(EU) 2017\/745 T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc, Nisan 2017\u2019de Avrupa Birli\u011fi Resmi Gazetesi\u2019nde yay\u0131nlanm\u0131\u015ft\u0131r ve \u00fc\u00e7 y\u0131ll\u0131k ge\u00e7i\u015f s\u00fcresi sonunda May\u0131s 2020\u2019de T\u00fcrkiye\u2019de Avrupa Birli\u011fi\u2019ne \u00fcye devletlerle ayn\u0131 anda uygulamaya al\u0131nacakt\u0131r. \u00d6nceki direktiflerle ayr\u0131 ayr\u0131 belirlenmi\u015f olan \u2018t\u0131bbi cihazlar\u2019 ve \u2018v\u00fccuda yerle\u015ftirilebilir aktif t\u0131bbi cihazlar\u2019 i\u00e7in gerekli \u015fartlar\u0131n bir araya getirildi\u011fi bu t\u00fcz\u00fck, Avrupa\u2019da piyasaya arz edilecek bir t\u0131bbi cihaz\u0131n, CE i\u015faretini alabilmesi i\u00e7in ta\u015f\u0131mas\u0131 gereken \u015fartlar\u0131 belirleyen ve \u00f6nceki mevzuat\u0131 y\u00fcksek seviyede detayland\u0131ran bir mevzuatt\u0131r. \u201cT\u00fcz\u00fck\u201d mertebesinde yay\u0131nlanm\u0131\u015f olmas\u0131, bu mevzuata tabi her bir devletin; mevzuat \u015fartlar\u0131n\u0131 kendi i\u00e7 i\u015fleyi\u015fine uygulanma bi\u00e7imleriyle birlikte oldu\u011fu gibi adapte etmesini de zorunlu hale getirmektedir. Bu kitap, May\u0131s 2020 itibariyle y\u00fcr\u00fcrl\u00fckten kald\u0131r\u0131lacak olan t\u0131bbi cihaz mevzuat\u0131na ili\u015fkin k\u0131sa bilgiler vermekte ve (EU) 2017\/745 T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc\u2019n\u00fcn, yerini ald\u0131\u011f\u0131 mevzuattan farkl\u0131l\u0131klar\u0131n\u0131 bir \u00f6zet niteli\u011finde sunmaktad\u0131r. Ayn\u0131 zamanda b\u00f6yle b\u00fcy\u00fck bir de\u011fi\u015fikli\u011fe neden olan s\u00fcreci \u00f6zetlemekte ve yeni yasan\u0131n, \u00f6nceki mevzuattaki bo\u015fluklara yan\u0131t verebilme derecesine ili\u015fkin de\u011ferlendirmelerde bulunulmaktad\u0131r. T\u00fcrkiye\u2019de t\u0131bbi cihaz mevzuat\u0131na ili\u015fkin bas\u0131l\u0131 tek kaynak olma \u00f6zelli\u011findeki bu kitap, t\u0131bbi cihazlar\u0131n tasar\u0131m\u0131, imalat\u0131 ve sat\u0131\u015f\u0131n\u0131 yapan kurum ve kurulu\u015flar ve mevzuata uyumdan sorumlu \u00e7al\u0131\u015fanlar; ilerde bu alanda \u00e7al\u0131\u015fmak isteyen \u00f6\u011frenciler ve CE belgelendirme s\u00fcrecinde denetim ve dan\u0131\u015fmanl\u0131k gibi alanlarda rol alan ger\u00e7ek ve t\u00fczel ki\u015filer i\u00e7in bir ba\u015fvuru kayna\u011f\u0131 niteli\u011findedir. <\/p>\n","protected":false},"excerpt":{"rendered":"
(EU) 2017\/745 T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc, Nisan 2017\u2019de Avrupa Birli\u011fi Resmi Gazetesi\u2019nde yay\u0131nlanm\u0131\u015ft\u0131r ve \u00fc\u00e7 y\u0131ll\u0131k ge\u00e7i\u015f s\u00fcresi sonunda May\u0131s 2020\u2019de T\u00fcrkiye\u2019de Avrupa Birli\u011fi\u2019ne \u00fcye devletlerle ayn\u0131 [\u2026]<\/span><\/p>\n","protected":false},"featured_media":0,"template":"","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"product_brand":[],"product_cat":[15350,17602],"product_tag":[],"class_list":{"0":"post-719247","1":"product","2":"type-product","3":"status-publish","5":"product_cat-hukuk","6":"product_cat-hukuk-uzerine","7":"pa_cilt-ciltsiz","8":"pa_tur-kitap","9":"pa_yayinevi-gazi-kitabevi","10":"pa_yazar-esra-akdag-tatli","12":"first","13":"instock","14":"sale","15":"shipping-taxable","16":"purchasable","17":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/roveyayinevi.com.tr\/index.php\/wp-json\/wp\/v2\/product\/719247","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/roveyayinevi.com.tr\/index.php\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/roveyayinevi.com.tr\/index.php\/wp-json\/wp\/v2\/types\/product"}],"wp:attachment":[{"href":"https:\/\/roveyayinevi.com.tr\/index.php\/wp-json\/wp\/v2\/media?parent=719247"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/roveyayinevi.com.tr\/index.php\/wp-json\/wp\/v2\/product_brand?post=719247"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/roveyayinevi.com.tr\/index.php\/wp-json\/wp\/v2\/product_cat?post=719247"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/roveyayinevi.com.tr\/index.php\/wp-json\/wp\/v2\/product_tag?post=719247"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}