{"id":1250,"date":"2024-02-13T11:49:23","date_gmt":"2024-02-13T08:49:23","guid":{"rendered":"https:\/\/nuve.com.tr\/NHaber\/?p=1250"},"modified":"2024-02-13T12:32:19","modified_gmt":"2024-02-13T09:32:19","slug":"tibbi-cihazlar-yonetmeligi-mdr-tibbi-cihazlar-direktifi-mdd-surecleri","status":"publish","type":"post","link":"https:\/\/nuve.com.tr\/NHaber\/?p=1250","title":{"rendered":"T\u0131bbi Cihazlar Y\u00f6netmeli\u011fi (MDR) \/ T\u0131bbi Cihazlar Direktifi\u00a0(MDD) S\u00fcre\u00e7leri"},"content":{"rendered":"\n

Cihaz\u0131n\/\u00fcr\u00fcn\u00fcn gerekli b\u00fct\u00fcn uygunluk de\u011ferlendirme kriterleri a\u00e7\u0131s\u0131ndan uygun oldu\u011funu ve \u00fcretici taraf\u0131ndan belirtilen kullan\u0131m amac\u0131na y\u00f6nelik kullan\u0131ld\u0131\u011f\u0131nda insana, hayvana, \u00e7evreye, di\u011fer \u00fcr\u00fcnlere zarar vermeyece\u011fini g\u00f6steren, CE i\u015faretidir. D\u0131\u015f pazar\u0131m\u0131z a\u00e7\u0131s\u0131ndan, bu i\u015fareti ta\u015f\u0131mas\u0131 gerekti\u011fi halde ta\u015f\u0131mayan cihaz\u0131n\/\u00fcr\u00fcn\u00fcn AB \u00fcyesi \u00fclkelere ihracat\u0131 m\u00fcmk\u00fcn de\u011fildir. \u0130\u00e7 pazar\u0131m\u0131z a\u00e7\u0131s\u0131ndan ise, mevzuat uyumu tamamlanm\u0131\u015f ve zorunlu uygulamaya girmi\u015f \u00fcr\u00fcn y\u00f6netmelikleri kapsam\u0131na giren N\u00dcVE\u2019de \u00fcretilen t\u0131bbi cihazlar\u0131n \u00fclkemiz piyasas\u0131na arz edilmesi m\u00fcmk\u00fcn de\u011fildir.<\/p>\n\n\n\n

Y\u00fcksek risk ta\u015f\u0131yan cihazlar\/\u00fcr\u00fcnler piyasaya arz edilmeden \u00f6nce yetkili otoritelerce g\u00f6revlendirilen kurulu\u015flar taraf\u0131ndan uygunluk de\u011ferlendirmesine tabi tutulurlar. Bu kurulu\u015flar Onaylanm\u0131\u015f Kurulu\u015f (Notified Body) olarak ifade edilmektedir, Avrupa Komisyonu taraf\u0131ndan tan\u0131nmaktad\u0131rlar. N\u00fcve\u2019nin t\u0131bbi cihaz kapsam\u0131ndaki t\u00fcm cihazlar\u0131n\u0131n 93\/42\/EEC T\u0131bbi Cihaz Y\u00f6netmeli\u011fi\u2019ne g\u00f6re uygunluk de\u011ferlendirmeleri Kiwa T\u00fcrkiye taraf\u0131ndan ger\u00e7ekle\u015ftirilmektedir. 2017\/745 MDR<\/strong> ( Medical Device Regulation ) kapsam\u0131ndaki uygunluk de\u011ferlendirmeleri ise Kiwa \u0130talya taraf\u0131ndan ger\u00e7ekle\u015ftirilecektir.<\/p>\n\n\n\n

Bahsi ge\u00e7en 93\/42\/EEC T\u0131bbi Cihaz Y\u00f6netmeli\u011fi, 1993 y\u0131l\u0131nda y\u00fcr\u00fcrl\u00fc\u011fe girmi\u015ftir. Bu y\u00f6netmeli\u011fin amac\u0131 t\u0131bbi cihaz ve aksesuarlar\u0131n\u0131n ta\u015f\u0131mas\u0131 gereken temel gerekleri belirlemek ve bu cihazlar ile aksesuarlar\u0131n\u0131n kullan\u0131m\u0131 s\u0131ras\u0131nda hastalar\u0131n, uygulay\u0131c\u0131lar\u0131n, kullan\u0131c\u0131lar\u0131n ve \u00fc\u00e7\u00fcnc\u00fc \u015fah\u0131slar\u0131n sa\u011fl\u0131k ve g\u00fcvenli\u011fi a\u00e7\u0131s\u0131ndan ortaya \u00e7\u0131kabilecek tehlikelere kar\u015f\u0131 korunmalar\u0131n\u0131 sa\u011flamak amac\u0131yla tasar\u0131m\u0131na, s\u0131n\u0131fland\u0131r\u0131lmas\u0131na, \u00fcretimine, piyasaya arz\u0131na, hizmete sunulmas\u0131na ve denetlenmesine ili\u015fkin usul ve esaslar\u0131 d\u00fczenlemektir.<\/p>\n\n\n\n

(EU) 2017\/745<\/strong> say\u0131l\u0131 T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc (MDR) ise, “Medical Device Regulation”\u0131n k\u0131saltmas\u0131 olan T\u0131bbi Cihaz Y\u00f6netmeli\u011fidir. May\u0131s 2017\u2019de y\u00fcr\u00fcrl\u00fc\u011fe girmi\u015ftir. MDR; \u00fcr\u00fcn g\u00fcvenli\u011fi, izlenebilirlik, belgelendirme, sat\u0131\u015f, sat\u0131\u015f sonras\u0131 s\u00fcre\u00e7ler gibi alanlarda daha kat\u0131 kurallar koyarak, end\u00fcstriyi daha g\u00fcvenli hale getirmeyi hedeflemi\u015ftir.<\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

MDD varken MDR neden g\u00fcndeme geldi?<\/strong><\/p>\n\n\n\n

2010 y\u0131l\u0131nda Fransa\u2019da \u00fcnl\u00fc bir meme protezi \u00fcreticisi taraf\u0131ndan piyasaya s\u00fcr\u00fclen milyonlarca meme protezinin i\u00e7erisinde medikal safl\u0131kta silikon yerine \u201csanayi silikonu\u201d oldu\u011fu ve 300.000\u2019den fazla kad\u0131na bu protezlerin tak\u0131ld\u0131\u011f\u0131 tespit edilmesi, s\u0131n\u0131rl\u0131 testlerle piyasaya s\u00fcr\u00fclen stentlerin tespit edilmesi, g\u00fcvenli olmayan ila\u00e7 sal\u0131n\u0131ml\u0131 stentlerin tespiti vb. ya\u015fananlar, onaylanm\u0131\u015f kurulu\u015flar\u0131n d\u00fczenledi\u011fi sertifikalara duyulan g\u00fcvensizlik, yeni teknolojilerin geli\u015fmesi gibi pek \u00e7ok neden de\u011ferlendirildi\u011finde, mevcut direktifin yetersiz kald\u0131\u011f\u0131na karar verilmi\u015ftir. 2012\u2019de Avrupa komisyonu, t\u0131bbi cihazlar i\u00e7in daha s\u0131k\u0131 piyasa g\u00f6zetimi gereklilikleri i\u00e7eren iki yeni AB d\u00fczenlemesi i\u00e7in teklif yay\u0131nlam\u0131\u015ft\u0131r. Piyasa g\u00f6zetimi de dahil olmak \u00fczere iyile\u015ftirme alanlar\u0131na odaklanan ortak eylem plan\u0131 ve bir uygulama t\u00fcz\u00fc\u011f\u00fc yay\u0131nlanm\u0131\u015ft\u0131r. En nihayetinde ise (EU) 2017\/745<\/strong> say\u0131l\u0131 T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc (MDR) 5 May\u0131s 2017 <\/strong>tarihinde AB Resmi Gazetesi\u2019nde yay\u0131nlan\u0131p, pandemi nedeniyle bir y\u0131l uzat\u0131larak 4 y\u0131ll\u0131k ge\u00e7i\u015f s\u00fcresini tamamlay\u0131p 25 May\u0131s 2021<\/strong> tarihinde uygulamaya al\u0131nm\u0131\u015ft\u0131r. Mevcut y\u00f6netmelik ve MDR uyumla\u015ft\u0131r\u0131lmas\u0131na istinaden de \u00fclkemizde 02.06.2021<\/strong> tarihli 31499 nolu m\u00fckerrer Resmi Gazete\u2019de yay\u0131nlanm\u0131\u015ft\u0131r.<\/p>\n\n\n\n

\u0130malat\u00e7\u0131lar\u0131n haz\u0131r olmamas\u0131, sertifikaland\u0131rma s\u00fcrecinde onaylanm\u0131\u015f kurulu\u015flar\u0131n kapasitelerinin yetersiz kalmas\u0131, piyasada t\u0131bbi cihaz bulunmamas\u0131 tehlikesi vb. sebepler ile Komisyon taraf\u0131ndan (AB) 2023\/607<\/strong> Say\u0131l\u0131 T\u00fcz\u00fck 20 Mart 2023<\/strong> tarihinde AB Resmi Gazetesinde s\u00fcre uzat\u0131m\u0131 yay\u0131mlanm\u0131\u015ft\u0131r. \u00dclkemizde ise AB mevzuat\u0131na uyum faaliyetleri kapsam\u0131nda, s\u00f6z konusu T\u00fcz\u00fc\u011fe paralel De\u011fi\u015fiklik Y\u00f6netmeli\u011fi yay\u0131mlanm\u0131\u015ft\u0131r. Her ne kadar s\u00fcre uzat\u0131m\u0131 yay\u0131mlanm\u0131\u015f olsa da piyasadaki t\u00fcm t\u0131bbi cihaz firmalar\u0131 do\u011frudan bu s\u00fcre uzat\u0131m\u0131ndan faydalanabilir anlam\u0131na gelmemektedir. S\u00fcre uzat\u0131m\u0131ndan faydalanabilmek i\u00e7in belli ko\u015fullar koyulmu\u015ftur. Bu ko\u015fullar; MDD\u2019ye uymaya devam etmek, kabul edilemez sa\u011fl\u0131k ve g\u00fcvenlik riskleri olu\u015fturmamak, cihazlar\u0131n tasar\u0131mda ve kullan\u0131m amac\u0131nda \u00f6nemli bir de\u011fi\u015fikli\u011fe u\u011framam\u0131\u015f olmas\u0131, 26\/5\/24<\/strong> tarihine kadar kalite y\u00f6netim sisteminin MDR\u2019ye adaptasyonunun sa\u011flanmas\u0131, 26\/5\/24 <\/strong>tarihinden \u00f6nce bir onaylanm\u0131\u015f kurulu\u015fa uygunluk de\u011ferlendirme ba\u015fvurusunun yap\u0131lmas\u0131, 26\/9\/24<\/strong> tarihine kadar onaylanm\u0131\u015f kurulu\u015f ile yaz\u0131l\u0131 bir s\u00f6zle\u015fme imzalamas\u0131d\u0131r. Bu ko\u015fullar\u0131 sa\u011flad\u0131ktan sonra EBS ( Elektronik Bilgi Sistemi ) ve akabinde \u00dcTS ( \u00dcr\u00fcn takip sistemi ) \u00fczerinden, (AB) 2023\/607<\/strong> Say\u0131l\u0131 T\u00fcz\u00fck H\u00fck\u00fcmlerinin Uygulanmas\u0131na Dair Duyurulardaki usul ve esaslara g\u00f6re s\u00fcre uzat\u0131m\u0131 ba\u015fvurusu yap\u0131lmal\u0131d\u0131r. T\u0130TCK taraf\u0131ndan ba\u015fvurusu uygun bulunan firmalar\u0131n sertifika s\u00fcreleri cihaz s\u0131n\u0131f\u0131na g\u00f6re belirtilen uzatma takvimine kadar uzat\u0131l\u0131r. S\u00fcre uzat\u0131m\u0131n\u0131n al\u0131nmas\u0131, uzat\u0131lan tarihe kadar g\u00fcvendeyiz demek de\u011fildir. Sertifikan\u0131n uzat\u0131ld\u0131\u011f\u0131 tarihe kadar, s\u00f6zle\u015fme imzalanan onaylanm\u0131\u015f kurulu\u015f taraf\u0131ndan periyodik olarak denetlenerek, s\u00fcre\u00e7 kontrol alt\u0131nda tutulacakt\u0131r. S\u00fcre uzat\u0131m\u0131 boyunca firmalar\u0131n hem ge\u00e7i\u015f h\u00fck\u00fcmlerini yerine getirmeleri hem de MDR belgelendirme \u00e7al\u0131\u015fmalar\u0131 konusunda faaliyetlerini ivedilikle tamamlayarak MDR ge\u00e7i\u015fi sa\u011flamalar\u0131 gerekmektedir. Aksi halde, s\u00fcre uzat\u0131m\u0131n\u0131n biti\u015fi ile beraber t\u0131bbi cihaz sat\u0131\u015f\u0131 yapmas\u0131 m\u00fcmk\u00fcn olamayacakt\u0131r.<\/p>\n\n\n\n

S\u00fcrecin ciddiyetinin fark\u0131nda olan N\u00dcVE, \u00fczerine d\u00fc\u015fen sorumlulu\u011fun fark\u0131ndal\u0131\u011f\u0131n\u0131 m\u00fctemadiyen firma k\u00fclt\u00fcr\u00fcne de yans\u0131tmaktad\u0131r. Bu kapsamda; sekt\u00f6r\u00fcn en ba\u015far\u0131l\u0131 onaylanm\u0131\u015f kurulu\u015flar\u0131ndan Kiwa \u0130talya ile MDR s\u00f6zle\u015fmesini 2023 y\u0131l\u0131 i\u00e7erisinde imzalayarak ilk ad\u0131m\u0131n\u0131 atm\u0131\u015ft\u0131r. Akabinde EBS ve \u00dcTS \u00fczerinden s\u00fcre uzat\u0131m\u0131 ba\u015fvurusunu yapm\u0131\u015f ve \u00e7ok k\u0131sa s\u00fcre i\u00e7erisinde s\u00fcre uzat\u0131m\u0131n\u0131 onay\u0131n\u0131 alarak, mevcut CE sertifikas\u0131n\u0131n ge\u00e7erlili\u011fini 31 Aral\u0131k 2028<\/strong>\u2019e kadar uzatmay\u0131 ba\u015farm\u0131\u015ft\u0131r. E\u015f zamanl\u0131 olarak MDR belgelendirme \u00e7al\u0131\u015fmalar\u0131n\u0131 da t\u00fcm gayretiyle devam ettirmekte olup s\u00fcreci en k\u0131sa s\u00fcrede neticelendirmeyi hedeflemektedir.<\/p>\n","protected":false},"excerpt":{"rendered":"

Cihaz\u0131n\/\u00fcr\u00fcn\u00fcn gerekli b\u00fct\u00fcn uygunluk de\u011ferlendirme kriterleri a\u00e7\u0131s\u0131ndan uygun oldu\u011funu ve \u00fcretici taraf\u0131ndan belirtilen kullan\u0131m amac\u0131na y\u00f6nelik kullan\u0131ld\u0131\u011f\u0131nda insana, hayvana, \u00e7evreye, di\u011fer \u00fcr\u00fcnlere zarar vermeyece\u011fini g\u00f6steren, CE i\u015faretidir. D\u0131\u015f pazar\u0131m\u0131z a\u00e7\u0131s\u0131ndan, bu i\u015fareti ta\u015f\u0131mas\u0131 gerekti\u011fi halde ta\u015f\u0131mayan cihaz\u0131n\/\u00fcr\u00fcn\u00fcn AB \u00fcyesi \u00fclkelere ihracat\u0131 m\u00fcmk\u00fcn de\u011fildir. \u0130\u00e7 pazar\u0131m\u0131z a\u00e7\u0131s\u0131ndan ise, mevzuat uyumu tamamlanm\u0131\u015f ve zorunlu uygulamaya girmi\u015f \u00fcr\u00fcn […]<\/p>\n","protected":false},"author":1,"featured_media":1253,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24,26],"tags":[],"class_list":["post-1250","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bilim","category-surdurulebilirlik"],"_links":{"self":[{"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=\/wp\/v2\/posts\/1250","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1250"}],"version-history":[{"count":3,"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=\/wp\/v2\/posts\/1250\/revisions"}],"predecessor-version":[{"id":1258,"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=\/wp\/v2\/posts\/1250\/revisions\/1258"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=\/wp\/v2\/media\/1253"}],"wp:attachment":[{"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1250"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1250"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nuve.com.tr\/NHaber\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1250"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}