{"id":6490,"date":"2023-03-11T21:50:50","date_gmt":"2023-03-11T18:50:50","guid":{"rendered":"https:\/\/www.katsanas.com\/?p=6490"},"modified":"2025-07-30T12:24:25","modified_gmt":"2025-07-30T12:24:25","slug":"kilavuz-belgeleri-takip-ediyor-musunuz","status":"publish","type":"post","link":"https:\/\/www.katsanas.com\/en\/kilavuz-belgeleri-takip-ediyor-musunuz\/","title":{"rendered":"KILAVUZ BELGELER\u0130 TAK\u0130P ED\u0130YOR MUSUNUZ?"},"content":{"rendered":"

Home \u00bb \u00a0 \u00a0 <\/a>Blog \u00bb \u00a0 \u00a0 <\/a>KILAVUZ BELGELER\u0130 TAK\u0130P ED\u0130YOR MUSUNUZ? \u00bb \u00a0 \u00a0 <\/strong><\/h4>\n
\n
\"\"<\/div>\n
\n

\"\"<\/p>\n

K\u0131lavuz belgeler, t\u0131pk\u0131 uluslararas\u0131 standartlar gibi, ba\u011flay\u0131c\u0131 de\u011fildir ancak ilgili taraflar\u0131n olmay\u0131p ilgili taraflar\u0131n y\u00f6netmeli\u011fi do\u011fru yorumlamalar\u0131na yard\u0131mc\u0131 olan faydal\u0131 ara\u00e7lard\u0131r. D\u00fczenlemenin ana \u00e7er\u00e7evesinin her zaman ilgili taraflarca a\u00e7\u0131k ve anla\u015f\u0131l\u0131r olmas\u0131 gerekse de, durum her zaman b\u00f6yle de\u011fildir. Bu nedenle, MDR ge\u00e7i\u015f s\u00fcreci uzatma de\u011fi\u015fikli\u011fi yolda oldu\u011fundan, t\u00fcm kaynaklardan elde edilen k\u0131lavuz belgelerin sa\u011flad\u0131\u011f\u0131 g\u00fcncel bilgilere sahip olman\u0131n \u00f6nemi, \u015fimdi daha da b\u00fcy\u00fck \u00f6nem ta\u015f\u0131maktad\u0131r.<\/p>\n

T\u0131bbi Cihaz Koordinasyon Grubu (MDCG), \u00dcye Devletler taraf\u0131ndan atanan, farkl\u0131 uzmanl\u0131klara sahip bireylerin yer ald\u0131\u011f\u0131 13 farkl\u0131 alt gruptan olu\u015fan bir gruptur. MDCG, do\u011frudan MDR ve IVDR’yi konu alan k\u0131lavuz belgeleri d\u00fczenli olarak yay\u0131nlar. MDCG grubu, sadece 2022 Aral\u0131k ay\u0131nda MDCG 2022-1:21 PGGR PSUR K\u0131lavuzu ve MDCG 2022-4 rev.1: Mad. 120 Uygun G\u00f6zetim gibi reva\u00e7taki konular\u0131 da i\u00e7eren 7 rehber dok\u00fcman\u0131 yay\u0131nlam\u0131\u015f ya da revize etmi\u015ftir.<\/p>\n

Avrupa Onaylanm\u0131\u015f Kurulu\u015flar\u0131n T\u0131bbi Cihazlar\u0131 Birli\u011fi (TEAM NB), Avrupa’daki onaylanm\u0131\u015f kurulu\u015flar i\u00e7in \u015feffafl\u0131\u011f\u0131 sa\u011flamak amac\u0131yla olu\u015fturulmu\u015f, yaln\u0131zca farkl\u0131 \u00fclkelerden Onaylanm\u0131\u015f Kurulu\u015flardan \u00fcyelerin bulundu\u011fu bir kurulu\u015ftur. Do\u011fal olarak, TEAM NB, d\u00fczenleyici geli\u015fmeleri yak\u0131ndan takip eder ve Onaylanm\u0131\u015f Kurulu\u015flar\u0131n d\u00fc\u015f\u00fcnce zincirine yap\u0131s\u0131na y\u00f6nelik i\u00e7 g\u00f6r\u00fc sa\u011flayan durum pozisyon belgeleri yay\u0131nlar.<\/p>\n

Uluslararas\u0131 T\u0131bbi Cihaz Reg\u00fclat\u00f6rleri Forumu (IMDRF), uluslararas\u0131 t\u0131bbi cihaz mevzuat uyumunu ve harmonizasyonunu h\u0131zland\u0131rmak amac\u0131yla g\u00f6n\u00fcll\u00fc t\u0131bbi cihaz d\u00fczenleyicileri taraf\u0131ndan olu\u015fturulmu\u015f bir gruptur. Bir IMDRF taraf\u0131ndan belirlenen Pazar \u00f6ncesi ve sonras\u0131 aktiviteler ve ilgili payda\u015flar aras\u0131ndaki ili\u015fikleri hedef alan stratejik bir plan,, olan pazar \u00f6ncesi, pazar sonras\u0131 ve payda\u015flarla ili\u015fkileri i\u00e7ermektedir ve di\u011fer rehber dok\u00fcman yay\u0131nlayan gruplarla m\u00fckemmel bir uyum i\u00e7indedir. IMDRF halihaz\u0131rda da, t\u0131bbi cihaz end\u00fcstrisinin s\u0131cak pop\u00fcler konular\u0131na ili\u015fkin \u00e7ok kapsaml\u0131 belgelere sahiptir.<\/p>\n

T\u0131bbi cihaz end\u00fcstrisindeki d\u00fczenleyici gerekliliklere uygunluk hi\u00e7 de k\u00fc\u00e7\u00fck bir ba\u015far\u0131 de\u011fildir. Bununla birlikte, MDCG, Team NB, IMDRF ve bunlar gibi daha pek \u00e7ok grup, ilgili taraflara mevzuata uyum konusunda aktif olarak yard\u0131m ve rehberlik etmeye \u00e7al\u0131\u015fmaktad\u0131r.<\/p>\n

Daha fazla bilgi:<\/p>\n

https:\/\/www.team-nb.org\/team-nb-documents\/
\n<\/a>
\nhttps:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en<\/a><\/p>\n

https:\/\/www.imdrf.org\/documents<\/a><\/p>\n

<\/div>\n
<\/div>\n
<\/div>\n<\/div>\n<\/div>\n
<\/div>\n
<\/div>\n
<\/div>\n","protected":false},"excerpt":{"rendered":"

K\u0131lavuz belgeler, t\u0131pk\u0131 uluslararas\u0131 standartlar gibi, ba\u011flay\u0131c\u0131 de\u011fildir ancak ilgili taraflar\u0131n olmay\u0131p ilgili taraflar\u0131n y\u00f6netmeli\u011fi do\u011fru yorumlamalar\u0131na yard\u0131mc\u0131 olan faydal\u0131 ara\u00e7lard\u0131r.<\/p>\n","protected":false},"author":2,"featured_media":6491,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50],"tags":[],"class_list":["post-6490","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog-tr"],"_links":{"self":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/posts\/6490","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/comments?post=6490"}],"version-history":[{"count":2,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/posts\/6490\/revisions"}],"predecessor-version":[{"id":14420,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/posts\/6490\/revisions\/14420"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/media\/6491"}],"wp:attachment":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/media?parent=6490"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/categories?post=6490"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/tags?post=6490"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}