{"id":656,"date":"2026-03-06T10:36:01","date_gmt":"2026-03-06T07:36:01","guid":{"rendered":"https:\/\/www.bplussolutions.com\/?p=656"},"modified":"2026-05-13T13:34:31","modified_gmt":"2026-05-13T10:34:31","slug":"devices-in-one-technical-documentation-mdr","status":"publish","type":"post","link":"https:\/\/www.bplussolutions.com\/tr\/devices-in-one-technical-documentation-mdr\/","title":{"rendered":"MDR Kapsam\u0131nda Bir Teknik Dok\u00fcmantasyon \u0130\u00e7erisine Ka\u00e7 Cihaz Dahil Edilebilir?"},"content":{"rendered":"
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\u00dcreticilerden s\u00fcrekli ald\u0131\u011f\u0131m sorulardan biri, EU MDR kapsam\u0131nda ayn\u0131 teknik dok\u00fcmantasyon dosyas\u0131na iki, be\u015f ya da yirmi cihaz varyant\u0131n\u0131 koyup koyamayacaklar\u0131. K\u0131sa cevap \u015fu: reg\u00fclasyon sana bir say\u0131 vermiyor. Sana bir mant\u0131k veriyor. Bu mant\u0131\u011f\u0131 kavrad\u0131\u011f\u0131nda, kendi portf\u00f6y\u00fcn i\u00e7in do\u011fru cevap genellikle kendili\u011finden ortaya \u00e7\u0131k\u0131yor.<\/p>

Bir de kimsenin konu\u015fmay\u0131 sevmedi\u011fi ticari boyut var. Sundu\u011fun her teknik dok\u00fcmantasyon dosyas\u0131 Onaylanm\u0131\u015f Kurulu\u015f taraf\u0131ndan ayr\u0131 bir paket olarak de\u011ferlendiriliyor ve MDR de\u011ferlendirme d\u00f6ng\u00fcleri MDD'ninkinden \u00e7ok daha uzun ve maliyetli. Yani \u00fcreticinin dosyalar\u0131 konsolide etme y\u00f6n\u00fcnde ger\u00e7ek bir motivasyonu var, de\u011ferlendiricinin de konsolidasyon ayakta durmad\u0131\u011f\u0131nda geri itme y\u00f6n\u00fcnde ger\u00e7ek bir motivasyonu var. Erken MDR ba\u015fvurular\u0131ndaki s\u00fcrt\u00fc\u015fmenin b\u00fcy\u00fck k\u0131sm\u0131 tam olarak bu bo\u015flukta ya\u015fand\u0131.<\/p>

Reg\u00fclasyon asl\u0131nda ne diyor<\/h2>

(EU) 2017\/745 say\u0131l\u0131 T\u00fcz\u00fc\u011f\u00fcn Annex II ve Annex III'\u00fc teknik dok\u00fcmantasyonun i\u00e7eri\u011fini tan\u0131ml\u0131yor. Dosyada neyin olmas\u0131 gerekti\u011fini s\u00f6yl\u00fcyor. \u0130kisi de cihaz say\u0131s\u0131 i\u00e7in bir \u00fcst limit koymuyor.<\/p>

Asl\u0131nda kar\u015f\u0131 kar\u015f\u0131ya oldu\u011fun s\u0131n\u0131r Annex VI Part C'de, yani Basic UDI-DI'yi tan\u0131mlayan b\u00f6l\u00fcmde. Basic UDI-DI, MDR'deki temel grupland\u0131rma tan\u0131mlay\u0131c\u0131s\u0131 ve \u00fc\u00e7 kriteri var: ayn\u0131 kullan\u0131m amac\u0131, ayn\u0131 risk s\u0131n\u0131f\u0131 ve ayn\u0131 esas tasar\u0131m ve \u00fcretim \u00f6zellikleri. \u0130ki cihaz bu \u00fc\u00e7\u00fcn\u00fc de payla\u015f\u0131yorsa ayn\u0131 Basic UDI-DI alt\u0131na giriyor ve genelde ayn\u0131 teknik dok\u00fcmantasyon dosyas\u0131n\u0131 payla\u015fabiliyor. Bu \u00fc\u00e7ten biri bile kopuyorsa, ayr\u0131 bir Basic UDI-DI ve \u00e7o\u011fu durumda ayr\u0131 bir dosya konu\u015fuyoruz.<\/p>

MDCG 2018-1, Basic UDI-DI atamas\u0131n\u0131n pratikte nas\u0131l yap\u0131laca\u011f\u0131n\u0131 detayland\u0131r\u0131yor. MDCG 2019-13 ise CE markalama dok\u00fcmantasyonu i\u00e7in kabul edilebilir grupland\u0131rma \u00f6rnekleri veriyor. Grupland\u0131rma stratejisine karar vermeden \u00f6nce ikisinin de okunmas\u0131 gerekli, \u00e7\u00fcnk\u00fc Onaylanm\u0131\u015f Kurulu\u015flar\u0131n bu konuda nas\u0131l de\u011ferlendirme yapmalar\u0131 gerekti\u011fini bu dok\u00fcmanlar \u015fekillendiriyor.<\/p>

Grupland\u0131rman\u0131n genelde i\u015fledi\u011fi yerler<\/h2>

En kolay vaka boyut ve \u00f6l\u00e7\u00fc varyantlar\u0131. Farkl\u0131 uzunluk ve \u00e7apta kateterler, farkl\u0131 boyutlarda implantlar, farkl\u0131 kal\u0131nl\u0131klarda sunulan aletler. Malzemeler ayn\u0131, \u00fcretim s\u00fcreci ayn\u0131, sterilizasyon y\u00f6ntemi ayn\u0131 ve klinik kullan\u0131m ayn\u0131 oldu\u011fu s\u00fcrece bunlar tipik olarak tek dosyada kal\u0131yor. Klinik de\u011ferlendirme t\u00fcm aral\u0131\u011f\u0131 kapsayabiliyor, risk dosyas\u0131 varyantlar\u0131 konfig\u00fcrasyon olarak listeleyebiliyor, do\u011frulama testleri ise gerek\u00e7esi belgelenmi\u015f worst-case temsilciler \u00fczerinden yap\u0131labiliyor.<\/p>

Kullan\u0131m amac\u0131n\u0131 veya g\u00fcvenlik profilini de\u011fi\u015ftirmeyen k\u00fc\u00e7\u00fck tasar\u0131m farkl\u0131l\u0131klar\u0131 da genelde kabul ediliyor. \u0130ki farkl\u0131 sap tasar\u0131m\u0131 olan tekrar kullan\u0131labilir bir alet, ayn\u0131 aktif y\u00fczeyin iki farkl\u0131 konfig\u00fcrasyonundaki bir elektrot, ayn\u0131 kontrol cihaz\u0131n\u0131 payla\u015fan aksesuarlar. Buradaki p\u00fcf nokta, fark\u0131n ger\u00e7ekten k\u00fc\u00e7\u00fck oldu\u011funu g\u00f6sterebilmek. E\u011fer bu de\u011fi\u015fikli\u011fin performans, biyolojik g\u00fcvenlik veya sterilite \u00fczerinde etkisi olmad\u0131\u011f\u0131n\u0131 g\u00f6steren spesifik bir risk de\u011ferlendirmesine i\u015faret edemiyorsan, hen\u00fcz bir grupland\u0131rma arg\u00fcman\u0131n yok demektir.<\/p>

Grupland\u0131rman\u0131n \u00e7\u00f6kt\u00fc\u011f\u00fcn\u00fc g\u00f6rd\u00fc\u011f\u00fcm yerler<\/h2>

Onaylanm\u0131\u015f Kurulu\u015fun bir dosyay\u0131 b\u00f6lmesinin en s\u0131k nedeni, \u00fcreticinin farkl\u0131 sterilizasyon y\u00f6ntemlerine sahip cihazlar\u0131 ayn\u0131 dosyada gruplamas\u0131. Etilen oksit ve gama \u0131\u015f\u0131nlama, biyolojik g\u00fcvenlik veya proses validasyonu a\u00e7\u0131s\u0131ndan birbirinin yerine ge\u00e7miyor ve Basic UDI-DI mant\u0131\u011f\u0131 sterilizasyonu esas \u00f6zelliklerin par\u00e7as\u0131 kabul ediyor. Yani geri kalan her \u015fey \u00f6rt\u00fc\u015fse bile iki sterilizasyon yolu iki Basic UDI-DI demek.<\/p>

Hasta ile temas eden malzemeler bir di\u011fer hassas nokta. Bir varyantta hayvan kaynakl\u0131 bir bile\u015fen varsa di\u011ferinde yoksa, biyolojik de\u011ferlendirme, risk dosyas\u0131 ve \u00e7o\u011fu zaman reg\u00fclasyon yolu birbirinden ayr\u0131l\u0131yor. Ayn\u0131 durum, bir varyantta Annex I b\u00f6l\u00fcm 10.4 kapsam\u0131na giren bir madde (CMR veya endokrin bozucu) varsa di\u011ferinde yoksa da ge\u00e7erli.<\/p>

Kullan\u0131m amac\u0131 kaymas\u0131 s\u0131k\u00e7a g\u00f6rd\u00fc\u011f\u00fcm bir durum. Genelde \u00fcreticinin tan\u0131sal bir varyant ile terap\u00f6tik bir varyant\u0131 ayn\u0131 dosyada tutmaya \u00e7al\u0131\u015fmas\u0131yla kar\u015f\u0131m\u0131za \u00e7\u0131k\u0131yor ya da farkl\u0131 anatomik b\u00f6lgelerde ve farkl\u0131 klinik risk profillerinde kullan\u0131lan cihazlar\u0131 ayn\u0131 dosyada gruplamas\u0131yla. Klinik de\u011ferlendirme bu iki kullan\u0131m\u0131 analizi b\u00f6lmeden makul bi\u00e7imde kapsayam\u0131yor ve klinik de\u011ferlendirme b\u00f6l\u00fcnd\u00fc\u011f\u00fc anda tek teknik dosya gerek\u00e7esi de \u00e7\u00f6k\u00fcyor.<\/p>

Etki mekanizmas\u0131 daha sessiz bir konu ama aktif cihazlarda s\u0131k\u00e7a \u00e7\u0131k\u0131yor. Mekanik olarak birbirine benzeyen ama farkl\u0131 kontrol algoritmalar\u0131 kullanan iki pompa, ya da farkl\u0131 fiziksel ilkelerle enerji veren iki cihaz. Kasa ve kullan\u0131c\u0131 aray\u00fcz\u00fc ayn\u0131 g\u00f6r\u00fcnse bile bunlar genelde ayr\u0131 Basic UDI-DI.<\/p>

Temiz bir grupland\u0131rma gerek\u00e7esi neye benzer<\/h2>

Grupland\u0131rma sa\u011flam durdu\u011funda teknik dok\u00fcmantasyonun da bunu a\u00e7\u0131k\u00e7a g\u00f6stermesi gerekiyor. Dosyan\u0131n ba\u015f\u0131na yak\u0131n bir yerde, kapsama dahil edilen her varyant\u0131n listelendi\u011fi, varyant tan\u0131mlay\u0131c\u0131s\u0131n\u0131n verildi\u011fi ve \u00fc\u00e7 Basic UDI-DI kriterinin her varyant i\u00e7in tek tek anlat\u0131ld\u0131\u011f\u0131 bir b\u00f6l\u00fcm ar\u0131yorum. Klinik de\u011ferlendirme ayn\u0131 listeye at\u0131fta bulunmal\u0131. Risk y\u00f6netimi dosyas\u0131 ayn\u0131 listeye at\u0131fta bulunmal\u0131. Do\u011frulama protokolleri ayn\u0131 listeye at\u0131fta bulunmal\u0131 ve hangi varyant\u0131n test edildi\u011fini, o varyant\u0131n her test i\u00e7in neden worst-case temsilcisi oldu\u011funu a\u00e7\u0131k\u00e7a yazmal\u0131.<\/p>

\u00dcreticiler bunu iyi yapt\u0131\u011f\u0131nda de\u011ferlendirme h\u0131zlan\u0131yor, \u00e7\u00fcnk\u00fc de\u011ferlendirici \u201cbu kan\u0131t hangi varyant i\u00e7in ge\u00e7erli\u201d sorusunu be\u015f ayr\u0131 dok\u00fcman\u0131n i\u00e7inde kovalamak zorunda kalm\u0131yor. \u0130yi yapmad\u0131klar\u0131 zaman ise tam olarak o soru deficiency mektubunun kendisi haline geliyor.<\/p>

Ticari etki \u00fczerine bir not<\/h2>

Bir dosyay\u0131 b\u00f6lmek sadece evrak i\u015fi de\u011fil. Her ek teknik dok\u00fcmantasyon dosyas\u0131, ayr\u0131 bir Onaylanm\u0131\u015f Kurulu\u015f de\u011ferlendirmesi, ayr\u0131 de\u011ferlendirme \u00fccreti, ayr\u0131 bir g\u00f6zetim plan\u0131 ve s\u00fcrd\u00fcr\u00fclmesi gereken ayr\u0131 bir CAPA ve piyasaya s\u00fcr\u00fcm sonras\u0131 veri izi demek. Yirmi cihaz varyant\u0131 olan bir \u00fcretici i\u00e7in iyi gruplanm\u0131\u015f iki dosya ile gev\u015fek gruplanm\u0131\u015f on dosya aras\u0131ndaki fark, sertifika \u00f6mr\u00fc boyunca anlaml\u0131 bir maliyet fark\u0131na d\u00f6n\u00fc\u015f\u00fcyor.<\/p>

Bununla birlikte cihazlar\u0131 ait olmad\u0131klar\u0131 bir dosyaya zorla sokmak genelde geri tepiyor. \u0130lk b\u00fcy\u00fck deficiency, ya da yaln\u0131zca bir varyant\u0131 etkileyen ilk piyasa sonras\u0131 sinyal, altta yatan sorunu y\u00fczeye \u00e7\u0131kar\u0131yor ve dosya yine b\u00f6l\u00fcnmek zorunda kal\u0131yor, sadece daha ge\u00e7 ve daha fazla s\u00fcrt\u00fc\u015fmeyle. Yani daha do\u011fru ticari karar, grupland\u0131rma analizini en ba\u015fta dikkatle yapmak ve kriterler gerektirdi\u011fi yerde b\u00f6l\u00fcnmeyi kabul etmek oluyor.<\/p>

Sonu\u00e7<\/h2>

MDR, bir teknik dok\u00fcmantasyon dosyas\u0131na ka\u00e7 cihaz konulabilece\u011fine dair bir say\u0131 koymuyor. Yerine bir mant\u0131k koyuyor. Ayn\u0131 kullan\u0131m amac\u0131, ayn\u0131 risk s\u0131n\u0131f\u0131, ayn\u0131 esas tasar\u0131m ve \u00fcretim \u00f6zellikleri varsa genelde tek dosya. Bunlardan biri k\u0131r\u0131l\u0131yorsa birden fazla dosya. Onaylanm\u0131\u015f Kurulu\u015flar bu gerek\u00e7enin yaz\u0131l\u0131 olmas\u0131n\u0131, kapsamdaki her varyanta uygulanm\u0131\u015f olmas\u0131n\u0131 ve t\u00fcm aral\u0131\u011f\u0131 ger\u00e7ekten kapsayan klinik ve risk kan\u0131tlar\u0131yla desteklenmi\u015f olmas\u0131n\u0131 bekliyor.<\/p>\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

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MDR teknik dok\u00fcmantasyonu konusunda destek mi laz\u0131m?<\/strong><\/p>

Cihazlar\u0131n\u0131 nas\u0131l gruplayaca\u011f\u0131ndan emin de\u011filsen, ya da mevcut grupland\u0131rman\u0131n Onaylanm\u0131\u015f Kurulu\u015f de\u011ferlendirmesinden ge\u00e7ip ge\u00e7meyece\u011fini sorguluyorsan, B Plus Solutions sunum \u00f6ncesi stratejiyi birlikte d\u00fc\u015f\u00fcnmene yard\u0131mc\u0131 olabilir.<\/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\tBize Ula\u015f\u0131n<\/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":"

A question I keep getting from manufacturers is whether they can put two, five, or twenty device variants in the same technical documentation file under EU MDR. The short answer is that the regulation does not give you a number. It gives you a logic. Once you understand that logic, the right answer for your […]<\/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":[19],"tags":[],"class_list":["post-656","post","type-post","status-publish","format-standard","hentry","category-insights"],"yoast_head":"\nHow Many Devices Can Be Included in One MDR Technical Documentation?<\/title>\n<meta name=\"description\" content=\"How many medical devices can be included in one MDR technical documentation? Learn the rules for device family grouping and Basic UDI-DI under EU MDR.\" \/>\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\/devices-in-one-technical-documentation-mdr\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How Many Devices Can Be Included in One MDR Technical Documentation?\" \/>\n<meta property=\"og:description\" content=\"How many medical devices can be included in one MDR technical documentation? 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