{"id":16655,"date":"2026-07-18T07:17:31","date_gmt":"2026-07-18T07:17:31","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=16655"},"modified":"2026-07-18T07:17:38","modified_gmt":"2026-07-18T07:17:38","slug":"mdr-2026-guncellemesi-klinik-arastirma-ve-teknik-dokumantasyon-istisnasi","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/mdr-2026-guncellemesi-klinik-arastirma-ve-teknik-dokumantasyon-istisnasi\/","title":{"rendered":"MDR 2026 G\u00fcncellemesi: Klinik Ara\u015ft\u0131rma ve Teknik Dok\u00fcmantasyon \u0130stisnas\u0131"},"content":{"rendered":"\n<!--\nKAL\u0130TEK\u0130T | MDR 2026 WET C\u0130HAZLAR G\u00dcNCELLEMES\u0130\n\u00d6nerilen SEO Ba\u015fl\u0131\u011f\u0131:\nMDR 2026 G\u00fcncellemesi: Klinik Ara\u015ft\u0131rma ve Teknik Dok\u00fcmantasyon \u0130stisnas\u0131 Getirilen Cihazlar\n\n\u00d6nerilen Odak Anahtar Kelime:\nMDR klinik ara\u015ft\u0131rma muafiyeti cihaz listesi\n\n\u00d6nerilen URL:\nmdr-klinik-arastirma-teknik-dokumantasyon-istisnasi-cihaz-listesi-2026\n\n\u00d6nerilen Meta A\u00e7\u0131klama:\nAB 2026\/1451 ve 2026\/1359 ile MDR kapsam\u0131nda klinik ara\u015ft\u0131rma ve her cihaz i\u00e7in teknik dok\u00fcmantasyon de\u011ferlendirmesi istisnas\u0131na giren cihazlar\u0131n tam listesi.\n-->\n\n<style>\n.kk-wet-2026{\n  --kk-navy:#071b33;\n  --kk-blue:#155c9b;\n  --kk-blue-dark:#0c477c;\n  --kk-cyan:#eaf5ff;\n  --kk-green:#16794b;\n  --kk-green-bg:#edf9f3;\n  --kk-amber:#946200;\n  --kk-amber-bg:#fff8e7;\n  --kk-red:#9d2638;\n  --kk-red-bg:#fff2f4;\n  --kk-ink:#172638;\n  --kk-muted:#5d6f82;\n  --kk-line:#dce7f0;\n  --kk-soft:#f6f9fc;\n  --kk-white:#ffffff;\n  --kk-shadow:0 16px 44px rgba(7,27,51,.08);\n  max-width:1120px;\n  margin:0 auto;\n  font-family:-apple-system,BlinkMacSystemFont,\"Segoe UI\",Roboto,Arial,sans-serif;\n  color:var(--kk-ink);\n  font-size:16px;\n  line-height:1.72;\n}\n\n.kk-wet-2026 *,\n.kk-wet-2026 *::before,\n.kk-wet-2026 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 background:#fff;\n  color:var(--kk-navy) !important;\n  font-size:14px;\n  font-weight:800;\n  text-decoration:none !important;\n  box-shadow:0 8px 20px rgba(0,0,0,.14);\n}\n\n.kk-wet-footnote{\n  margin-top:18px;\n  color:var(--kk-muted);\n  font-size:12px;\n  line-height:1.55;\n}\n\n@media(max-width:760px){\n  .kk-wet-hero{\n    padding:30px 22px;\n    border-radius:17px;\n  }\n\n  .kk-wet-hero::after{\n    right:6px;\n    font-size:88px;\n  }\n\n  .kk-wet-summary,\n  .kk-device-grid,\n  .kk-wet-checklist{\n    grid-template-columns:1fr;\n  }\n\n  .kk-wet-section{\n    padding:22px 17px;\n    border-radius:16px;\n  }\n\n  .kk-wet-section h2{\n    font-size:23px;\n  }\n\n  .kk-wet-table-wrap{\n    overflow-x:auto;\n    -webkit-overflow-scrolling:touch;\n  }\n\n  .kk-wet-compare{\n    min-width:690px;\n  }\n}\n<\/style>\n\n<article class=\"kk-wet-2026\">\n\n  <header class=\"kk-wet-hero\">\n    <div class=\"kk-wet-eyebrow\">MDR 2017\/745 \u2022 Mevzuat G\u00fcncellemesi<\/div>\n\n    <h2>Klinik Ara\u015ft\u0131rma ve Teknik Dok\u00fcmantasyon \u0130stisnas\u0131 Getirilen Cihazlar\u0131n Tam Listesi<\/h2>\n\n    <p>\n      Avrupa Komisyonu, iyi yap\u0131land\u0131r\u0131lm\u0131\u015f teknoloji olarak de\u011ferlendirilen baz\u0131\n      implante edilebilir cihazlar ile S\u0131n\u0131f III ve S\u0131n\u0131f IIb cihazlara ili\u015fkin iki\n      \u00f6nemli d\u00fczenleme yay\u0131mlad\u0131. Bu yaz\u0131da iki d\u00fczenlemenin kapsam\u0131n\u0131, aralar\u0131ndaki\n      fark\u0131 ve cihazlar\u0131n tam listesini anla\u015f\u0131l\u0131r bi\u00e7imde bulabilirsiniz.\n    <\/p>\n\n    <div class=\"kk-wet-dates\">\n      <div class=\"kk-wet-date\">Yay\u0131mlanma: 29 Haziran 2026<\/div>\n      <div class=\"kk-wet-date\">Y\u00fcr\u00fcrl\u00fck: 19 Temmuz 2026<\/div>\n      <div class=\"kk-wet-date\">D\u00fczenlemeler: AB 2026\/1451 ve AB 2026\/1359<\/div>\n    <\/div>\n  <\/header>\n\n  <section class=\"kk-wet-summary\">\n\n    <div class=\"kk-wet-summary-card\">\n      <div class=\"kk-number\">1<\/div>\n      <h3>Klinik ara\u015ft\u0131rma istisnas\u0131<\/h3>\n      <p>\n        Komisyon Devredilmi\u015f D\u00fczenlemesi (AB) 2026\/1451, MDR Madde 61(6)(b)\n        kapsam\u0131ndaki implante edilebilir ve S\u0131n\u0131f III cihaz listesini geni\u015fletmektedir.\n      <\/p>\n    <\/div>\n\n    <div class=\"kk-wet-summary-card\">\n      <div class=\"kk-number\">2<\/div>\n      <h3>Teknik dok\u00fcmantasyon de\u011ferlendirmesi istisnas\u0131<\/h3>\n      <p>\n        Komisyon Devredilmi\u015f D\u00fczenlemesi (AB) 2026\/1359, belirli S\u0131n\u0131f IIb\n        implante edilebilir cihazlarda her cihaz i\u00e7in ayr\u0131 teknik dok\u00fcmantasyon\n        de\u011ferlendirilmesi zorunlulu\u011funa istisna getirmektedir.\n      <\/p>\n    <\/div>\n\n  <\/section>\n\n  <section class=\"kk-wet-section\">\n    <h2>\u00d6ncelikle: \u0130ki d\u00fczenleme ayn\u0131 anlama gelmiyor<\/h2>\n\n    <div class=\"kk-wet-table-wrap\">\n      <table class=\"kk-wet-compare\">\n        <thead>\n          <tr>\n            <th>D\u00fczenleme<\/th>\n            <th>\u0130lgili MDR maddesi<\/th>\n            <th>Kapsam<\/th>\n            <th>Getirdi\u011fi istisna<\/th>\n          <\/tr>\n        <\/thead>\n        <tbody>\n          <tr>\n            <td><strong>(AB) 2026\/1451<\/strong><br>C(2026) 1798<\/td>\n            <td>MDR Madde 61(6)(b)<\/td>\n            <td>\u0130mplante edilebilir cihazlar ve S\u0131n\u0131f III cihazlar<\/td>\n            <td>Ko\u015fullar kar\u015f\u0131land\u0131\u011f\u0131nda klinik ara\u015ft\u0131rma ger\u00e7ekle\u015ftirme y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcne istisna<\/td>\n          <\/tr>\n          <tr>\n            <td><strong>(AB) 2026\/1359<\/strong><br>C(2026) 1809<\/td>\n            <td>MDR Madde 52(4)<\/td>\n            <td>Belirli S\u0131n\u0131f IIb implante edilebilir cihazlar<\/td>\n            <td>Her cihaz\u0131n teknik dok\u00fcmantasyonunun ayr\u0131 ayr\u0131 de\u011ferlendirilmesi zorunlulu\u011funa istisna<\/td>\n          <\/tr>\n        <\/tbody>\n      <\/table>\n    <\/div>\n\n    <div class=\"kk-wet-alert danger\">\n      <strong>\u00d6nemli ayr\u0131m<\/strong>\n      Bir cihaz\u0131n listede bulunmas\u0131, cihaz\u0131n MDR y\u00fck\u00fcml\u00fcl\u00fcklerinin tamam\u0131ndan muaf\n      oldu\u011fu anlam\u0131na gelmez. Klinik de\u011ferlendirme, teknik dok\u00fcmantasyon, risk\n      y\u00f6netimi, PMS, PMCF ve di\u011fer uygulanabilir MDR y\u00fck\u00fcml\u00fcl\u00fckleri devam eder.\n    <\/div>\n  <\/section>\n\n  <section class=\"kk-wet-section\">\n    <h2>1. Klinik ara\u015ft\u0131rma istisnas\u0131 kapsam\u0131ndaki cihazlar<\/h2>\n\n    <div class=\"kk-wet-law\">\n      <span>Komisyon Devredilmi\u015f D\u00fczenlemesi (AB) 2026\/1451<\/span>\n      <span>C(2026) 1798<\/span>\n      <span>MDR Madde 61(6)(b)<\/span>\n    <\/div>\n\n    <p>\n      Bu d\u00fczenleme, klinik de\u011ferlendirmesi yeterli klinik verilere dayanan ve\n      mevcutsa ilgili \u00fcr\u00fcne \u00f6zg\u00fc ortak spesifikasyonlara uygun olan belirli\n      implante edilebilir ve S\u0131n\u0131f III cihazlar i\u00e7in klinik ara\u015ft\u0131rma\n      ger\u00e7ekle\u015ftirme y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcne istisna tan\u0131maktad\u0131r.\n    <\/p>\n\n    <div class=\"kk-wet-alert warning\">\n      <strong>Klinik de\u011ferlendirme zorunlulu\u011fu devam eder<\/strong>\n      \u00dcretici, listede bulunan cihazlar i\u00e7in de MDR Madde 61 uyar\u0131nca klinik\n      de\u011ferlendirmeyi planlamak, y\u00fcr\u00fctmek, g\u00fcncellemek ve dok\u00fcmante etmek zorundad\u0131r.\n    <\/div>\n\n    <div class=\"kk-wet-list-title\">\n      <span class=\"kk-wet-badge\">Mevcut listedeki cihazlar<\/span>\n    <\/div>\n\n    <ul class=\"kk-device-grid\">\n      <li><strong>S\u00fct\u00fcrler<\/strong><small>Official English: sutures<\/small><\/li>\n      <li><strong>Cerrahi z\u0131mbalar<\/strong><small>Official English: staples<\/small><\/li>\n      <li><strong>Dental dolgular<\/strong><small>Official English: dental fillings<\/small><\/li>\n      <li><strong>Di\u015f telleri<\/strong><small>Official English: dental braces<\/small><\/li>\n      <li><strong>Di\u015f kronlar\u0131<\/strong><small>Official English: tooth crowns<\/small><\/li>\n      <li><strong>Vidalar<\/strong><small>Official English: screws<\/small><\/li>\n      <li><strong>Kamalar<\/strong><small>Official English: wedges<\/small><\/li>\n      <li><strong>Plaklar<\/strong><small>Official English: plates<\/small><\/li>\n      <li><strong>Teller<\/strong><small>Official English: wires<\/small><\/li>\n      <li><strong>Pinler<\/strong><small>Official English: pins<\/small><\/li>\n      <li><strong>Klipsler<\/strong><small>Official English: clips<\/small><\/li>\n      <li><strong>Ba\u011flant\u0131 elemanlar\u0131<\/strong><small>Official English: connectors<\/small><\/li>\n    <\/ul>\n\n    <div class=\"kk-wet-list-title\">\n      <span class=\"kk-wet-badge new\">2026 d\u00fczenlemesiyle eklenen cihazlar<\/span>\n    <\/div>\n\n    <ul class=\"kk-device-grid new-list\">\n      <li><strong>Kraniyal perforat\u00f6rler<\/strong><small>cranial perforators<\/small><\/li>\n      <li><strong>Kraniyal kesici b\u0131\u00e7aklar<\/strong><small>cranio-blades<\/small><\/li>\n      <li><strong>Kateter ge\u00e7iriciler<\/strong><small>catheter passers<\/small><\/li>\n      <li><strong>Cerrahi pedler ve \u015feritler<\/strong><small>patties and strips<\/small><\/li>\n      <li><strong>\u0130mplante edilebilir puls jenerat\u00f6rleri i\u00e7in m\u0131knat\u0131slar<\/strong><small>magnets for implantable pulse generators<\/small><\/li>\n      <li><strong>Port t\u0131ka\u00e7lar\u0131<\/strong><small>port plugs<\/small><\/li>\n      <li><strong>Stileler ve stile k\u0131lavuzlar\u0131<\/strong><small>stylets and stylet guides<\/small><\/li>\n      <li><strong>\u0130\u011fneler<\/strong><small>needles<\/small><\/li>\n      <li><strong>\u0130\u011fne tutucular<\/strong><small>needle holders<\/small><\/li>\n      <li><strong>Forsepsler<\/strong><small>forceps<\/small><\/li>\n      <li><strong>Kan\u00fcller<\/strong><small>cannulas<\/small><\/li>\n      <li><strong>Atriyoseptostomi balon kateterleri<\/strong><small>atrioseptostomy balloon catheters<\/small><\/li>\n      <li><strong>Antikoag\u00fclan kapl\u0131 kateterler<\/strong><small>catheters coated with anticoagulants<\/small><\/li>\n      <li><strong>Antikoag\u00fclan i\u00e7eren kan torbalar\u0131<\/strong><small>blood bags incorporating anticoagulants<\/small><\/li>\n      <li><strong>Port kateterleri<\/strong><small>port catheters<\/small><\/li>\n      <li><strong>\u0130ntrod\u00fcserler ve giri\u015f cihazlar\u0131<\/strong><small>introducers<\/small><\/li>\n      <li><strong>Dilatat\u00f6rler<\/strong><small>dilators<\/small><\/li>\n      <li><strong>Ventrik\u00fcler drenler<\/strong><small>ventricular drains<\/small><\/li>\n      <li><strong>Beslenme t\u00fcpleri<\/strong><small>feeding tubes<\/small><\/li>\n      <li><strong>S\u00fct\u00fcr pledgetleri ve destek pedleri<\/strong><small>suture pledgets<\/small><\/li>\n      <li><strong>S\u00fct\u00fcr k\u0131l\u0131flar\u0131<\/strong><small>suture sleeves<\/small><\/li>\n      <li><strong>S\u00fct\u00fcr d\u00fc\u011fmeleri<\/strong><small>suture buttons<\/small><\/li>\n      <li><strong>Gastrostomi d\u00fc\u011fmeleri<\/strong><small>gastrostomy buttons<\/small><\/li>\n      <li><strong>Kemik tespit tack\u2019leri<\/strong><small>bone tacks<\/small><\/li>\n      <li><strong>Kemik mumu<\/strong><small>bone wax<\/small><\/li>\n      <li><strong>Kemik dolgu materyalleri<\/strong><small>bone fillers<\/small><\/li>\n      <li><strong>Kemik ikame materyalleri<\/strong><small>bone substitutes<\/small><\/li>\n      <li><strong>Stem santraliz\u00f6rleri<\/strong><small>stem centralisers<\/small><\/li>\n      <li><strong>Diyafiz obturat\u00f6rleri<\/strong><small>diaphyseal obturators<\/small><\/li>\n      <li><strong>Radyografi i\u015faretleyicileri<\/strong><small>radiography markers<\/small><\/li>\n      <li><strong>Fiber ligat\u00fcrler<\/strong><small>fiber ligatures<\/small><\/li>\n      <li><strong>Tubal ekstral\u00fcminal ligasyon cihazlar\u0131<\/strong><small>tubal extraluminal ligation devices<\/small><\/li>\n      <li><strong>Transpalatal distrakt\u00f6rler<\/strong><small>transpalatal distractors<\/small><\/li>\n      <li><strong>\u00c7iviler<\/strong><small>nails<\/small><\/li>\n      <li><strong>Ankrajlar<\/strong><small>anchors<\/small><\/li>\n      <li><strong>Posterior spinal fiksasyonlar<\/strong><small>spinal posterior fixations<\/small><\/li>\n      <li><strong>Tekstil \u00f6rg\u00fcler<\/strong><small>textile braids<\/small><\/li>\n      <li><strong>Dental implantlar<\/strong><small>dental implants<\/small><\/li>\n      <li><strong>Ortodontik cihazlar<\/strong><small>orthodontic devices<\/small><\/li>\n      <li><strong>Dental bariyerler<\/strong><small>dental barriers<\/small><\/li>\n      <li><strong>Dental veneerler ve kaplamalar<\/strong><small>dental veneers<\/small><\/li>\n      <li><strong>S\u00fcspansiyon fiksasyonlar\u0131 ve s\u0131k\u0131\u015ft\u0131rma ba\u011flar\u0131<\/strong><small>suspensory fixations and cinches<\/small><\/li>\n      <li><strong>Yeniden kullan\u0131labilir cerrahi aletler<\/strong><small>reusable surgical instruments<\/small><\/li>\n      <li><strong>Kafatas\u0131 geni\u015fletme yaylar\u0131<\/strong><small>springs for skull enlargement<\/small><\/li>\n      <li><strong>K\u0131lavuz teller<\/strong><small>guidewires<\/small><\/li>\n      <li><strong>Bas\u0131n\u00e7 telleri<\/strong><small>pressure wires<\/small><\/li>\n      <li><strong>Kalp pili telleri ve lead\u2019leri<\/strong><small>pacing wires and leads<\/small><\/li>\n      <li><strong>Snare cihazlar\u0131 ve yakalama halkalar\u0131<\/strong><small>snares<\/small><\/li>\n      <li><strong>Lead kapaklar\u0131<\/strong><small>lead caps<\/small><\/li>\n      <li><strong>Fiksasyon ve ba\u011flant\u0131 ara\u00e7lar\u0131<\/strong><small>fixation and connector tools<\/small><\/li>\n      <li><strong>Endovask\u00fcler embolizasyon koilleri<\/strong><small>endovascular embolisation coils<\/small><\/li>\n      <li><strong>Embolizasyon partik\u00fclleri<\/strong><small>embolisation particles<\/small><\/li>\n      <li><strong>Kablolar<\/strong><small>cables<\/small><\/li>\n      <li><strong>\u015eantlar<\/strong><small>shunts<\/small><\/li>\n      <li><strong>\u0130nternal defibrilasyon paddle\u2019lar\u0131<\/strong><small>internal defibrillation paddles<\/small><\/li>\n    <\/ul>\n  <\/section>\n\n  <section class=\"kk-wet-section\">\n    <h2>2. Her cihaz i\u00e7in teknik dok\u00fcmantasyon de\u011ferlendirmesi istisnas\u0131<\/h2>\n\n    <div class=\"kk-wet-law\">\n      <span>Komisyon Devredilmi\u015f D\u00fczenlemesi (AB) 2026\/1359<\/span>\n      <span>C(2026) 1809<\/span>\n      <span>MDR Madde 52(4)<\/span>\n      <span>Yaln\u0131zca S\u0131n\u0131f IIb implante edilebilir cihazlar<\/span>\n    <\/div>\n\n    <p>\n      MDR Madde 52(4) uyar\u0131nca S\u0131n\u0131f IIb cihazlarda normal yakla\u015f\u0131m, her jenerik\n      cihaz grubu i\u00e7in en az bir temsil\u00ee cihaz\u0131n teknik dok\u00fcmantasyonunun\n      de\u011ferlendirilmesidir. S\u0131n\u0131f IIb implante edilebilir cihazlarda ise genel\n      kural her cihaz\u0131n ayr\u0131 de\u011ferlendirilmesidir.\n    <\/p>\n\n    <p>\n      Yeni d\u00fczenleme, a\u015fa\u011f\u0131daki iyi yap\u0131land\u0131r\u0131lm\u0131\u015f teknoloji kapsam\u0131ndaki S\u0131n\u0131f IIb\n      implante edilebilir cihazlar\u0131, her cihaz i\u00e7in ayr\u0131 de\u011ferlendirme zorunlulu\u011funun\n      d\u0131\u015f\u0131nda b\u0131rakmaktad\u0131r.\n    <\/p>\n\n    <div class=\"kk-wet-alert info\">\n      <strong>Bu d\u00fczenleme ne sa\u011flar?<\/strong>\n      Listede bulunan S\u0131n\u0131f IIb implante edilebilir cihazlarda teknik dok\u00fcmantasyon\n      de\u011ferlendirmesi, her bir cihaz\u0131n ayr\u0131 ayr\u0131 de\u011ferlendirilmesi yerine jenerik\n      cihaz grubu i\u00e7indeki temsil\u00ee cihaz yakla\u015f\u0131m\u0131na g\u00f6re y\u00fcr\u00fct\u00fclebilir.\n    <\/div>\n\n    <div class=\"kk-wet-alert danger\">\n      <strong>Bu d\u00fczenleme ne sa\u011flamaz?<\/strong>\n      Teknik dosya haz\u0131rlama y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcn\u00fc, MDR Annex II ve Annex III gereklerini,\n      kalite y\u00f6netim sistemi denetimini veya onaylanm\u0131\u015f kurulu\u015fun uygunluk\n      de\u011ferlendirmesini ortadan kald\u0131rmaz.\n    <\/div>\n\n    <div class=\"kk-wet-list-title\">\n      <span class=\"kk-wet-badge\">Mevcut listedeki S\u0131n\u0131f IIb implantlar<\/span>\n    <\/div>\n\n    <ul class=\"kk-device-grid\">\n      <li><strong>S\u00fct\u00fcrler<\/strong><small>sutures<\/small><\/li>\n      <li><strong>Cerrahi z\u0131mbalar<\/strong><small>staples<\/small><\/li>\n      <li><strong>Dental dolgular<\/strong><small>dental fillings<\/small><\/li>\n      <li><strong>Di\u015f telleri<\/strong><small>dental braces<\/small><\/li>\n      <li><strong>Di\u015f kronlar\u0131<\/strong><small>tooth crowns<\/small><\/li>\n      <li><strong>Vidalar<\/strong><small>screws<\/small><\/li>\n      <li><strong>Kamalar<\/strong><small>wedges<\/small><\/li>\n      <li><strong>Plaklar<\/strong><small>plates<\/small><\/li>\n      <li><strong>Teller<\/strong><small>wires<\/small><\/li>\n      <li><strong>Pinler<\/strong><small>pins<\/small><\/li>\n      <li><strong>Klipsler<\/strong><small>clips<\/small><\/li>\n      <li><strong>Ba\u011flant\u0131 elemanlar\u0131<\/strong><small>connectors<\/small><\/li>\n    <\/ul>\n\n    <div class=\"kk-wet-list-title\">\n      <span class=\"kk-wet-badge new\">2026 d\u00fczenlemesiyle eklenen S\u0131n\u0131f IIb implantlar<\/span>\n    <\/div>\n\n    <ul class=\"kk-device-grid new-list\">\n      <li><strong>Kan\u00fcller<\/strong><small>cannulas<\/small><\/li>\n      <li><strong>Kateterler<\/strong><small>catheters<\/small><\/li>\n      <li><strong>Beslenme t\u00fcpleri<\/strong><small>feeding tubes<\/small><\/li>\n      <li><strong>S\u00fct\u00fcr pledgetleri ve destek pedleri<\/strong><small>suture pledgets<\/small><\/li>\n      <li><strong>S\u00fct\u00fcr k\u0131l\u0131flar\u0131<\/strong><small>suture sleeves<\/small><\/li>\n      <li><strong>S\u00fct\u00fcr d\u00fc\u011fmeleri<\/strong><small>suture buttons<\/small><\/li>\n      <li><strong>Gastrostomi d\u00fc\u011fmeleri<\/strong><small>gastrostomy buttons<\/small><\/li>\n      <li><strong>Kemik mumu<\/strong><small>bone wax<\/small><\/li>\n      <li><strong>Kemik dolgu materyalleri<\/strong><small>bone fillers<\/small><\/li>\n      <li><strong>Kemik ikame materyalleri<\/strong><small>bone substitutes<\/small><\/li>\n      <li><strong>Stem santraliz\u00f6rleri<\/strong><small>stem centralisers<\/small><\/li>\n      <li><strong>Diyafiz obturat\u00f6rleri<\/strong><small>diaphyseal obturators<\/small><\/li>\n      <li><strong>Radyografi i\u015faretleyicileri<\/strong><small>radiography markers<\/small><\/li>\n      <li><strong>Fiber ligat\u00fcrler<\/strong><small>fiber ligatures<\/small><\/li>\n      <li><strong>Transpalatal distrakt\u00f6rler<\/strong><small>transpalatal distractors<\/small><\/li>\n      <li><strong>\u00c7iviler<\/strong><small>nails<\/small><\/li>\n      <li><strong>Ankrajlar<\/strong><small>anchors<\/small><\/li>\n      <li><strong>Posterior spinal fiksasyonlar<\/strong><small>spinal posterior fixations<\/small><\/li>\n      <li><strong>Tekstil \u00f6rg\u00fcler<\/strong><small>textile braids<\/small><\/li>\n      <li><strong>Dental implantlar<\/strong><small>dental implants<\/small><\/li>\n      <li><strong>Ortodontik cihazlar<\/strong><small>orthodontic devices<\/small><\/li>\n      <li><strong>Dental bariyerler<\/strong><small>dental barriers<\/small><\/li>\n      <li><strong>S\u00fcspansiyon fiksasyonlar\u0131 ve s\u0131k\u0131\u015ft\u0131rma ba\u011flar\u0131<\/strong><small>suspensory fixations and cinches<\/small><\/li>\n    <\/ul>\n  <\/section>\n\n  <section class=\"kk-wet-section\">\n    <h2>\u00dcreticiler a\u00e7\u0131s\u0131ndan ne yap\u0131lmal\u0131?<\/h2>\n\n    <p>\n      Cihaz\u0131n listede bulunmas\u0131 tek ba\u015f\u0131na istisnan\u0131n do\u011frudan uygulanmas\u0131 i\u00e7in\n      yeterli kabul edilmemelidir. \u00dcreticinin cihaz baz\u0131nda a\u015fa\u011f\u0131daki kontrolleri\n      ger\u00e7ekle\u015ftirmesi gerekir:\n    <\/p>\n\n    <div class=\"kk-wet-checklist\">\n      <div class=\"kk-wet-check\">\n        <strong>1. Cihaz tan\u0131m\u0131<\/strong>\n        <span>Cihaz\u0131n resm\u00ee listedeki cihaz tipiyle ger\u00e7ekten e\u015fle\u015fti\u011fi gerek\u00e7elendirilmelidir.<\/span>\n      <\/div>\n\n      <div class=\"kk-wet-check\">\n        <strong>2. S\u0131n\u0131fland\u0131rma<\/strong>\n        <span>MDR Annex VIII kapsam\u0131ndaki risk s\u0131n\u0131f\u0131 ve uygulanabilir kural do\u011frulanmal\u0131d\u0131r.<\/span>\n      <\/div>\n\n      <div class=\"kk-wet-check\">\n        <strong>3. Klinik veri yeterlili\u011fi<\/strong>\n        <span>Klinik de\u011ferlendirmeyi destekleyen yeterli ve g\u00fcncel klinik veri g\u00f6sterilmelidir.<\/span>\n      <\/div>\n\n      <div class=\"kk-wet-check\">\n        <strong>4. Ortak spesifikasyonlar<\/strong>\n        <span>\u00dcr\u00fcne \u00f6zg\u00fc ortak spesifikasyon varsa uygunluk ayr\u0131ca de\u011ferlendirilmelidir.<\/span>\n      <\/div>\n\n      <div class=\"kk-wet-check\">\n        <strong>5. Teknik dosya etkisi<\/strong>\n        <span>CER, CEP, PMCF, PMS, risk y\u00f6netimi ve uygunluk de\u011ferlendirme stratejisi g\u00fcncellenmelidir.<\/span>\n      <\/div>\n\n      <div class=\"kk-wet-check\">\n        <strong>6. Onaylanm\u0131\u015f kurulu\u015f g\u00f6r\u00fc\u015f\u00fc<\/strong>\n        <span>\u0130stisnan\u0131n uygulanma yakla\u015f\u0131m\u0131, gerekti\u011finde ilgili onaylanm\u0131\u015f kurulu\u015fla netle\u015ftirilmelidir.<\/span>\n      <\/div>\n    <\/div>\n\n    <div class=\"kk-wet-alert success\">\n      <strong>\u00d6nerilen dok\u00fcmantasyon<\/strong>\n      \u00dcreticinin teknik dosya i\u00e7inde \u201cWET cihaz istisnas\u0131 uygulanabilirlik\n      de\u011ferlendirmesi\u201d ba\u015fl\u0131kl\u0131 gerek\u00e7eli ve onayl\u0131 bir de\u011ferlendirme kayd\u0131\n      olu\u015fturmas\u0131 faydal\u0131 olacakt\u0131r.\n    <\/div>\n  <\/section>\n\n  <section class=\"kk-wet-section kk-wet-faq\">\n    <h2>S\u0131k sorulan sorular<\/h2>\n\n    <details>\n      <summary>Listedeki cihazlar klinik de\u011ferlendirmeden tamamen muaf m\u0131?<\/summary>\n      <p>\n        Hay\u0131r. \u0130stisna yaln\u0131zca klinik ara\u015ft\u0131rma ger\u00e7ekle\u015ftirme y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcyle\n        ilgilidir. MDR Madde 61 kapsam\u0131nda klinik de\u011ferlendirme planlanmal\u0131,\n        y\u00fcr\u00fct\u00fclmeli, dok\u00fcmante edilmeli ve g\u00fcncel tutulmal\u0131d\u0131r.\n      <\/p>\n    <\/details>\n\n    <details>\n      <summary>Listedeki her cihaz otomatik olarak istisnadan yararlanabilir mi?<\/summary>\n      <p>\n        Hay\u0131r. Cihaz\u0131n listelenen cihaz tipiyle e\u015fle\u015fmesi, yeterli klinik veriye\n        sahip olmas\u0131 ve mevcutsa ilgili \u00fcr\u00fcne \u00f6zg\u00fc ortak spesifikasyonlara uygunlu\u011fu\n        cihaz baz\u0131nda de\u011ferlendirilmelidir.\n      <\/p>\n    <\/details>\n\n    <details>\n      <summary>AB 2026\/1359 teknik dosya haz\u0131rlama zorunlulu\u011funu kald\u0131r\u0131yor mu?<\/summary>\n      <p>\n        Hay\u0131r. D\u00fczenleme yaln\u0131zca belirli S\u0131n\u0131f IIb implante edilebilir cihazlarda\n        teknik dok\u00fcmantasyonun her cihaz i\u00e7in ayr\u0131 ayr\u0131 de\u011ferlendirilmesi\n        zorunlulu\u011funa istisna getirir. Teknik dosya ve uygunluk de\u011ferlendirme\n        y\u00fck\u00fcml\u00fcl\u00fckleri devam eder.\n      <\/p>\n    <\/details>\n\n    <details>\n      <summary>D\u00fczenlemeler hangi tarihte y\u00fcr\u00fcrl\u00fc\u011fe giriyor?<\/summary>\n      <p>\n        Her iki d\u00fczenleme de 29 Haziran 2026 tarihinde Avrupa Birli\u011fi Resm\u00ee\n        Gazetesi\u2019nde yay\u0131mlanm\u0131\u015f olup 19 Temmuz 2026 tarihinde y\u00fcr\u00fcrl\u00fc\u011fe girer.\n      <\/p>\n    <\/details>\n  <\/section>\n\n  <section class=\"kk-wet-section\">\n    <h2>Resm\u00ee kaynaklar<\/h2>\n\n    <ul class=\"kk-wet-sources\">\n      <li>\n        <strong>Komisyon Devredilmi\u015f D\u00fczenlemesi (AB) 2026\/1451:<\/strong><br>\n        <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_del\/2026\/1451\/oj\/eng\" target=\"_blank\" rel=\"noopener\">\n          EUR-Lex resm\u00ee metnini g\u00f6r\u00fcnt\u00fcleyin\n        <\/a>\n      <\/li>\n\n      <li>\n        <strong>Komisyon Devredilmi\u015f D\u00fczenlemesi (AB) 2026\/1359:<\/strong><br>\n        <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_del\/2026\/1359\/oj\/eng\" target=\"_blank\" rel=\"noopener\">\n          EUR-Lex resm\u00ee metnini g\u00f6r\u00fcnt\u00fcleyin\n        <\/a>\n      <\/li>\n\n      <li>\n        <strong>Avrupa Birli\u011fi T\u0131bbi Cihaz Y\u00f6netmeli\u011fi \u2013 MDR 2017\/745:<\/strong><br>\n        <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng\" target=\"_blank\" rel=\"noopener\">\n          MDR 2017\/745 resm\u00ee metnini g\u00f6r\u00fcnt\u00fcleyin\n        <\/a>\n      <\/li>\n    <\/ul>\n\n    <p class=\"kk-wet-footnote\">\n      Bu sayfadaki T\u00fcrk\u00e7e cihaz adlar\u0131 bilgilendirme amac\u0131yla haz\u0131rlanm\u0131\u015ft\u0131r.\n      Hukuki ve d\u00fczenleyici de\u011ferlendirmelerde Avrupa Birli\u011fi Resm\u00ee Gazetesi\u2019nde\n      yay\u0131mlanan orijinal metin ve resm\u00ee terminoloji esas al\u0131nmal\u0131d\u0131r.\n    <\/p>\n  <\/section>\n\n  <section class=\"kk-wet-cta\">\n    <h2>Cihaz\u0131n\u0131z\u0131n istisna kapsam\u0131nda olup olmad\u0131\u011f\u0131ndan emin de\u011fil misiniz?<\/h2>\n\n    <p>\n      Cihaz s\u0131n\u0131fland\u0131rmas\u0131, klinik de\u011ferlendirme, teknik dok\u00fcmantasyon ve MDR\n      uygunluk de\u011ferlendirme stratejisinin cihaz baz\u0131nda incelenmesi i\u00e7in\n      KaliteKit ile ileti\u015fime ge\u00e7ebilirsiniz.\n    <\/p>\n\n    <a class=\"kk-wet-button\" href=\"\/iletisim\/\">\n      KaliteKit ile ileti\u015fime ge\u00e7in\n    <\/a>\n  <\/section>\n\n<\/article>\n\n<!-- G\u00f6r\u00fcn\u00fcr i\u00e7erikle uyumlu FAQ yap\u0131land\u0131r\u0131lm\u0131\u015f verisi -->\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"FAQPage\",\n  \"mainEntity\": [\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Listedeki cihazlar klinik de\u011ferlendirmeden tamamen muaf m\u0131?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Hay\u0131r. \u0130stisna yaln\u0131zca klinik ara\u015ft\u0131rma ger\u00e7ekle\u015ftirme y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcyle ilgilidir. MDR Madde 61 kapsam\u0131nda klinik de\u011ferlendirme planlanmal\u0131, y\u00fcr\u00fct\u00fclmeli, dok\u00fcmante edilmeli ve g\u00fcncel tutulmal\u0131d\u0131r.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Listedeki her cihaz otomatik olarak istisnadan yararlanabilir mi?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Hay\u0131r. Cihaz\u0131n listelenen cihaz tipiyle e\u015fle\u015fmesi, yeterli klinik veriye sahip olmas\u0131 ve mevcutsa ilgili \u00fcr\u00fcne \u00f6zg\u00fc ortak spesifikasyonlara uygunlu\u011fu cihaz baz\u0131nda de\u011ferlendirilmelidir.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"AB 2026\/1359 teknik dosya haz\u0131rlama zorunlulu\u011funu kald\u0131r\u0131yor mu?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Hay\u0131r. D\u00fczenleme yaln\u0131zca belirli S\u0131n\u0131f IIb implante edilebilir cihazlarda teknik dok\u00fcmantasyonun her cihaz i\u00e7in ayr\u0131 ayr\u0131 de\u011ferlendirilmesi zorunlulu\u011funa istisna getirir. Teknik dosya ve uygunluk de\u011ferlendirme y\u00fck\u00fcml\u00fcl\u00fckleri devam eder.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"D\u00fczenlemeler hangi tarihte y\u00fcr\u00fcrl\u00fc\u011fe giriyor?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Her iki d\u00fczenleme de 29 Haziran 2026 tarihinde Avrupa Birli\u011fi Resm\u00ee Gazetesi\u2019nde yay\u0131mlanm\u0131\u015f olup 19 Temmuz 2026 tarihinde y\u00fcr\u00fcrl\u00fc\u011fe girer.\"\n      }\n    }\n  ]\n}\n<\/script>\n","protected":false},"excerpt":{"rendered":"<p>MDR 2017\/745 \u2022 Mevzuat G\u00fcncellemesi Klinik Ara\u015ft\u0131rma ve Teknik Dok\u00fcmantasyon \u0130stisnas\u0131 Getirilen Cihazlar\u0131n Tam Listesi Avrupa Komisyonu, iyi yap\u0131land\u0131r\u0131lm\u0131\u015f teknoloji [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[],"tags":[],"class_list":["post-16655","post","type-post","status-publish","format-standard","hentry"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/16655","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=16655"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/16655\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=16655"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/categories?post=16655"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/tags?post=16655"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}