\u00fcl\u00e9shez"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"2500\" class=\"elementor elementor-2500\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1edfedf1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1edfedf1\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-10b52117\" data-id=\"10b52117\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-771dddd4 elementor-widget elementor-widget-text-editor\" data-id=\"771dddd4\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul>\n<li><strong>A 2017 \u00e1prilis\u00e1ban elfogadott MDR \u00e9s IVDR-rendeletek megalkot\u00e1s\u00e1val, amelyek az orvostechnikai \u00e9s az in vitro diagnosztikai eszk\u00f6z\u00f6k szab\u00e1lyoz\u00e1s\u00e1r\u00f3l sz\u00f3lnak, a jogalkot\u00f3 c\u00e9lja els\u0151sorban egy egys\u00e9ges \u00e9s az orvostechnikai eszk\u00f6z\u00f6k biztons\u00e1goss\u00e1g\u00e1t \u00e9s eg\u00e9szs\u00e9gess\u00e9g\u00e9t biztos\u00edt\u00f3, az eg\u00e9sz EU-s piacra azonos jogszab\u00e1lyi k\u00f6rnyezet l\u00e9trehoz\u00e1sa volt.<\/strong><\/li>\n<li><strong>Az eredeti tervek szerint az MDR 2020. m\u00e1jus 26. napj\u00e1t\u00f3l lett volna alkalmazhat\u00f3 k\u00f6zvetlen\u00fcl az Eur\u00f3pai Uni\u00f3 tag\u00e1llamaiban, azonban a koronav\u00edrus (COVID-19) vil\u00e1gj\u00e1rv\u00e1ny miatt az Eur\u00f3pai Parlament \u00e9s a Tan\u00e1cs az utols\u00f3 pillanatban \u00fagy d\u00f6nt\u00f6tt, hogy a nagyobb szab\u00e1lyoz\u00e1si terhet jelent\u0151 MDR tekintet\u00e9ben a k\u00f6telez\u0151 alkalmaz\u00e1s id\u0151pontj\u00e1t egy \u00e9vvel elhalasztja.<\/strong><\/li>\n<li><strong>Az al\u00e1bbiakban a DLA Piper Hungary life sciences szektor tan\u00e1csad\u00f3i, Alm\u00e1sy M\u00e1rk \u00e9s Papp G\u00e1bor bemutatj\u00e1k az MDR \u00e9s az IVDR-rendeletekben tervezett, az orvostechnikai eszk\u00f6z\u00f6k eur\u00f3pai piac\u00e1t \u00e9rint\u0151 v\u00e1ltoztat\u00e1sokat \u00e9s az azok m\u00f6g\u00f6tt megh\u00faz\u00f3d\u00f3 okokat.<\/strong><\/li>\n<\/ul>\n<h2>1. Az orvostechnikai eszk\u00f6z\u00f6kre vonatkoz\u00f3 eur\u00f3pai uni\u00f3s szab\u00e1lyoz\u00e1s m\u00e1ra elavultt\u00e1 v\u00e1lt<\/h2>\n<p>Az orvostechnikai eszk\u00f6z\u00f6kre vonatkoz\u00f3 szab\u00e1lyok egys\u00e9ges rendszert alkotnak az Eur\u00f3pai Uni\u00f3ban. A ter\u00fcletet jelenleg az Eur\u00f3pai Uni\u00f3 ir\u00e1nyelvi szinten szab\u00e1lyozza. A szab\u00e1lyoz\u00e1st a mai napig az 1990-es \u00e9vek folyam\u00e1n elfogadott ir\u00e1nyelvek hat\u00e1rozz\u00e1k meg.<\/p>\n<p>A szab\u00e1lyoz\u00e1s ugyanakkor, mind tartalm\u00e1ban \u00e9s form\u00e1j\u00e1ban, a 2010-es \u00e9vekre jelent\u0151s m\u00e9rt\u00e9kben elavultt\u00e1 v\u00e1lt. Sz\u00e1mos ok indokolta, hogy mindez alapos fel\u00fclvizsg\u00e1latra ker\u00fclj\u00f6n. Ezek k\u00f6z\u00fcl is kiemelend\u0151, hogy<\/p>\n<blockquote><p>az alapvet\u0151en ir\u00e1nyelvi szint\u0171 szab\u00e1lyoz\u00e1s logik\u00e1ja k\u00f6vetkezt\u00e9ben Eur\u00f3pa-szerte egyes k\u00e9rd\u00e9sekben az egyes tag\u00e1llamok elt\u00e9r\u0151en \u00e9rtelmezt\u00e9k a l\u00e9tez\u0151 joganyagot.<\/p><\/blockquote>\n<p>Erre az ir\u00e1nyelvi szab\u00e1lyoz\u00e1si logika az\u00e9rt ad lehet\u0151s\u00e9get, mivel az ir\u00e1nyelvekben szerepl\u0151, eur\u00f3pai uni\u00f3s szint\u0171 szab\u00e1lyokat minden tag\u00e1llamnak k\u00fcl\u00f6n-k\u00fcl\u00f6n kellett \u00e9rtelmeznie \u00e9s a saj\u00e1t jogrendj\u00e9be \u00fcltetnie. Term\u00e9szetszer\u0171leg ez a modell ak\u00e1r jelent\u0151s elt\u00e9r\u00e9sekhez is vezethetett a tag\u00e1llamok k\u00f6z\u00f6tti r\u00e9szletszab\u00e1lyok tekintet\u00e9ben.<\/p>\n<p>Az \u00e9rtelmez\u00e9si k\u00fcl\u00f6nb\u00f6z\u0151s\u00e9gek mellett, az elm\u00falt t\u00f6bb mint k\u00e9t \u00e9vtizedben v\u00e9gbemen\u0151 technol\u00f3giai fejl\u0151d\u00e9s is elavultt\u00e1 \u00e9s nehezen alkalmazhat\u00f3v\u00e1 tette az ir\u00e1nyelvi szab\u00e1lyoz\u00e1st. Tov\u00e1bb\u00e1, az ut\u00f3bbi id\u0151ben t\u00f6bb olyan eset is napvil\u00e1gra ker\u00fclt, amelyek \u2013 orvostechnikai eszk\u00f6z\u00f6k hi\u00e1nyoss\u00e1gai k\u00f6vetkezt\u00e9ben \u2013 h\u00e1tr\u00e1nyosan \u00e9rintett\u00e9k a betegek eg\u00e9szs\u00e9g\u00e9t \u00e9s \u00e9let\u00e9t.<\/p>\n<h2>2. \u00daj, imm\u00e1r k\u00f6telez\u0151en alkalmazand\u00f3 (rendeleti) szint\u0171 EU-s szab\u00e1lyoz\u00e1s sz\u00fcletett<\/h2>\n<p>Mindezen okok alapj\u00e1n teh\u00e1t az Eur\u00f3pai Bizotts\u00e1g 2012-ben kezdem\u00e9nyezte kett\u0151, imm\u00e1r rendeleti szint\u0171 norma megalkot\u00e1s\u00e1t, amely eredm\u00e9nyek\u00e9nt 2017. \u00e1prilis 5-\u00e9n elfogad\u00e1sra ker\u00fclt az orvostechnikai eszk\u00f6z\u00f6kr\u0151l sz\u00f3l\u00f3 2017\/745\/EU rendelet (MDR), \u00e9s az in vitro diagnosztikai orvostechnikai eszk\u00f6z\u00f6kr\u0151l sz\u00f3l\u00f3 2017\/746\/EU rendelet (IVDR).<\/p>\n<blockquote><p>Az eredeti tervek szerint az MDR 2020. m\u00e1jus 26. napj\u00e1t\u00f3l, az IVDR pedig 2022. m\u00e1jus 26. napj\u00e1t\u00f3l alkalmazand\u00f3k k\u00f6zvetlen\u00fcl az Eur\u00f3pai Uni\u00f3 tag\u00e1llamaiban. Az ir\u00e1nyelvi szab\u00e1lyoz\u00e1s logik\u00e1j\u00e1val szemben, az imm\u00e1r rendeleti form\u00e1ban megalkotott, \u00faj szab\u00e1lyok nem ig\u00e9nylik \u2013 \u00e9s nem is teszi lehet\u0151v\u00e9 \u2013 az egyes tag\u00e1llami \u00e9rtelmez\u00e9seket.<\/p><\/blockquote>\n<p>A rendeleti szint\u0171 szab\u00e1lyok k\u00f6zvetlen\u00fcl \u00e9s egyform\u00e1n alkalmazand\u00f3ak \u00e9s hivatkozhat\u00f3ak valamennyi eur\u00f3pai uni\u00f3s tag\u00e1llamban, an\u00e9lk\u00fcl, hogy a szab\u00e1lyokat a tag\u00e1llami jogrendszerek r\u00e9sz\u00e9v\u00e9 kellene tenni.<\/p>\n<h2>3. Az \u00faj szab\u00e1lyok alkalmazand\u00f3s\u00e1ga elhalaszt\u00e1sra ker\u00fclt<\/h2>\n<blockquote><p>A folyamatban l\u00e9v\u0151 COVID-19 koronav\u00edrus (COVID-19) vil\u00e1gj\u00e1rv\u00e1ny miatt az Eur\u00f3pai Parlament \u00e9s a Tan\u00e1cs az utols\u00f3 pillanatban, 2020. \u00e1prilis 23-\u00e1n \u00fagy d\u00f6nt\u00f6tt, hogy az MDR tekintet\u00e9ben a k\u00f6telez\u0151 alkalmaz\u00e1s id\u0151pontj\u00e1t egy \u00e9vvel elhalasztja, \u00e9s \u00edgy az MDR csak 2021. m\u00e1jus 26-t\u00f3l lesz alkalmazand\u00f3, szemben az id\u00e9n m\u00e1jusra tervezett id\u0151ponttal. (Az IVDR tov\u00e1bbra is 2022. m\u00e1jus 26-\u00e1n v\u00e1lik k\u00f6telez\u0151en alkalmazand\u00f3v\u00e1.)<\/p><\/blockquote>\n<p>A halaszt\u00e1s legf\u0151bb indoka, hogy a pand\u00e9mi\u00e1s k\u00fczdelem sor\u00e1n a tag\u00e1llami eg\u00e9szs\u00e9g\u00fcgyi rendszerek &nbsp;\u201enagy val\u00f3sz\u00edn\u0171s\u00e9ggel nem lesznek k\u00e9pesek biztos\u00edtani az eml\u00edtett rendelet megfelel\u0151 v\u00e9grehajt\u00e1s\u00e1t \u00e9s alkalmaz\u00e1s\u00e1t\u201d az eredetileg meghat\u00e1rozott id\u0151pontt\u00f3l kezd\u0151d\u0151en \u2013 fogalmaz a halaszt\u00e1sr\u00f3l sz\u00f3l\u00f3 d\u00f6nt\u00e9s indokol\u00e1sa. Az uni\u00f3s jogalkot\u00f3 ezzel leveszi az MDR-nek val\u00f3 megfelel\u00e9s nyom\u00e1s\u00e1t az \u00e9rintett felekr\u0151l annak \u00e9rdek\u00e9ben, hogy azok a COVID-19 t\u00e1masztotta kih\u00edv\u00e1sok lek\u00fczd\u00e9s\u00e9re tudj\u00e1k koncentr\u00e1lni er\u0151forr\u00e1saikat.<\/p>\n<p>A halaszt\u00e1st kedvez\u0151en fogadta az \u00e1gazat \u2013 k\u00fcl\u00f6n\u00f6s tekintettel a kis- \u00e9s k\u00f6zepes v\u00e1llalkoz\u00e1sokra \u2013 hiszen az MDR-nek val\u00f3 megfelel\u00e9s nagy kih\u00edv\u00e1sok el\u00e9 \u00e1ll\u00edtotta az \u00f6sszes ipar\u00e1gi szerepl\u0151t. M\u00e1s k\u00e9rd\u00e9s, hogy a k\u00f6telez\u0151 alkalmaz\u00e1s elhalaszt\u00e1s\u00e1r\u00f3l az utols\u00f3 pillanatban hozott d\u00f6nt\u00e9s tal\u00e1n \u00e9ppen azokat, az orvostechnikai eszk\u00f6z\u00f6kkel foglalkoz\u00f3 gy\u00e1rt\u00f3kat, forgalmaz\u00f3kat \u00e9s egy\u00e9b piaci szerepl\u0151ket \u00e9rinti h\u00e1tr\u00e1nyosan, akik a fokozott neh\u00e9zs\u00e9gek ellen\u00e9re is felk\u00e9sz\u00fcltek az \u00faj szab\u00e1lyok alkalmaz\u00e1s\u00e1ra.<\/p>\n<p>Ezen a ponton \u00e9rdemes r\u00f6viden \u00e1ttekinteni, hogy val\u00f3j\u00e1ban miben hoz \u00fajat az MDR az orvostechnikai eszk\u00f6z\u00f6k eur\u00f3pai piac\u00e1n.<\/p>\n<h2>4. Mi v\u00e1ltozik az MDR hat\u00e1s\u00e1ra?<\/h2>\n<p>Az MDR megalkot\u00e1s\u00e1val az eur\u00f3pai uni\u00f3s jogalkot\u00f3 c\u00e9lja els\u0151sorban egy egys\u00e9ges \u00e9s az orvostechnikai eszk\u00f6z\u00f6k biztons\u00e1goss\u00e1g\u00e1t \u00e9s eg\u00e9szs\u00e9gess\u00e9g\u00e9t biztos\u00edt\u00f3, az eg\u00e9sz EU-s piacra azonos jogszab\u00e1lyi k\u00f6rnyezet l\u00e9trehoz\u00e1sa.<\/p>\n<p>A rendelet \u00e1ltal bevezetni tervezett legfontosabb v\u00e1ltoztat\u00e1sok az al\u00e1bbiak:<\/p>\n<ul>\n<li>Az MDR hat\u00e1lya \u2013 meghat\u00e1rozott k\u00f6rben \u2013 kiterjed, a rendelet \u00e9rtelm\u00e9ben \u201eorvosi rendeltet\u00e9ssel nem b\u00edr\u00f3 term\u00e9kcsoportokra\u201d is, \u00edgy olyan term\u00e9kk\u00f6r\u00f6ket is hat\u00e1lya al\u00e1 von, amelyek piaca jelent\u0151s, \u00e9s amelyekre a szigor\u00fa(bb) szab\u00e1lyok kor\u00e1bban nem voltak alkalmazand\u00f3ak. P\u00e9ldak\u00e9nt el\u00e9g a kontaktlencs\u00e9ket eml\u00edteni ezen term\u00e9kekre.<\/li>\n<li>A gy\u00e1rt\u00f3kra ezent\u00fal az orvostechnikai eszk\u00f6z\u00f6k forgalomba hozatal\u00e1t k\u00f6vet\u0151en is fel\u00fcgyeleti k\u00f6telezetts\u00e9g vonatkozik, amit az orvostechnikai eszk\u00f6z oszt\u00e1ly\u00e1ra tekintettel vagy \u201eforgalomba hozatal ut\u00e1ni fel\u00fcgyeleti jelent\u00e9s\u201d (I. oszt\u00e1ly), vagy \u201eid\u0151szakos eszk\u00f6zbiztons\u00e1gi jelent\u00e9s\u201d (egy\u00e9b oszt\u00e1ly eset\u00e9ben) form\u00e1j\u00e1ban kell teljes\u00edteni.<\/li>\n<li>Az orvostechnikai eszk\u00f6z\u00f6ket \u201eegyedi eszk\u00f6zazonos\u00edt\u00f3val\u201d (<em>unique device identifier, UDI<\/em>) kell ell\u00e1tni, tov\u00e1bb\u00e1 regisztr\u00e1lni kell azokat az orvostechnikai eszk\u00f6z\u00f6k eur\u00f3pai adatb\u00e1zis\u00e1ba (Eudamed), amely az eszk\u00f6z\u00f6k nyilv\u00e1nos regiszterek\u00e9nt szolg\u00e1l.<\/li>\n<li>A gy\u00e1rt\u00f3k nem csak harmoniz\u00e1lt szabv\u00e1nyoknak val\u00f3 megfelel\u00e9ssel bizony\u00edthatj\u00e1k, hogy az orvostechnikai eszk\u00f6z megfelel az MDR \u00e1ltal t\u00e1masztott k\u00f6vetelm\u00e9nyeknek, hanem lehet\u0151s\u00e9g\u00fck van \u00fan. \u201eegys\u00e9ges el\u0151\u00edr\u00e1sok\u201d (<em>common specifications<\/em>) figyelembe v\u00e9tel\u00e9re is. Ezen egys\u00e9ges el\u0151\u00edr\u00e1sokat a Bizotts\u00e1g alkotja meg, amennyiben nincsenek harmoniz\u00e1lt szabv\u00e1nyok, a harmoniz\u00e1lt szabv\u00e1nyok nem el\u00e9gs\u00e9gesek, vagy k\u00f6zeg\u00e9szs\u00e9g\u00fcgyi probl\u00e9m\u00e1k kezel\u00e9s\u00e9re van sz\u00fcks\u00e9g.<\/li>\n<li>A gy\u00e1rt\u00f3knak gondoskodniuk kell egy olyan szem\u00e9ly kijel\u00f6l\u00e9s\u00e9r\u0151l, aki rendelkezik az MDR \u00e1ltal megk\u00f6vetelt szak\u00e9rtelemmel, \u00e9s az a kiz\u00e1r\u00f3lagos feladata, hogy biztos\u00edtsa a rendelet rendelkez\u00e9seinek val\u00f3 megfelel\u00e9st.<\/li>\n<li>A rendelet nem csak lehet\u0151v\u00e9 tesz, de k\u00f6telez\u0151 jelleggel el\u0151\u00edr sz\u00far\u00f3pr\u00f3baszer\u0171, rajta\u00fct\u00e9s jelleg\u0171 (el\u0151re be nem jelentett) helysz\u00edni vizsg\u00e1latokat az orvostechnikai eszk\u00f6z\u00f6k gy\u00e1rt\u00f3in\u00e1l, \u00e9s adott esetben a gy\u00e1rt\u00f3 besz\u00e1ll\u00edt\u00f3in\u00e1l \u00e9s\/vagy alv\u00e1llalkoz\u00f3in\u00e1l. A helysz\u00edni auditok c\u00e9lja az arr\u00f3l val\u00f3 meggy\u0151z\u0151d\u00e9s, hogy egy adott eszk\u00f6z mindenben megfelel-e a vonatkoz\u00f3 m\u0171szaki dokument\u00e1ci\u00f3nak.<\/li>\n<\/ul>\n<p>A fentiekben felv\u00e1zolt v\u00e1ltoz\u00e1sokb\u00f3l is l\u00e1tszik, hogy az MDR nagyobb szab\u00e1lyoz\u00e1si terhet r\u00f3 az orvostechnikai \u00e1gazat szerepl\u0151ire. Nem v\u00e9letlen, hogy t\u00f6bb piaci szerepl\u0151 m\u00e1r a COVID-19-et megel\u0151z\u0151en is lobbitev\u00e9keny\u00e9get folytatott a rendelet alkalmaz\u00e1s\u00e1nak elhalaszt\u00e1sa \u00e9rdek\u00e9ben, amely tendenci\u00e1val feltehet\u0151en a j\u00f6v\u0151ben is sz\u00e1molni kell.<\/p>\n<hr>\n<p><em>A cikk szerz\u0151i:<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-78bc5e4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"78bc5e4\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-9d7c095\" data-id=\"9d7c095\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9bdac2d elementor-flip-box--direction-left elementor-flip-box--effect-flip elementor-widget elementor-widget-global elementor-global-2940 elementor-widget-flip-box\" data-id=\"9bdac2d\" data-element_type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__image\">\n\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/blogs.dlapiper.com\/advocatus\/files\/elementor\/thumbs\/Nevtelen-terv-52-pf8i9wqicsm4qq9ik64j95xtmcli9ocj5usili9300.png\" title=\"Alm\u00e1sy M\u00e1rk\" alt=\"Alm\u00e1sy M\u00e1rk\" loading=\"lazy\" \/>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\t\t Alm\u00e1sy M\u00e1rk*\t\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\t\u00dcgyv\u00e9d<p>Associate\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<a class=\"elementor-flip-box__layer elementor-flip-box__back\" href=\"mailto:mark.almasy@dlapiper.com\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\t Alm\u00e1sy M\u00e1rk\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tM\u00e1rk a DLA Piper Hungary Szellemi Alkot\u00e1sok \u00e9s Technol\u00f3gia csoportj\u00e1nak \u00fcgyv\u00e9dje. Sz\u00e1mos k\u00fcl\u00f6nb\u00f6z\u0151 adatv\u00e9delmi, szellemi tulajdonnal kapcsolatos \u00fcgyben, valamint gy\u00f3gyszer\u00e9szeti jog \u00e9s munkajogi \u00fcgyben vett r\u00e9szt.\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-flip-box__button elementor-button elementor-size-xs\">\n\t\t\t\t\t\t\tE-mailt k\u00fcld\u00f6k\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6ce8751\" data-id=\"6ce8751\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5fdc7c9 elementor-flip-box--direction-left elementor-flip-box--effect-flip elementor-widget elementor-widget-global elementor-global-2901 elementor-widget-flip-box\" data-id=\"5fdc7c9\" data-element_type=\"widget\" data-widget_type=\"flip-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-flip-box\" tabindex=\"0\">\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__front\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__image\">\n\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/blogs.dlapiper.com\/advocatus\/files\/2021\/10\/Nevtelen-terv-29.png\" title=\"\" alt=\"\" loading=\"lazy\" \/>\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\t\tPapp G\u00e1bor*\t\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\t\tLife Sciences csoport t\u00e1rsvezet\u0151je\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div class=\"elementor-flip-box__layer elementor-flip-box__back\">\n\t\t\t<div class=\"elementor-flip-box__layer__overlay\">\n\t\t\t\t<div class=\"elementor-flip-box__layer__inner\">\n\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-flip-box__layer__title\">\n\t\t\t\t\t\t\t Papp G\u00e1bor\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-flip-box__layer__description\">\n\t\t\t\t\t\t\tPapp G\u00e1bor 2011 \u00f3ta dolgozik \u00fcgyv\u00e9dk\u00e9nt. 2014-ben csatlakozott az iroda t\u00e1rsas\u00e1gi jogi \u00e9s M&amp;A csoportj\u00e1hoz vezet\u0151 \u00fcgyv\u00e9dk\u00e9nt. Szakmai tev\u00e9kenys\u00e9ge kiterjed t\u00e1rsas\u00e1gi jogi \u00fcgyekre, M&amp;A tranzakci\u00f3kra, compliance \u00fcgyekre, gy\u00f3gyszerjogra, munkajogra, k\u00f6zigazgat\u00e1si jogra, illetve kodifik\u00e1ci\u00f3s\/szab\u00e1lyoz\u00e1si k\u00e9rd\u00e9sekre is. \t\t\t\t\t\t<\/div>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-flip-box__button elementor-button elementor-size-xs\" href=\"mailto:gabor.papp@dlapiper.com\">\n\t\t\t\t\t\t\tE-mailt k\u00fcld\u00f6k\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Alm\u00e1sy M\u00e1rk \u00e9s Papp G\u00e1bor bemutatj\u00e1k az MDR \u00e9s az IVDR-rendeletekben tervezett, az orvostechnikai eszk\u00f6z\u00f6k eur\u00f3pai piac\u00e1t \u00e9rint\u0151 v\u00e1ltoztat\u00e1sokat \u00e9s az azok m\u00f6g\u00f6tt megh\u00faz\u00f3d\u00f3 okokat.<\/p>\n","protected":false},"author":1,"featured_media":2502,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[312],"tags":[659,222,179,1201,851,658,850,660,32],"coauthors":[705,764,690],"class_list":["post-2500","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmalife-science","tag-egeszsegugy","tag-eu","tag-europai-unio","tag-europai-unios-szabalyozas","tag-ivdr-rendelet","tag-life-sciences","tag-mdr-rendelet","tag-orvostechnikai-eszkozok","tag-szabalyozas"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u00dajabb \u00e9vet nyertek az orvostechnikai eszk\u00f6z\u00f6k gy\u00e1rt\u00f3i \u00e9s forgalmaz\u00f3i<\/title>\n<meta name=\"description\" content=\"A szak\u00e9rt\u0151k bemutatj\u00e1k az MDR \u00e9s az IVDR-rendeletekben tervezett, az orvostechnikai eszk\u00f6z\u00f6k eur\u00f3pai piac\u00e1t \u00e9rint\u0151 v\u00e1ltoztat\u00e1sokat \u00e9s okokat.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.dlapiper.com\/advocatus\/2020\/05\/ujabb-evet-nyertek-az-orvostechnikai-eszkozok-gyartoi-es-forgalmazoi-az-egyseges-szigoru-europai-unios-szabalyokra-valo-felkeszuleshez\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u00dajabb \u00e9vet nyertek az orvostechnikai eszk\u00f6z\u00f6k gy\u00e1rt\u00f3i \u00e9s forgalmaz\u00f3i\" \/>\n<meta property=\"og:description\" content=\"A szak\u00e9rt\u0151k bemutatj\u00e1k az MDR \u00e9s az IVDR-rendeletekben tervezett, az orvostechnikai eszk\u00f6z\u00f6k eur\u00f3pai piac\u00e1t \u00e9rint\u0151 v\u00e1ltoztat\u00e1sokat \u00e9s okokat.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/blogs.dlapiper.com\/advocatus\/2020\/05\/ujabb-evet-nyertek-az-orvostechnikai-eszkozok-gyartoi-es-forgalmazoi-az-egyseges-szigoru-europai-unios-szabalyokra-valo-felkeszuleshez\/\" \/>\n<meta property=\"og:site_name\" content=\"Advocatus\" \/>\n<meta property=\"article:published_time\" content=\"2020-05-26T11:50:57+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-03-03T14:45:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/blogs.dlapiper.com\/advocatus\/files\/2020\/05\/advocatus_lifesciences-e1636729610922.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"318\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"DLA Piper, Alm\u00e1sy M\u00e1rk, Papp G\u00e1bor\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"DLA Piper, Alm\u00e1sy M\u00e1rk, Papp G\u00e1bor\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/blogs.dlapiper.com\/advocatus\/2020\/05\/ujabb-evet-nyertek-az-orvostechnikai-eszkozok-gyartoi-es-forgalmazoi-az-egyseges-szigoru-europai-unios-szabalyokra-valo-felkeszuleshez\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/blogs.dlapiper.com\/advocatus\/2020\/05\/ujabb-evet-nyertek-az-orvostechnikai-eszkozok-gyartoi-es-forgalmazoi-az-egyseges-szigoru-europai-unios-szabalyokra-valo-felkeszuleshez\/\"},\"author\":{\"name\":\"DLA Piper\",\"@id\":\"https:\/\/blogs.dlapiper.com\/advocatus\/#\/schema\/person\/e4f1320bd6f7e07fbf942762d3bd3206\"},\"headline\":\"\u00dajabb \u00e9vet nyertek az orvostechnikai eszk\u00f6z\u00f6k gy\u00e1rt\u00f3i \u00e9s forgalmaz\u00f3i az egys\u00e9ges, szigor\u00fa eur\u00f3pai uni\u00f3s szab\u00e1lyokra val\u00f3 felk\u00e9sz\u00fcl\u00e9shez\",\"datePublished\":\"2020-05-26T11:50:57+00:00\",\"dateModified\":\"2022-03-03T14:45:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/blogs.dlapiper.com\/advocatus\/2020\/05\/ujabb-evet-nyertek-az-orvostechnikai-eszkozok-gyartoi-es-forgalmazoi-az-egyseges-szigoru-europai-unios-szabalyokra-valo-felkeszuleshez\/\"},\"wordCount\":1683,\"publisher\":{\"@id\":\"https:\/\/blogs.dlapiper.com\/advocatus\/#organization\"},\"image\":{\"@id\":\"https:\/\/blogs.dlapiper.com\/advocatus\/2020\/05\/ujabb-evet-nyertek-az-orvostechnikai-eszkozok-gyartoi-es-forgalmazoi-az-egyseges-szigoru-europai-unios-szabalyokra-valo-felkeszuleshez\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/blogs.dlapiper.com\/advocatus\/files\/2020\/05\/advocatus_lifesciences-e1636729610922.jpg\",\"keywords\":[\"eg\u00e9szs\u00e9g\u00fcgy\",\"EU\",\"Eur\u00f3pai Uni\u00f3\",\"eur\u00f3pai uni\u00f3s szab\u00e1lyoz\u00e1s\",\"IVDR-rendelet\",\"life sciences\",\"MDR-rendelet\",\"orvostechnikai 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