{"id":1642,"date":"2020-11-05T11:42:18","date_gmt":"2020-11-05T10:42:18","guid":{"rendered":"https:\/\/lifelonghearing.com\/?p=1642"},"modified":"2025-04-17T05:02:23","modified_gmt":"2025-04-17T05:02:23","slug":"nova-certifikace-pro-vyrobce-sluchovych-implantatu","status":"publish","type":"post","link":"https:\/\/lifelonghearing.com\/cs\/nova-certifikace-pro-vyrobce-sluchovych-implantatu\/","title":{"rendered":"Nov\u00e1 certifikace pro v\u00fdrobce sluchov\u00fdch implant\u00e1t\u016f"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:10px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:10px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one\" style=\"--awb-margin-top:0px;\"><h1 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:45;line-height:1.4;\">Certifikace MDR pro MED-EL<\/h1><\/div><div class=\"fusion-text fusion-text-1\"><p><strong>Spole\u010dnost MED-EL se v b\u0159eznu 2020 stala prvn\u00edm v\u00fdrobcem sluchov\u00fdch implant\u00e1t\u016f na sv\u011bt\u011b, kter\u00fd z\u00edskal certifikaci podle nov\u00fdch p\u0159edpis\u016f EU o l\u00e9\u010div\u00fdch p\u0159\u00edpravc\u00edch. P\u0159\u00edsn\u011bj\u0161\u00ed po\u017eadavky maj\u00ed chr\u00e1nit ve\u0159ejn\u00e9 zdrav\u00ed a bezpe\u010dnost a od roku 2024 budou povinn\u00e9 pro v\u0161echny v\u00fdrobce zdravotnick\u00fdch v\u00fdrobk\u016f v EU.<\/strong><\/p>\n<\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1200\" height=\"481\" title=\"mdr-certification-medel-1200&#215;481\" src=\"https:\/\/lifelonghearing.com\/cs\/wp-content\/uploads\/sites\/8\/2025\/01\/mdr-certification-medel-1200x481-1.jpg\" data-orig-src=\"https:\/\/lifelonghearing.com\/cs\/wp-content\/uploads\/sites\/8\/2025\/01\/mdr-certification-medel-1200x481-1.jpg\" alt class=\"lazyload img-responsive wp-image-32052\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271200%27%20height%3D%27481%27%20viewBox%3D%270%200%201200%20481%27%3E%3Crect%20width%3D%271200%27%20height%3D%27481%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/lifelonghearing.com\/cs\/wp-content\/uploads\/sites\/8\/2025\/01\/mdr-certification-medel-1200x481-1-200x80.jpg 200w, https:\/\/lifelonghearing.com\/cs\/wp-content\/uploads\/sites\/8\/2025\/01\/mdr-certification-medel-1200x481-1-400x160.jpg 400w, https:\/\/lifelonghearing.com\/cs\/wp-content\/uploads\/sites\/8\/2025\/01\/mdr-certification-medel-1200x481-1-600x241.jpg 600w, https:\/\/lifelonghearing.com\/cs\/wp-content\/uploads\/sites\/8\/2025\/01\/mdr-certification-medel-1200x481-1-800x321.jpg 800w, https:\/\/lifelonghearing.com\/cs\/wp-content\/uploads\/sites\/8\/2025\/01\/mdr-certification-medel-1200x481-1.jpg 1200w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;width:100%;\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\"><p>\u201eV minulosti v na\u0161em odv\u011btv\u00ed v\u017edy panovaly obavy, \u017ee nebude mo\u017en\u00e9 implementovat p\u0159edpisy v\u010das,\u201c vysv\u011btluje DI Ewald Thurner, oblastn\u00ed mana\u017eer MED-EL Rakousko. \u201eSpole\u010dnost MED-EL v\u0161ak znovu ukazuje, \u017ee jako p\u0159edn\u00ed sv\u011btov\u00fd poskytovatel kompletn\u00edch implantovan\u00fdch sluchadel \u2013 vyroben\u00fdch v Rakousku \u2013 jsme tak\u00e9 pr\u016fkopn\u00edkem v oblasti p\u0159edpis\u016f. Dostupnost i bezpe\u010dnost l\u00e9ka\u0159sk\u00fdch produkt\u016f v EU je d\u00edky pr\u016fkopnick\u00e9 pr\u00e1ci MED-EL absolutn\u011b zaru\u010dena.\u201c<\/p>\n<p>Spole\u010dnost MED-EL se ji\u017e v roce 2016 rozhodla b\u00fdt jedn\u00edm z prvn\u00edch v\u00fdrobc\u016f, kte\u0159\u00ed implementovali pokyny na\u0159\u00edzen\u00ed o zdravotnick\u00fdch prost\u0159edc\u00edch. D\u00edky tomu se MED-EL stal \u201eEarly Adopter\u201c a zaru\u010dil pacient\u016fm je\u0161t\u011b v\u011bt\u0161\u00ed transparentnost a bezpe\u010dnost dlouho p\u0159ed koncem p\u0159echodn\u00e9ho obdob\u00ed do roku 2024.<\/p>\n<p>Na\u0159\u00edzen\u00ed o zdravotnick\u00fdch prost\u0159edc\u00edch (MDR)<sup>1<\/sup> , t\u0159\u00edd\u00ed produkty do \u010dty\u0159 hlavn\u00edch kategori\u00ed: invazivn\u00ed, neinvazivn\u00ed, aktivn\u00ed a se speci\u00e1ln\u00edmi p\u0159edpisy, s nimi\u017e jsou spojeny i rizikov\u00e9 t\u0159\u00eddy. Sluchov\u00e9 implant\u00e1ty jsou v\u00fdrobky t\u0159\u00eddy III a pat\u0159\u00ed do nejvy\u0161\u0161\u00ed rizikov\u00e9 kategorie, pro kterou plat\u00ed nejp\u0159\u00edsn\u011bj\u0161\u00ed bezpe\u010dnostn\u00ed p\u0159edpisy. Spolu se samotn\u00fdmi sluchov\u00fdmi implant\u00e1ty MED-EL vyv\u00edj\u00ed, vyr\u00e1b\u00ed a prod\u00e1v\u00e1 i dal\u0161\u00ed produkty, jako jsou opakovan\u011b pou\u017eiteln\u00e9 chirurgick\u00e9 n\u00e1stroje t\u0159\u00eddy 1 nebo sluchov\u00fd syst\u00e9m ADHEAR, kter\u00fd nevy\u017eaduje \u017e\u00e1dnou operaci.<a href=\"#_ftn1\" name=\"_ftnref1\">[1]<\/a><\/p>\n<h2>Konkr\u00e9tn\u00ed zm\u011bny v d\u016fsledku nov\u00fdch pokyn\u016f pro zdravotnick\u00e9 v\u00fdrobky<\/h2>\n<div id=\"attachment_1650\" style=\"width: 170px\" class=\"wp-caption alignright\"><a href=\"\/wp-content\/uploads\/sites\/8\/2025\/01\/ewald-thurner.jpg\"><img decoding=\"async\" aria-describedby=\"caption-attachment-1650\" class=\"lazyload wp-image-1650\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27160%27%20height%3D%27221%27%20viewBox%3D%270%200%20160%20221%27%3E%3Crect%20width%3D%27160%27%20height%3D%27221%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"\/wp-content\/uploads\/sites\/8\/2025\/01\/ewald-thurner.jpg\" alt=\"DI Ewald\u202fThurner\u202fArea Manager MED-EL Wien \u00a9 MED-EL\" width=\"160\" height=\"221\" \/><\/a><p id=\"caption-attachment-1650\" class=\"wp-caption-text\">DI Ewald\u202fThurner\u202fArea Manager MED-EL Wien \u00a9 MED-EL<\/p><\/div>\n<p>\u201eJako v\u00fdrobce aktivn\u00edch implantovan\u00fdch za\u0159\u00edzen\u00ed podl\u00e9hal MED-EL v\u017edy nejvy\u0161\u0161\u00ed \u00farovni kontrol a v\u017edy vyr\u00e1b\u011bl za\u0159\u00edzen\u00ed podle nejvy\u0161\u0161\u00edho standardu.Nen\u00ed nutn\u00e9 m\u011bnit design na\u0161ich za\u0159\u00edzen\u00ed, abychom vyhov\u011bli nov\u00fdm p\u0159edpis\u016fm,\u201c \u0159\u00edk\u00e1 Thurner. P\u0159\u00edsn\u011bj\u0161\u00ed po\u017eadavky plat\u00ed nap\u0159\u00edklad na pro klinick\u00e9 testy a hodnocen\u00ed, pro syst\u00e9m pozorov\u00e1n\u00ed a pod\u00e1v\u00e1n\u00ed zpr\u00e1v o l\u00e9\u010div\u00fdch p\u0159\u00edpravc\u00edch a pro dohled nad trhem.<\/p>\n<p>Rovn\u011b\u017e byla zavedena nov\u00e1 ustanoven\u00ed t\u00fdkaj\u00edc\u00ed se transparentnosti a sledovatelnosti. Byl nap\u0159. nainstalov\u00e1n syst\u00e9m UDI: \u201eUnique Device Identification System\u201c, pomoc\u00ed kter\u00e9ho lze sledovat ka\u017ed\u00fd jednotliv\u00fd kus produktu.<\/p>\n<p>Dal\u0161\u00edm d\u016fle\u017eit\u00fdm aspektem je z\u0159\u00edzen\u00ed evropsk\u00e9 datab\u00e1ze EUDAMED. \u00da\u010delem t\u00e9to datab\u00e1ze l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f je obecn\u011b zv\u00fd\u0161it transparentnost a usnadnit p\u0159\u00edstup k informac\u00edm pro ve\u0159ejnost i pro zdravotnick\u00e9 pracovn\u00edky. Prvn\u00ed ze \u0161esti modul\u016f datab\u00e1ze by m\u011bl b\u00fdt hotov\u00fd na konci tohoto roku a dal\u0161\u00ed dva by m\u011bly n\u00e1sledovat do kv\u011btna 2021 <a href=\"#_ftn2\" name=\"_ftnref2\">[2]<\/a><\/p>\n<h2><strong>Dal\u0161\u00ed krok k bezpe\u010dnosti a kvalit\u011b<\/strong><\/h2>\n<div id=\"attachment_1657\" style=\"width: 170px\" class=\"wp-caption alignright\"><a href=\"\/wp-content\/uploads\/sites\/8\/2025\/01\/elizabeth-gfoeller.jpg\"><img decoding=\"async\" aria-describedby=\"caption-attachment-1657\" class=\"lazyload wp-image-1657\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27160%27%20height%3D%27213%27%20viewBox%3D%270%200%20160%20213%27%3E%3Crect%20width%3D%27160%27%20height%3D%27213%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"\/wp-content\/uploads\/sites\/8\/2025\/01\/elizabeth-gfoeller.jpg\" alt=\"Elizabeth\u202fGf\u00f6ller,\u202fCorporate Director, Regulatory Affairs, MED-EL \u00a9 MED-EL\" width=\"160\" height=\"213\" \/><\/a><p id=\"caption-attachment-1657\" class=\"wp-caption-text\">Elizabeth\u202fGf\u00f6ller,\u202fCorporate Director, Regulatory Affairs, MED-EL \u00a9 MED-EL<\/p><\/div>\n<p>U\u017e v dob\u011b sv\u00e9ho zalo\u017een\u00ed p\u0159ed asi 40 lety se spole\u010dnost MED-EL zav\u00e1zala vyr\u00e1b\u011bt bezpe\u010dn\u00e9 a \u00fa\u010dinn\u00e9 v\u00fdrobky podle nejvy\u0161\u0161\u00edch standard\u016f. Po certifikaci MDR samotn\u00e9 spole\u010dnosti lze nyn\u00ed certifikovat i jednotliv\u00e9 produkty. T\u00edm je zaji\u0161t\u011bno, \u017ee v\u0161echny aktu\u00e1ln\u00ed produkty v Evrop\u011b budou k dispozici bez p\u0159eru\u0161en\u00ed i po roce 2024. Nov\u00e9 produkty spl\u0148uj\u00ed v\u0161echny po\u017eadavky MDR od sv\u00e9ho uveden\u00ed na trh.<\/p>\n<p>Elizabeth Gf\u00f6ller je korpor\u00e1tn\u00ed \u0159editelkou pro regula\u010dn\u00ed z\u00e1le\u017eitosti ve spole\u010dnosti MED-EL a shrnuje: \u201eCertifikace MDR je pro na\u0161i spole\u010dnost absolutn\u011b d\u016fle\u017eit\u00e1. D\u00edky mimo\u0159\u00e1dn\u00e9mu spole\u010dn\u00e9mu \u00fasil\u00ed jsme tohoto c\u00edle dos\u00e1hli dlouho p\u0159ed po\u017eadovan\u00fdm term\u00ednem. Po obdr\u017een\u00ed certifikace MDR m\u016f\u017eeme nyn\u00ed pokra\u010dovat v na\u0161\u00ed misi, kter\u00e1 spo\u010d\u00edv\u00e1 v \u0159e\u0161en\u00ed ztr\u00e1ty sluchu a v\u00fdrob\u011b \u0161pi\u010dkov\u00fdch sluchov\u00fdch pom\u016fcek pro pacienty a l\u00e9ka\u0159e, kter\u00e1 spl\u0148uj\u00ed nov\u00e9 p\u0159\u00edsn\u00e9 standardy.\u201c<\/p>\n<p><a href=\"#_ftnref1\" name=\"_ftn1\">[1]<\/a> Spole\u010dnost MED-EL v sou\u010dasnosti v r\u00e1mci v\u00fdzkumu koronaviru dokonce vyv\u00edj\u00ed speci\u00e1ln\u00ed aerosol. Je ur\u010den k nast\u0159\u00edk\u00e1n\u00ed na sluch\u00e1tka, co\u017e m\u00e1 zaru\u010dit boj proti bakteri\u00edm a vir\u016fm a ochranu jejich u\u017eivatele.<br \/>\n<a href=\"#_ftnref2\" name=\"_ftn2\">[2]<\/a> <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-eudamed\/overview_en\" target=\"_blank\" rel=\"noopener\">https:\/\/ec.europa.eu\/health\/md_eudamed\/overview_en<\/a> 8. 5. 2020<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Spole\u010dnost MED-EL se v b\u0159eznu 2020 stala prvn\u00edm v\u00fdrobcem sluchov\u00fdch implant\u00e1t\u016f na sv\u011bt\u011b, kter\u00fd z\u00edskal certifikaci podle nov\u00fdch p\u0159edpis\u016f EU o l\u00e9\u010div\u00fdch p\u0159\u00edpravc\u00edch.<\/p>\n","protected":false},"author":5,"featured_media":32052,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[470],"tags":[417,422,412],"class_list":["post-1642","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-veda","tag-ci","tag-hearing-implant-reliability","tag-hearing-implants"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.3 - 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