{"id":6508,"date":"2023-03-12T03:34:15","date_gmt":"2023-03-12T00:34:15","guid":{"rendered":"https:\/\/www.katsanas.com\/?p=6508"},"modified":"2023-10-10T21:46:08","modified_gmt":"2023-10-10T21:46:08","slug":"hastalarin-mdrye-gercekten-ihtiyaci-var-mi","status":"publish","type":"post","link":"https:\/\/www.katsanas.com\/en\/hastalarin-mdrye-gercekten-ihtiyaci-var-mi\/","title":{"rendered":"HASTALARIN MDR’YE GER\u00c7EKTEN \u0130HT\u0130YACI VAR MI?"},"content":{"rendered":"

Home \u00bb \u00a0 \u00a0 <\/a>Blog \u00bb \u00a0 \u00a0 <\/a>HASTALARIN MDR’YE GER\u00c7EKTEN \u0130HT\u0130YACI VAR MI? \u00bb \u00a0 \u00a0 <\/strong><\/h4>\n
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MDR’nin tek hedefi ve amac\u0131, t\u0131bbi cihazlar\u0131n g\u00fcvenlik ve performans\u0131na ili\u015fkin AB kurallar\u0131n\u0131 g\u00fcncelleyerek hastalar\u0131n minimum mutlakm\u00fcmk\u00fcn olan en d\u00fc\u015f\u00fck riskle m\u00fcmk\u00fcn olan en iyi teknolojiye eri\u015febilmesini i almas\u0131n\u0131 sa\u011flamakt\u0131r. i\u00e7in ve t\u0131bbi cihazlar\u0131n g\u00fcvenli\u011fi ve performans\u0131na ili\u015fkin AB kurallar\u0131n\u0131 g\u00fcncellemektir.<\/p>\n

MDR, k\u00f6kleri 1990’lara dayanan eski kurallarda baz\u0131 \u00f6nemli de\u011fi\u015fiklikler yaparak hastalar i\u00e7in bunu sa\u011flamay\u0131 planlar. MDR\u2019\u0131n hayata ge\u00e7irdikleri \u015fu \u015fekilde \u00f6zetlenebilir;;<\/p>\n

1) \u00d6zellikle y\u00fcksek riskli cihazlar i\u00e7in, Onaylanm\u0131\u015f Kurulu\u015flar d\u0131\u015f\u0131ndaki uzmanlar\u0131n dahil oldu\u011fu bir
\npiyasaya arz \u00f6ncesi inceleme mekanizmas\u0131 sistemi arac\u0131l\u0131\u011f\u0131 ileyoluyla \u00e7ok s\u0131k\u0131 bir kontrol mekanizmas\u0131.<\/p>\n

2) Klinik verilerin kalitesinin art\u0131r\u0131lmas\u0131 i\u00e7in yeni gereklilikler.<\/p>\n

3) \u00dcreticileri, kullan\u0131m\u0131 kamuya a\u00e7\u0131k olan Avrupa T\u0131bbi Cihazlar Veri Taban\u0131 (EUDAMED) arac\u0131l\u0131\u011f\u0131yla cihazlar\u0131na ili\u015fkin g\u00fcvenlik ve performans verilerini sa\u011flamaya zorlayan bir \u015feffafl\u0131k sistemi.<\/p>\n

4) Tedarik zinciri boyunca \u00fcr\u00fcn\u00fcn benzersiz bir \u015fekilde tan\u0131mlanmas\u0131n\u0131 sa\u011flayan yeni bir cihaz izlenebilirlik sistemi.<\/p>\n

5) Teyakkuz ve piyasa g\u00f6zetimi ile ilgili veri payla\u015f\u0131m\u0131n\u0131 \u00fcye \u00fclkeler aras\u0131nda art\u0131rmak i\u00e7in \u00fcye \u00fclkeler i\u00e7in geli\u015ftirilmi\u015f bir i\u015fbirli\u011fi sistemi.<\/p>\n

6) T\u0131bbi cihazlardan zarar g\u00f6ren hastalar i\u00e7in maddi tazminat mekanizmas\u0131. \u00d6zetle, MDR, hastalar\u0131n en iyi klinik performansa sahip en g\u00fcvenli t\u0131bbi cihazlara eri\u015febilmeleri i\u00e7in t\u0131bbi cihazlardaki h\u0131zla geli\u015fen teknolojik geli\u015fmeler<\/p>\n<\/div>\n<\/div>\n

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MDR’nin tek hedefi ve amac\u0131, t\u0131bbi cihazlar\u0131n g\u00fcvenlik ve performans\u0131na ili\u015fkin AB kurallar\u0131n\u0131 g\u00fcncelleyerek hastalar\u0131n minimum<\/p>\n","protected":false},"author":2,"featured_media":6509,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50],"tags":[],"class_list":["post-6508","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\/6508","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=6508"}],"version-history":[{"count":1,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/posts\/6508\/revisions"}],"predecessor-version":[{"id":10885,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/posts\/6508\/revisions\/10885"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/media\/6509"}],"wp:attachment":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/media?parent=6508"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/categories?post=6508"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/tags?post=6508"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}