Bir \u00fcr\u00fcn\u00fcn \u00dcTS\u2019de pasif olmas\u0131, stokta veya sahada hi\u00e7 bulunmad\u0131\u011f\u0131 anlam\u0131na gelmeyebilir. Firma stok, sat\u0131\u015f, servis, \u015fikayet ve geri \u00e7a\u011f\u0131rma kay\u0131tlar\u0131nda pasif \u00fcr\u00fcnlerin durumunu izlemelidir. Pasife alma gerek\u00e7esi ve tarihi dok\u00fcmante edilmelidir.<\/p>\n\n\n
\u00dcTS\u2019de pasif \u00fcr\u00fcnler, sistemdeki kay\u0131t durumu ile fiziksel \u00fcr\u00fcnlerin piyasadaki durumunun birlikte de\u011ferlendirilmesini gerektirir. Bir \u00fcr\u00fcn kayd\u0131n\u0131n pasif g\u00f6r\u00fcnmesi; \u00fcr\u00fcn\u00fcn piyasada, distrib\u00fct\u00f6r stoklar\u0131nda, sa\u011fl\u0131k kurulu\u015flar\u0131nda veya son kullan\u0131c\u0131larda hi\u00e7 bulunmad\u0131\u011f\u0131n\u0131 g\u00f6stermez. Bu nedenle pasif stat\u00fc yaln\u0131zca sistem ekran\u0131 \u00fczerinden de\u011fil, stok ve da\u011f\u0131t\u0131m kay\u0131tlar\u0131yla birlikte y\u00f6netilmelidir.<\/p>\n\n\n\n
\u00dcTS\u2019deki \u201cpasif\u201d ifadesi, MDR s\u0131n\u0131fland\u0131rmas\u0131nda kullan\u0131lan aktif veya aktif olmayan cihaz kavram\u0131yla kar\u0131\u015ft\u0131r\u0131lmamal\u0131d\u0131r. Buradaki pasiflik cihaz\u0131n enerji kayna\u011f\u0131na de\u011fil, \u00dcTS \u00fcr\u00fcn kayd\u0131n\u0131n sistemdeki durumuna ili\u015fkindir.<\/p>\n\n\n\n
\u00dcr\u00fcn\u00fcn neden pasif h\u00e2le geldi\u011fi ilk olarak belirlenmelidir. Pasiflik; firman\u0131n \u00fcr\u00fcn\u00fc piyasadan kald\u0131rma karar\u0131, belge s\u00fcresinin sona ermesi, yeni mevzuata ge\u00e7i\u015f, \u00fcr\u00fcn kayd\u0131n\u0131n de\u011fi\u015ftirilmesi, yeni barkod veya UDI-DI kullan\u0131lmas\u0131, m\u00fckerrer kayd\u0131n kapat\u0131lmas\u0131, firma ya da belge bilgilerindeki de\u011fi\u015fiklik veya idari i\u015flem nedeniyle ortaya \u00e7\u0131kabilir.<\/p>\n\n\n\n
Pasif stat\u00fcn\u00fcn nedeni \u00dcTS ekran\u0131ndan a\u00e7\u0131k\u00e7a anla\u015f\u0131lam\u0131yorsa \u00fcr\u00fcn kayd\u0131, ba\u011fl\u0131 belge, firma kayd\u0131 ve ba\u015fvuru ge\u00e7mi\u015fi birlikte incelenmelidir. \u00dcr\u00fcn\u00fcn hangi tarihte, hangi i\u015flem sonucunda ve kim taraf\u0131ndan pasife al\u0131nd\u0131\u011f\u0131 belirlenmeli; gerekiyorsa T\u0130TCK\u2019ye resmi ba\u015fvuru yap\u0131larak kay\u0131t durumu a\u00e7\u0131kl\u0131\u011fa kavu\u015fturulmal\u0131d\u0131r.<\/p>\n\n\n\n
Pasif g\u00f6r\u00fcnen bir \u00fcr\u00fcn i\u00e7in sat\u0131\u015fa do\u011frudan devam edilmemelidir. \u00d6ncelikle \u00fcr\u00fcn\u00fcn piyasaya arz ko\u015fullar\u0131n\u0131n h\u00e2len kar\u015f\u0131lan\u0131p kar\u015f\u0131lanmad\u0131\u011f\u0131 do\u011frulanmal\u0131d\u0131r. \u00dcr\u00fcn\u00fcn uygunluk beyan\u0131, sertifikas\u0131, etiketi, kullan\u0131m k\u0131lavuzu, \u00fcretici ve ithalat\u00e7\u0131 bilgileri, \u00dcTS\u2019de ba\u011fl\u0131 oldu\u011fu belge ve ge\u00e7i\u015f h\u00fck\u00fcmlerinden yararlanma durumu kontrol edilmelidir.<\/p>\n\n\n\n
\u00dcr\u00fcn\u00fcn pasif olmas\u0131 her durumda piyasadaki b\u00fct\u00fcn \u00fcr\u00fcnlerin otomatik olarak geri \u00e7a\u011fr\u0131lmas\u0131 gerekti\u011fi anlam\u0131na gelmez. Ancak pasifli\u011fin ge\u00e7ersiz sertifika, mevzuata ayk\u0131r\u0131l\u0131k, yanl\u0131\u015f \u00fcr\u00fcn kayd\u0131 veya g\u00fcvenlilik problemi nedeniyle olu\u015fmas\u0131 h\u00e2linde stok blokaj\u0131, da\u011f\u0131t\u0131m\u0131n durdurulmas\u0131, m\u00fc\u015fterilerin bilgilendirilmesi ve gerekti\u011finde geri \u00e7ekme veya geri \u00e7a\u011f\u0131rma de\u011ferlendirmesi yap\u0131lmal\u0131d\u0131r.<\/p>\n\n\n\n
Firma deposunda bulunan pasif \u00fcr\u00fcn stoklar\u0131 di\u011fer \u00fcr\u00fcnlerden ayr\u0131lmal\u0131 ve stat\u00fc netle\u015fene kadar kontroll\u00fc alanda tutulmal\u0131d\u0131r. \u00dcr\u00fcn ad\u0131, barkod veya UDI-DI, lot veya seri numaras\u0131, miktar, son kullanma tarihi ve \u00fcr\u00fcn\u00fcn bulundu\u011fu lokasyon kay\u0131t alt\u0131na al\u0131nmal\u0131d\u0131r. Stok program\u0131ndaki \u00fcr\u00fcn durumu ile \u00dcTS kay\u0131t durumu aras\u0131nda ba\u011flant\u0131 kurulmal\u0131d\u0131r.<\/p>\n\n\n\n
Distrib\u00fct\u00f6r, bayi veya sa\u011fl\u0131k kurulu\u015flar\u0131na daha \u00f6nce g\u00f6nderilmi\u015f \u00fcr\u00fcnler i\u00e7in da\u011f\u0131t\u0131m listesi haz\u0131rlanmal\u0131d\u0131r. Hangi m\u00fc\u015fteriye, hangi lot veya seri numaras\u0131ndan, hangi miktarda ve hangi tarihte \u00fcr\u00fcn g\u00f6nderildi\u011fi belirlenmelidir. Pasiflik nedeni \u00fcr\u00fcn g\u00fcvenlili\u011fini veya mevzuata uygunlu\u011funu etkiliyorsa m\u00fc\u015fterilere yap\u0131lacak bilgilendirme kontroll\u00fc bi\u00e7imde y\u00fcr\u00fct\u00fclmelidir.<\/p>\n\n\n\n
Tekil takip kapsam\u0131ndaki cihazlarda \u00fcr\u00fcn\u00fcn pasif olmas\u0131, sistemde daha \u00f6nce olu\u015fturulmu\u015f tekil \u00fcr\u00fcn kay\u0131tlar\u0131n\u0131 kendili\u011finden ortadan kald\u0131rmaz. \u00dcretim, ithalat, verme, alma, kullan\u0131m, t\u00fcketiciye verme, HEK, zayiat veya imha bildirimlerinin durumu kontrol edilmelidir. Firma, pasif \u00fcr\u00fcn kayd\u0131 \u00fczerinden yeni bir hareket yapmadan \u00f6nce i\u015flemin \u00dcTS taraf\u0131ndan ve y\u00fcr\u00fcrl\u00fckteki k\u0131lavuzlar kapsam\u0131nda uygun olup olmad\u0131\u011f\u0131n\u0131 do\u011frulamal\u0131d\u0131r.<\/p>\n\n\n\n
Pasif kay\u0131tla i\u015flem yap\u0131lamamas\u0131 h\u00e2linde ayn\u0131 \u00fcr\u00fcn i\u00e7in kontrols\u00fcz bi\u00e7imde yeni bir \u00fcr\u00fcn kayd\u0131 a\u00e7\u0131lmas\u0131 do\u011fru de\u011fildir. Yeni kay\u0131t gereklili\u011fi; barkod veya UDI-DI de\u011fi\u015fikli\u011fi, \u00fcr\u00fcn kimli\u011fi, \u00fcretici, model, ambalaj seviyesi, belge ve mevzuat ge\u00e7i\u015fi \u00fczerinden de\u011ferlendirilmelidir. M\u00fckerrer kay\u0131tlar izlenebilirli\u011fi bozabilir ve ayn\u0131 fiziksel \u00fcr\u00fcn\u00fcn sistemde birden fazla kimlikle g\u00f6r\u00fcnmesine neden olabilir.<\/p>\n\n\n\n
\u00dcr\u00fcn MDR veya IVDR kapsam\u0131nda yeniden kaydedilmi\u015fse eski kay\u0131t ile yeni kay\u0131t aras\u0131ndaki ge\u00e7i\u015f belgelenmelidir. Eski ve yeni barkod veya UDI-DI, ilgili uygunluk beyanlar\u0131, sertifikalar, \u00fcr\u00fcn modelleri ve stok ge\u00e7i\u015f tarihleri bir kar\u015f\u0131la\u015ft\u0131rma tablosunda g\u00f6sterilmelidir. Eski kay\u0131t pasif olsa bile daha \u00f6nce piyasaya arz edilen \u00fcr\u00fcnlerin hangi kay\u0131t \u00fczerinden izlendi\u011fi a\u00e7\u0131k olmal\u0131d\u0131r.<\/p>\n\n\n\n
Pasifli\u011fin hatal\u0131 veya yanl\u0131\u015fl\u0131kla ger\u00e7ekle\u015ftirildi\u011fi d\u00fc\u015f\u00fcn\u00fcl\u00fcyorsa do\u011frudan yeni kay\u0131t a\u00e7mak yerine mevcut kayd\u0131n yeniden aktifle\u015ftirilmesi veya d\u00fczeltilmesi i\u00e7in izlenecek s\u00fcre\u00e7 ara\u015ft\u0131r\u0131lmal\u0131d\u0131r. Ba\u015fvuruda \u00fcr\u00fcn kayd\u0131, ge\u00e7erli belge, uygunluk beyan\u0131, etiket, firma bilgileri ve pasiflik nedenini a\u00e7\u0131klayan destekleyici dok\u00fcmanlar sunulmal\u0131d\u0131r.<\/p>\n\n\n\n
\u00dcreticinin \u00fcr\u00fcn\u00fc kal\u0131c\u0131 olarak piyasadan kald\u0131rmas\u0131 durumunda \u00fcr\u00fcn sonland\u0131rma plan\u0131 haz\u0131rlanmal\u0131d\u0131r. Son \u00fcretim ve sat\u0131\u015f tarihi, kalan stoklar\u0131n durumu, distrib\u00fct\u00f6rlerin bilgilendirilmesi, yedek par\u00e7a ve servis deste\u011fi, \u015fik\u00e2yetlerin y\u00f6netimi, teknik dosyan\u0131n saklanmas\u0131 ve piyasadaki \u00fcr\u00fcnlerin izlenmesi plan i\u00e7erisinde tan\u0131mlanmal\u0131d\u0131r.<\/p>\n\n\n\n
\u00dcr\u00fcn\u00fcn art\u0131k \u00fcretilmemesi, \u00fcreticinin daha \u00f6nce piyasaya arz etti\u011fi cihazlara ili\u015fkin sorumluluklar\u0131n\u0131 sona erdirmez. \u015eik\u00e2yet, ciddi olay, FSCA, servis, CAPA, PMS ve gerekti\u011finde PSUR y\u00fck\u00fcml\u00fcl\u00fckleri piyasada bulunan cihazlar a\u00e7\u0131s\u0131ndan devam eder. Teknik dosya ve da\u011f\u0131t\u0131m kay\u0131tlar\u0131 mevzuatta belirlenen s\u00fcreler boyunca eri\u015filebilir tutulmal\u0131d\u0131r.<\/p>\n\n\n\n
Pasife alma karar\u0131 g\u00fcvenlilik veya performans problemiyle ba\u011flant\u0131l\u0131ysa risk y\u00f6netimi dosyas\u0131, klinik de\u011ferlendirme veya performans de\u011ferlendirmesi, PMS kay\u0131tlar\u0131 ve CAPA s\u00fcreci g\u00fcncellenmelidir. Sorunun ba\u015fka model, lot, yaz\u0131l\u0131m s\u00fcr\u00fcm\u00fc veya \u00fcr\u00fcn ailesini etkileyip etkilemedi\u011fi ayr\u0131ca de\u011ferlendirilmelidir.<\/p>\n\n\n\n
Denetim s\u0131ras\u0131nda yaln\u0131zca \u00fcr\u00fcn\u00fcn \u00dcTS ekran\u0131nda pasif g\u00f6r\u00fcnmesi yeterli a\u00e7\u0131klama olu\u015fturmaz. Firma; pasiflik nedenini, karar tarihini, sorumlu ki\u015fiyi, etkilenen stoklar\u0131, da\u011f\u0131t\u0131lm\u0131\u015f \u00fcr\u00fcnleri, belge durumunu, ger\u00e7ekle\u015ftirilen tekil hareketleri ve al\u0131nan aksiyonlar\u0131 kay\u0131tlarla g\u00f6sterebilmelidir.<\/p>\n\n\n\n
Sonu\u00e7 olarak \u00dcTS\u2019de pasif \u00fcr\u00fcn y\u00f6netimi, yaln\u0131zca sistemde bir stat\u00fc de\u011fi\u015fikli\u011fi yap\u0131lmas\u0131ndan ibaret de\u011fildir. \u00dcr\u00fcn kayd\u0131, belge ge\u00e7erlili\u011fi, fiziksel stok, da\u011f\u0131t\u0131m zinciri, tekil hareketler, teknik dosya ve piyasa sonras\u0131 y\u00fck\u00fcml\u00fcl\u00fckler birlikte de\u011ferlendirilmelidir. Pasiflik nedeni netle\u015fmeden \u00fcr\u00fcn\u00fcn sat\u0131\u015f\u0131na devam edilmesi veya ayn\u0131 \u00fcr\u00fcn i\u00e7in kontrols\u00fcz yeni kay\u0131t a\u00e7\u0131lmas\u0131 uygun de\u011fildir.<\/p>","protected":false},"excerpt":{"rendered":"
Bir \u00fcr\u00fcn\u00fcn \u00dcTS\u2019de pasif olmas\u0131, stokta veya sahada hi\u00e7 bulunmad\u0131\u011f\u0131 anlam\u0131na gelmeyebilir. Firma stok, sat\u0131\u015f, servis, \u015fikayet ve geri \u00e7a\u011f\u0131rma […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","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":""},"kkqa_category":[449],"kkqa_letter":[484],"class_list":["post-12648","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-uts","kkqa_letter-u"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/12648","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"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=12648"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/12648\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=12648"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=12648"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=12648"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}