It has been three years since Notified Body Opinions have been required for integral combination products in the European Union (EU) under the requirements of Article 117 of the EU Medical Device Regulations. In the intervening time, both industry and notified bodies have learned more about expectations of these submissions, however key elements also remain uncertain which places some combination products at approval risk due to lack of clarity on expectations. This session will provide an overview of Notified Body Opinions in EU, cover practical considerations and best practices in delivering the submissions, and explore some key areas of uncertainty such as post-approval substantial changes.