The industry continues to see a significant shift away from small molecule drugs toward more complex drug molecules, such as biologics. Simultaneously, there is a trend towards an increased use of medical device technologies specifically in the area of administration systems to reduce the burden on healthcare payers, providers and patients. Understanding the medical device design and how it forms integral and non-integral drug device combinations (DDC’s) is critical to navigate the new European regulatory landscape.

Examples of these expectations will be presented to outline the overall impact of Article 117 and additional elements of the MDR 2017/745 pertaining to combination drug products as regulated within the European community.