Understanding medical device and drug-device combination (DDC) product regulation is essential when integrating medical devices into pharmacovigilance (PV) portfolios. This article dives deeper into the reporting essentials and obligations associated with the post-marketing safety surveillance of these products both in the EU and U.S. markets. It discusses the current trends and challenges in the industry, offering insights into best practices and regulatory expectations, including how to navigate the complexities of safety surveillance and ensure compliance with international standards.

Global DDC

Trends DDCs are on the increase. The number of combined product submissions to the FDA increased from 317 in 2014 to 518 in 2019. The global combination product market continues to grow at a CAGR of 7%, with an estimated value of £139 billion by 2025. One of the biggest areas of growth is implants, which may have a software component to them, increasing their complexity.

With increasingly complex drug delivery systems, combined products become more common. This complexity impacts all parts of the product life cycle, from technical development to product quality and supply chain integrity. If we look specifically at the regulatory environment, identifying the most efficient regulatory pathway for complex product configuration depends on several factors, including its primary mode of action, regulatory precedents, and market experience with current products.

As awareness of product experience and risk increases, we are also gaining an understanding of the practical challenges we need to address. These include changes and inconsistencies in the classification of devices. This can be anything from software added to a device to products not described in the guidelines. Ambiguity regarding classification makes it necessary to seek clarification on how elements will be classified in the future.