{"id":23044,"date":"2022-06-14T10:45:23","date_gmt":"2022-06-14T10:45:23","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=23044"},"modified":"2022-06-14T12:34:30","modified_gmt":"2022-06-14T12:34:30","slug":"tibbi-cihazlarin-elektronik-kullanim-talimatlarina-iliskin-teblig-taslagi-yayimlandi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2022\/06\/14\/tibbi-cihazlarin-elektronik-kullanim-talimatlarina-iliskin-teblig-taslagi-yayimlandi\/","title":{"rendered":"T\u0131bbi Cihazlar\u0131n Elektronik Kullan\u0131m Talimatlar\u0131na \u0130li\u015fkin Tebli\u011f Tasla\u011f\u0131 Yay\u0131mland\u0131"},"content":{"rendered":"

\"\"<\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz!<\/strong><\/p>\n

 <\/p>\n

Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 (“Bakanl\u0131k”) (AB) 2021\/2226 say\u0131l\u0131 T\u00fcz\u00fc\u011fe paralel olarak haz\u0131rlanan T\u0131bbi Cihazlar\u0131n Elektronik Kullan\u0131m Talimatlar\u0131na \u0130li\u015fkin Tebli\u011f Tasla\u011f\u0131’n\u0131 yay\u0131mlad\u0131.<\/h2>\n

T\u0131bbi Cihazlar\u0131n Elektronik Kullan\u0131m Talimatlar\u0131na \u0130li\u015fkin Tebli\u011f Tasla\u011f\u0131 Neleri D\u00fczenlemektedir?<\/strong><\/h3>\n

Yeni Geli\u015fme<\/h3>\n

Bakanl\u0131k, 30 May\u0131s 2022 tarihinde T\u0131bbi Cihazlar\u0131n Elektronik Kullan\u0131m Talimatlar\u0131na \u0130li\u015fkin Tebli\u011f Tasla\u011f\u0131’n\u0131 yay\u0131mlad\u0131. Taslak tebli\u011f, T\u0131bbi Cihaz Y\u00f6netmeli\u011fi’nde g\u00f6sterilen kullan\u0131m talimatlar\u0131n\u0131n imalat\u00e7\u0131lar taraf\u0131ndan elektronik ortamda sa\u011flanmas\u0131na ili\u015fkin gereklilikleri d\u00fczenlemektedir. Taslak tebli\u011fe buradan <\/a>ula\u015fabilirsiniz.<\/p>\n

Taslak tebli\u011fe ili\u015fkin g\u00f6r\u00fc\u015fler 20 Haziran 2022 tarihine kadar md.reg@titck.gov.tr<\/a> e-posta adresine iletilebilecektir.<\/p>\n

Ne De\u011fi\u015fecek?<\/strong><\/h3>\n

Kapsam<\/em><\/p>\n

Taslak tebli\u011f, kontak lens, ya\u011f dokusunu azaltmak, uzakla\u015ft\u0131rmak veya par\u00e7alamak i\u00e7in kullan\u0131lan ekipmanlar, cilt yenileme, d\u00f6vme silme veya di\u011fer cilt uygulamalar\u0131na y\u00f6nelik lazer cihazlar\u0131 gibi t\u0131bbi ama\u00e7l\u0131 olmayan \u00fcr\u00fcn gruplar\u0131n\u0131 kapsamamaktad\u0131r.<\/p>\n

\u0130malat\u00e7\u0131lar, (i) implante edilebilir ve aktif implante edilebilir t\u0131bbi cihazlar ve aksesuarlar, (ii) sabit kurulumlu t\u0131bbi cihazlar ve aksesuarlar ve (iii) kullan\u0131m talimatlar\u0131n\u0131 g\u00f6rsel olarak g\u00f6steren d\u00e2hili bir sistem ile donat\u0131lm\u0131\u015f t\u0131bbi cihazlar ve bunlar\u0131n aksesuarlar\u0131na ili\u015fkin kullan\u0131m talimatlar\u0131n\u0131 ka\u011f\u0131t yerine elektronik ortamda sa\u011flayabilecektir. S\u00f6z konusu cihaz ve aksesuarlar\u0131n yaln\u0131zca profesyonel kullan\u0131c\u0131lar taraf\u0131ndan kullan\u0131lmak \u00fczere tasarlanm\u0131\u015f olmas\u0131 ve profesyonel kullan\u0131c\u0131lar d\u0131\u015f\u0131ndaki \u00fc\u00e7\u00fcnc\u00fc ki\u015filerin bu cihaz ve aksesuarlar\u0131 kullanmamas\u0131 gerekmektedir.<\/p>\n

\u0130malat\u00e7\u0131lar, yaz\u0131l\u0131mlar i\u00e7in kullan\u0131m talimatlar\u0131n\u0131 da k\u00e2\u011f\u0131t ortam yerine bizzat yaz\u0131l\u0131m vas\u0131tas\u0131yla elektronik ortamda sa\u011flayabilecektir.<\/p>\n

Gereklilikler<\/em><\/p>\n

Elektronik ortamda sa\u011flanacak kullan\u0131m talimatlar\u0131na ili\u015fkin ba\u015fl\u0131ca gereklilikler a\u015fa\u011f\u0131daki gibidir:<\/p>\n

    \n
  • T\u00fcrkiye\u2019de piyasaya arz edilecek olan t\u0131bbi cihaz kullan\u0131m talimatlar\u0131n\u0131n T\u00fcrk\u00e7e olmas\u0131 ve AB \u00fclkelerinde ilgili \u00fclkenin resmi dilinde olmas\u0131 gerekmektedir.\u200b<\/li>\n
  • K\u00e2\u011f\u0131t yerine elektronik ortamda kullan\u0131m talimatlar\u0131 sa\u011flayan imalat\u00e7\u0131lar\u0131n, asgari olarak; hedeflenen kullan\u0131c\u0131lar\u0131n ihtiya\u00e7lar\u0131na ve cihaz\u0131n kullan\u0131m\u0131na ili\u015fkin bilgi ve deneyimi, cihaz\u0131n kullan\u0131laca\u011f\u0131 ortam\u0131n \u00f6zellikleri, kullan\u0131c\u0131lar\u0131n elektronik kullan\u0131m talimatlar\u0131n\u0131 g\u00f6r\u00fcnt\u00fclemek i\u00e7in gerekli yaz\u0131l\u0131m ve donan\u0131m bilgisi ve deneyimi, kullan\u0131c\u0131lar\u0131n elektronik kaynaklara eri\u015fimi, eri\u015fim sorununa kar\u015f\u0131 al\u0131nan g\u00fcvenlik tedbirleri ve kullan\u0131c\u0131 talebine ba\u011fl\u0131 olarak talimatlar\u0131n ka\u011f\u0131t ortamda temin edilmesinin s\u00fcresi gibi hususlar\u0131 kapsayan belgelendirilmi\u015f bir risk de\u011ferlendirmesi yapmas\u0131 gerekmektedir.<\/li>\n
  • S\u00f6z konusu risk de\u011ferlendirmesi, elektronik ortamda temin edilen kullan\u0131m talimatlar\u0131n\u0131n, en az k\u00e2\u011f\u0131t ortamda temin edilen kullan\u0131m talimatlar\u0131 ile sa\u011flanan g\u00fcvenlik seviyesine sahip oldu\u011funu g\u00f6stermelidir.<\/li>\n
  • \u0130malat\u00e7\u0131lar kullan\u0131c\u0131 talebi \u00fczerine en ge\u00e7 yedi g\u00fcn i\u00e7inde veya sipari\u015f s\u0131ras\u0131nda talep edilmesi halinde cihaz\u0131n teslimi s\u0131ras\u0131nda kullan\u0131m talimatlar\u0131n\u0131 ek bir \u00fccret talep etmeksizin ka\u011f\u0131t ortamda sa\u011flayabilmelidir.<\/li>\n
  • \u0130malat\u00e7\u0131lar\u0131n, \u00f6ng\u00f6r\u00fclebilen acil t\u0131bbi durumlara ili\u015fkin bilgiyi ve kullan\u0131m talimatlar\u0131n\u0131 g\u00f6steren bir sisteme sahip cihazlar\u0131n nas\u0131l ba\u015flat\u0131laca\u011f\u0131na ili\u015fkin bilgiyi, cihaz ya da bro\u015f\u00fcr \u00fczerinde sa\u011flamas\u0131 gerekmektedir.<\/li>\n
  • \u0130malat\u00e7\u0131lar\u0131n, cihaz katalo\u011funda ya da di\u011fer cihaz materyallerinde, kullan\u0131m talimatlar\u0131n\u0131 g\u00f6r\u00fcnt\u00fclemek i\u00e7in gerekli yaz\u0131l\u0131m ve donan\u0131m hakk\u0131nda bilgi sa\u011flamas\u0131 gerekmektedir.<\/li>\n
  • \u0130malat\u00e7\u0131lar\u0131n, kullan\u0131c\u0131lara kullan\u0131m talimatlar\u0131n\u0131n revize edildi\u011fi zamanlar\u0131 ve nedenlerini g\u00f6steren bir sisteme sahip olmalar\u0131 gerekmektedir. Kullan\u0131m talimatlar\u0131n\u0131n ge\u00e7mi\u015f tarihli t\u00fcm s\u00fcr\u00fcmlerinin imalat\u00e7\u0131n\u0131n internet sitesinde bulundurulmas\u0131 gerekmektedir.<\/li>\n
  • \u0130malat\u00e7\u0131lar, implante edilebilir cihazlar hari\u00e7 olmak \u00fczere, son kullanma tarihi olan cihazlar i\u00e7in, son cihaz\u0131n piyasaya arz edilmesinden itibaren on y\u0131l ve en son \u00fcretilen cihaz\u0131n son kullanma tarihinin bitiminden itibaren en az iki y\u0131l boyunca kullan\u0131m talimatlar\u0131n\u0131 elektronik ortamda sunmaya devam etmesi gerekmektedir. \u0130mplante edilebilir cihazlar ve belirli bir son kullanma tarihi olmayan cihazlar i\u00e7inse bu s\u00fcre en son cihaz\u0131n piyasaya arz edilmesinden itibaren on be\u015f y\u0131ld\u0131r.<\/li>\n
  • Kullan\u0131m talimatlar\u0131n\u0131n k\u00e2\u011f\u0131t ortam yerine elektronik ortamda verildi\u011fi etiket, ambalaj\u0131 veya sat\u0131\u015f ambalaj\u0131 \u00fczerinde a\u00e7\u0131k bir \u015fekilde belirtilecektir. Sabit kurulumlu t\u0131bbi cihazlarda, bu bilgiye cihaz\u0131n \u00fczerinde yer verilmelidir.<\/li>\n
  • Elektronik ortamdaki kullan\u0131m talimatlar\u0131na eri\u015fim hakk\u0131ndaki bilgi, imalat\u00e7\u0131 bilgileri, ka\u011f\u0131t ortamdaki kullan\u0131m talimatlar\u0131n\u0131n nas\u0131l talep edilebilece\u011fi ve cihaz ad\u0131 ve modeli gibi bilgileri i\u00e7ermelidir.<\/li>\n
  • Elektronik depolama ortam\u0131nda sunulan veya cihaz i\u00e7indeki sistemde g\u00f6rsel olarak yer alan talimatlar\u0131n ayr\u0131ca bir internet sitesinde de kullan\u0131c\u0131 eri\u015fimine sunulmas\u0131 gerekmektedir.<\/li>\n<\/ul>\n

    Taslak tebli\u011fin y\u00fcr\u00fcrl\u00fc\u011fe girmesiyle birlikte T\u0131bbi Cihazlar\u0131n Elektronik Kullan\u0131m Talimatlar\u0131 Hakk\u0131nda Tebli\u011f y\u00fcr\u00fcrl\u00fckten kald\u0131r\u0131lacak olup T\u0131bbi Cihaz Y\u00f6netmeli\u011fi’nin Ge\u00e7ici Madde 1\/5 d\u00fczenlemesi kapsam\u0131nda 26 May\u0131s 2024 tarihine kadar piyasaya arz edilen cihazlara uygulanmaya devam edecektir.<\/p>\n

    Sonu\u00e7<\/strong><\/h3>\n

    Bakanl\u0131k, sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren \u015firketlere rehberlik etmeye devam etmektedir. Sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren t\u00fcm ilgili \u015firketler, yay\u0131mlanan d\u00fczenlemeleri yak\u0131ndan takip etmeli ve mevzuatta yer alan y\u00fck\u00fcml\u00fcl\u00fcklerini Bakanl\u0131k’\u0131n y\u00f6nlendirmeleri do\u011frultusunda yerine getirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"

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