{"id":5521,"date":"2021-07-23T23:13:13","date_gmt":"2021-07-23T23:13:13","guid":{"rendered":"https:\/\/neoemki.hu\/index.php\/qms-certification-en-iso-9001\/"},"modified":"2024-10-17T10:00:35","modified_gmt":"2024-10-17T10:00:35","slug":"qms-certification-en-iso-9001","status":"publish","type":"page","link":"https:\/\/neoemki.hu\/en\/our-services\/qms-certification-en-iso-9001\/","title":{"rendered":"certification (EU) 2017\/745 -MDR"},"content":{"rendered":"\n<h2 class=\"wp-block-heading has-accent-color has-text-color has-link-color wp-elements-7d278513024f47885e9c45d317bbd664\">ABOUT MDR<\/h2>\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading5521_d50894-60, .wp-block-kadence-advancedheading.kt-adv-heading5521_d50894-60[data-kb-block=\"kb-adv-heading5521_d50894-60\"]{max-width:1539px;font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading5521_d50894-60 mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading5521_d50894-60[data-kb-block=\"kb-adv-heading5521_d50894-60\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading5521_d50894-60 img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading5521_d50894-60[data-kb-block=\"kb-adv-heading5521_d50894-60\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h3 class=\"kt-adv-heading5521_d50894-60 wp-block-kadence-advancedheading has-contrast-2-color has-text-color\" data-kb-block=\"kb-adv-heading5521_d50894-60\">EU Regulation 2017\/745 on medical devices (MDR) entered into force at the end of May 2017 and applies from May 2021 after a transition period.<br><br>The new regulation replaced the Medical Devices Directive (MDD).<br><br>The purpose of the regulation is to significantly improve the quality, safety and reliability of medical devices and market surveillance mechanisms.<\/h3>\n\n\n\n<h2 class=\"wp-block-heading\">DESIGNATION<\/h2>\n\n\n\n<h3 class=\"wp-block-heading has-contrast-2-color has-text-color has-link-color wp-elements-398f8b6444b5d905988fa59a2fc35060\">NEOEMKI LLC. is a notified body (NB1011) registered in the NANDO database for conformity assessment of medical devices according to the MDR.<br><br>The area of \u200b designation (MDR codes and certification routes) is included in the <a href=\"https:\/\/webgate.ec.europa.eu\/single-market-compliance-space\/notified-bodies\/notifications\/1011203?organizationVersion=8\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-accent-color\">Notification details<\/mark><\/a>.<br><br>The designation is valid with the published and effective content in the NANDO database<strong>.<\/strong><\/h3>\n\n\n\n<h2 class=\"wp-block-heading\">CERTIFICATION PROCESS (flow diagram and process description)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading has-contrast-2-color has-text-color has-link-color wp-elements-a87e621769da371aeb2c81722c4c08a2\">This flow diagram helps our Clients in review the certifcation process.<\/h3>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"696\" height=\"901\" src=\"https:\/\/neoemki.hu\/wp-content\/uploads\/2024\/10\/flow-chart-EN.jpg\" alt=\"\" class=\"wp-image-5874\" srcset=\"https:\/\/neoemki.hu\/wp-content\/uploads\/2024\/10\/flow-chart-EN.jpg 696w, https:\/\/neoemki.hu\/wp-content\/uploads\/2024\/10\/flow-chart-EN-232x300.jpg 232w\" sizes=\"auto, (max-width: 696px) 100vw, 696px\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-contrast-2-color has-text-color has-link-color wp-elements-9f2027efd33eb206fc330a8a02bdb59c\">Detailed process description available here. <\/h3>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/neoemki.hu\/wp-content\/uploads\/2024\/10\/M7403-Ugyfeltajekoztato-k01v01-EN.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u25ba Read More<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>ABOUT MDR EU Regulation 2017\/745 on medical devices (MDR) entered into force at the end of May 2017 and applies from May 2021 after a transition period. The new regulation replaced the Medical Devices Directive (MDD). The purpose of the regulation is to significantly improve the quality, safety and reliability of medical devices and market surveillance mechanisms. DESIGNATION NEOEMKI LLC. is a notified body (NB1011) registered in the NANDO database for conformity assessment of medical devices according to the MDR. &#8230; <\/p>\n<p class=\"read-more-container\"><a title=\"certification (EU) 2017\/745 -MDR\" class=\"read-more button\" href=\"https:\/\/neoemki.hu\/en\/our-services\/qms-certification-en-iso-9001\/#more-5521\" aria-label=\"Read more about certification (EU) 2017\/745 -MDR\">B\u0151vebben<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"parent":5519,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5521","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/neoemki.hu\/en\/wp-json\/wp\/v2\/pages\/5521","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/neoemki.hu\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/neoemki.hu\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/neoemki.hu\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/neoemki.hu\/en\/wp-json\/wp\/v2\/comments?post=5521"}],"version-history":[{"count":10,"href":"https:\/\/neoemki.hu\/en\/wp-json\/wp\/v2\/pages\/5521\/revisions"}],"predecessor-version":[{"id":5876,"href":"https:\/\/neoemki.hu\/en\/wp-json\/wp\/v2\/pages\/5521\/revisions\/5876"}],"up":[{"embeddable":true,"href":"https:\/\/neoemki.hu\/en\/wp-json\/wp\/v2\/pages\/5519"}],"wp:attachment":[{"href":"https:\/\/neoemki.hu\/en\/wp-json\/wp\/v2\/media?parent=5521"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}