{"id":1642,"date":"2020-11-05T11:42:18","date_gmt":"2020-11-05T10:42:18","guid":{"rendered":"https:\/\/lifelonghearing.com\/?p=1642"},"modified":"2025-08-26T11:33:33","modified_gmt":"2025-08-26T11:33:33","slug":"nova-certifikacia-pre-vyrobcov-kochlearnych-implantatov","status":"publish","type":"post","link":"https:\/\/lifelonghearing.com\/sk\/nova-certifikacia-pre-vyrobcov-kochlearnych-implantatov\/","title":{"rendered":"Nov\u00e1 certifik\u00e1cia pre v\u00fdrobcov kochle\u00e1rnych implant\u00e1tov"},"content":{"rendered":"

Certifik\u00e1cia MDR pre MED-EL<\/h1><\/div>

Spolo\u010dnos\u0165 MED-EL sa v marci roku 2020 stala prv\u00fdm v\u00fdrobcom kochle\u00e1rnych implant\u00e1tov na svete, ktor\u00fd z\u00edskal certifik\u00e1ciu pod\u013ea nov\u00fdch predpisov E\u00da t\u00fdkaj\u00facich sa zdravotn\u00edckych v\u00fdrobkov. Pr\u00edsnej\u0161ie po\u017eiadavky maj\u00fa chr\u00e1ni\u0165 verejn\u00e9 zdravie a bezpe\u010dnos\u0165 a od roku 2024 bud\u00fa povinn\u00e9 pre v\u0161etk\u00fdch v\u00fdrobcov zdravotn\u00edckych v\u00fdrobkov v E\u00da.<\/strong><\/p>\n<\/div>

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\u201eV minulosti v tomto sektore v\u017edy prevl\u00e1dali obavy, \u017ee nov\u00e9 predpisy nebude mo\u017en\u00e9 implementova\u0165 v\u010das,\u201c vysvet\u013euje DI Ewald Thurner, region\u00e1lny mana\u017e\u00e9r MED-EL Rak\u00fasko. \u201eSpolo\u010dnos\u0165 MED-EL v\u0161ak op\u00e4\u0165 ukazuje, \u017ee ako popredn\u00fd svetov\u00fd poskytovate\u013e kompletn\u00fdch implantovan\u00fdch sl\u00fachadiel vyroben\u00fdch v Rak\u00fasku sme tie\u017e priekopn\u00edkmi v oblasti predpisov. Dostupnos\u0165 a bezpe\u010dnos\u0165 zdravotn\u00edckych v\u00fdrobkov v E\u00da je v\u010faka priekopn\u00edckej pr\u00e1ci spolo\u010dnosti MED-EL absol\u00fatne zaru\u010den\u00e1.\u201c<\/p>\n

Spolo\u010dnos\u0165 MED-EL sa u\u017e v roku 2016 rozhodla, \u017ee bude jedn\u00fdm z prv\u00fdch v\u00fdrobcov, ktor\u00ed implementuj\u00fa pokyny predpisov o zdravotn\u00edckych pom\u00f4ckach. Dostala sa tak do poz\u00edcie inov\u00e1tora a pacientom zaru\u010dovala e\u0161te v\u00e4\u010d\u0161iu transparentnos\u0165 a bezpe\u010dnos\u0165 dlho pred skon\u010den\u00edm prechodn\u00e9ho obdobia do roku 2024.<\/p>\n

Nariadenie o zdravotn\u00edckych pom\u00f4ckach (MDR)\u00a01<\/sup>\u00a0rozde\u013euje v\u00fdrobky do \u0161tyroch hlavn\u00fdch kateg\u00f3ri\u00ed: invaz\u00edvne, neinvaz\u00edvne, akt\u00edvne a v\u00fdrobky so \u0161peci\u00e1lnymi predpismi, medzi ktor\u00e9 patr\u00ed aj rizikov\u00e1 trieda. Kochle\u00e1rne implant\u00e1ty sa zara\u010fuj\u00fa do triedy III a do najrizikovej\u0161ej kateg\u00f3rie, na ktor\u00fa sa vz\u0165ahuj\u00fa tie najpr\u00edsnej\u0161ie bezpe\u010dnostn\u00e9 opatrenia. Spolo\u010dnos\u0165 MED-EL okrem samotn\u00fdch kochle\u00e1rnych implant\u00e1tov vyv\u00edja, vyr\u00e1ba a pred\u00e1va \u010fal\u0161ie v\u00fdrobky, ako napr\u00edklad znovu pou\u017eite\u013en\u00e9 prvotriedne chirurgick\u00e9 n\u00e1stroje alebo na\u010d\u00favac\u00ed syst\u00e9m\u00a0ADHEAR<\/a>, ktor\u00fd si nevy\u017eaduje oper\u00e1ciu.[1]<\/a><\/p>\n

Konkr\u00e9tne zmeny v d\u00f4sledku nov\u00fdch pokynov pre zdravotn\u00edcke pom\u00f4cky<\/h2>\n
\"DI<\/a>

DI Ewald\u202fThurner\u202fArea Manager MED-EL Wien \u00a9 MED-EL<\/p><\/div>\n

\u201eSpolo\u010dnos\u0165 MED-EL ako v\u00fdrobca akt\u00edvnych implantovan\u00fdch zariaden\u00ed v\u017edy podliehala najvy\u0161\u0161ej \u00farovni kontroly a zariadenia vyr\u00e1bala v\u017edy v s\u00falade s najvy\u0161\u0161\u00edmi \u0161tandardmi. Na to, aby sme sp\u013a\u0148ali nov\u00e9 predpisy, nemus\u00edme meni\u0165 dizajn na\u0161ich zariaden\u00ed,\u201c hovor\u00ed Thurner. Pr\u00edsnej\u0161ie po\u017eiadavky sa t\u00fdkaj\u00fa sk\u00f4r klinick\u00e9ho testovania a hodnoten\u00ed, syst\u00e9mu pozorovania a pod\u00e1vania spr\u00e1v o zdravotn\u00edckych v\u00fdrobkoch a doh\u013eadu nad trhom.<\/p>\n

Zaviedli sa tie\u017e nov\u00e9 ustanovenia t\u00fdkaj\u00face sa transparentnosti a sledovate\u013enosti. Nain\u0161taloval sa napr\u00edklad syst\u00e9m UDI (Unique Device Identification System), pomocou ktor\u00e9ho je mo\u017en\u00e9 sledova\u0165 ka\u017ed\u00fd jeden v\u00fdrobok.<\/p>\n

\u010eal\u0161\u00edm d\u00f4le\u017eit\u00fdm aspektom je zalo\u017eenie eur\u00f3pskej datab\u00e1zy EUDAMED. Ide o datab\u00e1zu zdravotn\u00edckych v\u00fdrobkov, ktorej \u00fa\u010delom je v\u0161eobecne zvy\u0161ova\u0165 transparentnos\u0165 a u\u013eah\u010dova\u0165 verejnosti a pracovn\u00edkom v zdravotn\u00edctve pr\u00edstup k inform\u00e1ci\u00e1m. Prv\u00fd zo \u0161iestich modulov datab\u00e1zy by mal by\u0165 dokon\u010den\u00fd najsk\u00f4r koncom tohto roka a \u010fal\u0161ie dva by mali by\u0165 dokon\u010den\u00e9 do m\u00e1ja 2021.[2]<\/a><\/p>\n

\u010eal\u0161\u00ed krok k bezpe\u010dnosti a kvalite<\/strong><\/h2>\n
\"Elizabeth\u202fGf\u00f6ller,\u202fCorporate<\/a>

Elizabeth\u202fGf\u00f6ller,\u202fCorporate Director, Regulatory Affairs, MED-EL \u00a9 MED-EL<\/p><\/div>\n

Spolo\u010dnos\u0165 MED-EL sa od svojho zalo\u017eenia pred asi 40 rokmi zaviazala vyr\u00e1ba\u0165 bezpe\u010dn\u00e9 a \u00fa\u010dinn\u00e9 v\u00fdrobky pod\u013ea najvy\u0161\u0161\u00edch \u0161tandardov. Po certifik\u00e1cii MDR samotnej spolo\u010dnosti je teraz mo\u017en\u00e9 certifikova\u0165 aj jednotliv\u00e9 v\u00fdrobky. Zais\u0165uje sa tak, \u017ee v\u0161etky aktu\u00e1lne v\u00fdrobky v Eur\u00f3pe bud\u00fa k dispoz\u00edcii bez preru\u0161enia aj po roku 2024. Nov\u00e9 v\u00fdrobky sp\u013a\u0148aj\u00fa v\u0161etky po\u017eiadavky MDR odkedy s\u00fa uveden\u00e9 na trh.<\/p>\n

\u201eCertifik\u00e1cia MDR je pre na\u0161u spolo\u010dnos\u0165 absol\u00fatne d\u00f4le\u017eit\u00e1. V\u010faka mimoriadnemu spolo\u010dn\u00e9mu \u00fasiliu sme tento cie\u013e dosiahli dlho pred stanoven\u00fdm term\u00ednom. Po z\u00edskan\u00ed certifik\u00e1cie MDR m\u00f4\u017eeme pokra\u010dova\u0165 v na\u0161ej misii, ktor\u00e1 spo\u010d\u00edva v rie\u0161en\u00ed straty sluchu a v\u00fdrobe \u0161pi\u010dkov\u00fdch na\u010d\u00favac\u00edch pom\u00f4cok pre pacientov a lek\u00e1rov pod\u013ea nov\u00fdch pr\u00edsnych \u0161tandardov,\u201c hovor\u00ed Elizabeth Gf\u00f6ller, korpor\u00e1tna riadite\u013eka pre regula\u010dn\u00e9 z\u00e1le\u017eitosti v spolo\u010dnosti MED-EL.<\/p>\n

[1]<\/a> Spolo\u010dnos\u0165 MED-EL teraz v r\u00e1mci v\u00fdskumu koronav\u00edrusu vyv\u00edja \u0161peci\u00e1lny aeros\u00f3l, ktor\u00fd sa nastrieka na sl\u00fachadl\u00e1, \u010d\u00edm zabr\u00e1ni prenikaniu bakt\u00e9ri\u00ed a v\u00edrusov a \u010dloveku poskytuje ochranu.<\/p>\n

[2]<\/a> 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":"

Spolo\u010dnos\u0165 MED-EL sa v marci roku 2020 stala prv\u00fdm v\u00fdrobcom kochle\u00e1rnych implant\u00e1tov na svete, ktor\u00fd z\u00edskal certifik\u00e1ciu pod\u013ea nov\u00fdch predpisov E\u00da t\u00fdkaj\u00facich sa zdravotn\u00edckych v\u00fdrobkov.<\/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":[418],"tags":[417,422,412],"class_list":["post-1642","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-veda-sk","tag-ci","tag-hearing-implant-reliability","tag-hearing-implants"],"yoast_head":"\nNov\u00e1 certifik\u00e1cia pre v\u00fdrobcov kochle\u00e1rnych implant\u00e1tov - Slovak<\/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:\/\/lifelonghearing.com\/sk\/nova-certifikacia-pre-vyrobcov-kochlearnych-implantatov\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nov\u00e1 certifik\u00e1cia pre v\u00fdrobcov kochle\u00e1rnych implant\u00e1tov - 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