{"id":646,"date":"2026-02-26T13:41:57","date_gmt":"2026-02-26T10:41:57","guid":{"rendered":"https:\/\/www.bplussolutions.com\/?p=646"},"modified":"2026-05-13T14:01:39","modified_gmt":"2026-05-13T11:01:39","slug":"mdr-technical-documentation","status":"publish","type":"post","link":"https:\/\/www.bplussolutions.com\/tr\/mdr-technical-documentation\/","title":{"rendered":"MDR teknik dok\u00fcmantasyon dosyas\u0131nda neler bulunmal\u0131?"},"content":{"rendered":"
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(EU) 2017\/745 say\u0131l\u0131 T\u00fcz\u00fck kapsam\u0131nda teknik dok\u00fcmantasyon, bir cihaz\u0131n reg\u00fclasyona uygunlu\u011funu kan\u0131tlayan belge paketidir. Annex II cihaz\u0131n kendisini kaps\u0131yor. Annex III piyasa sonras\u0131 g\u00f6zetimi kaps\u0131yor. \u0130kisi birlikte cihaz\u0131n t\u00fcm ya\u015fam d\u00f6ng\u00fcs\u00fcn\u00fc anlat\u0131yor ve Onaylanm\u0131\u015f Kurulu\u015fun CE sertifikas\u0131n\u0131 verip vermeme ya da s\u00fcrd\u00fcr\u00fcp s\u00fcrd\u00fcrmeme karar\u0131n\u0131 verirken inceledi\u011fi \u015fey tam olarak bu paket.<\/p>

\u00c7o\u011fu kontrol listesinin sana s\u00f6ylemedi\u011fi \u015fey \u015fu: Annex II'nin yap\u0131s\u0131 ayn\u0131 zamanda de\u011ferlendirmenin de yap\u0131s\u0131d\u0131r. De\u011ferlendirici dosyay\u0131 a\u00e7t\u0131\u011f\u0131nda, b\u00f6l\u00fcmleri kabaca Annex II'nin s\u0131ralad\u0131\u011f\u0131 d\u00fczende ar\u0131yor. E\u011fer dosyan farkl\u0131 bir yap\u0131daysa yine de ge\u00e7ebilirsin, ama deficiency mektubu i\u00e7erikten \u00f6nce yap\u0131ya de\u011finiyor. O y\u00fczden her b\u00f6l\u00fcm\u00fcn i\u00e7eri\u011fine girmeden \u00f6nce, dosyan\u0131n \u00fcst ba\u015fl\u0131k yap\u0131s\u0131n\u0131 Annex II'nin ba\u015fl\u0131klar\u0131yla e\u015fle\u015ftirmeni \u00f6neririm. Hi\u00e7bir maliyeti yok ve ilk de\u011ferlendirme toplant\u0131s\u0131n\u0131n tonunu de\u011fi\u015ftiriyor.<\/p>

Yaz\u0131n\u0131n geri kalan\u0131 Annex II'nin her b\u00f6l\u00fcm\u00fcn\u00fc ve Annex III'\u00fcn getirdi\u011fi y\u00fck\u00fcml\u00fcl\u00fckleri tek tek geziyor. Her b\u00f6l\u00fcmde en s\u0131k g\u00f6rd\u00fc\u011f\u00fcm deficiency kal\u0131plar\u0131n\u0131 ve de\u011ferlendiricinin assessment s\u0131ras\u0131nda tipik olarak sordu\u011fu sorular\u0131 payla\u015faca\u011f\u0131m.<\/p>

1. Cihaz tan\u0131m\u0131 ve spesifikasyonu<\/h2>

Bu b\u00f6l\u00fcm cihaz\u0131n ne oldu\u011funu, ne i\u00e7in oldu\u011funu ve teknik dosya kapsam\u0131na nelerin girdi\u011fini ortaya koymak i\u00e7in. \u0130\u00e7inde olmas\u0131 gerekenler: ticari isim, model ve konfig\u00fcrasyon numaralar\u0131, reg\u00fclatif dilde yaz\u0131lm\u0131\u015f kullan\u0131m amac\u0131 (pazarlama kopyas\u0131 de\u011fil), endikasyonlar ve kontrendikasyonlar, hasta ve kullan\u0131c\u0131 pop\u00fclasyonu, Annex VIII'in spesifik kural\u0131na ve bu kural\u0131n gerek\u00e7esine at\u0131fla yap\u0131lm\u0131\u015f s\u0131n\u0131fland\u0131rma, Basic UDI-DI, her varyant i\u00e7in UDI-DI ve \u00e7al\u0131\u015fma prensipleri.<\/p>

Ayr\u0131ca dosyan\u0131n kapsad\u0131\u011f\u0131 her varyant, aksesuar ve konfig\u00fcrasyonun listelenmesi gerekiyor. Cihaz\u0131n \u00f6nceki nesilleri ve piyasada zaten bulunan benzer cihazlar da bu b\u00f6l\u00fcmde olmal\u0131. \u00dcreticiler Annex II B\u00f6l\u00fcm 1.1(h)'in bu son maddeye verdi\u011fi a\u011f\u0131rl\u0131\u011f\u0131 hafife al\u0131yor. De\u011ferlendirici bu bilgiyi klinik de\u011ferlendirmenin demir att\u0131\u011f\u0131 nokta olarak kullan\u0131yor ve \u201c\u00f6nceki nesil\u201d diye an\u0131lan \u00fcr\u00fcn\u00fcn ger\u00e7ekten ayn\u0131 kullan\u0131m amac\u0131na sahip olup olmad\u0131\u011f\u0131n\u0131 buradan kontrol ediyor.<\/p>

Burada en s\u0131k \u00e7uvallayan \u015fey kullan\u0131m amac\u0131n\u0131n kendisi. Pazarlama ekibi web sitesi i\u00e7in yaz\u0131yor, reg\u00fclasyon ekibi teknik dosyaya kopyal\u0131yor ve klinik de\u011ferlendirmeye ula\u015ft\u0131\u011f\u0131nda ifade kaym\u0131\u015f oluyor. De\u011ferlendirici kullan\u0131m amac\u0131n\u0131 IFU'da, GSPR kontrol listesinde, risk dosyas\u0131nda ve CER'de kar\u015f\u0131la\u015ft\u0131r\u0131yor. Bu d\u00f6rt dok\u00fcmanda ayn\u0131 \u015fey yazm\u0131yorsa, hen\u00fcz teknik i\u00e7eri\u011fe bak\u0131lmadan \u00f6nce deficiency'ye d\u00f6n\u00fc\u015f\u00fcyor.<\/p>

De\u011ferlendiricinin sordu\u011fu: hangi Annex VIII kural\u0131, neden bu kural, varyantlar nerede listelenmi\u015f ve kullan\u0131m amac\u0131 IFU, GSPR kontrol listesi, risk dosyas\u0131 ve CER aras\u0131nda kelime kelime tutarl\u0131 m\u0131.<\/p>

2. Cihazla birlikte sunulan bilgiler<\/h2>

Bu b\u00f6l\u00fcm etiketleme, kullan\u0131m talimatlar\u0131 (IFU), ambalaj tasar\u0131m\u0131, sembol a\u00e7\u0131klamalar\u0131 ve uygulanabilir oldu\u011funda implant kart\u0131 ile hasta bilgi bro\u015f\u00fcr\u00fcn\u00fc kaps\u0131yor. \u0130\u00e7eri\u011fin ne olmas\u0131 gerekti\u011fini Annex I B\u00f6l\u00fcm III, a\u011f\u0131rl\u0131kl\u0131 olarak GSPR 23 s\u00f6yl\u00fcyor. Buradaki tuzak \u015fu: uyumluluk \u00fclkeye g\u00f6re de\u011fi\u015fiyor. IFU dil gereklilikleri her \u00dcye Devlette farkl\u0131. eIFU se\u00e7ene\u011fi yaln\u0131zca Komisyon T\u00fcz\u00fc\u011f\u00fc (EU) 2021\/2226'da tan\u0131mlanan cihaz kategorileri i\u00e7in ge\u00e7erli, bu t\u00fcz\u00fck 207\/2012'nin yerine ge\u00e7ti. Kulland\u0131\u011f\u0131n sembollerin ISO 15223-1:2021 ile uyumlu olmas\u0131 ve do\u011fru edisyonun referans verilmesi gerekiyor.<\/p>

Article 18 kapsam\u0131ndaki implant kartlar\u0131 implant edilebilir cihazlarda s\u0131k g\u00f6r\u00fclen bir gap. \u00c7\u00fcnk\u00fc reg\u00fclasyon hem kart\u0131n hem de hasta bilgisinin, cihaz\u0131n sat\u0131ld\u0131\u011f\u0131 \u00dcye Devletlerin dillerinde olmas\u0131n\u0131 \u015fart ko\u015fuyor. \u00dcreticiler sunum an\u0131nda \u0130ngilizce \u015fablonu haz\u0131r tutuyor ama yerel dil versiyonlar\u0131 hen\u00fcz tamamlanmam\u0131\u015f oluyor. De\u011ferlendirici bunu g\u00f6r\u00fcyor ve yaz\u0131yor.<\/p>

De\u011ferlendiricinin sordu\u011fu: beyan edilen pazarlar i\u00e7in dil versiyonlar\u0131 tam m\u0131, sembol a\u00e7\u0131klamalar\u0131 g\u00fcncel mi, eIFU gerek\u00e7esi 2021\/2226 ile uyumlu mu ve implant kart\u0131 i\u00e7eri\u011fi Article 18'i kar\u015f\u0131l\u0131yor mu.<\/p>

3. Tasar\u0131m ve \u00fcretim bilgileri<\/h2>

Bu b\u00f6l\u00fcm de\u011ferlendiriciye cihaz\u0131n nas\u0131l tasarland\u0131\u011f\u0131 ve nas\u0131l \u00fcretildi\u011fi konusunda net bir g\u00f6r\u00fcn\u00fcm vermeli. Tasar\u0131m ge\u00e7mi\u015fi, tasar\u0131m girdileri ve \u00e7\u0131kt\u0131lar\u0131, tasar\u0131m do\u011frulama, tasar\u0131m transferi ve kritik kontrol noktalar\u0131 i\u015faretlenmi\u015f bir \u00fcretim ak\u0131\u015f \u015femas\u0131. T\u00fcm \u00fcretim lokasyonlar\u0131n\u0131n adresleri ve her sitede yap\u0131lan faaliyet a\u00e7\u0131k\u00e7a belirtilmeli, \u00e7\u00fcnk\u00fc Onaylanm\u0131\u015f Kurulu\u015fun denetim kapsam\u0131 do\u011frudan bu listeden \u00e7\u0131k\u0131yor.<\/p>

Tedarik\u00e7iler ve alt y\u00fckleniciler \u00fcreticilerin en s\u0131k tak\u0131ld\u0131\u011f\u0131 b\u00f6l\u00fcm. Listede kritik tedarik\u00e7ilerin (g\u00fcvenlik, performans veya reg\u00fclatif uygunlu\u011fu etkileyen \u00e7\u0131kt\u0131y\u0131 \u00fcretenler) tan\u0131mlanmas\u0131, her tedarik\u00e7inin yapt\u0131\u011f\u0131 faaliyetin ve uygulanan kontrollerin yaz\u0131lmas\u0131 gerekiyor. QMS'de bir tedarik\u00e7i de\u011ferlendirme prosed\u00fcr\u00fc varsa ama teknik dosya bu prosed\u00fcr\u00fcn listedeki spesifik tedarik\u00e7ilere nas\u0131l uyguland\u0131\u011f\u0131n\u0131 g\u00f6stermiyorsa, de\u011ferlendirici kan\u0131t isteyecek.<\/p>

De\u011ferlendiricinin sordu\u011fu: hangi tedarik\u00e7iler kritik ve neden, her kritik tedarik\u00e7i i\u00e7in kontrol kan\u0131t\u0131 nerede, t\u00fcm \u00fcretim siteleri sertifika kapsam\u0131na dahil mi ve tasar\u0131m transferi dok\u00fcmantasyonu nerede duruyor.<\/p>

4. Genel g\u00fcvenlik ve performans gereklilikleri<\/h2>

Annex I'e kar\u015f\u0131l\u0131k gelen GSPR kontrol listesi, teknik dosyan\u0131n omurgas\u0131. Beklenti \u015fu: uygulanabilir her GSPR i\u00e7in kontrol listesi uygunlu\u011fu kan\u0131tlayan spesifik bir kayna\u011fa i\u015faret etmeli (dok\u00fcman ad\u0131, dok\u00fcman numaras\u0131, b\u00f6l\u00fcm ve sayfa ya da tablo numaras\u0131) ve de\u011ferlendirici o kayna\u011f\u0131 a\u00e7t\u0131\u011f\u0131nda, kayna\u011f\u0131n iddiay\u0131 ger\u00e7ekten destekledi\u011fini g\u00f6rmeli.<\/p>

Deficiency'yi tetikleyen iki kal\u0131p var: gerek\u00e7esiz uygulanm\u0131yor (not applicable) iddialar\u0131 ve fazla generic referanslar. Cihaz CMR veya endokrin bozucu kapsam\u0131na girebilecek bir madde i\u00e7eriyorsa, GSPR 10.4'\u00fc uygulanm\u0131yor olarak i\u015faretlemek i\u00e7in bir checkbox de\u011fil, yaz\u0131l\u0131 bir gerek\u00e7e gerekiyor. \u201cSee risk management file\u201d yaz\u0131p spesifik risk kontrol\u00fcn\u00fc ve do\u011frulama raporunu adland\u0131rmamak de\u011ferlendiricinin vaktini harc\u0131yor ve deficiency \u00fcretiyor.<\/p>

Biyolojik kaynakl\u0131 malzeme i\u00e7eren cihazlar i\u00e7in GSPR 14 ve \u00f6l\u00e7\u00fcm fonksiyonlu cihazlar i\u00e7in GSPR 22, \u00fcreticilerin kapsam\u0131 hafife ald\u0131\u011f\u0131 iki alan. \u0130kisi de yan reg\u00fclasyonlar\u0131 ve harmonize standartlar\u0131 devreye sokuyor, bunlar\u0131n generic bir referansa s\u0131k\u0131\u015ft\u0131r\u0131lmadan, spesifik olarak g\u00f6sterilmesi gerekiyor.<\/p>

De\u011ferlendiricinin sordu\u011fu: uygulanm\u0131yor iddialar\u0131 yaz\u0131l\u0131 olarak gerek\u00e7elendirilmi\u015f mi, at\u0131f yap\u0131lan her dok\u00fcman iddiay\u0131 ger\u00e7ekten destekliyor mu, harmonize standartlar edisyon numaras\u0131yla listelenmi\u015f mi ve kontrol listesi cihaz\u0131n mevcut konfig\u00fcrasyonuyla uyumlu mu.<\/p>

5. Fayda-risk analizi ve risk y\u00f6netimi<\/h2>

Risk y\u00f6netimi ISO 14971:2019 ile y\u00f6netiliyor. Avrupa ba\u011flam\u0131 i\u00e7in EN ISO 14971:2019\/A11:2021, MDR gerekliliklerine Annex Z e\u015fle\u015ftirmesini ekliyor. Teknik dosyada bulunmas\u0131 gerekenler: risk y\u00f6netim plan\u0131, tehlike analizi, risk tahmini ve de\u011ferlendirmesi, risk kontrol \u00f6nlemleri ve bunlar\u0131n etkinlik do\u011frulamas\u0131, kal\u0131nt\u0131 risk de\u011ferlendirmesi, genel fayda-risk analizi ve \u00fcretim ile \u00fcretim sonras\u0131 bilgi d\u00f6ng\u00fcs\u00fc.<\/p>

En s\u0131k g\u00f6rd\u00fc\u011f\u00fcm gap'ler \u00fc\u00e7 alanda yo\u011funla\u015f\u0131yor. Birincisi, risk kontrol etkinli\u011finin do\u011frulanmas\u0131: dosya kontrolleri listeliyor ama her birinin nas\u0131l do\u011fruland\u0131\u011f\u0131n\u0131 g\u00f6stermiyor, \u00f6zellikle prosed\u00fcrel kontroller (g\u00fcvenlik i\u00e7in bilgi) s\u00f6z konusu oldu\u011funda. \u0130kincisi, kal\u0131nt\u0131 riskin iletilmesi: ISO 14971 ve ISO\/TR 24971, kal\u0131nt\u0131 risklerin IFU'da kullan\u0131c\u0131ya iletilmesini \u015fart ko\u015fuyor. De\u011ferlendirici bunu risk dosyas\u0131ndaki uyar\u0131lar\u0131 IFU'daki uyar\u0131larla e\u015fle\u015ftirerek kontrol ediyor. \u00dc\u00e7\u00fcnc\u00fcs\u00fc, genel fayda-risk arg\u00fcman\u0131: bu \u00e7o\u011fu zaman risk y\u00f6netim raporunun sonundaki tek paragrafl\u0131k bir \u00f6zet oluyor. Oysa klinik kan\u0131tla ba\u011flanm\u0131\u015f yap\u0131land\u0131r\u0131lm\u0131\u015f bir arg\u00fcman olmas\u0131 gerekiyor.<\/p>

De\u011ferlendiricinin sordu\u011fu: her risk kontrol\u00fc nas\u0131l do\u011frulanm\u0131\u015f, her kal\u0131nt\u0131 risk kullan\u0131c\u0131ya nerede iletilmi\u015f, yap\u0131land\u0131r\u0131lm\u0131\u015f fayda-risk arg\u00fcman\u0131 nerede ve \u00fcretim ile \u00fcretim sonras\u0131 bilgi d\u00f6ng\u00fcs\u00fc nas\u0131l kapat\u0131l\u0131yor.<\/p>

6. \u00dcr\u00fcn do\u011frulama ve validasyon<\/h2>

Bu genelde hacim olarak en b\u00fcy\u00fck b\u00f6l\u00fcm ve i\u00e7eri\u011fi en heterojen olan b\u00f6l\u00fcm. Cihaza ba\u011fl\u0131 olarak i\u00e7erebilecekleri: biyolojik de\u011ferlendirme plan\u0131 \u00fczerinden hangi par\u00e7alar\u0131n ge\u00e7erli oldu\u011fu gerek\u00e7elendirilmi\u015f ISO 10993 serisi kapsam\u0131nda biyouyumluluk, ilgili koleteral ve \u00f6zel standartlarla birlikte IEC 60601-1 kapsam\u0131nda elektriksel g\u00fcvenlik, g\u00fcvenlik s\u0131n\u0131f\u0131 (A, B veya C) gerek\u00e7elendirilmi\u015f IEC 62304 kapsam\u0131nda yaz\u0131l\u0131m ya\u015fam d\u00f6ng\u00fcs\u00fc, IEC 62366-1 kapsam\u0131nda kullan\u0131labilirlik, etilen oksit i\u00e7in ISO 11135, radyasyon i\u00e7in ISO 11137 ya da nemli \u0131s\u0131 i\u00e7in ISO 17665 kapsam\u0131nda sterilizasyon validasyonu, ASTM F1980 kapsam\u0131nda h\u0131zland\u0131r\u0131lm\u0131\u015f ya\u015fland\u0131rma \u00e7al\u0131\u015fmalar\u0131yla desteklenmi\u015f ve ger\u00e7ek zamanl\u0131 verilerle teyit edilmi\u015f ambalaj ile raf \u00f6mr\u00fc, ve klinik performansa y\u00f6nelik bench testleri.<\/p>

Burada tekrarlayan kal\u0131p worst-case se\u00e7imi. Sterilizasyon, ambalaj, biyouyumluluk ya da performans testi fark etmeksizin, de\u011ferlendirici hangi varyant\u0131n ya da konfig\u00fcrasyonun her test i\u00e7in worst-case'i temsil etti\u011finin yaz\u0131l\u0131 bir gerek\u00e7esini bekliyor ve gerek\u00e7e ba\u015fka bir de\u011ferlendiricinin de ayn\u0131 sonuca varabilece\u011fi kadar spesifik olmal\u0131. Gerek\u00e7e \u201cXL boyu en b\u00fcy\u00fck oldu\u011fu i\u00e7in se\u00e7ildi\u201d seviyesinde kald\u0131\u011f\u0131nda, de\u011ferlendirici teste ba\u011fl\u0131 olarak aral\u0131k boyunca kimyasal farkl\u0131l\u0131klar\u0131, geometrinin sterilan penetrasyonuna etkisini ya da ya\u015fland\u0131rma varsay\u0131mlar\u0131n\u0131 soruyor.<\/p>

De\u011ferlendiricinin sordu\u011fu: her test i\u00e7in worst-case gerek\u00e7esi nerede, harmonize standartlar do\u011fru edisyonda uygulanm\u0131\u015f m\u0131, do\u011frulama protokol\u00fcn\u00fc do\u011frulama raporuna ba\u011flayan referans nerede ve test \u00f6rne\u011finin piyasadaki cihazla e\u015fle\u015fti\u011fini g\u00f6steren test \u00f6rne\u011fi tan\u0131m\u0131 nerede.<\/p>

7. Klinik de\u011ferlendirme<\/h2>

Klinik de\u011ferlendirme Article 61 ve Annex XIV B\u00f6l\u00fcm A ile y\u00f6netiliyor. MDCG 2020-13, Onaylanm\u0131\u015f Kurulu\u015flar\u0131n de\u011ferlendirmelerini belgelerken kulland\u0131\u011f\u0131 \u015fablonu sunuyor. CER'in kendisi MDR i\u00e7in g\u00fcncellenmi\u015f MEDDEV 2.7\/1 Rev. 4 yap\u0131s\u0131n\u0131 ya da MDCG 2020-13 \u015fablonunu izleyebilir. Ama daha \u00f6nemlisi, CER'in cihazla, kullan\u0131m amac\u0131yla ve teknik dosyan\u0131n 1. b\u00f6l\u00fcm\u00fcnde belirtilen endikasyonlarla bire bir uyumlu olmas\u0131.<\/p>

Tekrarlayan deficiency e\u015fde\u011ferlik iddias\u0131. Article 61(4) e\u015fde\u011ferli\u011fin teknik, biyolojik ve klinik kriterler kar\u015f\u0131s\u0131nda kan\u0131tlanmas\u0131n\u0131 \u015fart ko\u015fuyor. Onaylanm\u0131\u015f Kurulu\u015flar bu konuda \u00f6zellikle implant edilebilir ve Class III cihazlar i\u00e7in titiz inceleme yapmakla y\u00fck\u00fcml\u00fc. MDCG 2020-5 e\u015fde\u011ferli\u011fin pratikte ne anlama geldi\u011fini a\u00e7\u0131kl\u0131yor. \u00dcreticilerin yapt\u0131\u011f\u0131 hata, e\u015fde\u011ferli\u011fi yan yana konulmu\u015f verilere dayanan bir arg\u00fcman yerine bir checkbox al\u0131\u015ft\u0131rmas\u0131 gibi ele almak. Gerekti\u011finde, e\u015fde\u011fer cihaz\u0131n \u00fcreticisinden o cihaz\u0131n teknik dok\u00fcmantasyonuna s\u00fcrekli eri\u015fim i\u00e7in bir s\u00f6zle\u015fme imzalanm\u0131\u015f olmas\u0131 da bekleniyor.<\/p>

PMCF di\u011fer tekrarlayan deficiency. CER, PMCF'in gerekli oldu\u011fu sonucuna var\u0131yorsa (ki Class IIa ve \u00fczeri i\u00e7in varsay\u0131lan budur), PMCF plan\u0131 dosyada olmal\u0131, CER'de belirlenen spesifik gap'lere y\u00f6nelmeli ve ger\u00e7ek\u00e7i zaman \u00e7izelgeleri i\u00e7ermeli. \u201cVerileri \u015fikayet s\u00fcrecimizden toplayaca\u011f\u0131z\u201d bir plan de\u011fil. MDCG 2020-7 (PMCF plan \u015fablonu) ve MDCG 2020-8 (PMCF de\u011ferlendirme raporu \u015fablonu) yap\u0131n\u0131n nas\u0131l olmas\u0131 gerekti\u011fini tan\u0131ml\u0131yor.<\/p>

De\u011ferlendiricinin sordu\u011fu: yan yana veriyle desteklenmi\u015f e\u015fde\u011ferlik gerek\u00e7esi nerede, literat\u00fcr arama metodolojisinin gerek\u00e7esi nedir, istatistiksel de\u011ferlendirmeler i\u00e7eren veri analizi nerede ve PMCF plan\u0131 CER'de belirlenen spesifik gap'leri nas\u0131l kar\u015f\u0131l\u0131yor.<\/p>

8. Piyasa sonras\u0131 g\u00f6zetim (Annex III)<\/h2>

Annex III, piyasa sonras\u0131 g\u00f6zetim (PMS) dok\u00fcmantasyonunu kaps\u0131yor. Bu dok\u00fcmantasyon teknik dosyan\u0131n bir par\u00e7as\u0131 olmas\u0131na ra\u011fmen \u00fcreticiler bazen onu ayr\u0131 bir paket gibi ele al\u0131yor. PMS plan\u0131 Article 84 ile uyumlu olmal\u0131 ve proaktif ve reaktif veri kaynaklar\u0131n\u0131, analiz y\u00f6ntemlerini, g\u00f6sterge ve e\u015fik de\u011ferlerini, risk y\u00f6netimi ve klinik de\u011ferlendirme ile ba\u011flant\u0131y\u0131, \u00e7\u0131kt\u0131lar\u0131n CAPA'ya nas\u0131l beslendi\u011fini kapsamal\u0131. Article 86 kapsam\u0131ndaki PSUR, Class IIa, IIb ve III cihazlar i\u00e7in ge\u00e7erli. Article 85 kapsam\u0131ndaki PMS raporu ise Class I i\u00e7in ge\u00e7erli. Annex XIV B\u00f6l\u00fcm B kapsam\u0131ndaki PMCF plan ve raporlar\u0131 bunlar\u0131n yan\u0131nda konumlan\u0131yor.<\/p>

Article 87 ile 92 aras\u0131ndaki vijilans prosed\u00fcrleri PMS plan\u0131nda referans verilmeli ve dayana\u011f\u0131 olu\u015fturan prosed\u00fcrler incelemeye haz\u0131r olmal\u0131. 2 g\u00fcn, 10 g\u00fcn ve 15 g\u00fcn raporlama s\u00fcreleri s\u0131k g\u00f6r\u00fclen denetim bulgular\u0131ndan. Sebebi prosed\u00fcr\u00fcn eksik olmas\u0131 de\u011fil, prosed\u00fcr\u00fcn QMS kay\u0131tlar\u0131nda pratikte ne oldu\u011funu g\u00f6steren ak\u0131\u015fla \u00f6rt\u00fc\u015fmemesi.<\/p>

De\u011ferlendiricinin sordu\u011fu: proaktif veri kaynaklar\u0131 nerede tan\u0131mlanm\u0131\u015f, ciddi olay eskalasyonu i\u00e7in tetik e\u015fikleri ne, PMS \u00e7\u0131kt\u0131s\u0131 risk dosyas\u0131na ve CER'e nas\u0131l geri besleniyor ve \u00fcretici Basic UDI-DI grubundaki t\u00fcm varyantlar genelinde piyasa sonras\u0131 sinyali nas\u0131l izliyor.<\/p>

S\u0131k g\u00f6r\u00fclen Onaylanm\u0131\u015f Kurulu\u015f bulgular\u0131, a\u00e7\u0131k dille<\/h2>

En s\u0131k kar\u015f\u0131la\u015f\u0131lan deficiency'ler egzotik de\u011fil. Kullan\u0131m amac\u0131 dok\u00fcmanlar aras\u0131nda kay\u0131yor. GSPR kontrol listesi, iddiay\u0131 ger\u00e7ekten desteklemeyen bir kayna\u011fa at\u0131f veriyor. Risk kontrolleri listelenmi\u015f ama do\u011frulanmam\u0131\u015f. CER'deki e\u015fde\u011ferlik arg\u00fcman\u0131 Article 61(4) incelemesinden ge\u00e7emiyor. PMCF plan\u0131 generic. Sterilizasyon ya da raf \u00f6mr\u00fc h\u0131zland\u0131r\u0131lm\u0131\u015f model kullan\u0131yor ama ger\u00e7ek zamanl\u0131 veri yok. Tedarik\u00e7i listesi QMS'in tedarik\u00e7i de\u011ferlendirmesiyle \u00f6rt\u00fc\u015fm\u00fcyor.<\/p>

Bunlar\u0131n hi\u00e7biri teknik bir s\u00fcrpriz de\u011fil. Hepsi izlenebilirlik (traceability) problemi. Teknik dosya, her iddian\u0131n tek bir spesifik kan\u0131t referans\u0131na ba\u011fl\u0131 oldu\u011fu ve o referans a\u00e7\u0131ld\u0131\u011f\u0131nda iddiay\u0131 ek bir arg\u00fcmana ihtiya\u00e7 b\u0131rakmadan destekledi\u011fi zaman iyi i\u015f \u00e7\u0131kar\u0131yor.<\/p>

Sonu\u00e7<\/h2>

Eksiksiz bir MDR teknik dok\u00fcmantasyon dosyas\u0131, cihaz\u0131n reg\u00fclatif kimlik kart\u0131. Cihaz\u0131n ne oldu\u011funu, nas\u0131l tasarland\u0131\u011f\u0131n\u0131, nas\u0131l \u00fcretildi\u011fini, g\u00fcvenlik ve performans\u0131n\u0131n nas\u0131l g\u00f6sterildi\u011fini ve \u00fcreticinin piyasaya \u00e7\u0131kt\u0131ktan sonra cihaz\u0131 nas\u0131l izlemeye devam etti\u011fini tan\u0131ml\u0131yor. Onaylanm\u0131\u015f Kurulu\u015f de\u011ferlendirmesi \u00fcreticiyi yakalamak i\u00e7in yap\u0131lm\u0131yor. Amac\u0131 \u015fu: kullan\u0131m amac\u0131ndan ba\u015flayarak risk dosyas\u0131ndan, do\u011frulama testlerinden, klinik de\u011ferlendirmeden ge\u00e7ip piyasa sonras\u0131 plana kadar uzanan kan\u0131t ipli\u011fini takip edebilmek. Bu iplik g\u00f6r\u00fcn\u00fcr oldu\u011funda de\u011ferlendirme h\u0131zlan\u0131yor ve sertifika daha az tur gerektiriyor. G\u00f6r\u00fcn\u00fcr olmad\u0131\u011f\u0131nda ise her b\u00f6l\u00fcm bir deficiency'ye d\u00f6n\u00fc\u015f\u00fcyor.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tRequest Technical Documentation Review<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Under Regulation (EU) 2017\/745, the technical documentation is the evidence package that demonstrates a device complies with the regulation. Annex II covers the device itself. Annex III covers post-market surveillance. Together they cover the device’s full lifecycle, and they are what a Notified Body reviews to decide whether you get or keep your CE certificate. […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-646","post","type-post","status-publish","format-standard","hentry","category-general"],"yoast_head":"\nMDR Technical Documentation Requirements (Annex II & III Guide)<\/title>\n<meta name=\"description\" content=\"MDR technical documentation requirements explained. Learn what must be included in Annex II and III technical files, including GSPR, risk management, and clinical evaluation.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bplussolutions.com\/tr\/mdr-technical-documentation\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR Technical Documentation Requirements (Annex II & III Guide)\" \/>\n<meta property=\"og:description\" content=\"MDR technical documentation requirements explained. 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