{"id":19580,"date":"2021-06-14T08:05:27","date_gmt":"2021-06-14T08:05:27","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=19580"},"modified":"2022-06-09T13:24:53","modified_gmt":"2022-06-09T13:24:53","slug":"yeni-tibbi-cihaz-yonetmeligi-yayimlandi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2021\/06\/14\/yeni-tibbi-cihaz-yonetmeligi-yayimlandi\/","title":{"rendered":"Yeni T\u0131bbi Cihaz Y\u00f6netmeli\u011fi Yay\u0131mland\u0131"},"content":{"rendered":"<p><strong><a href=\"https:\/\/podcast.esin.av.tr\/?lang=tr&amp;playing=PFC1534543393?updated=1623581986\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" class=\"alignnone wp-image-18799\" src=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\" alt=\"\" width=\"56\" height=\"56\" srcset=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png 186w, https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1-150x150.png 150w\" sizes=\"(max-width: 56px) 100vw, 56px\" \/><\/a>\u00a0 \u00a0Art\u0131k b\u00fcltenlerimizi sesli olarak da dinleyebilirsiniz!<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (&#8220;Y\u00f6netmelik&#8221;) 2 Haziran 2021 tarihli ve 31499 say\u0131l\u0131 Resmi Gazete&#8217;de yay\u0131mland\u0131. Avrupa Birli\u011fi (AB) mevzuat\u0131 ile tam uyumlu olan Y\u00f6netmelik, t\u0131bbi cihazlar\u0131n kalitesini art\u0131rarak t\u0131bbi cihaz kullan\u0131c\u0131lar\u0131 ve hastalar i\u00e7in daha g\u00fcvenli bir kullan\u0131m sunmay\u0131 ama\u00e7l\u0131yor. S\u00f6z konusu Y\u00f6netmelik&#8217;e <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=KzhIR3pRbkRVNmxHQ0d6QTVHKzFYNmRBbGdUNThIeGRlVlNYN2Y3cnRYeGVPRXNHZm1UOVRLT1JrNTRxck5FNGJFbTl6TnV3WjZwQy9DOGVGZW9ZcnU2TW9kaEVCeDRlb2owTkNXTDErUnJMTFVPSGo0NUNrdkhnaEp0endYSmU=&amp;rh=ff007b7b2f8bd9ecfa68afd7134880fbfb3633ca__;!!Hj9Y_P0nvg!ExG7jU_YW7ifEy7R5dXusylIIRYUN08oT0HwXILpUwHQG-zELOEH8ecCX1-CIN8JgcURSg$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p><em>T\u0131bbi cihaz kavram\u0131 geni\u015fletildi<\/em><\/p>\n<p>Y\u00f6netmelik uyar\u0131nca t\u0131bbi cihaz kavram\u0131n\u0131n kapsam\u0131 geni\u015fletildi. Buna g\u00f6re kontakt lensler, liposak\u015f\u0131n ekipman\u0131, (d\u00f6vme ve pirsing hari\u00e7 olmak \u00fczere) cerrahi invaziv yollarla insan v\u00fccuduna uygulanan \u00fcr\u00fcnler, fasial veya di\u011fer dermal dolguda kullan\u0131lan maddeler, lazer cihazlar\u0131 ile beyin sim\u00fclasyonu ama\u00e7l\u0131 cihazlar t\u0131bbi cihaz olarak de\u011ferlendirilecek. Bu \u00fcr\u00fcnlere ili\u015fkin y\u00fck\u00fcml\u00fcl\u00fckler AB Komisyonu&#8217;nun ortak spesifikasyonlar\u0131 yay\u0131nlamas\u0131ndan itibaren alt\u0131 ay i\u00e7erisinde ge\u00e7erli olacakt\u0131r. Bu zamana kadar ilgili \u00fcr\u00fcnlerle ilgili mevcut mevzuat ge\u00e7erli olmaya devam edecek.<\/p>\n<p><em>Yeni Kalite Gereklilikleri<\/em><\/p>\n<p>Yeni Y\u00f6netmelik uyar\u0131nca bir cihaz\u0131n piyasaya sunulabilmesi i\u00e7in birtak\u0131m geli\u015ftirilmi\u015f kalite y\u00fck\u00fcml\u00fcl\u00fcklerine uymas\u0131 gerekmektedir. Cihaz \u00fcreticileri Y\u00f6netmelik&#8217;e uyum, tedarik\u00e7i ve y\u00fcklenici se\u00e7imi konusunda kaynak y\u00f6netimi, klinik de\u011ferlendirme ve risk y\u00f6netimi gibi konular\u0131 i\u00e7erecek bir kalite y\u00f6netim sistemi kurmakla y\u00fck\u00fcml\u00fcd\u00fcr. Kalite y\u00f6netim sistemi ayr\u0131ca \u00fcr\u00fcn\u00fcn piyasaya s\u00fcr\u00fclmesinden sonraki s\u00fcrece y\u00f6nelik piyasa g\u00f6zetim plan\u0131 kurmay\u0131 da kapsar. Buna g\u00f6re, cihaz \u00fcreticisi \u00fcr\u00fcnlerin g\u00fcvenli\u011fini g\u00f6zetmeli ve \u00f6nleyici ve d\u00fczeltici \u00f6nlemleri kapsaya uygun bir politika olu\u015fturmal\u0131d\u0131r.<\/p>\n<p><em>T\u0131bbi cihazlar\u0131n klinik ara\u015ft\u0131rmas\u0131<\/em><\/p>\n<p>T\u00fcm t\u0131bbi cihazlar (talep \u00fczerine \u00fcretilen ve ara\u015ft\u0131rma ama\u00e7l\u0131 olanlar hari\u00e7) kullan\u0131m \u00f6ncesinde klinik olarak test edilmelidir. \u00dcretimciler t\u0131bbi cihaz\u0131 piyasaya koymadan \u00f6nce bu y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc yerine getirmekle y\u00fck\u00fcml\u00fcd\u00fcr. Klinik ara\u015ft\u0131rmalar ulusal mevzuat ile uluslararas\u0131 iyi uygulama \u015fartlar\u0131 ile uyumlu olacak \u015fekilde planlanmal\u0131 ve y\u00fcr\u00fct\u00fclmelidir.<\/p>\n<p><em>T\u0131bbi Cihazlara ili\u015fkim Avrupa Birli\u011fi veri taban\u0131 (ing. EUDAMED)<\/em><\/p>\n<p>Yeni Y\u00f6netmelik, t\u0131bbi cihaz sekt\u00f6r\u00fcnde \u015feffafl\u0131\u011f\u0131 geli\u015ftirmek ve takip edilebilirli\u011fi art\u0131rmak ad\u0131na Avrupa Birli\u011fi Komisyonu&#8217;nun EUDAMED sistemini benimsemi\u015ftir. Y\u00f6netmelik uyar\u0131nca \u00fcreticiler t\u0131bbi cihazlar\u0131 (talep \u00fczerine \u00fcretilenler hari\u00e7) piyasaya s\u00fcrmeden \u00f6nce EUDAMED sistemine kaydetmekle y\u00fck\u00fcml\u00fcd\u00fcr. EUDAMED kay\u0131tlar\u0131 kamuya a\u00e7\u0131k olaca\u011f\u0131ndan, kullan\u0131lan dilin a\u00e7\u0131k ve anla\u015f\u0131labilir olmas\u0131 gerekir. S\u00f6z konusu sistem Avrupa Birli\u011fi Resmi Gazetesi&#8217;nde yay\u0131nlanmas\u0131 ve fonksiyonel spesikasyonlar\u0131n\u0131n kar\u015f\u0131land\u0131\u011f\u0131na dair bir bildiri yay\u0131mland\u0131\u011f\u0131 tarihten alt\u0131 ay sonra kullan\u0131ma haz\u0131r hale gelecektir.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>Yeni Y\u00f6netmelik t\u0131bbi cihaz sekt\u00f6r\u00fcnde temel de\u011fi\u015fiklikleri d\u00fczenlemektedir. Bu sekt\u00f6rde faaliyet g\u00f6steren \u015firketler Y\u00f6netmelik&#8217;i dikkatle de\u011ferlendirmeli ve uyum i\u00e7in gerekli ad\u0131mlar\u0131 atmal\u0131d\u0131r.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u00a0Art\u0131k b\u00fcltenlerimizi sesli olarak da dinleyebilirsiniz! &nbsp; Yeni Geli\u015fme T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (&#8220;Y\u00f6netmelik&#8221;) 2 Haziran 2021 tarihli ve 31499 [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_stopmodifiedupdate":false,"_modified_date":"","footnotes":""},"categories":[120],"tags":[92],"class_list":["post-19580","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Yeni T\u0131bbi Cihaz Y\u00f6netmeli\u011fi Yay\u0131mland\u0131<\/title>\n<meta name=\"description\" content=\"\u00a0 \u00a0Art\u0131k b\u00fcltenlerimizi sesli olarak da dinleyebilirsiniz! 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