{"id":1642,"date":"2020-11-05T11:42:18","date_gmt":"2020-11-05T10:42:18","guid":{"rendered":"https:\/\/lifelonghearing.com\/?p=1642"},"modified":"2025-04-22T16:02:22","modified_gmt":"2025-04-22T16:02:22","slug":"uj-tanusitvany-a-hallasjavito-implantatumok-gyartoinak","status":"publish","type":"post","link":"https:\/\/lifelonghearing.com\/hu\/uj-tanusitvany-a-hallasjavito-implantatumok-gyartoinak\/","title":{"rendered":"\u00daj Tan\u00fas\u00edtv\u00e1ny a Hall\u00e1sjav\u00edt\u00f3 Implant\u00e1tumok Gy\u00e1rt\u00f3inak"},"content":{"rendered":"

MDR Tan\u00fas\u00edtv\u00e1ny a MED-EL r\u00e9sz\u00e9re<\/h1><\/div>

A MED-EL a hall\u00e1sjav\u00edt\u00f3 implant\u00e1tum gy\u00e1rt\u00f3k k\u00f6z\u00fcl a vil\u00e1gon els\u0151k\u00e9nt, 2020 m\u00e1rcius\u00e1ban az EU orvosi term\u00e9kekre vonatkoz\u00f3 szab\u00e1lyoz\u00e1s\u00e1n alapul\u00f3 tan\u00fas\u00edtv\u00e1nyt szerzett. A szigor\u00fabb szab\u00e1lyoz\u00e1s c\u00e9lja a k\u00f6zeg\u00e9szs\u00e9g \u00e9s biztons\u00e1g v\u00e9delme; 2024-t\u0151l lesz k\u00f6telez\u0151 \u00e9rv\u00e9ny\u0171 minden, az EU-ban m\u0171k\u00f6d\u0151 orvosi term\u00e9ket gy\u00e1rt\u00f3 v\u00e1llalat sz\u00e1m\u00e1ra.<\/strong><\/p>\n<\/div>

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\u201cKor\u00e1bban mindig k\u00e9ts\u00e9ges volt, hogy a szektorra vonatkoz\u00f3 szab\u00e1lyoz\u00e1sok a hat\u00e1rid\u0151n bel\u00fcl bevezet\u00e9sre ker\u00fclnek-e\u201d, magyar\u00e1zza DI Ewald Thurner, a MED-EL Ausztria Ter\u00fcleti Igazgat\u00f3ja. “A MED-EL azonban ism\u00e9t bizony\u00edtotta, hogy mint a be\u00fcltetett hall\u00f3k\u00e9sz\u00fcl\u00e9kek ter\u00e9n komplett megold\u00e1sokat ny\u00fajt\u00f3 vil\u00e1gels\u0151 osztr\u00e1k v\u00e1llalat, a szab\u00e1lyoz\u00e1sok ter\u00e9n is vezet\u0151 szerepet t\u00f6lt be. A MED-EL \u00fatt\u00f6r\u0151 munk\u00e1ja garanci\u00e1t ny\u00fajt az EU-n bel\u00fcl az orvosi term\u00e9kek el\u00e9rhet\u0151s\u00e9g\u00e9re \u00e9s teljes k\u00f6r\u0171 biztons\u00e1goss\u00e1g\u00e1ra.\u201d<\/p>\n

A MED-EL m\u00e1r 2016-ban elhat\u00e1rozta, hogy gy\u00e1rt\u00f3k\u00e9nt az els\u0151k k\u00f6z\u00f6tt vezeti be az Orvosi Eszk\u00f6z\u00f6k Szab\u00e1lyoz\u00e1s\u00e1ra vonatkoz\u00f3 ir\u00e1nyelveket. Ezzel a MED-EL \u201cKorai Befogad\u00f3\u201d lett \u00e9s m\u00e1r j\u00f3val a 2024-es hat\u00e1rid\u0151 el\u0151tt garant\u00e1lta p\u00e1ciensei r\u00e9szre az \u00e1tl\u00e1that\u00f3bb \u00e9s biztons\u00e1gosabb m\u0171k\u00f6d\u00e9st.<\/p>\n

Az Orvosi Eszk\u00f6z\u00f6k Szab\u00e1lyoz\u00e1sa (MDR)1<\/sup> a term\u00e9keket n\u00e9gy csoportba sorolja be: ezek az invaz\u00edv, a non-invaz\u00edv, az akt\u00edv \u00e9s a speci\u00e1lis szab\u00e1lyoz\u00e1s al\u00e1 es\u0151 term\u00e9kek, s az ezeken bel\u00fcl kialak\u00edtott k\u00fcl\u00f6nb\u00f6z\u0151 kock\u00e1zati oszt\u00e1lyok. A hall\u00e1sjav\u00edt\u00f3 implant\u00e1tumok a III. oszt\u00e1lyba tartoznak, ezen bel\u00fcl a legmagasabb kock\u00e1zati kateg\u00f3ri\u00e1ba, melyre a legszigor\u00fabb biztons\u00e1gi szab\u00e1lyoz\u00e1s vonatkozik. A hall\u00e1sjav\u00edt\u00f3 implant\u00e1tumok mellett a MED-EL m\u00e1s term\u00e9kek kifejleszt\u00e9s\u00e9vel, gy\u00e1rt\u00e1s\u00e1val \u00e9s \u00e9rt\u00e9kes\u00edt\u00e9s\u00e9vel is foglalkozik, mint p\u00e9ld\u00e1ul az 1-es Oszt\u00e1lyba tartoz\u00f3 \u00fajrafelhaszn\u00e1lhat\u00f3 seb\u00e9szeti m\u0171szerek, vagy az ADHEAR hall\u00e1srendszer, melyhez nincs sz\u00fcks\u00e9g m\u0171t\u00e9ti beavatkoz\u00e1sra.[1]<\/a><\/p>\n

Konkr\u00e9t V\u00e1ltoztat\u00e1sok az Orvosi Eszk\u00f6z\u00f6k \u00daj Ir\u00e1nyelvei Kapcs\u00e1n<\/h2>\n
\"DI<\/a>

DI Ewald Thurner Ter\u00fcleti Igazgat\u00f3, MED-EL Wien \u00a9 MED-EL<\/p><\/div>\n

\u201cAkt\u00edv be\u00fcltetett eszk\u00f6z gy\u00e1rt\u00f3k\u00e9nt a MED-EL mindig a legszigor\u00fabb ellen\u0151rz\u00e9s al\u00e1 tartozott \u00e9s a legmagasabb elv\u00e1r\u00e1soknak is megfelel\u0151 eszk\u00f6z\u00f6ket gy\u00e1rtott. Eszk\u00f6zeink kialak\u00edt\u00e1s\u00e1ban nincs sz\u00fcks\u00e9g v\u00e1ltoztaz\u00e1sokra az \u00faj szab\u00e1lyoz\u00e1soknak val\u00f3 megfelel\u00e9s \u00e9rdek\u00e9ben\u201d- tudjuk meg Ewald Thurnert\u0151l. A v\u00e1ltoz\u00e1sok ink\u00e1bb olyan t\u00e9m\u00e1kat \u00e9rintenek, mint a klinikai tesztek \u00e9s azok \u00e9rt\u00e9kel\u00e9se, az orvosi eszk\u00f6z\u00f6kre vonatkoz\u00f3 megfigyel\u00e9si \u00e9s jelent\u00e9si rendszerek, vagy a piacfel\u00fcgyelet.<\/p>\n

Szigor\u00edt\u00e1sok ker\u00fcltek bevezet\u00e9sre az \u00e1tl\u00e1that\u00f3s\u00e1g \u00e9s k\u00f6vethet\u0151s\u00e9g ter\u00e9n is. P\u00e9ld\u00e1ul bevezet\u00e9sre ker\u00fclt egy \u00fan. UDI rendszer: ez egy olyan \u2018Egyedi Eszk\u00f6zazonos\u00edt\u00f3 Rendszer\u2019, melynek seg\u00edts\u00e9g\u00e9vel darabonk\u00e9nt minden egyes term\u00e9k k\u00f6vethet\u0151v\u00e9 \u00e9s visszakereshet\u0151v\u00e9 v\u00e1lik.<\/p>\n

Egy m\u00e1sik fontos l\u00e9p\u00e9s az eur\u00f3pai EUDAMED adatb\u00e1zis l\u00e9trehoz\u00e1sa volt. Ez az orvosi eszk\u00f6z adatb\u00e1zis azzal a c\u00e9llal j\u00f6tt l\u00e9tre, hogy n\u00f6velje az \u00e1ltal\u00e1nos \u00e1tl\u00e1that\u00f3s\u00e1got \u00e9s lehet\u0151v\u00e9 tegye az inform\u00e1ci\u00f3hoz val\u00f3 k\u00f6nnyebb hozz\u00e1f\u00e9r\u00e9st a nyilv\u00e1noss\u00e1g, valamint az eg\u00e9szs\u00e9g\u00fcgyi szakemberek r\u00e9sz\u00e9re. Az adatb\u00e1zis hat modulj\u00e1b\u00f3l az els\u0151 a 2020-as \u00e9v v\u00e9g\u00e9re k\u00e9sz\u00fclt el, s azt 2021 m\u00e1jus\u00e1ig k\u00e9t m\u00e1sik modul k\u00f6vette.[2]<\/a><\/p>\n

MDR Tan\u00fas\u00edtv\u00e1ny – A K\u00f6vetkez\u0151 L\u00e9p\u00e9s a Jobb Biztons\u00e1g \u00e9s Magasabb Min\u0151s\u00e9g Ir\u00e1ny\u00e1ba<\/strong><\/h2>\n
\"Elizabeth\u202fGf\u00f6ller,\u202fCorporate<\/a>

Elizabeth Gf\u00f6ller, V\u00e1llalati Igazgat\u00f3, Szab\u00e1lyoz\u00e1si \u00dcgyek, MED-EL \u00a9 MED-EL<\/p><\/div>\n

A MED-EL mintegy 40 \u00e9ves fenn\u00e1ll\u00e1s\u00e1nak kezdet\u00e9t\u0151l a legmagasabb min\u0151s\u00e9g\u0171, biztons\u00e1gos \u00e9s hat\u00e9kony eszk\u00f6z\u00f6k gy\u00e1rt\u00e1s\u00e1ra k\u00f6telezte el mag\u00e1t. A v\u00e1llalat eg\u00e9sz\u00e9re vonatkoz\u00f3 MDR tan\u00fas\u00edtv\u00e1ny megszerz\u00e9se ut\u00e1n most lehet\u0151s\u00e9g ny\u00edlt az egyes term\u00e9kek tan\u00fas\u00edtv\u00e1ny\u00e1nak a megszerz\u00e9s\u00e9re is. Ez biztos\u00edtja, hogy az Eur\u00f3p\u00e1ban jelenleg el\u00e9rhet\u0151 term\u00e9kek folyamatosan, megszak\u00edt\u00e1sok n\u00e9lk\u00fcl el\u00e9rhet\u0151ek legyenek 2024 ut\u00e1n is. Az \u00faj term\u00e9kek m\u00e1r piacra ker\u00fcl\u00e9s\u00fckkor meg fognak felelni az MDR el\u0151\u00edr\u00e1sainak.<\/p>\n

Elizabeth Gf\u00f6ller, a MED-EL szab\u00e1lyoz\u00e1si \u00fcgyek\u00e9rt felel\u0151s v\u00e1llalati igazgat\u00f3ja \u00edgy foglalja \u00f6ssze a l\u00e9nyeget: “Az MDR tan\u00fas\u00edtv\u00e1ny nagyon fontos c\u00e9g\u00fcnk sz\u00e1m\u00e1ra. Az \u00fcggyel kapcsolatos nagym\u00e9rt\u00e9k\u0171 k\u00f6z\u00f6s er\u0151fesz\u00edt\u00e9snek h\u00e1la j\u00f3val a hat\u00e1rid\u0151 lej\u00e1rta el\u0151tt teljes\u00edtett\u00fck ezt a c\u00e9lkit\u0171z\u00e9s\u00fcnket. Most, hogy megszerezt\u00fck az MDR tan\u00fas\u00edtv\u00e1nyt, folytathatjuk az utat k\u00fcldet\u00e9s\u00fcnk teljes\u00edt\u00e9se fel\u00e9, mely egyr\u00e9szt a hall\u00e1sk\u00e1rosod\u00e1s okozta probl\u00e9m\u00e1k orvosl\u00e1s\u00e1t, m\u00e1sr\u00e9szt a szigor\u00fa, \u00faj szab\u00e1lyoz\u00e1soknak megfelel\u0151, piacvezet\u0151 szerepet bet\u00f6lt\u0151 hall\u00e1sjav\u00edt\u00f3 eszk\u00f6z\u00f6k \u00e9s megold\u00e1sok l\u00e9trehoz\u00e1s\u00e1t jelenti, mind az orvosok, mind p\u00e1cienseink r\u00e9sz\u00e9re.\u201d<\/p>\n

[1]<\/a> MED-EL<\/a> jelenleg – a koronav\u00edrushoz kapcsol\u00f3d\u00f3 kutat\u00e1s r\u00e9szek\u00e9nt – egy speci\u00e1lis aeroszol kifejleszt\u00e9s\u00e9n is dolgozik. Ezt a v\u00edrusok \u00e9s bakt\u00e9riumok elleni v\u00e9delemre kifejlesztett spray a fejhallgat\u00f3ra r\u00e1f\u00fajva, v\u00e9delmet ny\u00fajt a k\u00e9sz\u00fcl\u00e9k visel\u0151je sz\u00e1m\u00e1ra a k\u00fcl\u00f6nb\u00f6z\u0151 k\u00f3rokoz\u00f3kkal szemben.<\/p>\n

[2]<\/a> https:\/\/ec.europa.eu\/health\/md_eudamed\/overview_en<\/a> 2020-08-05<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"

A MED-EL a hall\u00e1sjav\u00edt\u00f3 implant\u00e1tum gy\u00e1rt\u00f3k k\u00f6z\u00fcl a vil\u00e1gon els\u0151k\u00e9nt, 2020 m\u00e1rcius\u00e1ban az EU orvosi term\u00e9kekre vonatkoz\u00f3 szab\u00e1lyoz\u00e1s\u00e1n alapul\u00f3 tan\u00fas\u00edtv\u00e1nyt szerzett.<\/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-tudomany","tag-ci","tag-hearing-implant-reliability","tag-hearing-implants"],"yoast_head":"\n\u00daj Tan\u00fas\u00edtv\u00e1ny a Hall\u00e1sjav\u00edt\u00f3 Implant\u00e1tumok Gy\u00e1rt\u00f3inak - Hungary<\/title>\n<meta name=\"description\" content=\"A MED-EL a hall\u00e1sjav\u00edt\u00f3 implant\u00e1tum gy\u00e1rt\u00f3k k\u00f6z\u00fcl a vil\u00e1gon els\u0151k\u00e9nt, 2020 m\u00e1rcius\u00e1ban megkapta az EU leg\u00fajabb, orvosi term\u00e9kekre vonatkoz\u00f3 szab\u00e1lyoz\u00e1s\u00e1n alapul\u00f3 MDR tan\u00fas\u00edtv\u00e1nyt.\" \/>\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\/hu\/uj-tanusitvany-a-hallasjavito-implantatumok-gyartoinak\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u00daj Tan\u00fas\u00edtv\u00e1ny a Hall\u00e1sjav\u00edt\u00f3 Implant\u00e1tumok Gy\u00e1rt\u00f3inak - 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