{"id":5235,"date":"2023-06-20T12:22:02","date_gmt":"2023-06-20T10:22:02","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/?post_type=product&p=5235"},"modified":"2025-12-19T10:05:19","modified_gmt":"2025-12-19T09:05:19","slug":"medical-device-regulatory-affairs","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/medical-device\/medical-device-regulatory-affairs\/","title":{"rendered":"Medical Device Regulatory Affairs"},"content":{"rendered":"

During the training course “Medical Device Regulatory Affairs”, key issues for those who want to operate or work in this field will be addressed in light of the changes introduced by the current Medical Devices Regulation (MDR 745\/2017). Based on the lecturer’s long experience in the field of medical devices, the new obligations of the various economic actors, the new UDI traceability system and the preparation of technical documentation based on the requirements of Reg. 745\/2017 will be examined.<\/p>\n

The Medical Device Regulatory Affairs training course will explain the current regulations and provide you with the tools you need to better manage the process of obtaining CE marking for a new medical device and for managing the entire regulatory life cycle of the medical device.<\/p>\n","protected":false},"excerpt":{"rendered":"

During the training course “Medical Device Regulatory Affairs”, key issues for those who want to operate or work in this field will be addressed in light of the changes introduced by the current Medical Devices Regulation (MDR 745\/2017).<\/p>\n","protected":false},"featured_media":5255,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_joinchat":[]},"product_brand":[],"product_cat":[105,98,117,96,106,118],"product_tag":[],"class_list":{"0":"post-5235","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-medical-device","7":"product_cat-affari-regolatori","8":"product_cat-corsi-di-formazione","9":"product_cat-dispositivi-medici","10":"product_cat-regulatory-affairs","11":"product_cat-trainings","12":"desktop-align-left","13":"tablet-align-left","14":"mobile-align-left","15":"ast-product-gallery-layout-horizontal-slider","16":"ast-product-gallery-with-no-image","17":"ast-magnify-disabled","18":"ast-product-single-variable","20":"first","21":"instock","22":"taxable","23":"shipping-taxable","24":"purchasable","25":"product-type-variable"},"acf":{"corso_new_label":false,"corso_promo_label":false,"corso_pdf_programma":"","corso_programma":"09:00 \u2013 13:00\u00a0 \u00a0COURSE SESSION - MODULE 1\r\n09:00 \u2013 13:00\u00a0 \u00a0COURSE SESSION - MODULE 2\r\n

Program<\/h5>\r\n
\r\n
\r\n
\r\n
\r\n
\r\n
\r\n\r\nMODULE 1\r\n
    \r\n \t
  • Regulatory framework: Directive 93\/42 vs. Regulation 745\/2017<\/li>\r\n \t
  • Main changes introduced by Reg. 745\/2017 and implementation timeline<\/li>\r\n \t
  • Medical devices: definitions and regulatory approach<\/li>\r\n \t
  • Roles and new responsibilities of economic operators<\/li>\r\n \t
  • The figure of the Person Responsible for compliance<\/li>\r\n \t
  • Classification of Medical Devices: updates introduced by Reg. 745\/2017<\/li>\r\n<\/ul>\r\nMODULE 2\r\n
      \r\n \t
    • EC conformity: notified bodies, EC certification, declaration of conformity<\/li>\r\n \t
    • The technical documentation: annexes II and III of Reg. 745\/2017<\/li>\r\n \t
    • The new UDI traceability system<\/li>\r\n \t
    • The medical device vigilance system<\/li>\r\n \t
    • The national database and the European database for Medical Devices (EUDAMED)<\/li>\r\n<\/ul>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>","corso_target":"

      Regulatory Affairs, Quality Assurance, management personnel, research and development managers, production managers, process managers, managers\/coordinators, complaint management and corrective and preventive actions, supervisory managers, marketing\/sales managers.<\/p>","corso_competenze":[{"corso_competenze_item":"Understand the main requirements on European medical device regulation and the changes brought about by MDR 745\/2017"},{"corso_competenze_item":"Provide the basic information for developing and drafting the technical documentation required to obtain CE marking for a new device"},{"corso_competenze_item":"Give you the tools to ensure regulatory compliance of your medical device throughout its journey"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/5235","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media\/5255"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=5235"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=5235"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=5235"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=5235"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}