{"id":19244,"date":"2025-11-11T10:44:31","date_gmt":"2025-11-11T09:44:31","guid":{"rendered":"https:\/\/lsacademy.com\/?post_type=product&#038;p=19244"},"modified":"2026-09-23T15:44:52","modified_gmt":"2026-09-23T14:44:52","slug":"combination-products-under-the-eu-medical-devices-regulation-mdr-6","status":"publish","type":"product","link":"https:\/\/lsacademy.com\/en\/product\/combination-products-under-the-eu-medical-devices-regulation-mdr-6\/","title":{"rendered":"Combination Products under the EU Medical Devices Regulation (MDR)"},"content":{"rendered":"<h2>Combination Products under the EU Medical Devices Regulation (MDR)<\/h2>\n<p>The implementation of the EU Medical Devices Regulation (MDR) 2017\/745 has brought significant changes to the regulatory landscape, impacting both the pre-clinical and clinical components of medical device dossiers, the market approval process, and the roles of notified bodies in conformity assessment.<\/p>\n<p>As research and innovation progress, the range of device-drug and drug-device combination products is expanding. The MDR introduces a new approach for demonstrating compliance for integral device-drug combinations via Article 117.<\/p>\n<p>This training program provides participants with:<\/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>A clear understanding of the regulatory requirements for devices containing medicinal substances and devices provided in combination with medicinal products (DDCP)<\/li>\n<li>Practical insight into achieving compliance, including requirements for regulatory documentation and CE marking<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Combination Products under the EU Medical Devices Regulation (MDR) The implementation of the EU Medical Devices Regulation (MDR) 2017\/745 has brought significant changes to the regulatory landscape, impacting both the pre-clinical and clinical components of medical device dossiers, the market approval process, and the roles of notified bodies in conformity assessment. As research and innovation &hellip; <a href=\"https:\/\/lsacademy.com\/en\/product\/combination-products-under-the-eu-medical-devices-regulation-mdr-6\/\">Continued<\/a><\/p>\n","protected":false},"featured_media":3446,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-19244","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\/19244","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=19244"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_brand?post=19244"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_cat?post=19244"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_tag?post=19244"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}