{"id":15918,"date":"2024-10-22T11:06:38","date_gmt":"2024-10-22T10:06:38","guid":{"rendered":"http:\/\/lsacademy.com\/?post_type=product&#038;p=15918"},"modified":"2025-09-25T15:34:52","modified_gmt":"2025-09-25T14:34:52","slug":"combination-products-under-the-eu-medical-devices-regulation-mdr-5","status":"publish","type":"product","link":"https:\/\/lsacademy.com\/en\/product\/combination-products-under-the-eu-medical-devices-regulation-mdr-5\/","title":{"rendered":"Combination Products under the EU Medical Devices Regulation (MDR)"},"content":{"rendered":"<p>Significant regulatory changes came along with the EU Medical Devices Regulation (MDR) 2017\/745 (MDR) and evolutions affecting pre-clinical and clinical modules of medical device dossiers, their market approval process and notified bodies involved in the conformity assessment.<\/p>\n<p>Also, due to research and innovation, the varieties of Device-Drug and Drug-Device Combination Products is growing and the MDR integrates a new process how to demonstrate compliance of integral device-drug combinations via Article 117.<\/p>\n<p>This training gives you:<\/p>\n<ul>\n<li>An overview of the requirements for combination products under the MDR.<\/li>\n<li>Guidance through the regulatory conformity pathways for combination products.<\/li>\n<li>Clear understanding of the regulatory requirements for devices containing medicinal substances, devices provided in combination with drug products, devices combining software and medicinal products, and devices associated with natural substances.<\/li>\n<li>Hands-on insight on how to achieve compliance and the requirements for regulatory documentation and CE marking.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Significant regulatory changes came along with the EU Medical Devices Regulation (MDR) 2017\/745 (MDR) and evolutions affecting pre-clinical and clinical modules of medical device dossiers, their market approval process and notified bodies involved in the conformity assessment. Also, due to research and innovation, the varieties of Device-Drug and Drug-Device Combination Products is growing and the &hellip; <a href=\"https:\/\/lsacademy.com\/en\/product\/combination-products-under-the-eu-medical-devices-regulation-mdr-5\/\">Continued<\/a><\/p>\n","protected":false},"featured_media":3446,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-15918","product","type-product","status-publish","has-post-thumbnail","course_topics-dispositivi-medici","course_topics-regolatorio","course_types-corso-online","productgroup-combination-products-under-the-eu-medical-devices-regulation","product_cat-corsi","first","instock","taxable","shipping-taxable","purchasable","product-type-variable"],"_links":{"self":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product\/15918","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media\/3446"}],"wp:attachment":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media?parent=15918"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_brand?post=15918"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_cat?post=15918"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_tag?post=15918"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}