As the European Union Medical Device Regulation (EU MDR) continues to shape global regulatory landscapes, Article 117 plays a crucial role in how drug-device combination products are assessed for market entry into the EU. For Indian pharmaceutical and medical device manufacturers looking to export to the EU, understanding Article 117 is vital. This article delves into the key requirements of MDR Article 117, which mandates that drug-device combinations containing a device component classified under Annex XVI must undergo a Notified Body opinion before receiving marketing authorization. We explore its implications for Indian exporters, regulatory challenges, and how to prepare the technical documentation, CE marking prerequisites, and collaborative submission strategies required for compliance. Whether you’re a regulatory affairs professional or a manufacturer, this article will help you navigate the complexities of MDR Article 117 and align your product strategy with European compliance expectations.