Safely Navigating The Transition From MDD To MDR For Co-Packaged Drug-Device Combination Products

Combination products are becoming increasingly vital in modern healthcare. Roughly a quarter of all medicines approved in the European Union (EU) include a medical device, highlighting their growing influence. This rise is due to advancements in drug delivery technologies, which have expanded device capabilities, and shifts in healthcare trends. For instance, the push for more self-care and home-based treatments relies heavily on easy-to-use administration methods combined with the necessary medicine.

However, combining a medical device and a medicinal product isn't as simple as it sounds. These interdisciplinary products introduce significant regulatory complexities. In the EU, the regulatory environment for combination products is distinct from the US system. It demands a deep understanding of two separate but intertwined frameworks.

Successfully bringing a combination product to the European market requires carefully navigating the complexities of both these regulations.